Severe atopic dermatitis can have an enormous impact on a child and the child’s caregivers. Topical corticosteroids can be highly effective, but not all patients respond. If atopic dermatitis does not improve with a topical corticosteroid, poor adherence should be strongly considered as the cause of treatment failure. We report a child with horrendous atopic dermatitis whose disease resolved rapidly in the hospital when therapy was changed to a product that was easier to apply.

J Drugs Dermatol. 2016;15(1):114-115.

The repair and maintenance of the epidermal barrier is of the utmost importance in the treatment of atopic dermatitis (AD). While barrier creams and emollients are considered to be a foundation of AD therapy, there is little comparative data between various product options. This was a pilot study with a small sample size to investigate the use of skin barrier emulsion cream vs a commonly used moisturizing lotion to improve the epidermal barrier in subjects with atopic dermatitis.

J Drugs Dermatol. 2014;13(12):1482-1484.

Despite multiple therapeutic modalities, treatment of atopic dermatitis with its chronic, relapsing nature remains a challenge. Chronic use of standard therapies is associated with variable efficacy and potential side effects. Targeted therapeutic approaches using biologic agents may prove to be a novel alternative. We present a case of severe recalcitrant atopic dermatitis successfully treated with efalizumab.

Atopic dermatitis is increasing in prevalence throughout the developed world, in parallel with asthma and hay fever. The reasons for the increase remain unclear. As a practical question, it is valuable to understand which interventions might decrease risk for childhood atopic disease. Prospective studies among infants and children are challenging to design and to execute. Fortunately, several large studies from Europe and the United States are better characterizing whether behavioral interventions such as breastfeeding, delayed introduction of solid foods, hydrolyzed protein infant formulas, or pets in the home might be protective or impart increased risk of developing atopic dermatitis. As this body of literature grows, physicians will be able to recommend behavioral interventions that can prevent atopic dermatitis in individuals and ideally decrease prevalence over the population.

Background: Pimecrolimus cream 1% is approved for mild to moderate atopic dermatitis in children older than two years of age and adults. Tacrolimus ointment 0.03% is approved for moderate to severe atopic dermatitis in the patient population between two to seventeen years of age and Tacrolimus 0.1% ointment for moderate to severe atopic dermatitis in patients 18 years of age and older. However, beyond safety and efficacy, the delivery system or vehicle used in topical treatment formulations is equally important in affecting patient satisfaction, tolerability, and subsequent treatment compliance and hence clinical resolution of active disease.

J Drugs Dermatol. 2013;12(10):1145-1148.

Severe childhood atopic dermatitis refers to the presence of recurrent, widespread, eczematous dermatitis that significantly interferes with the daily activities and/or the quality of life of the affected child and family. The vast majority of children with severe, long-standing atopic dermatitis can be managed with the appropriate use of topical treatments, including long-term maintenance therapy and adjunctive treatments. In the recalcitrant patient, second line therapies such as narrowband ultraviolet light therapy and systemic immunosuppressants such as cyclosporine, azathioprine, mycophenolate moefetil, and methotrexate have been shown to be safe and effective in children with severe atopic dermatitis and can lead to sustained clinical improvement. To date, biologic therapy has not been uniformly effective in childhood atopic dermatitis. Management of severe childhood atopic dermatitis, including topical and adjunctive treatments and second-line therapies including systemic immunosuppressants will be reviewed here.

J Drugs Dermatol. 2012;11(10):1158-1165.

Type 2 helper T cell (Th2)-mediated inflammation plays a critical role in the pathogenesis of allergic asthma and atopic dermatitis (AD). Recent research focusing on the suppression of the Th2 axis with targeted inhibitors in atopic disease is showing promising early results. In particular, the simultaneous blockage of interleukin (IL)-4 and IL-13 has successfully mitigated symptoms of allergic asthma and AD in preliminary clinical trials. Given the current therapeutic challenges of treating these chronic and severe diseases, this review brings to light new data demonstrating that agents targeting IL-4 and IL-13 are relatively safe and effective medications in blocking the inflammatory cascade responsible for allergic asthma and atopic dermatitis.

J Drugs Dermatol. 2016;15(2):165-171.

Atopic dermatitis is a common skin disease characterized by eczematous eruptions and impaired skin barrier function. Patients, as well as their families, frequently report reductions in quality of life. Pruritus, lack of sleep, and impaired social functioning all contribute to this reduction. A skincare regimen of gentle cleansing and daily moisturization is integral to managing atopic dermatitis. While there are a multitude of reports supporting the use of moisturizers, there is a paucity regarding the use of cleansers, especially cleansers formulated with ingredients known to improve skin hydration. A clinical study was conducted to assess the tolerability and cosmetic acceptability of a body wash formulated with the filaggrin break-down products arginine and pyrrolidone carboxylic acid in subjects with atopic dermatitis-prone skin (Cetaphil® RestoraDerm® Body Wash). The results of this study indicate that Cetaphil RestoraDerm Body Wash was well tolerated, reduced itch, improved quality of life, and was well-liked by subjects with atopic dermatitis-prone skin.

J Drugs Dermatol. 2014;13(9):1108-1111.

Atopic Dermatitis (AD) is a chronic inflammatory skin disease that is a significant cause of morbidity, quality-of-life impairment and health-care costs. Although many patients can be treated satisfactorily with topical medications and phototherapy, a smaller subset requires more aggressive systemic therapies. Multiple studies have shown promise for the use of mycophenolate mofetil (MMF) to treat refractory AD. This report summarizes the evidence for use of MMF in the treatment of recalcitrant AD for both children and adults. Familiarity with these studies on the benefits and risks of MMF will enable the clinician and patient to select the most appropriate therapy.

J Drugs Dermatol. 2016;15(6):715-718.

Galderma's Novel OTC Formulations are a Game Changer for Atopic Dermatitis

The efficacy of Galderma’s Cetaphil® and Restoraderm® support the emerging and available data that epidermal barrier function and its repair are a crucial element in treating patients with atopic dermatitis and several other common dermatoses. The Galderma Restoraderm products are novel formulations that support the epidermal barrier by enhancing filaggrin expression, which restores natural moisturizing factors in the skin and helps to rebuild a healthy skin barrier. The Restoraderm products are over-the-counter, widely available, and competitively priced, making them accessible to a large majority of the patient population.

BACKGROUND: Atopic dermatitis (AD) is a chronic, relapsing, inflammatory skin disorder. One of the most disturbing symptoms of AD is pruritus. The first line treatment for AD is topical corticosteroids, topical immunomodulators, topical barrier creams, oral antihistamines, and systemic treatments. Desoximetasone 0.25% spray is a superpotent topical corticosteroid delivered in a novel way and it may be a suitable option for the treatment of pruritus in adult atopic dermatitis patients. STUDY DESIGN: A single-center, open labeled pilot study was conducted to investigate the efficacy and safety of desoximetasone 0.25% spray for pruritus in adult atopic dermatitis patients. RESULTS: Twice daily application of desoximetasone 0.25% spray to affected areas resulted in a significant reduction in all outcomes (IGA, pruritus, VAS assessment of pruritus) within 1 week of initiation of treatment. The reductions exhibited were sustained throughout the study period of 4 weeks. Significant improvements in quality of life, as measured by the DLQI, were observed. No adverse events were reported. CONCLUSION: Desoximetasone 0.25% spray is effective for treating pruritic symptoms of AD. Given its efficacy and convenience as a spray, desoximetasone 0.25% spray should continue to be evaluated as a treatment for AD in larger trials.

J Drugs Dermatol. 2017;16(9):919-922.

Atopic dermatitis (AD) is a chronic, prevalent, multi-factorial condition that affects infants, children, and adults. Beyond topical therapy, a variety of systemic agents such as steroids, methotrexate, cyclosporine, azathioprine, mycophenoloic acid, and other agents are utilized to treat moderate to severe AD. However, these agents are associated with potential long term adverse events and organ toxicity. There is an unmet need for a safer, long-term systemic agent to adequately control moderate to severe AD. The role of the Th2 cytokines, IL-4 and IL-13, in AD has led to the development of biologic agents to treat AD. The aim of this article is to review the role of IL-4 and IL-13 in the pathogenesis of AD and discuss some of the clinical trial data that target and inhibit IL-4 and IL-13 in positively altering the course and outcome of AD.

J Drugs Dermatol. 2016;15(8):925-929.

The purpose of this supplement is to provide both the biological basis and clinical impact of several targeted products aimed at specific physiologic and pathologic states including aging skin, diaper dermatitis, occupational irritant dermatitis, and atopic dermatitis.

Itch is a common and troubling symptom of atopic dermatitis. It is not mediated by histamine, and standard anti-itch therapies, therefore, have limited benefit for most AD patients. Instead, anti-inflammatory agents are used to reduce inflammation and therefore improve associated itch. Studies confirm that long-term use of corticosteroids can lead to a reduction in pruritus. A pilot study was designed to assess the effects of one week of twice-daily application of desonide hydrogel 0.05% for the treatment of atopic dermatitis. Active treatment was associated with significant improvements in IGA scores at day 3 and day 7 (mean score 0.55, 75.83% improvement from Baseline; P<.0001) and pruritus VAS scores at day 3 and day 7 (mean 6.35-point, 86.61% reduction in VAS scores; P<.0001). Treatment with the convenient, hydrating hydrogel formulation is effective and associated with an improvement in subjects’ quality of life.

J Drugs Dermatol. 2014;13(6):725-728.

Atopic dermatitis (AD), often called eczema, is a disease characterized by intense pruritus, erythema, dry skin, and inflammation. Pimecrolimus is a novel steroid-free treatment for AD. Consistently positive results have been found with pimecrolimus treatment in infants, children/adolescents, and adults. Its safety record is excellent, and studies have found no clinically relevant drug-related systemic adverse events. In this article, we first review atopic dermatitis and conventional treatment strategies. We then discuss various aspects of pimecrolimus, including pharmacologic properties, toxicology, short- and long-term studies, and safety and adverse events. Finally, we propose a new steroid-sparing treatment strategy for AD.

Atopic dermatitis and prurigo nodularis result from complex interactions between the skin, the immune system, and the external environment. The pruritus associated with these conditions greatly impacts patients’ quality of life and lacks uniformly effective treatment. A 57-year-old patient presented with severe atopic dermatitis and subsequent prurigo nodularis refractory to numerous standard therapies. The supplement isoquercetin was initiated and he noted significant, sustained reduction in his pruritus after only four weeks. Isoquercetin is a glycoside derivative with antihistamine properties of quercetin, a natural polyphenol flavonoid found in many plants. It may offer itch relief in patients who have failed more conventional therapies.

J Drugs Dermatol. 2017;16(11):1156-1158.

Atopic dermatitis has been characterized as an autoimmune or auto-allergic phenomenon in which environmental allergens resembling human proteins activate auto-reactive T-cells to release pro-inflammatory cytokines of the T-helper 2 (Th2) cytokine profile (IL-4, IL-5, IL-10, and IL-13)1-3. Infliximab is a chimeric IgG1 monoclonal antibody that blocks the effects of the inflammatory cytokine tumor necrosis factor (TNF)-?. Infliximab has been shown to benefit greatly patients suffering from diseases associated with a Th1 profile (IL-1, TNF-?, and IFN-?), such as psoriasis, Crohn’s disease and rheumatoid arthritis4-8. Some researchers have suggested that disrupting the Th1-Th2 balance by downregulating Th1 cytokines may result in manifestations of Th2 disease. Consistent with this hypothesis, we present the cases of three patients who exhibited vivid manifestations of atopic dermatitis after the inception of infliximab induction therapy.

Atopic dermatitis (AD) is a common chronic inflammatory skin disease caused by a combination of genetic susceptibility, epidermal barrier dysfunction and immune dysregulation. The intense pruritus associated with the disease causes an itch-scratch cycle that worsens symptoms and can cause significant discomfort for the patient. Recently, the focus of the atopic dermatitis treatment paradigm has shifted from targeting inflammation to the use of agents that normalize the skin barrier, which may reduce the current dependence on topical steroids and immunomodulators. A new barrier repair cream (EpiCeram® Skin Barrier Cream, Promius Pharma, Bridgewater, NJ) is a prescription topical agent indicated for the treatment of dry skin conditions and the relief of itching and burning associated with various dermatoses. This article describes the pathogenic rationale for using a barrier repair cream for the treatment of AD and discusses case report results focused on its clinical benefit for AD.

Colloidal oatmeal has been used for decades to soothe and ameliorate atopic dermatitis and other pruritic and/or xerotic dermatoses. In-vitro and/or in-vivo studies have confirmed the anti-inflammatory, barrier repair, and moisturizing properties of this compound. A broad set of studies has been conducted in recent years to assess the effects of colloidal oatmeal as adjunct treatment in the management of atopic dermatitis (AD). This paper will review these studies. In these investigations, patients in all age groups (3 months to 60 years) with mild to moderate atopic dermatitis were included and allowed to continue their prescribed topical medications. These studies found that the daily use of moisturizers and/or cleansers containing colloidal oatmeal significantly improved many clinical outcomes of atopic dermatitis from baseline: investigator's assessment (IGA), eczema area and severity index (EASI), itch, dryness, and quality of life indices. Safety results showed that the formulations were well tolerated in babies, children, and adults with AD.

J Drugs Dermatol. 2012;11(7):804-807.

Background. Moderate-to-severe atopic dermatitis can be difficult and costly to treat. The long-term health and economic outcomes of a new therapy, dupilumab, have yet to be evaluated. We aimed to identify the cost-effectiveness of dupilumab compared to usual care in moderate-to-severe atopic dermatitis. Methods. We compared dupilumab to usual care with emollients for adults with moderate-to-severe atopic dermatitis inadequately controlled with topical therapy, or for whom topical therapies were medically inadvisable. Subpopulations of moderate and severe patients were examined separately. We used a lifetime Markov model from a US payer perspective with health states categorized by the percent decrease in Eczema Area and Severity Index (EASI) score after a patient began an intervention: at least a 50% decrease (EASI 50), 75% decrease (EASI 75), 90% decrease (EASI 90), or no response. Results. The expected lifetime cost for patients treated with dupilumab was $509,600, including $267,800 in dupilumab drug costs and $241,800 in other healthcare costs. Average lifetime cost for usual care was $271,500. Dupilumab provided an additional 1.91 quality-adjusted life years (QALYs) over the remaining lifetime of a patient, leading to an incremental cost-effectiveness ratio (ICER) of $124,500. The ICER was lower for patients with severe atopic dermatitis ($95,800) than those with moderate atopic dermatitis ($160,000). Key drivers of the model were utility values for quality-of-life for non-responders, and the price of dupilumab. Conclusions. This study was limited by data for health outcomes and costs over long time periods, particularly stratified by severity. We estimated that dupilumab improved health outcomes compared to usual care but with additional costs, with an ICER below commonly cited thresholds for cost-effectiveness. Dupilumab was projected to be more cost-effective in patients with severe atopic dermatitis, but even in patients with moderate atopic dermatitis, the ICER remained below the upper range of commonly cited thresholds. J Drugs Dermatol. 2018;17(7):750-756.

Skin microbiome studies have elucidated clinically pertinent information regarding its potential role in the pathogenesis of certain inflammatory skin disorders. Two of the most commonly diagnosed chronic inflammatory skin disorders that have been connected to perturbation of the skin microbiome are psoriasis (PS) and atopic dermatitis (AD). The objective of this brief review is to recapitulate some of the novel findings concerning the microbiome’s role in AD and PS.

J Drugs Dermatol. 2015;14(2):127-130.

BACKGROUND: Atopic dermatitis (AD) is primarily treated with topical therapies, systemic immunosuppressants, or adjunctive therapies. OBJECTIVE: As novel treatment approaches for AD emerge, we characterize AD treatment and examine trends in treatment over time. METHODS: Visits for AD were identified in the 2003-2012 National Ambulatory Medical Care Survey (NAMCS). We identified topical corticosteroids (TCS), antibiotics (Abx), antihistamines (AH), topical calcineurin inhibitors (TCI), and systemic immunosuppressants (SI) prescribed at AD visits. RESULTS: There were 990,000 annual visits for AD from 2003-2012 (3.2 visits/1000 people/year). TCS were the most frequently used medication (59% of visits). Topical calcineurin inhibitors (TCI) were the second most prescribed medication for AD among dermatologists (23% of visits), while antihistamines were second among all other physicians (16-44% of visits). Unlike other medications, use of TCIs decreased over time. LIMITATIONS: The NAMCS does not follow individual patients over time. CONCLUSIONS: TCI use has been decreasing. New topical AD treatments may provide an alternative to TCS, better treatment outcomes for moderate-to-severe atopic dermatitis, and an alternative to systemic antihistamines whose efficacy in AD is unproven and whose general use in AD management is discouraged by the American Academy of Dermatology. J Drugs Dermatol. 2018;17(2):135-140.

BACKGROUND: Leflunomide (LEF) is an immune modulator used most commonly for rheumatoid arthritis (RA). The mechanisms of action of LEF also include anti-microbial effects, particularly anti-viral effects.
OBSERVATIONS: We present three patients with atopic dermatitis on azathioprine therapy who had multiple verrucae and in two molluscum contagiosum (MC) that were resistant to repeated conventional therapies. These patients were switched to LEF, and all the patients showed complete resolution of their verrucae and MC within 2 months of starting therapy. In addition, all three patients showed equivalent to better control of their atopic dermatitis with LEF.
CONCLUSIONS: LEF has previously been reported to be a useful immune modulator for the treatment of severe atopic dermatitis. The spectrum of anti-viral effects previously seen with leflunomide did appear beneficial in these patients in clearing verrucae and MC, which had been resistant to conventional therapies while the patients were on azathioprine.

J Drugs Dermatol. 2015;14(3):230-234.

Background: Patients with atopic dermatitis (AD) are known to have a predisposition to colonization or infection by microbial organisms, including both Staphylococcus aureus and herpes simplex virus (HSV). S aureus infection leads to exacerbation of eczema and may induce flares in atopic skin by mediating inflammation. Retapamulin 1% ointment is a unique topical antibiotic formulation that may be a suitable option for the treatment of clinically infected AD.
Study Design: A single-center, open-label pilot study was conducted to investigate the efficacy and safety of retapamulin 1% (Altabax, Stiefel/ GlaxoSmithKline) ointment for the treatment of secondarily infected atopic dermatitis in subjects aged 9 months to 98 years old (n=29).
Results: Twice-daily application of retapamulin 1% produced a mean 8.1-point reduction from baseline in the mean Skin Infection Rating Scale score. The majority of subjects achieved clinical cure with topical retapamulin therapy. Retapamulin 1% ointment was effective against S aureus isolates, including methicillin-resistant Staphylococcus aureus (MRSA). Treatment was well tolerated.
Conclusion: Retapamulin 1% is effective for the treatment of atopic dermatitis infected with S aureus, and demonstrates efficacy against both methicillin-susceptible and methicillin-resistant strains. Given its efficacy and good tolerability in this pilot study, retapamulin 1% ointment should be further evaluated as a treatment for infected atopic dermatitis. It may provide convenience and efficacy with a low risk for development of bacterial resistance.

J Drugs Dermatol. 2012;11(7):858-860.

Clinicians treating corticosteroid-responsive dermatoses, such as eczema and atopic dermatitis, contact dermatitis, seborrheic dermatitis, and psoriasis, have numerous treatment options. The decision to choose a topical corticosteroid depends on several different factors, such as potency, formulation, dosage, cosmetic elegance, cost, etc. Among these, Promius Pharma's Cloderm (clocortolone pivalate cream 0.1%) was introduced into the market more than 3 decades ago, and it remains a versatile treatment option for dermatoses. Phase 3 clinical trial data have demonstrated the efficacy and tolerability of Cloderm in several steroid responsive dermatoses. In studies for eczema and atopic dermatitis, statistically significant improvement relative to placebo was seen at day 4 with Cloderm. In psoriasis trials, Cloderm cream demonstrated superiority to placebo by day 7, continuing at days 14, 21, and 28. Thus, Cloderm's early onset of action will contribute to increased compliance for patients.

Background: Patients with atopic dermatitis (AD) may have poor adherence for several reasons, including fear of side effects or dislike of messy topical therapies.

Purpose: To assess adherence to and efficacy of a multifaceted program for atopic dermatitis using a lightweight, easy-to-apply medication and more frequent return visits.

Methods: Forty-one subjects with mild-to-moderate atopic dermatitis were instructed to use desonide hydrogel 0.05% twice daily. Disease severity was measured at baseline and weeks 1, 2 and 4. Subjects also received a follow-up phone call on day 3. Adherence was assessed using electronic monitors. At the end of the study, subjects sampled and rated the vehicle attributes of six different topical corticosteroid formulations.

Results: Mean adherence to twice-daily application slowly declined over time, from 81% on day 1 to 50% by day 27. An improvement in pruritus was observed as early as day 3, and by week 4, mean pruritus and EASI scores improved from baseline by 60% and 61%, respectively. Mean SGA scores also improved to marked improvement/almost clear by week 4. In vehicle attribute surveys, the hydrogel was consistently rated higher than the other vehicles in all categories.

Conclusion: Subjects responded very well to treatment, and adherence to desonide hydrogel 0.05% was much better than previously reported with ointments. The early efficacy, favorable attributes of the hydrogel vehicle and judicious follow up likely increased adherence to topical therapy. The use of ointments or more potent topical steroids as a first choice may be counterproductive in the treatment of atopic dermatitis.

Background: MAS063DP cream has received marketing authorization in the US and the European Union for symptom relief of atopic dermatitis (eczema) and contact dermatitis.

Design: A multicenter, randomized, vehicle-controlled, phase IV study was completed in the US.

Methods: 218 patients aged 18 to 84 years joined this 50-day study. Patients self-administered MAS063DP cream (N=145) or vehicle cream (N=73) 3 times per day to affected areas and those areas prone to be affected. The primary endpoint for efficacy was the change in EASI at Day 22 of treatment, comparing the 2 treatment groups. Secondary outcomes included EASI scores at other time points, IGA, pruritus (100mm VAS), % BSA, and the need for rescue medication.

Results: MAS063DP was statistically (p<.0001) more effective than vehicle in all outcomes at all time points. The incidence of rash was 2.1% in the MAS063DP group versus 5.5% in the vehicle group. Only 2 patients discontinued MAS063DP due to an adverse event.

Conclusion: MAS063DP cream was confirmed to be a safe and effective treatment for mild to moderate atopic dermatitis in adults.

Atopic dermatitis (AD) is a chronic inflammatory disease that is mediated by cytokines. In patients with AD, the use of tumor necrosis factor (TNF) antagonists has had unpredictable results. Clinically significant improvements in skin symptoms of AD were observed in two patients with severe, chronic disease who were treated with the soluble TNF receptor etanercept. These observations suggest that etanercept therapy may be beneficial in patients with AD, particularly chronic variants with lichenification. Studies to identify features of AD that may predict responsiveness to etanercept therapy in these patients are warranted.

OBJECTIVE: To describe a case in which a patient developed Candida esophagitis (CE) after treatment of atopic dermatitis (AD) with mycophenolate mofetil (MMF) for 22 months. CASE SUMMARY: A 59-year-old Caucasian female with long-standing history of AD successfully treated with MMF presented to the dermatology clinic for follow-up appointment with 3 months’ history of projectile vomiting, choking, and trouble swallowing. Patient underwent esophagogastroduodenoscopy (EGD) that demonstrated whitish plaques in esophagus consistent with CE, which was confirmed by biopsy and cytology. DISCUSSION AND CONCLUSION: MMF is a lymphocyte selective immunosuppressive agent that has demonstrated very good therapeutic effects against cutaneous inflammatory skin disease and proved to have good efficacy and bioavailability. Generally, MMF is a safe medication with relatively low side effects. There are no case reports to date that describe CE in patients treated with MMF. Clinicians should be aware of this rare complication to enable timely intervention and treatment.

J Drugs Dermatol. 2016;15(10):1267-1269.

Corticosteroids are the mainstay of therapy for atopic dermatitis, but long-term use is associated with adverse effects. We sought to evaluate the clinical efficacy of two steroid-sparing creams for atopic dermatitis. Twenty patients were enrolled in an investigatorblinded, bilateral comparison study. Patients applied pimecrolimus cream twice daily to a target lesion on one side of the body and also applied a topical medical device cream three times daily on a symmetrical target lesion on the opposite side of the body for four weeks. Clinical assessments including Physician Global Assessment (PGA), Target Lesion Symptom Score (TLSS), subject selfassessment and digital photography were performed at the baseline, 2 week, and 4 week visits. Seventy-five percent of patients (pimecrolimus, 15 of 20; topical medical device, 15 of 20) were rated "clear" (0) or "almost clear" (1) by PGA for both medications after four weeks. Percent improvement of the PGA from randomization for pimecrolimus cream and the topical medical device cream were 72.50 and 71.67 respectively (P=0.9283). PGA scores decreased significantly from baseline for both treatments (P=0.004). Overall, there was no statistically significant difference between treatment groups for PGA scores throughout the study (P=0.8236). No cutaneous side effects were noted. Our study was limited by a small sample size and lack of double-blinding; however, both treatments were found to be safe and effective in treating atopic dermatitis over four weeks. Significant improvements were noted for all efficacy variables. In conclusion, a lipid-rich, non-steroidal, topical medical device cream was as effective in improving atopic dermatitis as pimecrolimus cream.

J Drugs Dermatol. 2011;10(7):735-743.

The objective of this study was to compare the effi cacy and safety of tacrolimus ointment and pimecrolimus cream in adults with moderate atopic dermatitis (AD). A randomized, investigator-blinded, 6-week, multicenter study enrolled patients (≥16 years) with mild to very severe AD. Patients with moderate AD at baseline were analyzed. At study completion, tacrolimus ointment-treated patients had signifi cantly greater improvement in Eczema Area Severity Index score compared with pimecrolimus cream-treated pa- tients (59% versus. 43% reduction, respectively; P=.01). Signifi cantly more tacrolimus ointment-treated patients than pimecrolimus cream-treated patients improved by 1 or more grades on the Investigators’ Global Atopic Dermatitis Assessment (P<.02). A total of 5 pimecrolimus cream-treated patients discontinued the study early due to lack of effi cacy compared with no tacrolimus ointment- treated patients (P=.02). Overall, reported adverse events occurred at a similar frequency for both treatment groups. Tacrolimus ointment is more effective than pimecrolimus cream in the management of adults with moderate AD.

Low to mid potency corticosteroids remain a cornerstone of therapy for atopic dermatitis (AD). Since AD is most prevalent in the younger pediatric population and is chronic in nature, safety is of particular concern especially for children under 2 years of age. A novel desonide (0.05%) formulation was developed in a nonirritating and moisturizing aqueous gel (hydrogel) that is free of alcohol and surfactants. The safety and efficacy of this new class VI low potency topical steroid was substantiated in 2 phase III clinical trials in mild to moderate AD subjects aged 3 months to 18 years (mean age 6.7 years and 30% under 3 years). A total of 425 subjects were treated with desonide hydrogel and 157 subjects with the hydrogel vehicle. Desonide hydrogel 0.05% was extremely well-tolerated and provided statistically significant improvements in all primary (P<.001) and secondary (P?.006) efficacy endpoints in both studies. This novel desonide formulation represents an advancement in the treatment of AD.

Dupilumab (Dupixent, Regeneron Pharmaceuticals and Sanofi Genzyme) is a novel biologic medication recently approved by the FDA for the treatment of moderate-to-severe atopic dermatitis in adults who have not achieved adequate control with topical medications. Dyshidrotic eczema is a distinct entity, often considered on the spectrum of atopic dermatitis, that primarily effects the palms and soles; it is often associated with considerable morbidity yet is frequently challenging to treat. We report two cases of recalcitrant dyshidrotic eczema treated successfully with dupilumab at standard dosing. Further studies to establish the efficacy of dupilumab in the treatment of dyshidrosis are warranted.

J Drugs Dermatol. 2018;17(3):355-356.

Two over-the-counter products have been clinically tested for efficacy and tolerability in the treatment of atopic dermatitis. Study 1 evaluated a daily maintenance Body Cream (Eucerin Eczema Relief Body Crème) applied twice daily for 14 days, followed by treatment withdrawal for 5 days (regression period) in subjects with a history of atopic dermatitis. Study 2 evaluated an acute treatment (Eucerin Eczema Relief Instant Therapy [Instant Therapy]) for active atopic dermatitis lesions administered for 14 days. Skin barrier function, hydration, tolerability, and relief of symptoms were assessed at baseline, day 7, and day 14. Study 2 also measured itch relief and treatment impact on work, social activities, and sleep. Body Cream significantly improved skin hydration and barrier function (P<.001) at 14 days, with improvements persisting through the 5-day regression phase. Itching was significantly improved in 93.8% of subjects (P<.001). Instant Therapy treatment of atopic dermatitis lesions significantly improved skin hydration and barrier function, as well as symptoms of erythema, pruritus, excoriation, and lichenification, with rapid improvement of itch reported within minutes of the first treatment application. Instant Therapy significantly reduced itch intensity and frequency, and demonstrated beneficial improvements in subjects’ quality of life. Body Cream and Instant Therapy were both safe and well tolerated.

J Drugs Dermatol. 2014;13(5):589-595.

Atopic dermatitis (AD) increases health care utilization, affects patient quality of life, places a burden on caregivers, decreases patient/parent productivity, and adds to health care costs. Few studies have examined the effect of specific treatment modalities across a variety of AD-related outcomes. This prospective, multicenter, open-label longitudinal study of adult and pediatric patients with moderate to severe AD was conducted to evaluate the effect of a specific therapeutic intervention on AD-related outcomes over a period of 6 months. Surveys collected physician clinical assessments and patient- and caregiverreported data across the following domains: clinical outcome, health care utilization/costs, quality of life, physical appearance, productivity/absenteeism, and medication compliance. This study is intended to help guide future research efforts on the net costs and benefits of different interventions across a diverse set of domains and in larger populations.

BACKGROUND: Early follow-up visits improve patient adherence, but the actual scheduling behavior of physicians is not known.
PURPOSE: To characterize the timing of first follow-up visits in US dermatologic practice.
Methods: Patients with a diagnosis of psoriasis, acne, or atopic dermatitis were identified in the 2003-2007 MarketScan Medicaid database. Factors affecting the length of time before first follow-up were assessed using a Cox proportional hazards model.
RESULTS: Mean length of time to the first follow-up visit was 153 days for adults and 142 days for children with psoriasis; 151 days for adults and 218 days for children with acne; and 161 days for adults and 209 days for children with atopic dermatitis. Black and those other than white patients were less likely than whites to receive early follow-up in psoriasis and acne, but more likely in atopic dermatitis. Dermatologists were more likely to schedule early follow-up visits than nondermatologists.
LIMITATIONS: The database includes only Medicaid patients. The rate of non-attendance at scheduled visits could not be determined.
CONCLUSIONS: Most physicians are missing the opportunity to maximize patient adherence by scheduling early follow-up visits. Contact by email or phone may be beneficial for physicians who cannot schedule early follow-up.

J Drugs Dermatol. 2014;13(7):833-836.

No abstract details for the moment.

Atopic dermatitis (AD) is well-recognized as a very common chronic and relapsing pruritic skin disorder affecting both children and adults worldwide. The adverse effects on the quality of life of affected individuals and their families is well-established. The pathophysiology of AD is complex, leading to interindividual variations in clinical presentation and severity. The chronicity of AD, characterized by periods of exacerbation and remission, supports a strong need to develop measures that can effectively and safely prolong remissions between flares of the disease. This article provides an overview of AD including prevalence, severity, and disease course/progression, succinct summaries of pathophysiology and medical management, and discussion of epidermal barrier dysfunction and skin microbiome shifting associated with AD. Additional emphasis is placed on adjunctive topical skin barrier approaches that may prolong disease-free remissions. Results from a panel of dermatologists queried about adjunctive approaches to AD, using a modified-Delphi approach, are also discussed. J Drugs Dermatol. 2018;17(10):1070-1076.

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Colloidal oatmeal suspensions are currently available in bath soaps, shampoos, shaving gels, and moisturizing creams, and several studies have been conducted that demonstrate the efficacy and safety of colloidal oatmeal for the treatment of inflammatory skin conditions. The diverse chemical polymorphism of oats translates into numerous clinical utilities for atopic dermatitis (AD) and eczema. Avenanthramides are the principle polyphenolic antioxidants in oats, and they have been shown to assuage inflammation in murine models of contact hypersensitivity and neurogenic inflammation and also reduce pruritogen-induced scratching in a murine itch model. Moreover, avenanthramides are a potent antioxidant. This paper will discuss various studies that have found colloidal oatmeal compounds to be beneficial in the treatment of AD and also as adjunctive treatments for AD.

J Drugs Dermatol. 2014;13(10):1180-1183.

Atopiclair® (Zarzenda®) is a topical non-steroidal anti-inflammatory agent for the treatment of allergic diseases of the skin. Three main ingredients are contained in this product: glycyrrhetinic acid, telmesteine and Vitis vinifera extracts. Other ingredients include: allantoin, α−bisabolol, capryloyl glycine, hyaluronic acid, shea butter and tocopheryl acetate. Two previous randomized, double-blind, vehicle-controlled clinical studies provided evidence that Atopiclair is effective in the treatment of atopic dermatitis. This article presents an open, multicenter, sponsor-free, study on the anti-pruritic activity of this product in adult patients with mild-to-moderate atopic dermatitis. The Median Visual Analogue Scale (VAS) values were: at the start of the study (T0), median VAS was 48.5 mm; three weeks later (T1), median VAS was 34.1 mm (-14.4 mm from baseline); six weeks later (T2), median VAS was 24.6 mm (-23.9 mm from baseline). Statistical analysis revealed that differences between T0 versus T1, T0 versus T2 and T1 versus T2 were highly significant (p<0.001). Side effects (local burning) were relatively common, although mild in severity. On the basis of the results of this study, Atopiclair showed efficacy in relief of pruritus in adult patients with mild-to-moderate atopic dermatitis.

Objective: To characterize the pharmacokinetics of tacrolimus after topical application in adult and pediatric patients with moderate to severe atopic dermatitis from all clinical trials in which tacrolimus blood levels were obtained.

Methods: Tacrolimus ointment 0.03% or 0.1% was applied twice daily. In the adult and pediatric pharmacokinetic studies, serial blood samples were obtained after single and repeated topical application. During the 12 clinical efficacy trials of tacrolimus ointment, single blood samples were obtained at various times relative to tacrolimus ointment application.

Results: In the pharmacokinetic studies, 89% to 95% of tacrolimus whole blood concentration samples were less than 1 ng/mL; mean maximum concentrations ranged from 0.2 to 1.6 ng/mL and mean area under the blood concentrationtime curves (0-12 hours) ranged from 1.4 to 13.1 ng·hr/mL. Likewise, in the clinical efficacy trials, the majority (85%- 99%) of tacrolimus concentration samples were less than 1 ng/mL.

Conclusions: Tacrolimus ointment is associated with minimal systemic absorption and no evidence of systemic accumulation in patients with moderate to severe atopic dermatitis and extensive disease.

INTRODUCTION: Atopic dermatitis (AD) is a chronic skin condition associated with decreased barrier function resulting in periodic flare-ups of erythematous and pruritic lesions. Guidelines recommend daily treatment of atopic skin with emollient moisturizers for prevention of flares and maintenance of the flare-free state. This study evaluated the efficacy of 2 steroid-free, nonprescription eczema skin care formulations for reducing the risk of flare and relieving symptoms in infants and children with AD: Body Cream for the daily maintenance treatment of atopic skin and Flare Treatment for the treatment of atopic flares.
METHODS: After a 2-week washout period, subjects (N=45; mean age 3.5 years) were randomized to cleanser plus daily moisturizing with Body Cream (moisturizer group) or cleanser only (control group) for 6 months or until flare. Subjects experiencing flare received Flare Treatment for 4 weeks.
RESULTS: The incidence of flare was significantly lower in the moisturizer group compared with the control group (21% vs 65%; P=.006), while the median time to flare was shorter in the control group (28 vs >180 days). Risk of flare was reduced by 44.1% after 6 months of Body Cream application. Flare Treatment reduced overall eczema symptom severity at week 2 and week 4; 78.9% of flares had improved or cleared at week 4.
CONCLUSIONS: Body Cream reduced the incidence of flare and the time to flare, reinforcing guidelines that daily emollient therapy should be an integral part of the maintenance treatment plan for the prevention of disease flares. Body Cream and Flare Treatment are effective over-the-counter steroid-free options for management of AD in children.

J Drugs Dermatol. 2015;14(5):478-485.

Introduction: Atopic dermatitis (AD) affects both adult and pediatric patients, and multiple practitioners encounter and manage AD. However, differences with regard to the treatment of AD between specialties are not well characterized. Objective: The primary objective of this study was to determine if there is a difference between dermatologists and non-dermatology specialties with regard to treatment strategies for AD and to describe those differences. Methods: Data from the 1993-2010 National Ambulatory Medical Care (NAMCS) and National Hospital Ambulatory Care (NHAMCS) Surveys were used to characterize outpatient visits made for AD. Differences in demographic, geographic and seasonal characteristics were obtained and compared. Additionally, the frequency of medications prescribed at dermatologist visits were compared to other specialties. Primary Outcome Measures: Frequency of modalities used in the treatment of atopic dermatitis between dermatologists and non-dermatology specialties. Results: An estimated 3.7 million visits for AD were made to outpatient offices and hospital departments from 1993 to 2010. The rates per capita of visits for atopic dermatitis were similar when evaluated by gender and season. However, Caucasians were almost 50% less likely than African Americans or individuals of other minority races to have visits for AD. Topical corticosteroids (TCS) were mentioned at 52% of visits, and dermatologists were more likely than non-dermatologists to prescribe TCS, emollients, and topical calcineurin inhibitors. Conclusions: Dermatologists were more likely to recommend TCS, emollients, and topical calciuneurin inhibitors for the treatment of AD. Dermatologists were also more likely to prescribe higher potency TCS in comparison to non-dermatology specialties, and these differences may ultimately affect patient care. As a result, there remains a disparity between dermatologists and non-dermatology specialties with regard to evidence-based approaches to the treatment of AD.

J Drugs Dermatol. 2017;16(3):250-255.

BACKGROUND: Though topical corticosteroids (TC) are used for treating atopic dermatitis (AD) as a standard, there exist several problems including topical steroid addiction (TSA) or Red skin syndrome. Moreover, the number of patients, who refrain from using TC because of steroid-phobia, is increasing. Recently, topical PPAR alpha ligand application has been reported to improve experimental allergic dermatitis. The purpose of this study was to investigate the short-term efficacy and safety of topical clofibrate, one of PPAR alpha ligand, in such steroid-phobic patients with AD.
METHODS: This study was conducted as a double-blind design to investigate the effects of random administration of topical clofibrate and base (placebo) on skin manifestation and blood parameters of patients for 2 weeks. Severity was digitized using severity scoring systems for atopic dermatitis by the Japanese Dermatological Association (SSS-JDA) before and after two weeks. Subjective severity of patients was evaluated using visual analog scale (Pt-VAS). Serum thymus and activation-regulated chemokine (TARC) and immunoglobulin E (IgE) were also investigated.
RESULTS: Twenty patients were enrolled, and 19 of 20 patients completed the study. In 19 patients, the value of severity score using SSS-JDA was decreased significantly after administration of topical clofibrate (P=0.001). Subjective evaluation using Pt-VAS (P=0.008) and serum TARC levels (P=0.03) were also significantly decreased after two weeks of topical clofibrate. There was not a significant difference in serum IgE levels. No adverse effect was observed.
CONCLUSIONS: Topical clofibrate is useful for patients with AD especially who are reluctant to use topical steroids.

J Drugs Dermatol. 2014;13(3):259-263.

Objectives: The authors assessed the efficacy of a ceramide-dominant, triple-lipid barrier repair formulation (EpiCeram®), which designed to correct the lipid-biochemical abnormalities in atopic dermatitis (AD) in comparison to fluticasone propionate cream.

Methods: In a five-center, investigator-blinded, randomized trial, EpiCeram was compared to fluticasone (Cutivate®) cream in 121 patients with moderate-to-severe AD. Primary outcome measures were: 1) reduction in disease severity, assessed as SCORAD (Severity Scoring for Atopic Dermatitis) scores; 2) improvement in pruritus; and 3) improvements in sleep habits.

Results: EpiCeram reduced clinical disease severity, decreased pruritus and improved sleep habits both 14 and 28 days after initiation of therapy. Although the fluticasone-treated group showed significantly greater improvement at 14 days, SCORAD, pruritus and sleep habit scores for EpiCeram did not differ significantly from the fluticasone-treated group by 28 days.

Conclusion: The ceramide-dominant, physiological-lipid based formulation could represent an effective stand-alone or ancillary therapy for many pediatric patients with AD.

Over the last half century, and especially over the last 15 years, understanding of the structure and function of the stratum corneum has evolved tremendously. Once conceptualized as an inactive film formed by lifeless, disintegrating keratinocytes, the stratum corneum is now recognized as a viable, functional structure that plays an important role in maintaining skin health and possibly mediating cutaneous diseases. Researchers and clinicians have also come to realize that the barrier functions not only to prevent the entry of exogenous factors, such as irritants or allergens, but that it also can mediate disease. We had already realized that dysfunction of the barrier may itself directly contribute to the pathogenesis of skin diseases, notably atopic dermatitis. More specifically, evidence shows that epidermal barrier dysfunction is likely to be a precursor of cutaneous inflammation.1,2

J Drugs Dermatol. 2013;12(9):1024-1027.

No abstract details for the moment.

Dysfunction of the epidermal barrier is generally considered a precursor of cutaneous inflammation that can directly contribute to the pathogenesis of skin diseases, notably atopic dermatitis (AD). We also know that topical corticosteroids may actually impair the epidermal barrier by interfering with epidermal lipid synthesis. Therefore, it is important to utilize topical corticosteroids in vehicles that will help at least to enhance the already disrupted epidermal barrier in atopic dermatitis patients. Two studies of identical design were conducted to determine and compare the occlusivity and moisturizing potential of three topical corticosteroid products when applied to skin whose barrier integrity has been disrupted by dry shaving. Findings in both studies showed the clocortolone pivalate cream decreased TEWL better than non-treatment or treatment with hydrocortisone butyrate lotion. Skin surface hydration increased significantly (P<0.001) in all three treated sites, compared to the non-treated damaged control and non-treated normal skin. Clocortolone pivalate cream increased skin surface hydration significantly (P<0.001) better than hydrocortisone butyrate lipocream or hydrocortisone butyrate lotion. These studies showed that clocortolone pivalate cream enhances barrier function by providing occlusion. While understanding of the structure and function of the stratum corneum (SC) and epidermal barrier function has evolved tremendously over the last several decades, and especially over the last 15 years,1 confusion and misinformation still persist. Dysfunction of the epidermal barrier is generally considered a precursor of cutaneous inflammation that can directly contribute to the pathogenesis of skin diseases, notably atopic dermatitis (AD).2,3 Topical steroids are standard of care in treatment of atopic dermatitis. However, we also know that topical corticosteroids may actually impair epidermal barrier by interfering with epidermal lipid synthesis.4,5 In addition to that, various penetration enhancers in the topical steroid formulations also contribute to the impairment of the epidermal barrier.4 Therefore, it is important to utilize topical corticosteroids in vehicles that will help at least to enhance the already disrupted epidermal barrier in atopic dermatitis patients. In this regard, these studies were designed to determine the hydrating effects of clocortolone pivalate cream 0.1% (Cloderm Cream, Promius Pharma).

J Drugs Dermatol. 2014;13(5):582-585.

BACKGROUND: A novel approach for treating atopic dermatitis (AD) is the inhibition of phosphodiesterase 4 (PDE4), an enzyme involved in the proinflammatory cascade. Crisaborole topical ointment, 2% is a novel, boron-based small-molecule PDE4 inhibitor with anti-inflammatory properties. The objective of this proof-of-concept study was to assess the efficacy and safety of crisaborole topical ointment, 2% in adults with mild to moderate AD.
METHODS: This phase 2a, randomized, double-blind, bilateral, 6-week study of crisaborole topical ointment, 2% was conducted in adult patients with mild to moderate AD with 2 comparable target AD lesions. Patients were randomly assigned to twice-daily application of crisaborole topical ointment, 2% or vehicle, each to 1 of the 2 target lesions. The primary efficacy endpoint was change from baseline in Atopic Dermatitis Severity Index (ADSI) score at day 28. Safety assessments included local tolerability and incidence of adverse events (AEs).
RESULTS: A total of 25 enrolled patients received study medication. At day 28, 17 patients (68%) experienced a greater decrease in ADSI score in the active-treated lesion than in the vehicle-treated lesion; 5 patients (20%) had a greater decrease in ADSI score in the vehicle-treated lesion than in the active-treated lesion. Local application-site reactions were reported in 3 patients (12%). A total of 29 AEs were reported in 11 patients; most (90%) were mild in intensity and unrelated to study medication. No serious or severe AEs were reported, and no patient discontinued due to an AE.
CONCLUSIONS: These findings provide preliminary evidence of the efficacy and safety of treatment with crisaborole topical ointment, 2% in adults with mild to moderate AD.
The study is registered on ClinicalTrials.gov (identifier NCT01301508).

J Drugs Dermatol. 2015;14(10):1108-1112.

Atopic dermatitis (AD) is a chronic inflammatory skin condition affecting a predominantly pediatric population and characterized by a cycle of flare and remission. Pruritus associated with AD results in substantial quality of life, societal, financial and emotional burdens for patients and their caregivers. Daily management of AD is usually based on application of an emollient and a topical corticosteroid, topical immunomodulator and/or oral antihistamine for the management of flares. A new nonsteroidal lamellar matrix cream has been introduced for use in a variety of dermatologic conditions including AD. Its ingredients mimic stratum corneum components which may help repair and restore skin barrier function and decrease transepidermal water loss. This article reviews the role of topical therapy in AD management, and evaluates the usefulness of the lamellar matrix cream in reducing time to flare, limiting the use of agents with greater side-effect profiles and lowering the overall cost of treatment.

Propolis is a beehive product known for its anti-inflammatory properties. With its growing use, propolis-induced contact dermatitis is increasing. While the dermatitis mostly occurs on areas directly exposed to propolis, our case presented an additional eczema at a site distant from the primary propolis-induced contact dermatitis twice in the same individual. We diagnosed it as an autosensitization dermatitis associated with propolis-induced allergic contact dermatitis.

Background: The role of vitamin D in Atopic Dermatitis (AD) is ambiguous and clinical trials are needed to assess the role of vitamin D in the treatment of AD. The aim of this clinical trial study to evaluate the effect of vitamin D supplementation on patients with AD.
Material and Methods: sixty AD patients were included in a randomized, double-blind, placebo-controlled trial study. They were randomly divided into two groups and treated for 60 days: group vitamin D (n=30), and placebo group (n=30). The two groups were as follows: Group D, 1600 IU cholecalciferol (vitamin D) and second group placebo. The severity of AD was evaluated based on SCORAD (Scoring Atopic Dermatitis) and TIS (Three Item Severity score) value by the same trained physician before and after the trial.
Results: According to SCORAD and TIS value index in the vitamin D group showed significant improvement in patients with mild, moderate and severe AD (P<0.05) and in patients who the intake placebo, this improvement didn't showed (P>0.05).
Conclusion: Results mention that supplementation with oral vitamin D dramatically improved disease severity in AD patients.

J Drugs Dermatol. 2012;11(3):327-330.

Persistent pruritus, or itch, is one of the earliest symptoms of atopic dermatitis (AD). When pruritus is untreated, the incessant scratching response by the patient can increase the inflammatory response, resulting in aggravation of disease symptoms and severity, increasing flares and worsening patient quality of life. Therefore, it is essential that pruritus be treated effectively, rapidly and safely for optimal management of AD. In this article, the authors review clinical trials using tacrolimus ointment, a topical calcineurin inhibitor, to treat adult and pediatric patients with AD over a wide range of disease severity focusing on its efficacy in rapidly reducing pruritus. Furthermore, the authors evaluate trials in which tacrolimus ointment was directly compared with topical corticosteroids, the mainstay of AD treatment, and pimecrolimus cream, another topical calcineurin inhibitor, as well as long-term safety trials in which patients applied tacrolimus ointment for extended periods.

Colloidal oatmeal has a long history of beneficial use in dermatology. It is a natural product that has an excellent safety record and has demonstrated efficacy for the treatment of atopic dermatitis, psoriasis, drug-induced rash and other conditions. In recent years, in vitro and in vivo studies have begun to elucidate the multiple mechanisms of action of naturally derived colloidal oatmeal. Evidence now describes its molecular mechanisms of anti-inflammatory and antihistaminic activity. The avenanthramides, a recently described component of whole oat grain, are responsible for many of these effects. Studies have demonstrated that avenanthramides can inhibit the activity of nuclear factor κB and the release of proinflammatory cytokines and histamine, well known key mechanisms in the pathophysiology of inflammatory dermatoses. Topical formulations of natural colloidal oatmeal should be considered an important component of therapy for atopic dermatitis and other conditions and may allow for reduced use of corticosteroids and calcineurin inhibitors.

Disruption of the epidermal barrier, as indicated by a reduction in skin hydration and an increase in transepidermal water loss (TEWL) is a feature of atopic dermatitis (AD). Novel formulations of dermatologic therapies may enhance patient satisfaction and adherence and may possibly preserve and enhance epidermal barrier function. A single-center, investigator-blinded, randomized, split-body exploratory study was undertaken to assess the hydrating and barrier preserving effects of a water-based hydrogel vehicle. Subjects (n=20) with mild to moderate disease at baseline applied hydrogel vehicle or a moisturizing lotion (Eucerin Lotion^®, Beiersdorf, Inc.) in a split-body fashion for two weeks. Corneometry and TEWL measurements were taken at baseline and week 2. Hydrogel vehicle produced a statistically significant improvement in skin hydration from baseline, as compared to a moisturizing lotion control. Hydrogel produced no statistically significant change in TEWL, while comparator lotion increased TEWL. Data from this pilot study indicate that the water-based hydrogel vehicle improves skin hydration and does not further impair epidermal barrier function, suggesting that it is an appropriate vehicle choice for patients with mild-to-moderate atopic dermatitis.

J Drugs Dermatol. 2012;11(2):180-184.

INTRODUCTION: Atopic dermatitis (AD) is characterized by impaired epidermal barrier with increased transepidermal water loss (TEWL). Scratching further compromises skin integrity, contributing to a cycle of inflammation. The objective of the present study was to investigate a topical anti-itch foam in improving skin barrier and itch. MATERIAL AND METHODS: A single center open study was performed on 26 adults previously diagnosed with AD but without active lesions. One leg was treated with a single application of an anti-itch foam. Dryness, scaling, roughness, cracking, and signs of scratching were assessed before, 6, and 24 hours after application. Skin hydration was measured at 24 hours. The same product was applied twice daily for 7.5 days to the other leg, and skin hydration and TEWL were measured at baseline and on days 2, 8, and 10. Pruritus was assessed by volunteers and by a dermatologist. RESULTS: A significant increase in skin moisture (P less than 0.001) was measured 6 hours after a single application. Scores of dryness, scaling, roughness (P less than 0.001) and cracking (P=0.002) were significantly improved up to 24 hours after a single application. After a 7.5-day repeated application period, the anti-itch foam significantly reduced TEWL (P less than 0.001) compared to baseline. Skin hydration significantly improved (P less than 0.001) in the same time period. 48 hours after the last application, these improvements remained significant (P less than 0.001). CONCLUSIONS: The anti-itch foam improved the skin barrier. It provided immediate relief of clinical signs of AD including pruritus. Moreover, it delivered a long-lasting moisturizing effect, comforting the skin, and improving overall skin condition. J Drugs Dermatol. 2016;15(suppl 11):s77-80.

Background: Atopic dermatitis (AD) is a common chronic relapsing disease particularly affecting children. The emollient used for protection of skin barrier function is the standard treatment for patients with AD. Currently, there is a growing interest in the use of nonsteroidal anti-inflammatory agents such as dexpanthenol (vitamin B5) as an alternative treatment.
Objective: To compare the effectiveness of 5% dexpanthenol (DT) ointment with 1% hydrocortisone (HC) ointment in childhood AD therapy.
Method: Patients were treated topically with 5% DT ointment on the right side of the body and 1% HC ointment on the other side twice daily for 4 weeks. The clinical responses were evaluated by SCORAD (Scoring Atopic Dermatitis index) with statistical analysis using paired t-test.
Result: Of the 30 children enrolled, 26 completed the protocol; mean age was 7.19 years. The average baseline SCORAD score of the DT-treated side and the HC-treated side was 30.95 and 30.54, respectively. There was no statistically significant difference in SCORAD score reduction between the 2 agents. The edematous score of the HC-treated side exhibited faster resolution than that of the DT-treated side, with a statistically significant difference at week 1 and without a statistically significant difference at weeks 2 to 4. The lichenification response rate of HC treatment was more rapid than that of DT treatment; however, there was no statistical group difference. No adverse events were observed with either agent.
Conclusion: The effectiveness of 5% DT ointment is equal to that of 1% HC ointment. DT ointment may be used as alternative treatment in mild to moderate childhood AD therapy.

J Drugs Dermatol. 2012;11(3):366-374.

BACKGROUND: Atopic dermatitis (AD) is a highly prevalent, chronic relapsing condition in childhood with significant financial burden and impact on the quality of life of patients and caregivers. Proactive maintenance treatment with moisturizing agents is the mainstay AD therapy. Objectives: The aim of this study was to assess the cost-effectiveness of a non-steroidal barrier cream (Atopiclair), compared to regular emollient in pediatric patients with mild-to-moderate AD. Methods: A Markov decision model was developed to evaluate the cost-effectiveness of Atopiclair versus regular emollient in 12 Asia-Pacific countries, grouped by income categories based on gross domestic product (GDP) per capita. Data was obtained from structured literature review, expert opinion, fee schedules, and findings from a 2012 survey of 12 Asia-Pacific countries. Analysis was performed a societal perspective. Results: In the base case analysis, Atopiclair was cost-effective against regular emollient, with USD786, USD499, and USD289 in cost savings per year for high, middle, and low-income countries, respectively. Sensitivity analyses showed that Atopiclair remained cost-effective versus regular emollient. Conclusions: Modelling analysis showed that Atopiclair is a cost-effective treatment compared to regular emollient for mild-to-moderate pediatric AD in the countries included in the study.

J Drugs Dermatol. 2015;14(2):169-175.

Atopic dermatitis (AD) is a chronic cyclical inflammatory skin disease that is increasing in incidence. Twenty percent of those affected with AD are infants and young children. Despite the development of newer nonsteroidal topical therapies, such as calcineurin inhibitors, topical corticosteroids remain the gold standard for the treatment of active eczematous disease and management of exacerbation due to established efficacy and safety with appropriate use. The xerotic, sensitive skin of AD patients mandates the use of nonirritating and nondrying topical vehicles. Recently, phase III clinical studies have demonstrated the safety and efficacy of a novel aqueous hydrogel vehicle for desonide delivery in mild to moderate AD, which is free of fragrances and surfactants. Corneometry and transepidermal water loss studies have demonstrated that this patented hydrogel vehicle alone offers advantages including moisturization and skin barrier enhancement, both of which are significant when treating eczematous and xerotic skin. Patient and physician preference surveys suggest that the novel properties of this vehicle may aid in patient compliance with AD therapy

The pathogenesis of atopic dermatitis (AD) requires the orchestration of multiple immune cells that mediate inflammation and tissue remodeling in the skin. T helper cell subsets that secrete specific cytokines have a central role in regulating the inflammatory process. In this review we discuss defined roles for T helper subsets in AD, how the microbiome might impact the development and function of T helper subsets, and animal models that will be useful for testing hypotheses on the interactions of a polarized T-cell response with skin inflammation. Future studies that link these areas will provide important insight into the development of skin inflammation and AD.

J Drugs Dermatol. 2012;11(10):1174-1178.

Atopic dermatitis (AD) may be considered the “poster disease” for exemplifying the significance of abnormalities of the epidermal barrier that occur predominantly within the stratum corneum (SC) and upper epidermis. Specifically, impairments of the SC permeability barrier, antimicrobial barrier, and immunologic barrier contribute markedly to the fundamental pathophysiology of AD. The multiple clinical sequelae associated with epidermal barrier impairments inherent to AD include dry skin, pruritus, increased skin sensitivity to irritants and allergens, eczematous skin changes, staphylococcal skin and anterior nares colonization, and increase in some cutaneous infections (ie, molluscum contagiosum). This article addresses the pathophysiology of AD with clinically relevant correlations, and discusses the scientific basis of a specially designed cleanser and moisturizer system that incorporates ceramide technology and filaggrin degradation products along with other “barrier-friendly” excipients.

J Drugs Dermatol. 2013;12(7 suppl 1):s85-s91

Atopic dermatitis (AD) is a chronic inflammatory and pruritic skin disorder marked by alternating periods of relapse and remission. This multicenter, randomized, active- and vehicle-controlled, investigator-blinded study compared the efficacy and safety of clobetasol propionate lotion to clobetasol propionate cream formulation and lotion vehicle in the treatment of moderate to severe AD. A total of 229 subjects applied treatment twice-daily for 2 weeks. Clobetasol propionate lotion was significantly more effective than its lotion vehicle at 2 weeks and comparable to the cream formulation. Clinical success after a 2-week, treatment-free follow-up period was greater in the clobetasol propionate lotion group than in the cream group. Clobetasol propionate lotion is effective, safe, well tolerated and offers a better remission profile in the treatment of moderate to severe AD as compared to clobetasol propionate emollient cream.

BACKGROUND: Crisaborole is a novel, boron-based, small-molecule, topical phosphodiesterase-4 inhibitor in development for the treatment of patients with mild to moderate atopic dermatitis (AD).
METHODS: In this multicenter, randomized, double-blind, dose-ranging, phase 2 study, adolescent patients 12 to 17 years of age with mild to moderate AD and 2 distinct target AD lesions were randomized to once-daily (QD) or twice-daily (BID) treatment with crisaborole topical ointment. For each patient, 2 target lesions were randomized to receive 29 days of treatment with 0.5% or 2% crisaborole topical ointment. The primary endpoint was change from baseline in AD severity index (ADSI) score for each lesion. Exploratory efficacy endpoints and safety were also assessed.
RESULTS: A total of 86 patients were enrolled and received crisaborole topical ointment 0.5% or 2% QD (n=44) or BID (n=42). All dosing regimens produced dose-related improvements in ADSI as well as in all 5 component signs and symptoms of AD (erythema, excoriation, exudation, lichenification, and pruritus). The greatest improvements were consistently observed with crisaborole topical ointment, 2% applied BID. With this regimen, ADSI improved from baseline by 71%, and total or partial clearance of target lesions (ADSI ≤2) was achieved by 62% of patients after 29 days of treatment. Both doses of crisaborole topical ointment were well tolerated; mild application site reactions were the only treatment-related adverse events (QD, n=3; BID, n=1).
CONCLUSION: These results provide preliminary evidence of the efficacy and safety of crisaborole topical ointment, 2% applied topically BID in adolescents with mild to moderate AD.

J Drugs Dermatol. 2015;14(12):1394-1399.

Crisaborole topical ointment, 2% (formerly known as AN2728) is a benzoxaborole, nonsteroidal, topical, anti-inflammatory phosphodiesterase 4 (PDE4) inhibitor investigational compound that recently completed phase 3 studies for the treatment of mild to moderate atopic dermatitis (AD). The unique configuration of boron within the crisaborole molecule enables selective targeting and inhibition of PDE4, an enzyme that converts the intracellular second messenger 3’5’-cyclic adenosine monophosphate (cAMP) into the active metabolite adenosine monophosphate (AMP). By inhibiting PDE4 and thus increasing levels of cAMP, crisaborole controls inflammation. The use of boron chemistry enabled synthesis of a low–molecular-weight compound (251 daltons), thereby facilitating effective penetration of crisaborole through human skin. In vitro experiments showed that crisaborole inhibits cytokine production from peripheral blood mononuclear cells in a pattern similar to other PDE4 inhibitors and distinct from corticosteroids. Crisaborole also displayed topical anti-inflammatory activity in a skin inflammation model. Once crisaborole reaches systemic circulation after topical application, it is metabolized to inactive metabolites. This limits systemic exposure to crisaborole and systemic PDE4 inhibition. In phase 1 and 2 clinical studies, crisaborole ointment, 2% was generally well tolerated and improved AD disease severity scores, pruritus, and all other AD signs and symptoms. Two large, randomized, controlled, phase 3, pivotal clinical trials assessing the efficacy and safety of crisaborole topical ointment, 2% in children, adolescents, and adults with mild to moderate AD were recently completed with positive results.

J Drugs Dermatol. 2016;15(4):390-396.

Background: Tacrolimus 0.1% and pimecrolimus 1.0% are used for short-term and noncontinuous treatment of atopic dermatitis (AD) in patients unresponsive to conventional therapies.

Objective: To assess the cost-effectiveness of tacrolimus versus pimecrolimus in adults with AD.

Methods: Using a Markov cohort model, the authors projected clinical and economic outcomes over six weeks in adults receiving tacrolimus versus pimecrolimus. Cost-effectiveness was assessed in terms of the ratio of the expected cost of AD-related care to the expected number of days with resolved AD.

Results: Patients receiving tacrolimus had an estimated 4.9 fewer days with active AD over six weeks (30.0 versus 34.9 for pimecrolimus). Expected costs (per patient) of AD-related care also were lower for tacrolimus patients ($501.27 versus $546.14, respectively).

Limitation: While pimecrolimus is indicated for use solely in patients with mild-to-moderate AD, the trial on which this study was based included some patients with severe AD.

Conclusion: In adults with AD, tacrolimus 0.1% may yield better clinical outcomes and lower costs of care than pimecrolimus 1.0%.

Atopic dermatitis (AD) is a chronic inflammatory skin disorder that results in areas of dry, itchy skin. Several cultivation-dependent and –independent studies have identified changes in the composition of microbial communities in these affected areas over time and when compared to healthy control individuals. However, how these communities vary on affected and unaffected skin of the same individual, and how these communities respond to emollient treatment, remains poorly understood. Here we characterized the microbial communities associated with affected and unaffected skin of 49 patients with AD before and after emollient treatment using high-throughput sequencing of the 16S rRNA gene. We found that microbial diversity and community composition was different between affected and unaffected skin of AD patients prior to treatment. Differences were driven primarily by the overabundance of Staphylococcus species on affected skin and a corresponding decrease in bacterial diversity. After 84-days of emollient treatment, the clinical symptoms of AD improved in 72% of the study population. Microbial communities associated with affected skin of these treatment responders more closely resembled unaffected skin after treatment as indicated by increased overall diversity and a decrease in the abundance of Staphylococcus species. Interestingly, Stenotrophomonas species were significantly more abundant in the communities of ‘responders’, suggesting a possible role in restoration of the skin microbiome in patients with AD. We demonstrated that the comparison of affected and unaffected skin from the same individual provides deeper insight into the bacterial communities involved in the skin dysbiosis associated with AD. These data support the importance of emollients in the management of AD although future studies should explore how emollients and other treatments help to restore skin dysbioses.

J Drugs Dermatol. 2014;13(11):1365-1372.

Background: Atopic dermatitis (AD) is a prevalent skin disorder with significant cost of treatment. Several prescription device moisturizers have been approved by the FDA to treat AD but are significantly more expensive than well-crafted over-the-counter (OTC) moisturizers. No studies have been performed to compare both the clinical efficacy and cost-efficacy of these prescription devices to OTC moisturizers.
Purpose: The purpose of this study is to compare the clinical efficacy and cost-efficacy of a glycyrrhetinic acid-containing barrier repair cream (BRC-Gly, Atopiclair^®), a ceramide-dominant barrier repair cream (BRC-Cer, EpiCeram^®) and an OTC petroleum-based skin protectant moisturizer (OTC-Pet, Aquaphor Healing Ointment^®) as monotherapy for mild-to-moderate AD in children.
Methods: Thirty-nine patients, age 2-17 years, with mild-to-moderate AD were randomized 1:1:1 to receive one of three treatments—BRC-Gly, BRC-Cer or OTC-Pet—with instructions to apply the treatment three times daily for three weeks. Disease severity and improvement was assessed at baseline and on days 7 and 21.
Results: No statistically significant difference for any efficacy assessment was found between the three groups at each time point. The OTC-Pet was found to be at least 47 times more cost-effective than BRC-Gly or BRC-Cer.
Limitations: The relatively small sample size of 39 subjects was not sufficient to establish OTC-Pet as superior treatment in AD.
Conclusions: OTC-Pet is as effective in treating mild-to-moderate AD as both BRC-Gly and BRC-Cer and is at least 47 times more cost-effective.
Name of registry: II-AF-ATD-Aquaphor, Comparing the Efficacy and Cost-Effectiveness of Aquaphor to Atopiclair and EpiCeram in Children with Mild to Moderate Atopic Dermatitis
Registration Identifier: NCT01093469

J Drugs Dermatol. 2011;10(5):531-537.

BACKGROUND: The epidermal barrier in patients with atopic dermatitis (AD) is deficient in ceramides and cathelicidins. Such epidermal defects may be a trigger for AD, thereby encouraging research toward development of skin-barrier-targeted preventive strategies.

METHODS: Two single-center, single-arm clinical trials were conducted (study 1, age greater than equal to 8 years and study 2, greater than equal to 10 years) in patients with mild to moderate AD to evaluate the effects of an over-the-counter 1% colloidal oatmeal cream administered for 14 days. Study 1 assessed the Eczema Area and Severity Index (EASI) and Investigator’s Global Atopic Dermatitis Assessment (IGADA) on day 3, and itch severity using a Visual Analogue Scale (VAS) immediately after application as primary efficacy endpoints. In study 2, the primary efficacy endpoint was change from baseline in patients’ assessment of itch. Both studies assessed safety through adverse event (AE) recording.

RESULTS: Study 1: 29 patients were enrolled (mean age [range], 27.07 [8 –67]). Comparing to baseline, EASI, IGADA, and itch were improved after the application, and improvements were maintained until day 14. Improvements of greater than/equal to 20% over baseline were noted in 53.6% and 25.0% patients at day 3 for EASI and IGADA scores, respectively, and in 37.9% patients for itch score immediately after the product application. On day 14, these percentages were 82.8%, 62.1%, and 85.7%, respectively.

STUDY 2: 30 patients were enrolled (mean age [range], 32.9 [10-80]). Itch severity and EASI score were significantly improved after product application and improvements were maintained until day 14. Transepidermal water loss values were significantly reduced and skin hydration was significantly increased at all assessment time points. No adverse events (AEs) were reported in study 2 and 2 AEs were reported by 1 patient in study 1.

CONCLUSIONS: The colloidal oatmeal cream was well tolerated and clinically effective in patients with mild to moderate AD.

J Drugs Dermatol. 2017;16(7):671-676.

BACKGROUND: Atopic dermatitis (AD) is a common chronic skin condition, associated with significant patient morbidity. There are a myriad of excellent evidenced based guidelines to guide clinicians by an extensive review of all the available treatments. However, while well written and complete these papers may not always allow easy transition to clinical application. OBJECTIVE: The purpose of this paper was to develop a practical case-based approach for the treatment and maintenance of AD, enabling translation of guidelines into clinical care. METHODS: After literature searches, selected AD trials and recent existing guidelines were reviewed. Using a nominal group process for consensus, an expert panel of Canadian dermatologists determined the case features and corresponding treatments. RESULTS: A patient focused clinical pathway with 7 cases was developed. For each case scenario, treatment for mild, moderate, and severe disease was recommended. CONCLUSION: A practical case-based clinical pathway was developed for easy clinical application and optimal patient care. J Drugs Dermatol. 2016;15(12):1485-1494.

BACKGROUND: Two post hoc analyses assessed the antipruritic activity of crisaborole topical ointment, 2% (crisaborole; Anacor Pharmaceuticals, Inc., Palo Alto, CA), a first-in-class boron-based phosphodiesterase-4 inhibitor in development for treatment of mild to moderate atopic dermatitis (AD).
METHODS: Two pooled analyses included data from 4 studies evaluating crisaborole in AD (study 1, phase 1b, systemic exposure, safety, and pharmacokinetics [PK] under maximal-use conditions in children and adolescents; study 2, phase 2a, safety and PK in adolescents; study 3, phase 2a, efficacy and safety in adults; study 4, phase 2, efficacy and safety in adolescents). Pooled data from studies 1 and 2 included whole body assessments; studies 3 and 4 included target lesion assessments. Pruritus severity was evaluated using a 4-point rating scale (0=none to 3=severe). Efficacy assessments included percent change from baseline in pruritus severity scores at days 8 (first pooled assessment), 15, 22, and 29 (whole body assessments) or days 15 (first pooled assessment), 22, and 29 (target lesions). Paired t-tests comparing change from baseline against zero were used to calculate P values. Categorical shifts in pruritus severity were also assessed (no to mild pruritus, 0–1.5; moderate to severe pruritus, 2–3).
RESULTS: In the pooled analysis of studies 1 and 2 (N=57), the percent change from baseline in pruritus severity scores were 63.0% and 64.9% at days 8 and 29, respectively (P<0.001 for each). Similar results were observed in the pooled analysis of studies 3 and 4 (N=67). In both analyses, most patients had mild to no pruritus from the first time point assessed through the remainder of treatment.
CONCLUSIONS: Treatment with crisaborole topical ointment, 2% resulted in statistically significant reductions in pruritus severity at the first time point evaluated in both analyses. These findings provide preliminary evidence of the antipruritic activity of crisaborole topical ointment, 2%.

J Drugs Dermatol. 2016;15(2):172-176.

Although allergic contact dermatitis to topical preparations of doxepin has been published1-6,10, systemic contact dermatitis from oral doxepin is more of a theoretical consideration and is rarely reported2. We report a case of a patient with contact allergy to doxepin hydrochloride 5% cream who developed a systemic contact dermatitis to oral doxepin.

Background: There is a long history of using topical coal tar for the treatment of psoriasis and atopic dermatitis (AD). Objective: To review the literature on coal tar and its derivatives, without the use of ultraviolet light, for the treatment of psoriasis or AD. Methods: MEDLINE/PubMed and Cochrane Database of Systematic Reviews literature searches were performed to identify randomized controlled trials and clinical trials of topical coal tar for the treatment of psoriasis or AD. Studies were graded according to a modified version of Sackett’s criteria for clinical evidence and evaluated to determine if they support or do not support the use of coal tar therapy. Results: Twenty-five studies meeting the authors’ search criteria were identified, only two of which were placebo-controlled. The majority (21, or 84%) supported the use of coal tar products in the treatment of psoriasis or AD, while four (16%) did not support the use of coal tar products. Conclusion: Most studies support the use of coal tar products, although their level of evidence is not strong. Topical coal tar was found to be efficacious in the treatment of psoriasis in two placebo-controlled trials. Coal tar products appear to be therapeutic in psoriasis and AD, are well tolerated with few side effects, and are cost-effective. Staining and odor are deterrents to coal tar therapy. Large, randomized, double-blind, placebo-controlled studies with precise point estimates of treatment effect are needed to establish the efficacy of coal tar preparations.

Objective: Evaluate the efficacy and safety of apremilast, a novel phosphodiesterase 4 (PDE4) inhibitor, in subjects with recalcitrant moderate to severe atopic dermatitis (AD) or allergic contact dermatitis (ACD).
Research design and methods: This was a proof-of-concept, phase 2, open-label, single institution trial that evaluated the efficacy and safety of apremilast, 20 mg twice daily, for twelve weeks, in ten subjects with either AD and/or ACD. The primary endpoint was a ≥2 point improvement in Investigator Global Assessment (IGA) score after 12 weeks of treatment. Secondary endpoints included a 75% reduction in the Eczema Assessment Severity Index (EASI-75), EASI-50, and the maximum EASI response.
Results: The primary endpoint of improvement in IGA by two or more points was met by 20% of subjects. Ten percent of subjects achieved EASI-75 and another 10% reached EASI-50. All subjects tolerated apremilast well with no serious adverse events or withdrawal due to side effects. Common adverse events associated with apremilast included headache, nausea, and soft stool.
Limitations: This study was limited by its small sample size and lack of a comparison group to serve as a control.
Conclusions: Apremilast was well tolerated in all subjects. Apremilast was minimally effective in AD and ACD and results were inferior to previous trials of apremilast in psoriasis.

J Drugs Dermatol. 2012;11(3):341-346.

INTRODUCTION: Atopic dermatitis (AD) is associated with changes in skin bacterial microbiome. Emollient treatment induces change in bacterial microbiome in AD, but its effect on fungal microbiome (“mycobiome”) and their inter-kingdom correlations is unknown. We used Ion-Torrent sequencing to characterize the mycobiome of AD patients in response to emollient treatment. METHODS: Skin swabs were collected from lesional and non-lesional skin of AD patients suffering from moderate AD, after informed consent and according to GCP guidelines. Genomic DNA was extracted from each swab using the MoBio PowerSoil DNA Isolation kit and used for mycobiome sequencing analyses as described in our earlier publications. Principal coordinates analyses (PCoA), diversity, abundance, and correlations analyses were conducted in R and relevant packages using non-parametric tests (P less than .05 was significant). RESULTS: Swab samples from 10 patients (7 females, 3 males; mean age, 10.5 years) were analyzed. Emollient treatment induced a significant reduction of Scoring Atopic Dermatitis (SCORAD) score (P less than .001). PCoA showed pre-treatment and post-treatment samples clustered differently at all taxa levels. Six genera were detected in only non-lesional samples, while four were detected in only lesional samples. In non-lesional samples, Shannon diversity index was significantly increased after emollient treatment (P less than equal to .04), while lesional skin exhibited non-significant decrease. Ascomycota was the most abundant phylum and Dothideomycetes was the most abundant Class in most samples. Eight fungal species were either significantly different (P less than .05) or showed a strong trend (P less than .1) between pre- and post-treatment samples of lesional and non-lesional skin. In lesional skin, Gram-negative Pseudomonas spp. correlated significantly with pathogenic fungal species (Aspergillus, Candida spp.) in pre-treatment samples; these correlations were not detected in post-treatment samples. Moreover, lesional skin exhibited significant correlations between Gram-positive bacteria (Corynebacterium kroppenstedtiian and Staphylococcus pettenkoferi) and pathogenic Candida species in pre-treatment samples, but not in post- treated samples. DISCUSSION: Emollient treatment may induce beneficial microbial changes in the mycobiome and augment host-microbe balance on skin in AD. Clinical relevance of these results need to be investigated. J Drugs Dermatol. 2018;17(10):1039-1048.

Diaper dermatitis is the most common dermatologic disorder of infancy. Its cause can often be determined clinically based on the clinical presentation. Primary diaper dermatitis is associated with irritants and spares the deep skin folds. Secondary diaper dermatitis is most often caused by Candida yeast overgrowth and typically presents as a well-defined area of beefy red erythema covering the diaper area and including the deep folds of skin with hallmark satellite pustules. Other causes include seborrheic dermatitis, psoriasis, acrodermatitis enteropathica, allergic contact dermatitis, Langerhans cell histiocytosis, and, in the setting of a primarily pustular eruption, bacterial folliculitis. A simple potassium hydroxide preparation (KOH) can confirm the diagnosis of candida diaper dermatitis and guide proper treatment.

Seborrheic dermatitis is a common chronic infection of the lipid-rich areas of skin. While seborrheic dermatitis has been a recognized clinical entity for decades, its etiology is far from clear. Early investigators of the development of seborrheic dermatitis focused on the role of the Malassezia (previously Pityrosporum) yeasts. These yeasts are also normal skin commensals, thus their importance as pathogens in this disorder came to be doubted. However, it was subsequently found that treatment of seborrheic dermatitis with an antifungal agent not only resulted in clinical improvement but also reduced the number of Malassezia yeasts on the skin. This has resulted in a resurgence of interest in the Malassezia yeasts. It has been hypothesized that there is an immunological component to seborrheic dermatitis, possibly representing an abnormal host response to the Malassezia yeasts. This paper will discuss the role of Malassezia in the etiology of seborrheic dermatitis, as well as the various treatment options.

Background: Lower leg edema is a common side effect of amlodipine therapy, but is often unrecognized as a contributor to stasis dermatitis.
Objective: To determine whether amlodipine therapy is more common among patients with stasis dermatitis than age-matched controls.
Methods: In this retrospective chart review study, the medication lists of all subjects with stasis dermatitis from a single practice site over the past 2 years were compared to alphabetically consecutive charts of patients with basal cell carcinoma to determine the relative usage of amlodipine.
Results: Patients with stasis dermatitis (n = 43) are more likely to take amlodipine than are basal cell carcinoma patients (n = 117) of similar age (19% vs. 5%, P < .02), even when controlled for the use of any antihypertensive medications (25% vs. 10%, P = .05).
Conclusion: Amlodipine therapy is associated with stasis dermatitis and discontinuing amlodipine should be considered when stasis dermatitis is diagnosed.

Background: Some dermatologic disorders are known to be much more common in patients of color, but the leading dermatologic disorders in patients of color have not yet been described on the basis of nationally representative data.
Purpose: To determine the leading dermatologic disorders for each major racial and ethnic group in the United States.
Methods: We queried the National Ambulatory Medical Care Survey (NAMCS) for the leading diagnoses in patient visits to U.S. dermatologists from 1993 to 2009. The leading diagnoses were tabulated for each racial and ethnic group, and the top conditions were compared between groups. In a separate analysis, visits for skin conditions regardless of physician specialty were analyzed for leading diagnoses in each racial and ethnic group.
Results: The top five diagnoses for African-American patients in dermatology clinics were acne, unspecified dermatitis or eczema, seborrheic dermatitis, atopic dermatitis, and dyschromia. For Asian or Pacific Islander patients, the top five were acne, unspecified dermatitis or eczema, benign neoplasm of skin, psoriasis, and seborrheic keratosis. By contrast, in Caucasian patients, the top five were actinic keratosis, acne, benign neoplasm of skin, unspecified dermatitis or eczema, and nonmelanoma skin cancer. In Hispanic patients of any race, the leading diagnoses were acne, unspecified dermatitis or eczema, psoriasis, benign neoplasm of skin, and viral warts. When the leading dermatologic diagnoses across all physician specialties were assessed, the top diagnoses for African-Americans were unspecified dermatitis or eczema, acne, dermatophytosis of scalp and beard, sebaceous cyst, and cellulitis or abscess; for Asians or Pacific Islanders were unspecified dermatitis or eczema, acne, atopic dermatitis, urticaria, and psoriasis; and for Caucasians were acne, unspecified dermatitis or eczema, actinic keratosis, viral warts, and sebaceous cyst. For Hispanics of any race, they were unspecified dermatitis or eczema, acne, sebaceous cyst, viral warts, and cellulitis or abscess. For a sole diagnosis of a dermatologic condition, only 28.5% of African-Americans' visits and 23.9% of Hispanics' visits were to dermatologists, as compared to 36.7% for Asians and Pacific Islanders and 43.2% for Caucasians.
Limitations: The data are based on numbers of ambulatory care visits rather than numbers of patients. Data on race or ethnicity were not collected for some patients.
Conclusions: Several dermatologic disorders are much more commonly seen in patients of color. Acne and unspecified dermatitis or eczema are in the top five for all major U.S. racial and ethnic groups. There may be an opportunity to improve the care of patients of color by ensuring they have equal access to dermatologists.

J Drugs Dermatol. 2012;11(4):466-473.

Objective: To investigate the efficacy, safety and tolerability of topical nalmefene (SRD174), a long acting opioid antagonist for the management of pruritus associated with atopic dermatitis (AD).
Design: Double-blind, vehicle-controlled, randomized, cross-over trial.
Setting: Eleven dermatology outpatient clinics in the U.S.
Patients: Sixty-two out of 136 screened adult subjects with confirmed AD affecting ≤20% of body surface area and with moderate-to-severe pruritus.
Interventions: SRD174 cream or matching vehicle cream applied as required during two 7-day periods separated by a wash-out period.
Main Outcome Measure(s): The primary efficacy variable was the period mean of the sum of pruritus intensity difference (SPID) from 0 to 4 hours (SPID_0-4) where pruritus was measured on a 0-100 scale Visual Analog Scale (VAS) at seven pre-specified time-points following study drug application. A range of secondary efficacy, safety and tolerance endpoints were included.
Results: The LS means for the SPID_0-4 (±SD) for SRD174 cream and Vehicle were 210.7 (20.4) and 212.1 (20.2), respectively (Difference = -1.3 (95% CI: -25.9, 23.3). None of the secondary efficacy endpoints tested demonstrated a statistically significant or clinically important difference between the test product and the vehicle. Overall, the SRD174 cream was well tolerated although there was a higher incidence of AEs when subjects took SRD174 cream (22, 36.7 percent of subjects) compared with when they were taking vehicle (14, 23.3 percent of subjects).
Conclusions: SRD174 cream did not demonstrate efficacy in the treatment of pruritus associated with atopic dermatitis raising questions on the role of peripheral opioid receptors as a target for the treatment of pruritus in this population. NCT00838708

J Drugs Dermatol. 2011;10(8):853-860.

Seborrheic dermatitis is a common papulosquamous disorder of the skin, affecting 3% to 5% of the population. Dandruff, a less severe form of seborrheic dermatitis, affects a greater proportion of the population. The exact pathogenesis of seborrheic dermatitis is unknown, however colonization of the lipophilic yeast, Malasezzia furfur, and an inflammatory reaction to this yeast each seem to play a role in disease etiology. Therefore, treatment for seborrheic dermatitis is aimed at yeast elimination and inflammation control. Several treatment modalities are available for seborrheic dermatitis and dandruff including shampoos, which contain both active ingredients related to antimycotic or anti-inflammatory effects and also surfactant ingredients that allow these shampoos to replace regular shampoos in affected patients. The literature regarding the treatment of therapeutic shampoos is reviewed, and treatment strategies for managing seborrheic dermatitis with therapeutic shampoos are provided.

Background: Hydrocortisone butyrate (HCB) is currently marketed as a cream, ointment, and solution. A new lotion formulation of hydrocortisone butyrate 0.1% (Locoid® lotion) has been developed and evaluated.

Objective: The objective of this study was to evaluate the efficacy and safety of HCB 0.1% lotion compared to the vehicle in subjects aged 3 months to less than 18 years with mild to moderate atopic dermatitis (AD).

Methods: In this multicenter double-blind study, 284 subjects with mild to moderate AD were randomized 1:1 to receive HCB 0.1% lotion or the vehicle for a duration of 4 weeks. “Treatment success” was defined as those subjects with a final Physician Global Assessment (PGA) score of 0 or 1 that had at least a 2-point reduction in the PGA score from baseline to day 29. Safety was assessed by monitoring adverse events.

Results: Analyses of the final PGA score showed a significant treatment effect (P<.001) in favor of the HCB 0.1% lotion group. The safety profile of the HCB 0.1% lotion was also favorable.

Limitations: The study did not assess the durability of the treatment effects (ie, safety and efficacy) after completion of the 4-week treatment period nor the potential need for longer term therapy given the chronic nature of AD.

Conclusion: Results demonstrate the safety and efficacy of HCB 0.1% lotion in the treatment of mild to moderate AD in children 3 months to 18 years of age.

Interstitial granulomatous dermatitis is most commonly associated with rheumatoid arthritis (RA) but may be induced by medications as well. Darifenacin is a muscarinic antagonist which was FDA approved for the treatment of overactive bladder in December 2004. The authors describe a case of interstitial granulomatous dermatitis associated with darifenacin.

Objective: To evaluate the speed of onset and duration of relief of two ceramide-containing formulations with 1% pramoxine hydroxide (CeraVe® Itch Relief Lotion and Cream,Valeant Pharmaceuticals North America LLC, Irvine, CA) in patients with atopic history, including those with active flare and the comparative efficacy of CeraVe Itch Relief Cream to hydrocortisone 1% cream and night-time itch relief with continued use. Methods: Two double-blind, split-body, randomized studies in 66 male and female subjects, ages 11+ years, with history of atopic dermatitis (AD). Itch severity was assessed on a 10-point scale (where 0=none and 7-9=severe). Study one: single applications of ceramide-containing lotion or cream incorporating 1% pramoxine hydrochloride applied to opposite sides of the body. Study two (part 1): single application of ceramide-containing cream or hydrocortisone 1% cream. Study two (part 2): ceramide-containing pramoxine cream applied up to 4 times in a 24-hour period, over the course of 6 days. Itch relief assessed at baseline, 2, and 5 minutes, 1 (2 in study two), 4, and 8 hours post-application. Efficacy and aesthetic attributes were assessed at the same timepoints. Clinical evaluation of performance and mildness of the ceramide-containing 1% pramoxine hydrochloride cream at day 6 (study two, part 2). Results: Study one: Relief of itching was rapid and long-lasting with significant reductions in severity after 2 minutes, and continued improvement over the 8 hour test period (P less than .001 versus baseline at all timepoints). Mean itch severity scores reduced progressively from 6 (moderate) at baseline to 1-2 (mild) after 8 hours, with all patients experiencing relief from itching. Rapid and long-lasting relief to dry, itchy, irritated skin was confirmed through patient self-assessment. Both lotion and cream formulations were non-greasy, absorbed quickly and easily, and were non-irritating. Study two: Ceramide-containing cream incorporating 1% pramoxine hydrochloride provided comparable improvement in itch relief (24.6% reduction in mean itch severity 2 minutes post-application, and 58.0% reduction 8 hours post-application) compared to hydrocortisone cream 1% (18.5% reduction and 59.7% reduction, respectively). Daily use of the ceramide-containing 1% pramoxine cream over 6-days provided all-night relief (87.5% agreement), and perception of skin looking and feeling healthier with each use (71.9% and 81.3% agreement, respectively). Limitations: Results of study one and subsequent comparative study with hydrocortisone 1% cream are based on a single application. There were no placebo controls. Conclusions: Ceramide-containing lotion or cream containing 1% pramoxine provides both rapid and long-lasting relief of itching following a single application in atopic patients with or without active flare. Both formulations were well tolerated with aesthetic appeal. Comparable itch relief to hydrocortisone 1% cream was seen with the ceramide-containing cream over an 8-hour period following a single application. Further ceramide-containing 1% pramoxine hydrochloride cream was well tolerated with continued use over 6 days, delivering comfort and all-night relief for patients with atopic history suffering from reoccurrant itching.

J Drugs Dermatol. 2017;16(3):243-247.

Moisturizers result in an increase of skin hydration and restoration of the skin barrier function and play a prominent role in the longterm management of atopic dermatitis (AD). Cetaphil Restoraderm™ Moisturizer (CRM) contains novel ingredients specifically designed for AD, and its effects on skin hydration, skin barrier function and signs of AD were assessed in four studies, three of which were evaluator-blinded, randomized and intra-individual comparison trials. A single application of CRM induced significantly greater hydration than the untreated control for at least 24 hours (P<0.001). After the skin was disrupted with 0.5% sodium dodecyl sulfate (SDS), applications of CRM led to a more rapid restoration of skin barrier function and maintained significantly greater skin hydration compared to the untreated control (both P<0.05). After four weeks of twice-daily CRM application among subjects with a history of AD, a significant decrease of itching/stinging scores compared to baseline was reported, as well as an improvement in the quality-of-life and a high level of satisfaction regarding the product. When CRM was used as an adjunctive treatment with topical steroid for four weeks among subjects with mild-to-moderate AD, a more rapid decrease of overall disease severity was observed on days 7, 14 and 21 by the blinded investigator (P<0.05), compared to steroid treatment alone. In summary, CRM is suitable for the specific needs of patients with AD and can be used either alone for long-term management or in adjunction with traditional treatment for both short and long-term disease control.

J Drugs Dermatol. 2011;10(7):744-749.

The physical and chemical compatibility of desoximetasone ointment 0.25% and tacrolimus ointment 0.1%, both widely used to treat atopic dermatitis, were determined. A 1:1 (w/w) mixture of desoximetasone ointment 0.25% (Topicort®, Taro Pharmaceuticals USA, Inc.) and tacrolimus ointment 0.1% (Protopic®, Fujisawa Healthcare, Inc.) were prepared and stored under three different temperature/ relative humidity conditions: 25oC/60% RH; 30oC/60% RH; and 40oC/75% RH. Unmixed ointments stored under the same temperature and humidity conditions as the mixture served as controls. Samples were evaluated at days 1, 2, 7, 14, and 28 for color, degree of physical separation, and chemical stability via reverse-phase high performance liquid chromatography. Ranges of relative recovery for each active ingredient for all storage conditions ((% Mixture/% Control) x 100) were 89.6 - 109.3% for tacrolimus and 99.0 - 103.4% for desoximetasone. No significant difference in physical appearance or chromatographic profile between the mixture and controls was observed. Therefore, we conclude that desoximetasone ointment 0.25% (Topicort®) and tacrolimus ointment 0.1% (Protopic®) are physically and chemically compatible up to four weeks when mixed in a ratio of 1:1 (w/w).

Topical corticosteroids have been the mainstay of treatment for atopic dermatitis (AD) over the last decade, especially in the setting of acute flares. However, heavy and prolonged use of topical corticosteroid is undesirable as it is associated with side effects such as, skin atrophy, telangiectasia, striae, steroid-induced dermatoses, rosacea, acne exacerbation, and in some severe and rare cases, systemic effects such as hypothalamic-pituitary-adrenal axis suppression, growth retardation and ocular problems. Non-steroidal antinflammatory agents specific for the treatment of AD (topical calcineurin inhibitors, or TCIs) are now available and they are a viable alternative to topical corticosteroids in treating dermatitis of the face, neck, eyelids, and intertriginous areas where there is a greater risk of the steroid-induced side effects. More recently, medical device emollients have entered the marketplace. These medical devices provide, but are not limited to, anti-oxidant, anti-protease, anti-inflammatory activity, and aid in restoring the natural balance of lipids, which is one of the causes of the epidermal abnormalities seen with AD. The present study evaluated the short-term effectiveness and appeal of a non-steroidal medicated device foam as compared to pimecrolimus cream 1% in the treatment of AD within a wide age group of subjects with active disease at baseline. In this study, both pimecrolimus and the medical device foam exhibited efficacy in mild-to-moderate AD. Primary efficacy was measured by IGA. After four weeks of treatment with the medical device foam, 82% of target lesions were scored "clear" (0) or "almost clear" (1) compared to 71% of target lesions under the pimecrolimus arm. This study confirmed that pimecrolimus cream 1% and the medical device foam work well in the treatment of AD in both adults and children with no associated adverse effects.

J Drugs Dermatol. 2011;10(6):666-672.

Objective: Study results evaluating the efficacy and safety of clocortolone pivalate 0.1% cream in the treatment of adults, young children, and infants with inflammatory facial dermatoses are reported in this article. Clocortolone pivalate 0.1% cream, indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, is a mid-potency topical corticosteroid (Class 4) that has been studied and used extensively to treat a variety of corticosteroid-responsive inflammatory dermatoses, many of which often involve facial skin in both adults and children.
Methods: Clocortolone pivalate 0.01% cream was applied to affected facial skin in subjects presenting with seborrheic dermatitis, contact dermatitis, atopic dermatitis, or psoriasis. Application was completed three times daily for 21 days. Assessments of erythema, edema, transudation, lichenification, scaling, pruritus and/or pain were completed at baseline and Days 4, 7, 14, and 21. Overall therapeutic response was assessed at all follow-up visits. Forty-nine subjects were entered, ranging in age from 1 month to 88 years of age. Thirty-eight subjects completed the studies, with 11 subjects lost to follow-up after the first visit. Individuals between the ages of 13 and 19 years were pre-emptively excluded to avoid potential application of a corticosteroid to acne-affected or acne-prone skin.
Results: Treatment with clocortolone pivalate 0.1% cream resulted in decreases in erythema, edema, transudation, lichenification, scaling, and pruritus/pain in 76% of treated study subjects. The overall therapeutic response in approximately two-thirds of the subjects (68%) was rated as good to excellent. There were 7 adverse events noted over the course of the study that were judged to be related to treatment, all of which were cutaneous and localized to the site of application (acneiform eruptions, burning, and folliculitis).
Conclusion: Clocortolone pivalate 0.1% cream was effective in relieving the signs and symptoms of corticosteroid-responsive inflammatory dermatoses involving facial skin, including seborrheic dermatitis, contact dermatitis, atopic dermatitis, and psoriasis. Overall, the safety profile was favorable and devoid of any treatment-related serious adverse events.

J Drugs Dermatol. 2012;11(10):1194-1198.

Psoriasis continues to be one of the most common and frustrating conditions that dermatologists and their patients face on a daily basis. Novel developments in basic science bring us closer than ever to understanding the pathogenesis of psoriasis. At the same time, the advent of biologic immunomodulators has opened doors in terms of treatment options and a better understanding of the underlying etiology of psoriasis. Genes involved in the immune system, keratinocyte differentiation, and vascular hyperplasia have all been implicated in psoriasis.

BACKGROUND: Recent studies have produced treatment algorithms for hand dermatitis, but there are limited current indications of systemic treatments for chronic hand dermatitis.
OBJECTIVE: To compare the efficacy and safety of methotrexate and acitretin in the treatment of chronic hand dermatitis.
METHODS: A chart-retrospective review of all patients with hand dermatitis seen by the primary author at the University of North Carolina Dermatology and Skin Cancer Center from September 2007 to April 2013.
RESULTS: Eighty-three hand dermatitis charts were reviewed. Twenty- nine patients received systemic therapy, of which 17 (26.5%) were treated systemically with acitretin and/or methotrexate. Of these 17 patients, four patients received courses of both acitretin and methotrexate independently after failing the alternative treatment course. At 6 months, acitretin achieved clearance/almost clearance in 44% of patients, compared to 0% of those treated with methotrexate. At 12 months, 100% of patients treated with acitretin achieved clearance/almost clearance compared to 40% of patients treated with methotrexate. Adverse effects were minimal and as expected.
LIMITATIONS: This was a retrospective study, and the small sample size makes it difficult to generalize results.
CONCLUSION: Systemic retinoids are a good alternative for the treatment of chronic hand dermatitis.

Background: Unique whole formula nature-based sensitive skin products are formulated to minimize irritation while providing conditioning and soothing benefits to clinically diagnosed sensitive skin. Objective: To evaluate and compare the efficacy and tolerability of a regimen of cleanser containing natural oils, beeswax, and witch hazel, and day & night creams containing natural oils, glycerin, and botanical anti-inflammatories (NR); and a synthetic dermatologist-recommended regimen of cetyl alcohol, sodium lauryl sulphate-containing cleanser and glycerin, polyisobutene-containing lotion (CR) in clinically diagnosed sensitive skin resulting from eczema/atopic dermatitis, rosacea, or cosmetic intolerance. Methods: 120 subjects were randomized to receive either NR or CR, twice daily for 4 weeks in this double-blind study. Blinded investigator-rated and subject-rated overall skin appearance was assessed using a 5-point scale (0=none, 4=severe) at baseline, 2 weeks, and 4 weeks. Noninvasive skin assessments for skin hydration and skin barrier function were made by corneometry and TEWL, respectively. Results: NR resulted in a 34% improvement from baseline in investigator-rated overall skin appearance (P less than 0.001); and CR resulted in a 4% improvement. Similar NR and CR results were found in the other efficacy parameters: tactile and visual smoothness, clarity, and radiance. Both regimens improved barrier function from baseline to week 4 (17%, 15%; NR, CR, P equals NS). NR maintained hydration from baseline to week 4 while CR increased hydration by 21% (P less than 0.001). No clinically significant tolerability issues were reported in either regimen at week 4. Conclusions: The study demonstrated that NR was effective, well tolerated, and superior to CR in the management of sensitive skin. J Drugs Dermatol. 2018;17(8):908-913.

The use of Polypodium leucotomos, a species of fern, has been reported to be beneficial in the treatment of atopic dermatitis, vitiligo, and psoriasis, and for prevention of polymorphic light eruption, sunburn, and squamous cell carcinoma. We review the in vivo animal, in vitro human, and human clinical studies performed to help elucidate the actions of and biologic pathways affected by P. leucotomos. These results serve as the scientific rationale and basis for the protection and effectiveness afforded by P. leucotomos in cutaneous diseases.

J Drugs Dermatol. 2016;15(2):224-228.

Active naturals in dermatology have been experiencing a renaissance. Many of the naturals that have been known for centuries to be effective for various skin conditions have now been scientifically validated with the unraveling of the pathophysiology behind their medicinal mechanism. This article seeks to present data on the clinical use of key dermatological active naturals such as oatmeal, feverfew, chamomile, aloe vera, licorice, and dexpanthenol, as well as on recent multicenter and international clinical studies that support their efficacy and safety profile for a variety of inflammatory skin conditions.

J Drugs Dermatol. 2013;12(suppl 9):s128-s132.

Seborrheic dermatitis is one of those conditions that dermatologists and patients alike tend to find a routine for, and in many cases those routines are hard to break. And, unlike the new treatment paradigms for eczema, acne, and even actinic keratoses, combination therapies for addressing the disease process typically have not been a part of the approach to treating seborrheic dermatitis. However, with the advent of new therapies and vehicles as well as a better understanding of how neutrophils and free oxygen radicals impact inflammation,1 there are new options to maintain and control the disease process of seborrheic dermatitis to minimize flares. Although the needs of the scalp, face and chest are different, as are the variations in skin types, the fundamental mechanisms of the inflammatory process are often the same. If it is understood that seborrheic dermatitis is histologically classified as a papulosquamous disorder with paucineutrophilic and lymphocytic infiltrates,¹ and if the trigger and etiologic agent most likely is Malassezia furfur,² then the ideal mechanisms of action of therapies should be directed as such.

J Drugs Dermatol. 2013;12(7):796-798.

No abstract details for the moment.

Dermatology is entering an exciting era with new, targeted immune-modulating medications for treating a variety of dermatologic conditions including psoriasis, atopic dermatitis (AD), and hidradenitis suppurativa. Previously, mainstay treatments consisted of topical corticosteroids or broad systemic immunosuppressants. Recently, our understanding of cytokine signaling cascades has grown, presenting new opportunities to target skewed immune responses. Two major classes are biologics and small molecules. Herein, we highlight the similarities and differences between these two categories of targeted medications. J Drugs Dermatol. 2018;17(12):1330-1332.

Cytokines are polypeptides that are produced by various cell types and act in an autocrine or paracrine manner. They have many different biological actions and have been used in dermatology to treat a wide range of dermatologic diseases. In this paper we review some of the more commonly used cytokines in dermatology, including interferon-alpha and -gamma, interleukins- 2 and -10, and granulocyte-macrophage colony-stimulating factor. We specifically examine their roles in the treatment of condyloma and verruca, hemangiomas, keloids, skin cancers, atopic dermatitis, psoriasis, Behçet disease, chronic granulomatous disease, wound healing, and cutaneous T cell lymphoma. In addition, some of the adverse effects associated with these cytokines are discussed.

Prednicarbate is a non-halogenated, double-ester derivative of prednisolone that has become of interest for the treatment of inflammatory skin diseases, for example atopic dermatitis. In the past, topical steroids have been a popular choice for treating these diseases; however, the potential for significant local and systemic adverse events, such as skin atrophy and hypothalamic-pituitary-adrenal (HPA) axis suppression have limited their use. Prednicarbate has been found to have a favorable benefit-risk ratio, with low skin atrophy potential, and a high anti-inflammatory action. Prednicarbate may be particularly advantageous when used intermittently in pediatric and elderly patients.

This supplement to the Journal of Drugs in Dermatology seeks to advance our knowledge of the structure and function of the stratum corneum. Previously considered a "static" or unremarkable barrier, it has now attained new clinical importance in regards to its role in conditions such as atopic dermatitis and other cutaneous abnormalities. Dr. Brian Berman provides an insightful introduction to articles by Dr. James Q. Del Rosso and Dr. Jacquelyn Levin, as well as by Dr. Paul C. Contard, that discuss the role and relevance of the stratum corneum in today's dermatologic world.

Topical corticosteroids are used to treat a wide variety of eczematous and inflammatory skin disorders, such as atopic dermatitis. However, as topical products become available as generic formulations, patients often experience problems of increased allergies and irritancy, impairment of the epidermal barrier, and loss of efficacy. This is because although the active ingredient and its potency are the same, the vehicle excipients may differ. Dermatologists therefore report concerns in prescribing these generics to their patients.

Fortunately, Promius Pharma, one of the leaders in this field, has now brought to market a generic formulation of clocortolone pivalate 0.1% that is exactly the same as their original branded product. This has been shown to be effective and well tolerated in the management of several corticosteroid-responsive dermatoses, and is a welcome addition to the treatment armamentarium.

Objective: To determine the effect a novel formulation of fluocinonide cream on skin barrier function in subjects with atopic dermatitis.
Design: The authors performed an open-label, investigator-blinded, side-by-side, controlled trial examining skin barrier function before and after a two-week course of a class I, super-potent topical steroid.
Setting: Outpatient university-based dermatology clinic in Portland, OR.
Subjects: Twenty-five subjects aged 12 or older with a diagnosis of moderate, severe, or very severe AD were recruited for this study. Intervention: Fluocinonide 0.1% cream, a novel formulation of a class I super-potent topical steroid was applied to all affected areas, except a control site, once daily for two weeks or until clear. The control target site was treated with the vehicle once daily. Main Outcome Measure(s): The study’s primary outcome was change in skin barrier function as measured by basal transepidermal water loss (TEWL) in acute lesional skin from baseline as measured at two weeks.
Results: TEWL readings significantly decreased (reflecting improved barrier function) in both the active and control target sites. The active target site decreased 14.35±16 mg/cm2 per hour; 95 percent confidence interval, P<0.001. The control target site decreased 8.75±11.80 mg/cm2 per hour in 25 subjects; 95 percent confidence interval, P<0.001. Skin electrical capacitance also improved significantly, reflecting improved stratum corneum hydration with therapy. Pruritus, clinical severity, and quality of life scores all showed significant improvement by the end of the study.
Conclusion: The authors have shown that short-term treatment with a novel formulation of 0.1% fluocinonide led to significantly improved barrier function as measured by basal TEWL in subjects with active moderate to severe AD. These data suggest short-term treatment with AD with a super-potent corticosteroid improves skin barrier function.

J Drugs Dermatol. 2011;10(2):171-176.

Trachyonychia is the term used to describe nail plate roughness, pitting, and ridging that may affect 1 to 20 nails. Alopecia areata, psoriasis, lichen planus, atopic dermatitis, ichthyosis vulgaris, as well as other skin conditions have been associated with trachyonychia, but the causal relationship is often challenging to demonstrate histologically. Clinical evidence of these cutaneous disorders in conjunction with a nail matrix biopsy may help elucidate an etiology of trachyonychia, but many cases often remain idiopathic. Nail biopsy findings may match skin histology, but more commonly show spongiotic or nonspecific changes. We present an interesting case of a female with progressive development of trachyonychia in all 20 nails coinciding with a new diagnosis of sarcoidosis.

Background: The potential for toxicity from systemic absorption of topical miconazole in infants is a concern. Objective: To assess the relative safety of 0.25% miconazole based on the amount absorbed through the skin of infants with diaper dermatitis after multiple applications. Methods: Of 24 infants with moderate to severe diaper dermatitis, 19 received 0.25% miconazole nitrate ointment and 5 received 2% miconazole nitrate cream for 7 days at each diaper change and after bathing. Blood samples were collected prior to treatment and after 7 days. Results: In the 0.25% treatment group, blood concentrations of miconazole were nondetectable (<1 ng/mL) in 83% (15/18) and minimal (3.0 to 3.8 ng/mL) in 17% (3/18). Samples were missing for one patient. For the 5 infants in the 2% treatment group, miconazole concentration was nondetectable in 20% (1/5) and less than 7.4 ng/mL in 4 infants. No adverse events were noted. Conclusions: Systemic absorption of 0.25% miconazole nitrate ointment was minimal, demonstrating its safety in the treatment of moderate to severe diaper dermatitis.

Background: The first gel formulation of ketoconazole has been tested in 2-week treatment courses. Objective: To evaluate the efficacy and safety of a new, once-daily, 2-week ketoconazole 2% gel treatment in moderate to severe seborrheic dermatitis. Methods: Four hundred fifty-nine subjects with moderate to severe seborrheic dermatitis were randomized to receive ketoconazole 2% gel or vehicle gel once daily for 14 days. The primary efficacy was the proportion of successfully treated subjects at day 28 (cleared and almost cleared). Results: A significantly greater percentage of subjects were successfully treated with ketoconazole 2% gel compared with vehicle (25.3% vs. 13.9%, P = .0014). Ketoconazole 2% gel improved erythema, scaling (P = .0022 vs. vehicle), and pruritus. Mean overall symptom severity was reduced by 53% and 39% with ketoconazole gel and vehicle, respectively. Adverse events were few, generally mild or moderate, and similar between treatment groups. Conclusion: Once-daily ketoconazole 2% gel is an effective, well-tolerated, convenient, and cosmetically acceptable treatment for moderate to severe seborrheic dermatitis.

Lichen planus (LP) is a disease distinguished by pruitic violaceous planar papules containing reticulated white striae. It can occur just about anywhere, but most commonly occurs in the mouth, genital, and distal extremity areas. The general treatment for LP consists of topical or systemic steroids, although a standard accepted treatment is still to be determined. Pimecrolimus has generated recognition as a topical non-steroidal drug labeled for treatment of atopic dermatitis. The proposed mechanism of action of pimecrolimus is inhibition of cytokine production and proliferation. Cytokine obstruction results in the limitation of T-cell propagation, which is the inciting factor in the pathological process of LP. This element may prove be advantageous in the treatment of LP.

Biologic drugs, a novel class of agents engineered to target specifc mediators of infammation, and small-molecule inhibitors that pen-etrate the cell membrane to interact with targets inside a cell represent the cutting-edge of pharmacological biomedical therapeutics. Clinical studies have already demonstrated the effectiveness of this new generation of drugs in treating a variety of medical illnesses and conditions that were refractory to traditional treatments. This review aims to describe the latest available or currently in-develop-ment drugs, biologic agents, and small molecule inhibitors for treatment of psoriasis, rosacea, alopecia areata, and atopic dermatitis.

J Drugs Dermatol. 2017;16(12):1224-1228

Polypodium leucotomos extract (PLE), derived from the tropical fern of Polypodiaceae family, has properties ranging from immunomodulatory and antioxidative to photoprotective. It is these multiple mechanisms of action, in combination with a favorable side effect profile, which makes PLE a promising adjunctive treatment for several dermatologic disorders. Studies are summarized on the use and potential applications of PLE in the treatment or management of photodermatoses, vitiligo, melasma, psoriasis, atopic dermatitis, and more recently, in minimizing infections in high-performance athletes. More data, however, with larger sample sizes are needed to confirm these benefits.

J Drugs Dermatol. 2014;13(2):148-153.

Contact irritant dermatitis can be defined by four interrelated elements: skin barrier disruption, epidermal skin changes, cytokine release, and nerve ending changes. The predominant symptom of eczema relates to the fourth constituent, which produces pruritic symptoms that are often neglected when using pre-formulated topical steroids and immunomodulators. Although the induction of pruritus with proteinases and cytokines demonstrates the close connections between immune and neurotrophic factors in the pathophysiology of pruritus, agents that specifically affect the cutaneous nerve endings are often beneficial for use in patients affected by dermatitis. Besides avoiding triggering factors, agents such as pramoxine, phenol, camphor, and menthol are extremely valuable in allaying patients’ symptoms of pruritus. Indeed, therapeutic remedies, which incorporate anti-pruritic agents in their formulation, may be advantageous for the bulk of patients with contact irritant dermatitis.

Autoimmune progesterone dermatitis (APD) is a cyclical cutaneous reaction to progesterone, with symptoms that typically begin 3-10 days before the onset of menstrual flow and end 1-2 days into menses. The symptoms vary in severity from barely visible to anaphylaxis, but most often include an eczematous eruption, erythema multiforme, urticaria, folliculitis, and angioedema. This is a rare disorder with only a handful of documented cases. The pathogenesis of this condition remains unknown and significant variations in the presentation and severity of symptoms complicates its diagnosis. Treatment seeks to inhibit progesterone secretion through suppression of ovulation, but it may be unsuccessful. We present a case of autoimmune progesterone dermatitis that eluded diagnosis for several years, and subsequently the patient was completely controlled with oral contraceptive pills.

J Drugs Dermatol. 2017;16(10):1040-1042.

Cyclosporine is an immunosuppressive drug that acts selectively on T-cells by inhibiting calcineurin phosphorylase. It has been used in dermatology since its approval for US Food and Drug Administration in 1997 for the use in psoriasis. While indicated only for the treatment of moderate to severe psoriasis, cyclosporine has also been used as an off-label drug for the treatment of various inflammatory skin conditions, including atopic dermatitis, blistering disorders, and connective tissue diseases. In this article, we review the use of cyclosporine in dermatology.

J Drugs Dermatol. 2012;11(8):979-987.

Hand dermatitis is estimated to affect greater than 15% of the general population. Childhood eczema, frequent hand washing, and occupational exposure to chemicals are predisposing factors. Hand dermatitis treatment involves both prevention of outbreaks and treatment of active disease. Moisturizers are essential to protect the skin from the environment, enhance hydration, and repair the skin barrier. They have been shown in large studies to prevent occupational related breakouts. Natural oils are commonly used in moisturizers for their moisturizing and emollient properties. Sweet almond oil is an oil that contains high levels of fatty acids and has been used for centuries to treat skin diseases such as eczema and psoriasis. In this study, a moisturizer with 7% sweet almond oil and 2% colloidal oatmeal was found to be both safe and effective in treating patients with moderate to severe hand dermatitis.

J Drugs Dermatol. 2018;17(1):78-82.

Background: There have been many reports of topical steroids treatment for the face causing perioral dermatitis, steroid acne, and steroid rebound phenomenon.
Objective: To assess patient reported outcomes in patients receiving compounded topical (hydrocortisone 0.75% and precipitated sulfur 0.5%) lotion for up to 15 years for common dermatological conditions of the face.
Methods: In a retrospective study, 300 patients were randomly sampled from the dermatology clinic who had used, or were continuing to use, a lotion based, pharmacy-compounded topical preparation for the face. The topical compound was used in therapies for seborrheic dermatitis and combination with prescription topical therapy for patients with acne and rosacea with tolerability problems.
Results: None of the 300 patients experienced steroid acne, rebound phenomenon, or perioral dermatitis associated with use of hydrocortisone 0.75% and precipitated sulfur 0.5% on the face.
Conclusion: There was no evidence found that perioral dermatitis, steroid acne, or rebound phenomenon occurs when sulfur is compounded with topical hydrocortisone 0.75%.

Herpes labialis remains a common worldwide affliction. Recent advances in understanding the basic pathogenesis have led to new therapeutic intervention, both on-label and off-label. Aside from reducing the duration and symptomatology of acute outbreaks, another goal of treatment is to decrease the frequency of future episodes. Oral and topical acyclovir and its analogues are the mainstay of both chronic suppressive and episodic therapy. A new muco-adhesive formulation of acyclovir provides a decrease in outbreaks, probably due to a diminution of herpesvirus load in all reservoir sites. Acyclovir-resistant strains are rare in immunocompetent hosts; parenteral foscarnet and cidofovir are administered in this situation. Parenteral acyclovir is the drug of choice for eczema herpeticum, which may begin as herpes labialis in an atopic dermatitis patient. Thermotherapy may be beneficial, and a certified device to deliver heat is available outside the United States.

J Drugs Dermatol. 2017;16(3 Suppl):s49-53.

Herpes labialis remains a common worldwide affliction. Recent advances in understanding the basic pathogenesis have led to new therapeutic intervention, both on-label and off-label. Aside from reducing the duration and symptomatology of acute outbreaks, another goal of treatment is to decrease the frequency of future episodes. Oral and topical acyclovir and its analogues are the mainstay of both chronic suppressive and episodic therapy. A new muco-adhesive formulation of acyclovir provides a decrease in outbreaks, probably due to a diminution of herpesvirus load in all reservoir sites. Acyclovir-resistant strains are rare in immunocompetent hosts; parenteral foscarnet and cidofovir are administered in this situation. Parenteral acyclovir is the drug of choice for eczema herpeticum, which may begin as herpes labialis in an atopic dermatitis patient. Thermotherapy may be beneficial, and a certified device to deliver heat is available outside the United States.

J Drugs Dermatol. 2017;16(3 Suppl):s49-53.

Topical corticosteroids have improved the management of many inflammatory skin diseases, such as psoriasis and atopic dermatitis. However, these medications are associated with certain adverse effects that are potentially serious. The potent anti-inflammatory actions of these drugs increase susceptibility to bacterial and fungal infections, and therefore may preclude them from use when infection is the known cause of the disease. In addition, children may be more vulnerable than adults to systemic effects of topical corticosteroids because percutaneous absorption is proportionately greater. These are important considerations, and physicians need to weigh and compare the risks and benefits associated with these medications before initiating treatment. This involves an appreciation of which patient populations are at high risk, which skin conditions are incompatible with topical corticosteroid therapy, and which alternative nonsteroidal medications are effective in treating inflammatory skin diseases.

Efaluzimab has recently been described as a treatment for alopecia areata. Conflicting reports and studies have spurred discussion as to whether efaluzimab is an effective treatment of alopecia areata. Proposed mechanisms for this immune-modifying agent have suggested that efficacy is derived from efaluzimab’s effects on T cells. However, a recent molecular study found no alteration in T cell action around hair follicles at six months of treatment and thus the study concluded that efaluzimab was not an effective treatment. This article describes a nine-year-old male with recalcitrant alopecia totalis for seven years who had been nonresponsive to therapeutic intervention. He was started on efaluzimab for severe atopic dermatitis and began to re-grow scalp hair at one year of treatment. This discussion suggests that longer treatment durations may be needed for treatment effects to be seen in some patients.

This CME supplement reviews the science behind a select group of natural ingredients in the context of treating cosmetic and medical conditions. Dr. Magdalene A. Dohil discusses the data supporting certain natural ingredients in the treatment of atopic dermatitis and a defective skin barrier. Drs. Whitney P. Bowe and Alan C. Logan address the role of antioxidants in acne vulgaris and aging and discuss biologically active ingredients as they relate to the skin. Finally, Dr. Andrew F. Alexis focuses on skin of color and the use of natural ingredients to aid in the management of hyperpigmentation. After reviewing this publication, practitioners should be in a better position to help their patients discriminate potentially effective over-the-counter products from those that lack any scientific basis for their claims. This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 1 AMA PRA Category 1 Credits.

Intravenous immunoglobulin (IVIG) therapy has been used to treat a variety of immune mediated disorders. Cutaneous reactions to IVIG are rare and have only been anecdotally described. We describe three cases with dyshidrotic-like biopsy proven spongiotic dermatitis after administration of IVIG. These three cases may highlight an uncommon and rarely reported side effect of IVIG.

Statins, initially developed as antimicrobials, are primarily considered cholesterol-lowering agents. Recently, researchers discovered anti-inflammatory properties of statins. Studies on the effects of statins and the alterations noted include: bench work that supported a Th1/Th2 skew to Th1, altered lymphocyte migration, inhibition of MHC-II induction and cytokine release on antigen-presenting cells, inhibition of mast cell degranulation and inhibition of Th17 cells and IL-17 production. In addition to the anti-inflammatory properties, statins have been found to induce apoptosis in melanoma models. The potential therapeutic value of statins is illustrated in the management of alopecia areata, atopic dermatitis, psoriasis, systemic lupus erythematosus, cutaneous T-cell lymphomas, cutaneous melanoma, mastocytosis and more. This manuscript presents a comprehensive review of statins and their potential dermatologic application.

Extravasation of medications can manifest as tenderness, pain, tissue necrosis, and thrombophlebitis and lead to infection and severe long-term complications. Risk factors for leakage of medications include mechanical and pharmacologic mechanisms such as cannulation technique, vasoconstriction, and cytotoxicity. Well-known vesicants like anthracyclines, vinca alkaloids, and vasopressors are usually administered with proper caution. Often overlooked are many antimicrobial agents, which typically act via differences in osmolality and pH. Vancomycin harms the vascular wall by the latter (pH 2.5-4.5). Although similar in appearance to vancomycin hypersensitivity reactions (eg, linear immunoglobulin A bullous dermatosis), we present a patient whose dermatitis and subsequent cellulitis likely originated due to extravasation of the drug from the peripheral intravenous catheter. The visible dermatitis mimicked bullous cellulitis from toxin-producing Staphylococcus aureus, Group A Streptococcus, and gram-negative rods or anaerobes in the setting of neutropenia. Our case illustrates the importance of getting an appropriate history and recognizing non-infectious causes of rashes that mimic chronic infections.

The Dermatologic Benefits of Back to Nature

Natural supplements are currently experiencing a renaissance in dermatology. Although they have been used for centuries, many have been recently validated for various skin conditions by scientific studies. Natural supplements, such as mushroom extracts, are capable of accelerating the skin turnover rate and repairing dermal molecular components that provide structure and elasticity to the skin. Moreover, teas and feverfew have anti-inflammatory, anti-irritant, and antioxidant properties, and their applications include the treatment of sensitive skin, shaving-induced irritation or redness, and photoprotection. Dyschromia is one of the most common dermatological concerns in patients with darker skin, and blinded controlled studies have found that hyperpigmentation can be assuaged by the skin lightening effects of soy, niacinamide, n-acetylglucosamine, licorice extract, arbutin, vitamin c, kojic acid, emblica extract, lignin peroxidase, and glutathione. Blinded controlled studies have also demonstrated that atopic dermatitis can be mitigated by oatmeal, feverfew, chamomile, aloe vera, licorice, and dexpanthenol.

INTRODUCTION AND OBJECTIVES: Newborns and babies are at risk of developing diaper dermatitis due to constant occlusion and exposure to irritants such as urine and feces. The aim of this study was to evaluate the clinical effectiveness of an almond oil-based ointment on diaper dermatitis in infants. MATERIALS AND METHODS: A multicenter open-label trial of 60 infants (1-36 months) with a known history of recurrent diaper dermatitis was performed. The infants were clear at the time of enrollment. Inclusion criteria was a minimum of 3 episodes of rashes in the diaper area in the four weeks prior to enrollment. The almond oil-based ointment was used daily after each diaper change over 28 days, and data was recorded by the users (persons who applied the product) with daily report logs for the study duration including presence of diaper dermatitis, severity, as well as reports of teething and/or diarrhea. During each visit, a clinical evaluation was performed by an assessor (dermatologist or pediatrician) recording the degree of erythema, skin dryness, skin roughness to the touch, and skin suppleness using a scoring scale from 0 (null) to 9 (very severe). The users also performed an evaluation on product effectiveness and cosmetic qualities. RESULTS: Clinical evaluations showed no erythema, a signi cant decrease (P less than 0.01) in skin dryness, roughness, and a signi cant in- crease (P less than 0.01) in skin suppleness after 28 days of product application compared to initial state. During the course of the study, 90% of the subjects showed a decrease in frequency or total absence of diaper dermatitis. One-hundred percent of users rated the product to have a pleasant texture, a good protective effect, spreads easily, and does not irritate the skin. The scent was judged as pleasant by 95%, and for 75% of those applying the product, the texture was described as non-oily. CONCLUSIONS: For newborns and infants regularly developing diaper dermatitis, the almond oil-based ointment appears to confer a protective effect from future episodes of diaper dermatitis, improves dryness and suppleness of skin, and is cosmetically acceptable by the users. J Drugs Dermatol. 2016;15(suppl 11):s86-90

Objective: To quantify and compare the physiochemical properties of various topical emollients and to correlate these findings with the products' potential to maintain the stratum corneum (SC) acid milieu, while possessing the appropriate water content for skin rehydration, user adherence, and comfort.
Material and Methods: The pH and hydrophilic fraction of 31 skin moisturizers sold in the US were measured. Hydrophilic Index (HI) was calculated using the "HI equation." The two parameters were charted using a scatter plot with quadrant divisions. Products with lower hydrophilicity were considered "more greasy" and assigned a lower HI as compared to their counterparts with a higher hydrophilicity.
Results: Our findings are in good accordance with common clinical impressions: lotions generally have higher HI, while ointments have lower HI. The majority of the products tested fall into low HI, suggesting that a large percentage of the products may be rich in overall lipid content. The pH values range widely, from 3.7 to 8.2, with the majority of the products close to the physiologic skin pH of 4 to 6.
Conclusion: This study introduces HI as a novel method of quantifying the aqueous content of topical emollients. When considered together with pH, the two indices can guide providers in choosing the most suitable emollients for patients with skin diseases involving altered acid mantle and barrier disruption, such as atopic dermatitis, irritant contact dermatitis, and ichthyosis vulgaris.

J Drugs Dermatol. 2012;11(5):633-636.

Natural ingredients have been used traditionally for millennia and their application in topical creams, lotions and preparations within the traditional medicines and healing traditions of many cultures has been observed. Over the last 20 years, clinical and laboratory studies have identified the benefits of an array of natural ingredients for skin care. Consequently, a number of these ingredients and compounds are today being developed, used or considered not only for anti-aging effects, but also for use in dermatologic disorders. Certain ingredients, such as colloidal oatmeal and aloe vera, have been identified as beneficial in the treatment of psoriasis and atopic dermatitis, respectively, due to their anti-inflammatory properties. For combating acne and rosacea, green tea, niacinamide and feverfew are considered efficacious. As to hyperpigmentation and antioxidative capabilities, licorice, green tea, arbutin, soy, acai berry, turmeric and pomegranate are among those plants and compounds found to be most beneficial. Additional research is needed to determine to confirm and elucidate the benefits of these ingredients in the prevention and management of skin disease.

Background: A novel topical foam formulation of ketoconazole has been developed for use on the scalp, body, and face. Objective: To evaluate the efficacy and safety of twice-daily treatment with ketoconazole 2%foam for seborrheic dermatitis on the scalp, body, and face. Methods: One thousand one hundred sixty-two subjects, aged 12 years or older, with mild to severe seborrheic dermatitis were randomized to receive ketoconazole foam (n=427), vehicle foam (n=420), ketoconazole cream (n=210), or vehicle cream(n=105) twice daily for 4 weeks. The primary endpoint was the proportion of subjects achieving an Investigator’s Static Global Assessment score of 0 or 1 at week 4 (treatment success). Results: A significantly greater percentage of subjects achieved treatment success using ketoconazole foam than vehicle foam (56% and 42%, respectively; P<.0001); ketoconazole foam was shown to be equivalent to ketoconazole cream. Ketoconazole foam was well-tolerated with a low incidence of treatment-related adverse events (14%; 59/427). Conclusion: Ketoconazole foam 2% is a safe, effective, and versatile formulation for use on the scalp, body, and face for the treatment of seborrheic dermatitis in patients aged 12 years or older.

Objective: To assess the safety and efficacy of clobetasol propionate 0.05% emulsion formulation (EF) foam in subjects with mild-to-moderate chronic hand dermatitis.
Methods: This was a single-center, open-label pilot study of 30 adults with chronic hand dermatitis. Subjects were treated with clobetasol propionate 0.05% EF foam twice-daily and returned for assessment at day 8 and day 15. The primary efficacy endpoint was the proportion of subjects who achieved treatment success, defined as improvement of ≥1 grade in their chronic hand dermatitis as per the Investigator's Static Global Assessment (ISGA) from baseline to day 15. Safety and quality-of-life measures were also assessed.
Results: A minimum 1-grade improvement in the ISGA was achieved by 96.7 percent (29/30) of subjects at day 15, with 80 percent (24/30) of subjects achieving a score of 0 (clear) or 1 (almost clear). Clobetasol propionate 0.05% EF foam appeared to be safe and well-tolerated, with only four subjects experiencing treatment-related adverse events. No pattern of adverse event occurrence or predisposition could be delineated from this study.
Conclusion: Clobetasol propionate 0.05% EF foam appeared to be safe and effective for the treatment of chronic hand dermatitis.

J Drugs Dermatol. 2011;10(12):1398-1402.

Betel quid is a drug used in Far East Asia, India, and the South Pacific. The habit of betel quid chewing is widely reported to cause oral cancer and tooth and gum disease. However, skin disease due to betel quid use is underreported. We report a case of irritant contact dermatitis to betel quid components in a 35-year-old male betel quid user who presented for evaluation of a persistent rash on his fingertips.

Scalp lesions are common among patients with psoriasis, seborrheic dermatitis and a number of other inflammatory and fungal conditions. Topical corticosteroids are a mainstay of treatment for many scalp dermatoses and they significantly reduce erythema, scaling and pruritus. Conventional corticosteroid formulations such as cream and ointments are often difficult or time consuming for patients to apply and may produce undesirable cosmetic effects. Medicated shampoos provide a more convenient alternative for patients who require topical administration of corticosteroids for scalp conditions. Tar shampoos have long been used to treat psoriasis and are effective for the long-term maintenance of remission in patients who respond to therapy. Antifungal shampoos are effective for the treatment of seborrheic dermatitis and other mycotic conditions. A shampoo formulation containing fluocinolone acetonide, 0.01% is also approved for the treatment of seborrheic dermatitis. One superpotent corticosteroid shampoo (clobetasol propionate 0.05%; Clobex® Shampoo) is approved in the United States (U.S.) for once-daily treatment of psoriasis of the scalp. The results of a 2007 pilot study also demonstrated that clobetasol propionate shampoo improved the signs and symptoms of seborrheic dermatitis. These findings suggest that high-potency corticosteroid shampoos may provide an important option for topical corticosteroid therapy in dermatologic conditions affecting the scalp

BACKGROUND: La Roche-Posay Thermal Spring Water (LRP-TSW) exhibits both probiotic and prebiotic properties enhancing the diversity of the skin microbiota. METHODS: A review was undertaken to explore the role of LRP-TSW as a topical probiotic and prebiotic therapy in improving the diversity of the skin microbiota and reducing dryness and pruritus in inflammatory skin diseases. RESULTS: The concentration of minerals and non-pathogenic microbes in LRP-TSW may explain its therapeutic benefit when used for inflammatory skin diseases. Clinical studies have shown that topical LRP-TSW treatment results in increases in Gram-negative bacteria with reduction of Gram-positive bacteria, and improvements in skin microbial diversity. At the same time skin condition in atopic dermatitis, psoriasis, and general dryness in otherwise healthy skin, has been shown to improve. CONCLUSIONS: Enhancement of skin microbiota diversity using topical LRP-TSW may offer a valuable option for the treatment and maintenance of inflammatory skin diseases. J Drugs Dermatol. 2018;17(6):657-662.

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BACKGROUND: Recent research has identified potential uses of cannabinoids in dermatology, including psoriasis, atopic dermatitis, and wound healing. OBJECTIVE: The extent of dermatologists’ familiarity with and interest in cannabinoids as therapeutics is unknown. METHODS: This study examined dermatology providers’ knowledge, attitudes, and perceptions on therapeutic cannabinoids using a 20-question online survey. RESULTS: The response rate was 21% (n=531). Most responders thought cannabinoids should be legal for medical treatment (86%). Nearly all (94%) believed it is worthwhile to research dermatologic uses of cannabinoids. 55% reported at least one patient-initiated discussion about cannabinoids in the last year. Yet, 48% were concerned about a negative stigma when proposing cannabinoid therapies to patients. While most responders (86%) were willing to prescribe an FDA-approved cannabinoid as a topical treatment, fewer (71%) were willing to prescribe an oral form. 64% of respondents did not know that cannabidiol is not psychoactive and 29% did not know that tetrahydrocannabinol is psychoactive. LIMITATIONS: Limited survey population. CONCLUSIONS: Dermatology providers are interested in prescribing cannabinoids and patients are speaking about cannabinoids with their dermatologists. However, providers’ fund of knowledge on this subject is lacking. These results highlight the need for further education and research to detangle the dermatologic benefits and risks of cannabinoids. J Drugs Dermatol. 2018;17(12):1273-1278.

We describe 3 cases of psoriatic patients who developed a severe eczematous eruption after the use of calcipotriol ointment. For all of them, the dermatitis recovered after the suspension of the calcipotriol ointment and topical application of corticosteroids. We performed patch tests with the standard series of SIDAPA (Italian Society of Environmental, Occupational and Allergological Dermatology), with an integrative series of vehicles and preservatives, with the commercial ointment containing calcipotriol, with its excipients and, finally, with a series of diluted calcipotriol in isopropanol and petrolatum. They all revealed a strong allergic reaction to calcipotriol and also to its dilution in isopropanol (for all patients) and in petrolatum (only one patient). It is interesting to underline that the reactions always occurred on the legs, even if the patients had applied the ointment elsewhere. We can hypothesize that the venom stasis dermatitis of the legs, associated with xerosis, may have favored the penetration of the drug through the skin, increasing the risk of allergic contact sensitization. Finally, cross-reactivity to other vitamin D3 analogue, tacalcitol, and calcitriol was excluded.

Lidocaine/prilocaine cream is a topical anesthetic commonly used in pediatric and dermatologic practice to obtain local anesthesia. Common side effects include: transient skin blanching, erythema, urticaria, allergic contact dermatitis, irritant contact dermatitis, and hyperpigmentation. The authors report a petechial and purpuric reaction after the application of lidocaine/prilocaine cream. This is a rare side effect, since to our knowledge only few case reports have been documented in literature.

Acute radiation dermatitis is an uncommon complication of fluoroscopic procedures. Cases secondary to cardiac catheterization are infrequently reported in the literature. The risk of developing this reaction is directly related to the skin dose of radiation, which is affected by the type of procedure, the technique used to achieve appropriate penetration, the duration of exposure, and the patient’s body habitus. We report a case of acute radiation dermatitis following prolonged coronary angiography initially presenting as a fixed drug eruption.

Seborrheic dermatitis, characterized by erythema and/or flaking or scaling in areas of high sebaceous activity, affects up to 5% of the US population and often appears in conjunction with other common skin disorders, such as rosacea and acne. Despite ongoing research, its etiology is puzzling. Increased sebaceous and hormonal (androgenic) activity is thought to play a part. Recent evidence suggests an important role for individual susceptibility to irritant metabolites of the skin commensal Malassezia, most probably M globosa. Current approaches thus include agents with antifungal as well as antikeratinizing, and anti-inflammatory activity. Azelaic acid, which has all 3 properties, may be a useful addition to first-line management, which now comprises of topical steroids, the immunosuppressant agents tacrolimus and pimecrolimus, azoles and other antifungals, and keratolytic agents. A recent exploratory study supports the efficacy and safety of azelaic acid 15% gel in seborrheic dermatitis. Azelaic acid may be especially valuable in this application because of its efficacy in treating concomitant rosacea and acne.

Antihistamines are among the most commonly used medications by allergists and dermatologists worldwide. They are used to treat indications such as rhinitis, urticaria, seasonal allergies, and pruritus, and their potential role in treating the itch and rash of atopic dermatitis remains unclear. However, many antihistamines have the drawback of causing sedation. New antihistamines have been developed and released in recent years to overcome the limitations of older agents.

First generation antihistamines such as hydroxizine are effetive but cause sedation. The initial second generation antihistamines, terfanadine and astemizole, were effective non-sedating medications but had drug interactions that caused cardiac problem and have been pulled from the market in the United States. Later second generation antihistamines, such as loratidine and cetirizine, have been found to be effective in the treatment of allergic rhinitis, and the latter to be effective in the treatment of chronic idiopathic urticaria. More recently, third generation antihistamines have been developed from existing agents (e.g. desloratadine is the active metabolite of loratidine, levocetirizine is the racemically active component of cetirizine, and fexofenadine is a derivative of terfanadine) to increase effectiveness and decrease side effects. Desloratadine has been released in the United States and Europe, while levocetirizine is currently only available in Europe. This article will review over 50 clinical studies and reviews regarding desloratadine and levocetirizine with an overview of their possible dermatological use.

BACKGROUND: Epidemiologic studies of patients who present to dermatology clinics are necessary to identify the needs of patients. OBJECTIVE: To quantify and compare diagnoses according to race, ethnicity, and socioeconomic status (SES) at 6 general dermatology clinics from January 2013 to December 2016. METHODS: A retrospective cohort of new patients was established using an electronic medical record database. Primary diagnoses and diagnostic codes were recorded. Geocoding was utilized to obtain SES. RESULTS: There were 65969 new patient visits. Racial and ethnic demographics were obtained with the overall top 3 conditions being eczema or dermatitis, benign skin neoplasm, and adnexal disease. In blacks, however, follicular disorders were the third most common condition seen. The most frequently encountered diagnoses at the clinics with the highest and lowest SES were benign skin neoplasm and eczema or dermatitis, respectively. LIMITATIONS: Only primary diagnoses were included in analysis. Determining one’s race is increasingly difficult. CONCLUSION: Follicular disorders occurred with an increased frequency in blacks. When examining SES, eczema or dermatitis was the most frequently encountered primary diagnosis at the clinic with the lowest SES, with benign skin neoplasm seen with the highest frequency at the clinic with the highest SES. J Drugs Dermatol. 2018;17(10):1032-1036.

Burn patients with extensive involvement of body surface area (BSA >30%) represent a challenge in wound treatment. Multiple topical agents may be used for cleansing, barrier protection, and antimicrobial control leading to complications of contact and/or irritant dermatitis, which may further complicate re-epithelization and eventual wound healing. We present 4 patients who sustained extensive burns during Operation Iraqi Freedom/Operation Enduring Freedom and later developed contact dermatitis to mafenide acetate, a common topical antimicrobial used in burn care treatment, also known as Sulfamylon® (alpha-amino-p-toluenesulfonamide monoacetate). All patients who were patch tested to mafenide acetate 7% solution were positive. A rechallenge with mafenide acetate resulted in recrudescence of the eruption in 2 out of the 4 patients. Though cutaneous reactions to mafenide acetate were reported by Yaffe and Dressler in 1969, the most recent case reports are from 1995. This paper presents more recent examples of cutaneous reactions to mafenide acetate, while also reviewing the literature.

BACKGROUND: There is a reported global decrease in the number of clinical trials conducted in recent years. We aimed to determine if this declining trend can be extrapolated to dermatologic clinical trials.
METHODS: We conducted a query of ClinicalTrials.gov for dermatologic clinical trials from 2009 to 2013 for 6 common skin conditions: acne, psoriasis, rosacea, eczema and atopic dermatitis, actinic keratosis, and skin cancer. Results were sorted by condition and number of study subjects. This study did not involve any participants apart from the researchers.
RESULTS: Although there is an increasing trend in the number of trials performed annually, the results were not significant (P=.08). The average number of patients per study has not significantly changed (P=.12), but there was a significant increase in the number of large studies (201+ subjects) conducted over time (P=.002). Although there was significant variation based on dermatologic condition studied (global statistic P=.01), only skin cancer demonstrated a significant change in the number of studies registered annually (β=10.6 studies/year, P=.04).
CONCLUSIONS AND RELEVANCE: The sky does not appear to be falling, at least not yet, with regard to continued development of treatments for patients with skin disease.

J Drugs Dermatol. 2015;14(5):497-500.

Topical corticosteroids (TCSs) are a major part of the foundation of treatment for a wide variety of eczematous and inflammatory skin disorders in both adults and children. Mid-potency TCSs represent an important category as they are often used to treat eczematous dermatoses, such as atopic dermatitis. The TCS product must effectively release the active ingredient and promote cutaneous penetration so that therapeutic activity can occur. As many topical products eventually become available as generic formulations, it is important to recognize that although the active ingredient and its concentration are the same, the vehicle excipients may differ significantly, occasionally leading to potential differences in irritancy, in allergenicity, in effects on epidermal permeability barrier function, and, possibly, in efficacy. Clocortolone pivalate 0.1% cream is a mid-potency TCS formulated in an emollient formulation that has been shown to be effective and well-tolerated in the management of several corticosteroid-responsive dermatoses. This article outlines the pharmacologic and clinical data achieved with the original brand formulation of clocortolone pivalate 0.1% cream, and discusses the establishment of an authorized generic formulation that is identical in formulation to the original brand.

J Drugs Dermatol. 2014;13(suppl 7):s77-s83.

Introduction: Diaper dermatitis is a common condition that develops in the diaper area due to factors such as elevated moisture, increased skin surface pH, and exposure to irritants from urine and feces. These factors suggest interventions to prevent or treat diaper dermatitis such as exposing the skin to air, frequent diaper changes, and thorough cleansing of the diaper area. Barrier creams and powders also have a role in preventing and treating diaper dermatitis. We developed a cream-to-powder product with a formula based on corn starch and other natural ingredients for use in the diaper area. Methods: Dye exclusion study: The barrier properties of the cream-to-powder product were assessed using a dye exclusion protocol. Skin color at treated and untreated forearm sites was measured at baseline and after exposure to crystal violet stain. The cream-to-powder product’s ability to inhibit the water-soluble dye from reaching the skin was judged by comparing color changes at the treated and untreated sites. Tolerance-in-use study: The safety of the cream-to-powder product was assessed in a four-week tolerance-in-use study conducted in a group of 52 diaper-wearing infants and toddlers. Subjects’ parents/guardians applied the cream-to-powder product at each diaper change. A pediatrician judged safety endpoints of erythema, dryness, and edema in the diaper area at baseline and at study end. Parents/guardians also completed a questionnaire at study end. These studies have complied with Good Clinical Practices (GCP/ICH). Outcomes: The cream-to-powder product prevented about 70% of the test dye from reaching the skin surface, demonstrating its ability to supplement the skin barrier. The tolerance-in-use study showed no statistically significant changes in any of the safety endpoints; there were no adverse events. Parents/guardians responses to the cream-to-powder product were overwhelmingly positive. Taken together, these results support that the cream-to-powder formulation is safe and effective for helping to prevent diaper dermatitis. J Drugs Dermatol. 2018;17(5):566-570.

No abstract details for the moment.

Erythema multiforme is an acute, hypersensitivity reaction of the skin often secondary to medications. Lamotrigine is a relatively new anticonvulsant medication approved for seizure and psychiatric disorders. Although the overall incidence of cutaneous reactions to lamotrigine is high, the incidence of serious eruptions such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis is low. Vigilant surveillance for any cutaneous eruption in patients on lamotrigine is important, particularly in the first 8 weeks, as prompt discontinuation of the medication can prevent progression. We report a case of erythema multiforme secondary to lamotrigine, which clinically resembled a contact dermatitis, and review the management of lamotrigine associated cutaneous eruptions.

A 35-year-old Asian woman was referred to the dermatology clinic with a 2-week history of enlarging, fluid-filled, pruritic lesions on the right foot. The affected area had a recent history of minor trauma for which the patient applied an over-the-counter propolis ointment. At presentation, the patient was also noted to have been using the following, as prescribed by her primary care physician: valacyclovir, ciprofloxacin, terbinafine cream, mupirocin ointment, and 2% hydrocortisone cream. No clinical improvement was observed with these agents. Examination revealed grouped erythematous papules progressing into vesicles and bulla on the lateral side of the right foot. A KOH scraping was negative. We diagnosed the patient with allergic contact dermatitis to propolis.

BACKGROUND: Occupational irritant contact dermatitis (OICD) is a dif cult and hard to manage condition. It occurs more frequently in certain occupations where contact with harsh chemicals, use of alcohol-based disinfectants, and frequent hand washing heightens the risk. Treatment for OICD includes patient education in addition to physical, topical, and systemic therapies. OBJECTIVE: To review the pathogenesis and treatment options for OICD and evaluate the ef cacy of a selective skin-care regimen involv- ing a hand protectant cream alone as well as combined with a repair cream and speci c cleanser. MATERIALS AND METHODS: A single-center open study was performed comprising 42 healthy male and female adult volunteers prone to occupational irritant contact dermatitis due to frequent wet work or contact with detergents. Between day 0 and day 7, subjects applied a hand protectant cream as needed on both hands (at least twice daily). On days 7 to 14, subjects applied a hand protectant cream and cleanser as needed on both hands (at least twice daily) as well as a repair cream each evening. A diary log was given to each volunteer for application control and for a subjective evaluation of daily tolerability. RESULTS: In these subjects prone to occupational irritant contact dermatitis, the hand protectant cream applied during the initial 7-day period was effective in restoring the damaged skin barrier and improving the stratum corneum hydration. A regimen that combined the hand protectant and repair creams with a speci c cleanser during a further 7-day period allowed contin- ued improvement of skin hydration and additional clinical bene ts while respecting the skin barrier function. CONCLUSION: The results of this study support the use of a 3-step approach for patients who are at risk of repeated exposure to external irritants. J Drugs Dermatol. 2016;15(suppl 11):s81-85.

BACKGROUND: Chronic hand dermatitis may have a significant detrimental effect on daily home-related and work-related activities, and quality of life (QOL). Clobetasol propionate foam, 0.05%, is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged 12 years and older.
OBJECTIVES: To demonstrate superior efficacy, similar safety, and superior QOL outcomes in subjects with moderate to severe chronic hand dermatitis following treatment with clobetasol propionate foam, 0.05%, compared with vehicle foam.
METHODS: In this randomized, double-blind, vehicle-controlled, parallel-group, multicenter study (ClinicalTrials.gov identifier NCT01323673), subjects aged 12 years and older with moderate to severe chronic hand dermatitis and an Investigator's Static Global Assessment (ISGA) score of 3 or 4 at baseline were randomized 1:1 to receive clobetasol propionate foam, 0.05%, or vehicle foam, twice daily over 15 days. The primary end point was the proportion of subjects who achieved treatment success, defined as improvement from baseline of ≥2 ISGA grades for the target hand at day 15.
RESULTS: In total, 125 subjects were enrolled: 62 subjects were randomized to the clobetasol propionate foam group and 63 subjects were randomized to the vehicle foam group. The proportion of subjects with treatment success at day 15 did not differ significantly between treatment groups. Adverse events (AEs) were reported in 18% of subjects in the clobetasol propionate foam group and 8% of subjects in the vehicle foam group. No serious AEs, AEs resulting in discontinuation of study product, or severe AEs were reported in the clobetasol propionate foam group.
CONCLUSIONS: Clobetasol propionate foam, 0.05%, was not significantly more efficacious than vehicle foam at improving chronic hand dermatitis on investigator-assessed end points. Emollient properties of the study product vehicle may be a confounder in the study.

J Drugs Dermatol. 2013;12(3):328-334.

Ciclopirox is a broad-spectrum antifungal, antibacterial, and anti-inflammatory agent. This open-label study investigated the safety and efficacy of ciclopirox topical suspension 0.77% in the treatment of diaper dermatitis due to Candida albicans (C. albicans). Forty-four male and female subjects aged 6 to 29 months were included in the study. Study medication was applied topically to the affected diaper area twice daily for 1 week. Subjects were clinically evaluated at baseline and days 3, 7, and 14 (7 days post-treatment). Safety and efficacy variables included adverse events, mycological culture studies, KOH tests, Severity Scores, and Global Evaluation of Clinical Response. All adverse events were mild to moderate and considered not related to the study medication. Treatment provided statistically significant improvement (P < .05) for both the rate of mycological cure and reduction of Severity Score at each time point compared with baseline. Ciclopirox was safe and effective in the treatment of diaper dermatitis due to C. albicans

BACKGROUND & AIMS: Nutrition has long been associated with skin health, beauty, integrity and aging through multiple pathways and cofactors implicated in skin biology. The onset and clinical course of various common skin diseases, especially acne, psoriasis, atopic dermatitis, and hair loss, have been suggested to be critically affected by nutrition patterns and habits. The relationship between acne and diet, predominantly the role of high glycemic load diets and dairy consumption have recently gained increased interest. Abnormal nutritional conditions such as obesity or malnutrition often manifest themselves by specific cutaneous features and altered skin function. Skin photoprotection, rendered by various nutrients, is well documented and appropriate nutritional supplementation has been shown to exert beneficial effects upon impaired skin integrity, restore its appearance and promote skin health. It is our intention to provide a comprehensive review of the most recent information on the role of nutrition for common skin diseases and regulation of skin biology.
METHODS: Nutritional clinical studies in dermatology have been reviewed using the MedLine literature source and the terms "diet" or "nutrition" and "skin".
RESULTS & CONCLUSIONS: The data on the relationship between nutrition and skin are until now controversial and much more work is needed to be done to clarify possible etiological correlations.

J Drugs Dermatol. 2013;12(10):1104-1109.

Keratosis pilaris (KP) is a common skin finding that presents as follicular hyperkeratotic papules on the proximal extremities in patients with a propensity for atopy. Although often asymptomatic, the stippled appearance is cosmetically disturbing to patients and difficult to treat as current therapies are limited in availability and efficacy. Nitric oxide (NO) has been found to be essential in basic systemic and cutaneous physiologic function, specifically in terms of its anti-microbial and anti-inflammatory properties, which evolutionarily was maintained by ammonia-oxidizing bacteria (AOB). As modern hygiene practices have improved, there has been a gradual loss of cutaneous AOB and, therefore, the availability of an important source of human physiologic NO. We propose that restoring this dermal microflora with a purified strain of AOB, Nitrosomonas eutropha (D23), may reduce the overall cutaneous inflammatory state and, thus, be a potential therapeutic option for improving the cosmetic appearance of a skin condition such as KP which is often found in association with xerosis and atopic dermatitis. Clinical trial registry number: NCT03243617

J Drugs Dermatol. 2018;17(3):285-288.

Urea is an important hygroscopic component of the epidermis, where it participates in the maintenance of skin hydration as part of the skin’s source of natural moisturizing factor (NMF) in the outer most layers. Xerotic skin, which is frequently characterized as NMF-deficient, is a unifying trait of dermatoses such as atopic dermatitis (AD), psoriasis, and ichthyosis vulgaris. The reduced hygroscopic potential of pathologically dry skin leads to unregulated transepidermal water loss (TEWL), epidermal hyperproliferation, and inhibited desquamation; all which clinically translate to hyperkeratotic and possibly pruritic skin. Common underlying etiologies link these dermatoses to aberrant expression of genes encoding epidermal structural and catalytic proteins. Intervention of dry skin pathologies with topical moisturizer formulations is a foundational management strategy. For over a century urea-containing formulations have been used in a concentration-dependent manner to restore skin hydration, thin hyperkeratosis, debride dystrophic nails, and enhance topical drug penetration. Recently, urea’s role in skin hydration and repair has expanded to include regulation of epidermal genes necessary for proper barrier function. Taken together, urea’s versatility in topical formulations and broad range of therapeutic mechanism highlights its utility to clinicians and benefit to patients.

J Drugs Dermatol. 2016;15(5):633-639.

Background: Chronic dermatitis that is refractory to topical therapy poses a difficult treatment problem. Many patients are corticosteroid dependent. Mycophenolate mofetil (MMF) is a systemic B- and T-cell inhibitor that has some effect on delayed-type hypersensitivity.

Design, Setting, Interventions: In this open-label study conducted in a university-affiliated private practice setting, 16 patients with chronic and refractory eczema of three months duration or longer were enrolled consecutively into one of three cohorts based on dosage of MMF: five at 1 g /d, six at 1.5 g/d and five at 2.0 g/d. Patients in each cohort were allowed to increase dosage to a maximum of 3 g/d during the study. The authors evaluated the improvement of eczema and the presence of side effects over a 34-week period. Trends in patient and investigator global assessments were analyzed with the fitting of models using generalized estimating equations (GEE).

Main Outcome Measures: To determine the efficacy and safety of mycophenolate mofetil (MMF) in the treatment of chronic and refractory eczema.

Results: Twelve of 16 patients improved by patient global assessment and 14 of 16 patients improved by investigator global assessment during the study. Three patients cleared completely and six patients were almost clear. MMF was well-tolerated. One patient experienced a serious adverse event (pancreatic cancer), early in the study, while on therapy. This patient had dermatitis that improved, but pruritus that was out of proportion to exam and a further workup to evaluate newly elevated liver functions after study initiation revealed the pancreatic cancer.

Conclusion: Mycophenolate mofetil is an effective and well-tolerated treatment for some patients with chronic dermatitis.

No abstract details for the moment.

Oats (Avena sativa) are a centuries-old topical treatment for a variety of skin barrier conditions, including dry skin, skin rashes, and eczema; however, few studies have investigated the actual mechanism of action for the skin barrier strengthening activity of colloidal oatmeal. Four extracts of colloidal oatmeal were prepared with various solvents and tested in vitro for skin barrier related gene expression and activity. Extracts of colloidal oatmeal were found to induce the expression of genes related to epidermal differentiation, tight junctions and lipid regulation in skin, and provide pH-buffering capacity. Colloidal oatmeal boosted the expression of multiple target genes related to skin barrier, and resulted in recovery of barrier damage in an in vitro model of atopic dermatitis. In addition, an investigator-blinded study was performed with 50 healthy female subjects who exhibited bilateral moderate to severe dry skin on their lower legs. Subjects were treated with a colloidal oatmeal skin protectant lotion. Clinically, the colloidal oatmeal lotion showed significant clinical improvements in skin dryness, moisturization, and barrier. Taken together, these results demonstrate that colloidal oatmeal can provide clinically effective benefits for dry and compromised skin by strengthening skin barrier.

J Drugs Dermatol. 2016;15(6):684-690.

Pegylated liposomal doxorubicin (PLD) is a chemotherapeutic agent used in the treatment of solid tumors. It has a considerably lower risk of cardiotoxicity than its parent compound, doxorubicin. PLD also has a different cutaneous side effect profile than doxorubicin, and its cutaneous toxicity can be dose limiting. We report the case of a 60-yearold woman who developed erythema and erosions in the axilla and groin while on PLD for breast cancer. Nystatin was ineffective. Biopsies revealed an interface dermatitis with epidermal dysmaturation. Bland emollients and reduction in the dose of PLD resulted in resolution of the eruption. An intertriginous eruption with histological features of epidermal dysmaturation and an interface dermatitis has been previously reported in the dermatopathology literature. This eruption appears to be a distinct cutaneous toxicity of PLD.

Background: Hand dermatitis is a chronic inflammatory skin disorder for which systemic immunosuppressive therapy is often needed. Topical treatments could complement the use of systemic corticosteroids.

Objective: To evaluate symptoms of hand dermatitis in subjects treated with a prednisone taper combined with topical tacrolimus 0.1% ointment versus vehicle.

Methods: Thirty-two subjects with moderate to severe hand dermatitis were enrolled in a randomized double-blind controlled trial. Subjects received a 3-week taper of prednisone and was randomized 2:1 to apply topical tacrolimus or its vehicle twice daily for 12 weeks. Disease severity was evaluated at baseline and at 5 follow-up visits (weeks 1-14). Any occurrence of relapse was recorded by patients.

Results: Twenty-two of the 32 subjects (69%) had relapse of their disease. The mean time to recurrence for tacrolimus versus vehicle was 48 versus 39 days, respectively (P=.78). A greater improvement of induration (P=.003) and scaling (P=.003) for patients with tacrolimus compared to vehicle was detected, as well as subjective improvement (%) from week 1 to week 12 (P=.04) compared to vehicle. Improvement in erythema (P<.0001), fissuring (P=.0003), pruritus (P=.06), and investigator’s global assessment (P<.0001) with tacrolimus was not found to exceed improvement with vehicle.

Limitations: Small sample size provides limited power to detect differences in response.

Conclusions: Topical tacrolimus improves induration and scaling, and there is a trend suggesting it prolongs the time to recurrence.

No abstract details for the moment.

Objectives: To demonstrate the efficacy and evaluate the safety of sertaconazole nitrate cream 2% in the treatment of seborrheic dermatitis (SD).
Design: Single-center, open-label study.
Setting: One academic medical center.
Participants: Twenty adult male and female subjects aged 22 to 85 years (average, 56 years) with mild-to-severe seborrheic dermatitis of the face.
Measurements: The primary efficacy evaluation was the proportion of subjects with a score of 0 or 1 at the end of treatment (week 4) on the Investigator's Static Global Assessment scale. Secondary end points included percent change from baseline to week 4 in sum individual scores of erythema, scaling, induration, and pruritus at a preselected target lesion. Other end points included change in scores on Subject's Global Assessment scale and the Dermatology Life Quality Index.
Results: Success on the primary end point was achieved by 10 of 17 evaluable subjects (58.8%). Improvements in Investigator's Static Global Assessment score from baseline were statistically significant at each week. Significant improvements were also demonstrated in erythema, scaling, induration, and pruritus at week 4 compared to baseline. Improvement in Subject's Global Assessment scores compared to baseline were significant only at week 1 (P=0.031). Change in total mean SD Dermatology Life Quality Index scores from baseline to week 4 was 0.34 (± 0.62, P=0.039).
Conclusion: The results of this preliminary study support the efficacy and safety of sertaconazole nitrate cream, 2%, for the treatment of seborrheic dermatitis.

J Drugs Dermatol. 2011;10(8):898-902.

Background: There are no published studies examining either the effectiveness of topical steroids in the treatment of stasis dermatitis or indicating what steroid strength or duration of treatment is optimal to treat this common condition.

Objective: To investigate the efficacy of twice-daily application of the topical steroid betamethasone valerate 0.12% foam for the treatment of stasis dermatitis.

Design: 42-day randomized, double-blinded, vehicle-controlled, pilot study.

Settings: Outpatient dermatology clinic at a university-affiliated clinic.

Subjects: 19 subjects, mean age of 73, with mild to moderate bilateral stasis dermatitis.

Intervention: Twice-daily application of betamethasone valerate 0.12% foam versus vehicle foam to bilateral randomly assigned lower legs for 28 days with follow-up to day 42.

Main Outcome Measures: The primary clinical endpoints were the mean change in erythema, scale, swelling, petechiae, post-inflammatory hyperpigmentation, and self-reported pruritus, assessed on a 5-point Likert scale (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe). Secondary endpoints were changes in health related quality of life (HRQL) using the EuroQol-5D (EQ-5D) utility score and visual analog scale (VAS) and the Dermatology Life Quality Index (DLQI).

Results: Although there was no overall difference between the foam and vehicle-treated leg at days 14 and 28, the steroid-treated leg, but not the vehicle-treated leg, showed statistical improvement over baseline. Improvement in the steroid-treated leg was statistically better than vehicle at days 14 and 28 in terms of erythema (P < .05) and petechiae (P < .05). Improvement in VAS was notable at days 14 (7.1%), 28 (9.7%), and 42 (9.6%) (P < .001). Similarly, there was a statistically significant improvement in the DLQI compared to baseline on visit days 14 (188.9%) and 28 (126.1%) (P < .001).

Conclusions: This study suggests that betamethasone valerate 0.12% foam is an effective and well-tolerated short-term treatment of stasis dermatitis, but that higher potency steroids may be needed to achieve better efficacy. Furthermore, these results are the first to suggest that the application of effective topical anti-inflammatory therapy can lead to improvement in HRQL.

BACKGROUND: Topical corticosteroids offer great efficacy in controlling a wide variety of dermatoses. Traditional ointment vehicles are messy and difficult to apply, which might limit adherence. Alternative vehicle formulations such as topical sprays might improve adherence due to their ease of application. The potency of desoximetasone spray is not fully characterized. OBJECTIVE: To evaluate the relative vasoconstrictive potency of desoximetasone 0.25% topical spray formulation. METHODS: This is a randomized, blinded, single-center study comparing the vasoconstrictive properties of desoximetasone 0.25% topical spray to placebo and seven other known potency topical corticosteroid formulations. The primary endpoint was the degree of vasoconstriction measured using a colorimeter device. RESULTS: Thirty-two healthy subjects met eligibility criteria. Desoximetasone 0.25% topical spray (REGWQ Grouping = A) showed a trend toward greater vasoconstrictive potency compared to clobetasol propionate 0.05% spray (REGWQ Grouping = A). No adverse or serious events were reported. Limitations: The trial enrolled 90% females, which may affect the external validity of the study. Different populations may respond differently to desoximetasone spray. CONCLUSIONS: Desoximetasone 0.25% topical spray is a high to super high range of potency (Class I to Class II) steroid formulation. Given the cosmetic acceptability of spray products, we anticipate that this type of product would be highly effective for the treatment of inflammatory diseases in clinical practice.

J Drugs Dermatol. 2017;16(10):972-975.

Background: Ketoconazole foam, 2%, is approved in the United States for seborrheic dermatitis therapy in immunocompetent patients aged ≥12 years. While short-term trials have demonstrated its safety and efficacy, seborrheic dermatitis often requires long-term treatment.
Objective: To assess the long-term safety of ketoconazole foam, 2%, twice daily, as required.
Methods: A 12-month, open-label, multicenter study. Subjects were evaluated at baseline and at weeks 4, 8, 16, 26, 39, and 52 (or early termination [ET]) for adverse events (AEs), serious AEs (SAEs), target lesion erythema, scaling, and pruritus, as well as Investigator's Static Global Assessment (ISGA) scores. Physical examinations were performed at baseline and at week 52/ET, and laboratory evaluations at baseline and at weeks 8, 26, and 52. A poststudy product-preference questionnaire was completed.
Results: Of 500 subjects enrolled, 498 were included in the safety population, and 363 completed the study. Overall, 57% of subjects reported ≥1 AE. Treatment-related AEs occurred in 14% of subjects, including application-site irritation (8%), application-site pain (4%), application-site pruritus (1%), and increased alanine aminotransferase (1%). Seven subjects were withdrawn because of treatment-related AEs. No SAEs (21 in 17 subjects) were considered to be related to study drug. Mean target lesion erythema, scaling, and pruritus scores improved by 2 units from baseline at all study visits; mean ISGA score improved by 1 unit at week 4 and by 2 units at subsequent visits. The foam vehicle was preferred by 67% of subjects.
Limitations: Evaluation of severity was limited to target lesion; no objective measure of adherence.
Conclusion: The long-term safety profile of ketoconazole foam, 2%, in subjects with seborrheic dermatitis was favorable and efficacy was maintained. This trial was registered at clinicaltrials.gov (NCT00703846).

J Drugs Dermatol. 2013;12(1):e1-e6.

Prior to 1962, some of the most versatile drugs in dermatology were approved by the U.S. Food and Drug Administration (FDA) solely on the basis of safety. One of these is the combination 10% sodium sulfacetamide and 5% sulfur. Sodium sulfacetamide possesses anti-inflammatory and antibacterial properties while sulfur is a nonspecific antibacterial and antifungal. A new emollient foam formulation of 10% sodium sulfacetamide and 5% sulfur allows a thinner application film and leaves behind no residue on hair bearing or nonhair bearing skin. The sulfur smell is also more quickly dissipated with reduced irritation. This uncontrolled, observational, prospective, open-label, single site, eight-week study enrolled 24 subjects (eight with rosacea, eight with seborrheic dermatitis, eight with acne vulgaris) to evaluate the safety and efficacy of this novel foam formulation. At eight weeks, statistically significant improvement was seen in inflammatory rosacea lesion counts and the signs of seborrheic dermatitis. A 50% reduction was noted in the total acne lesion counts. These findings confirm the versatility of an emollient 10% sodium sulfacetamide and 5% sulfur foam.

Background: Although consistently associated with sun exposure, melasma is common among sun-shy Filipino women who generally prefer to have lighter skin, use skin lighteners, regularly practice sun avoidance, and are more exposed to indoor lights. Objective: To determine presence/absence of photocontact dermatitis in melasma/no-melasma patients using photopatch testing (PhPT) with standard photocontactants and an indoor visible light (VL) source. Design: Cross-sectional study: random population of 40 female patients aged 30-55 years, 20 with and 20 without melasma. The PhPT included 67 photocontactant allergens: 59 from Chemotechnique Diagnostics (24 fragrance, 22 North American photopatch, 13 plants) and 8 cosmetic allergens from Skin Sciences Laboratory Inc. (Pasig, Philippines) in sets of paired test patches. One of the pairs was irradiated with a 500-watt tungsten halogen lamp as the VL source; the other was the nonirradiated control. The standard protocols of the North American Contact Dermatitis Group (NACDG) was used to examine the nonirradiated control patches after 48 and 72 hours, the DAPT (German/ Austrian/ Swiss Photopatch Study Group) was used to examine the VL-irradiated patches, and both protocols were used to interpret relevance of the readings as to the presence or absence of contact dermatitis (CD) or photocontact dermatitis (PhCD). Results: Fifty-five percent of patients in the melasma group (N=11/20) had 29 positive (+) PhPT reactions to VL-irradiated allergens (11 fragrances, 11 North American, 7 plants). In the no-melasma group, none had (+) PhPT. This association is highly significant (P=0.00 using 2-tailed Fischer’s exact test), such that compared to a (–) PhPT, a (+) PhPT has 12.67 times more likelihood to develop melasma (P=0.05: 1.402-114). All 29 (+) PhPT were decrescendo type, replaced by pigmentation observed up to 7 days suggesting phototoxic reactions, and all had (+) clinical relevance establishing phototoxic low-energy VL-PhCD. Conclusion: Melasma worsens with sun exposure, but this study shows that the low energy of artificial indoor VL is enough to react with photocontactants followed by a pigmentation response that may account for its clinical appearance as a mostly noninflammatory slowly evolving facial pigmentation.

Background: Topical corticosteroids are often considered to have greater safety and poorer efficacy than oral corticosteroids in treating psoriasis and atopic dermatitis. There are limited data for assessing relative efficacy of topical and systemic corticosteroids, however. The concentration of corticosteroid in skin, adjusted for the relative potency of the active compound, may be a predictor of clinical efficacy and can be estimated for both topical and oral administration.

Purpose: To analyze the assumption that oral corticosteroid therapy should be more potent than topical therapy by comparing relative corticosteroid concentrations in the skin expected with topical versus systemic administration.

Methods: The estimated skin concentration of prednisone following oral dosing was calculated based on data showing 70–100% bioavailability and an even tissue distribution. Data on the concentration of corticosteroids found in skin after topical application were obtained from the literature. The relative potencies of corticosteroid molecules were then used to compare skin concentrations of corticosteroid following topical versus oral treatment.

Results: Data derived from the existing literature demonstrated that hydrocortisone 2.5% ointment, triamcinolone 0.1% ointment, and clobetasol 0.05% foam achieved effective skin concentrations greater than the effective concentration achieved by oral prednisone. Betamethasone 0.1% cream achieved effective concentrations in skin within the range created by oral prednisone.

Limitations: This analysis was limited by the paucity of data regarding cutaneous concentrations of corticosteroids after topical application, and by the differing experimental designs utilized in the available studies.

Conclusion: Most topical corticosteroids have the potential to achieve greater effective drug levels in the superficial layers of skin than those achieved with standard doses of oral prednisone. The apparently greater efficacy of oral corticosteroid therapy may be attributable, in part, to poor patient compliance with topical therapy. Systemic alterations in immune function following oral, but not topical, corticosteroid use may also play a role.

CD70 (CD27L) has been shown to be preferentially expressed on Th1, but not Th2, CD4+ lymphocytes in murine contact sensitivity. The CD70-CD27 co-stimulatory pathway as well as the Th17 subset of lymphocytes have also been identified in human contact sensitivity reactions. The authors have previously reported increased expression of CD70 and the Th17-specific transcription factor retinoid orphan receptor gamma T in the elicitation phase of allergic contact dermatitis by reverse transcriptase-polymerase chain reaction. The manipulation of these pathways has potential for ameliorating autoimmune and inflammatory disorders such as allergic contact dermatitis, psoriasis and rheumatoid arthritis. Also, upregulation of the CD70-CD27 and Th17 pathways has been associated with the remarkable ability of topical sensitizers to treat warts and skin cancers including melanoma. As natural killer and natural killer T cells are also involved in contact sensitivity, future studies investigating the function of these cells are necessary to elucidate the transition between innate and acquired immune responses in the context of the Th1/Th2/Th17 and regulatory T cell paradigm.

J Drugs Dermatol. 2011;10(10):1192-1194.

Occupational irritant contact dermatitis (ICD) affecting the hands is a common and difficult-to-manage condition. Occupations that necessitate contact with harsh chemicals, use of alcohol-based disinfectants, and frequent hand washing elevate the risk of ICD. Management strategies that do not adequately prevent accumulated damage and repair skin, can develop into chronic dermatoses which negatively impact work productivity and quality of life. A 2-step skin-care regimen (Excipial Daily Protection Hand Cream (EP) and Excipial Rapid Repair Hand Cream (ER), Galderma Laboratories, L.P.) has been developed as a daily-use management strategy to protect and repair vulnerable hands. The protective barrier cream is formulated with aluminum chlorohydrate and designed for pre-exposure application to enhance the skin’s natural protective barrier and minimize excessive moisture while wearing protective gloves. The repair cream, a lipid-rich formulation, is intended for post-exposure application to rehydrate and facilitate the skin’s natural healing process. The results of 3 clinical studies highlighted in this review demonstrate how the use of a 2-step skin-care regimen offers a greater protective effect against ICD than the use of barrier cream alone, and also how the formulation of the barrier cream used in these studies helps minimize the occlusion effect caused by gloves and does not interfere with the antibacterial efficacy of an alcohol-based hand sanitizer. This 2-step skin-care regimen is effectively designed to manage and minimize the risk of ICD development in a variety of patients and provides clinicians an additional tool for helping patients manage ICD. J Drugs Dermatol. 2016;15(12):1504-1510.

A healthy 47-year-old woman developed diffuse pustules and edema of the skin after exposure to diltiazem and cephalexin. Bacterial, fungal and viral cultures were sterile suggesting a noninfectious etiology. A skin biopsy showed spongiosis, subcorneal collection of neutrophils, papillary dermal edema and a superficial perivascular mixed cell infiltrate. The clinical and histopathologic findings were consistent with acute generalized exanthematous pustulosis (AGEP). The patient was treated with supportive care and the pustular dermatitis cleared. AGEP is a rare complication of drug therapy and should be considered in the differential diagnosis of patients presenting with acute onset pustular dermatitis.

Drug reactions are an uncommon and unpredictable complication of medical therapy. Cutaneous drug reaction rates occur with a frequency of 1% to 8% and can be higher for certain classes of drugs¹. They can range from mild morbilliform eruptions to more severe forms such as drug-hypersensitivity syndrome, toxic epidermal necrolysis or anaphylaxis. Acute generalized exanthematous pustulosis (AGEP) is a rare presentation of a drug reaction and can be difficult to distinguish from other pustular dermatoses. Herein we review a case of AGEP and include a discussion of salient clinical and histological features of AGEP.

Dermatologists frequently employ combination therapy to treat various diseases, but the evidence to support the use of such combinations is often lacking. Synergy is an appealing although somewhat ambiguous concept in medicine. Utilizing synergy allows clinicians to provide the most efficacious combination of treatments to patients, while potentially minimizing adverse effects and reducing the development of drug resistance. Definitions of synergy vary, but ultimately converge on finding a therapeutic advantage in combining treatments. Here we discuss the concept of

BACKGROUND: Seborrheic dermatitis (SD) is a chronic mild skin disorder with high prevalence. Various treatment options are available, including topical antifungals and anti-inflammatories. Antifungal and anti-inflammatory properties of Quassia amara have been reported.
AIM: To check the efficacy and safety of a topical gel with 4% Quassia amara extract and compare it with topical 2% ketoconazole and 1% topical ciclopiroxolamine in the treatment of facial SD.
METHODS: A group of 60 patients displaying facial SD were randomly distributed in 3 groups and given either a topical gel with 4% Quassia amara extract, a topical gel with 2% ketoconazole, or a topical gel with 1% ciclopirox olamine for 4 weeks. Disease severity was assessed at the start and weekly along treatment, as well as 4 weeks after the end of treatment. In each selected area, severity of erythema, scaling, pruritus, and papules were scored from 0 to 3, the sum of these values representing the score of SD on the face. This evaluation was conducted at each visit. The decrease in SD score with all 3 products was compared at each visit. At each stage, overall improvement, safety, and tolerability were also assessed.
RESULTS: Of the 60 patients, 54 (90%) completed the study. The 3 therapeutic options resulted to be very effective, with a significant advantage in efficacy for 4% Quassia extract. For the other 2 drugs, the results were in line with those previously published in the literature.
CONCLUSION: Topical gel with 4% Quassia extract represents a new, safe, and effective treatment for facial SD.

J Drugs Dermatol. 2013;12(3):312-315.

No abstract details for the moment.

Paclitaxel (Taxol®) is an intravenously administered antineoplastic agent derived from the yew tree, Taxus brevifolia, whose mecha- nism of action involves inhibition of mitosis. Some of the mucocutaneous reactions to the drug that have been observed include alopecia, mucositis, hypersensitivity reactions (with erythema and urticaria), nail changes, changes occurring at intravenous sites, and radiation recall dermatitis. Less commonly, acral erythema, erythema multiforme, pustular dermatitis, and scleroderma-like changes have been described. A female patient who was receiving adjuvant weekly paclitaxel for the treatment of intraductal breast carcinoma developed photodistributed erythema multiforme and onycholysis after sun exposure to the affected areas. Including this woman, paclitaxel-associated photosensitve conditions have only been reported in 9 female oncology patients: onycholysis (5), erythema multiforme and onycholysis (2), photo-recall phenomenon (1), and subacute cutaneous lupus erythematosus (1). The patients were either receiving treatment for breast carcinoma (8) or lung cancer (1). The skin lesions developed on sun-exposed areas, usually after the patient had received several weekly doses of paclitaxel, and resolved following discontinuation of the drug. Several of the patients were subsequently able to receive additional cycles of paclitaxel without recurrence of their drug-associated photosensitive conditions by concurrently using photoprotection to prevent additional sun exposure to the previously affected sites during treatment.

Treatment of prurigo nodularis (PN) is often very difficult even with strong corticosteroid dressing and other available means. Macrolide roxithromycin (RXM) is used in consideration of its immunosuppressive effects in treating several skin disorders. Tranilast (N-(3,4-dimethoxycinnamoyl) is useful for treating atopic disorders and hypertrophic scars as well, suggesting its capacity to inhibit fibroblast proliferation. More adequate and effective therapy for this disorder has been requested. We report 3 cases of uncontrollable PN treated with 300 mg/day roxithromycin and 200 mg/day tranilast. Complete and/or remarkable regression of PN was observed on treatment with roxithromycin and tranilast in combination within 4 to 6 months. The 2 agents in combination can be used effectively for the treatment of uncontrollable PN.

Three conditions, erythema dyschromicum perstans (EDP), granulomatous periorificial dermatitis (GPD), and Kawasaki disease (KD) are seen more frequently in children of color. EDP and GPD are benign and self-limited dermatoses; therapy can shorten the course of the diseases. KD, a systemic vasculitis, can have life threatening cardiac consequences and timely therapy is essential. In all 3 conditions, clinicians should proceed with prompt and appropriate evaluation, diagnosis, and intervention when indicated. A case representing each condition is presented, followed by a discussion.

Heat-shock proteins (HSPs) serve as both a valuable target as well as a potent tool in the therapy of melanoma and human papillomavirus infections. HSPs have been found to associate with key pathogenic antigens and, under different circumstances, activate or suppress both innate and adaptive immunity via several mechanisms. The dominant mechanism of HSP is as a chaperonin to upregulate antigens on antigen-presenting cell surfaces. While no HSP-based therapies are currently FDA approved, several are currently in phase III clinical trials. This study reviews the current literature on therapeutic studies of HSP and the significant role these proteins are likely to play in future therapeutic approaches to neoplasms, infections, and inflammatory diseases of the skin.

Sulfur has antifungal, antibacterial, and keratolytic activity. In the past, its use was widespread in dermatological disorders such as acne vulgaris, rosacea, seborrheic dermatitis, dandruff, pityriasis versicolor, scabies, and warts. Adverse events associated with topically applied sulfur are rare and mainly involve mild application site reactions. Sulfur, used alone or in combination with agents such as sodium sulfacetamide or salicylic acid, has demonstrated efficacy in the treatment of many dermatological conditions.

INTRODUCTION: Dermatologists are becoming more aware of the irritant and allergic potential of laundry detergents that incorporate harsh surfactants and potentially sensitizing ingredients. It is difficult however for the physician to distinguish one laundry detergent from another because the only distinguishing feature advertised tends to be the lack of dyes and fragrances.

DESIGN: A new objective method was developed for measuring the harshness of laundry detergents using a three-pronged laboratory testing approach consisting of zein, corneosurfametry, and cytokine testing. Combing these methods, a Detergent Mildness Index was created which conveniently provides a single value by which products can be compared.

Results: A new mild laundry detergent was formulated with ingredients carefully selected by dermatologists who are experts in con-tact dermatitis. The irritancy potential of the formula was measured using the Detergent mildness index score. Compared to 11 other commercial laundry detergents marketed for sensitive skin, the new formula is measurably the mildest formula.

Discussion: The Detergent Mildness Index provides dermatologists with an objective method to compare commercial laundry deter-gents. Currently the only method available is patch testing, this new test is able to more finely differentiate between products and thus enables more informed recommendations on laundry detergent choices for their patients with sensitive skin.

J Drugs Dermatol. 2017;16(12):1235-1239.

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Telemedicine is the practice of medicine across distance via telecommunications and interactive video technology. Telemedicine is most widely deployed in the US Military, prisons, rural areas, and ships. This article reviews the current status of Medicare reimbursement for telemedicine, selected state legislation regarding telemedicine, the lack of formation of a doctor-patient relationship by teleconsultation between doctors and the hold that digital images are valid as legal evidence and legally sufficient medical records.

Shaving is an ubiquitous practice, and cutaneous irritation and inflammation are common sequelae, which may be worsened by underlying skin conditions or poor hair removal techniques. Moisturizing shaving creams and aftershaves are available to help maintain or restore the epidermal barrier; however, many continue to suffer from post-shave redness, itching, and pain. To reduce post-shave inflammation, some products have included botanical and other natural ingredients, which are often favored by consumers. We evaluated Bensal HP, an ointment containing 3% oak bark extract, 3% salicylic acid, and 6% benzoic acid, which has documented anti-inflammatory and antimicrobial properties, in a murine model of shave irritation to determine whether it would be useful in this clinical setting. Shaving dermatitis was simulated using a depilatory agent and electric clippers, and the shaved area was photographed and treated with Bensal HP daily for four days. Compared to untreated controls, mice treated with Bensal HP experienced a visible reduction in skin irritation and inflammation. These findings were mirrored on histology, as Bensal HP-treated areas demonstrated increased epidermal integrity and decreased dermal inflammatory infiltrate compared to untreated skin. Using immunohistochemistry, fewer neutrophils and macrophages were noted, and cytokine analysis also revealed decreased IL-6 in Bensal HP-treated skin at 24 and 96 hours after shaving. These results highlight the potential of Bensal HP as an anti-inflammatory treatment for shave irritation. Given the product’s application against a variety of inflammatory and infectious skin disorders, its use against shave irritation may also improve comorbid skin conditions, such as pseudofolliculitis barbae.

J Drugs Dermatol. 2016;15(7):836-840.

A case is presented of a 55-year old woman who developed an eruption suggestive of contact dermatitis on repeated occasions after receiving anesthesia for dermatologic procedures. Patch testing revealed a positive reaction to lidocaine. Basic structures of anesthetics are reviewed, and the classification of immunologically-mediated allergic reactions is discussed. The presence of cutaneous lidocaine allergy has profound implications for the field of dermatology.

Zinc pyrithione (ZPT) is an active material that has been used for over 50 years to effectively treat dandruff and seborrheic dermatitis (D/SD). It has become the most common material for that purpose, its use has expanded to include other skin benefits such as skin hygiene. However, there is much about ZPT that is unappreciated. It is a rationally developed molecule that was modeled after the naturally occurring antimicrobial aspergillic acid. The molecular basis for its antifungal activity has been elucidated. The efficacy of ZPT originates from two attributes. First, it has a very broad antimicrobial spectrum of activity, including fungi, gram-positive and -negative bacteria. Second, the material has very low solubility, resulting in formulation and delivery as a particulate material, which has distinct performance advantages. The particles are deposited and retained on the target skin surfaces even when delivered from rinse-off products. These particles slowly release molecularly active material to interact with the surface fungal and bacteria cells to control their population, functioning as slow-release reservoirs to provide extended and persistent benefits. This particulate nature, though, results in complex pharmaceutics to realize the full efficacy benefits; it is common to see products with the same ZPT level having widely varying levels of clinical performance. Several product matrix-determined factors directly impact resultant benefits: ZPT must be retained on the skin surface achieving uniform spatial distribution laterally as well as within hair follicles (especially on scalp); ZPT must be maintained as a physically stable dispersion in product; ZPT must be maintained in a chemically active form as there are many chemical reactions that can occur that can harm ZPT bioactivity. The benefits achievable by employing ZPT require significant pharmaceutics expertise to realize the full benefits of this active material.

J Drugs Dermatol. 2016;15(2):140-144.

KD is an 8 year-old male patient who presented to our clinic in December 2016 with a history of patchy hair loss for many months duration that was worsening. KD’s past medical history was notable for atopic dermatitis, and a positive family history of autoimmune thyroid disease. Upon examination he had well circumscribed areas of hair loss throughout his scalp, with exclamation mark hairs seen on dermoscopy. Eyebrows and eyelashes were intact, no epidermal changes of scale or erythema were noted on the scalp and no palpable lymph nodes were present. He was diagnosed with alopecia areata at this time and was treated with Clobetasol 0.05% solution QHS as well as Kenalog 2.5 mg/ml injections to the areas of hair loss. Patient followed up two months later with worsening of his alopecia at a rapid pace, presenting now with hair loss of the entire scalp and loss of the eyebrows. He was diagnosed with progression to alopecia universalis at that time, with a corresponding SALT (Severity of Alopecia Tool) score of 100. Both KD and his mother stated the hair loss was causing much distress in the patient’s life both at school and at home. After a thorough discussion of treatment alternatives to include continued topical high dose steroids, intralesional injections, high dose oral methylprednisolone, topical irritation with anthralin, topical immunotherapy with diphenylcyclopropenone (DPCP) or squaric acid dibutylester (SADBE) and systemic immunosuppressives, both the mother, patient and clinician agreed to try tofacitinib 5 mg twice daily with continued usage of topical steroids. Patient and his family was counseled about support groups, and local meetings to ease the mental distress associated with this condition. After baseline labs were obtained and reported within normal limits, to include CBC, CMP, thyroid studies, lipids and Quanitferon gold, KD was started on tofacitinib 5 mg BID. Labs were repeated one month later, and 3 months ongoing thereafter. At KD’s 3 month follow up, after starting tofacitinib 5 mg twice daily, KD showed complete regrowth of the eyebrows with minimal hair growth of the posterior occiput (Figure 1 a-d). At KD’s 6 month follow up he had 100% regrowth of eyebrows and complete scalp regrowth, resulting in a SALT score of 0 (Figure 2). KD reported no side effects until month 6, after full hair regrowth, when patient started to report mild headaches. Drug holiday was offered but the patients family chose to discontinue treatment at this time as they were concerned side effects were secondary to medication usage. Unfortunately, patient was lost to follow-up after the discontinuation of treatment. From previous case reports we can postulate that his alopecia returned to baseline after discontinuation of tofacitinib. KD had an incredible response to treatment, as has been reported previously in literature of adolescents using these novel therapies. This is the youngest patient ever reported to be successfully treated with oral tofacitinib 5 mg twice daily for alopecia and its variants. J Drugs Dermatol. 2018;17(8):914-917.

We present a case of a 55-year-old female with breast cancer who developed radiation recall dermatitis (RRD) 3 years later after administration of levofloxacin. A vast majority of cases occur after administration of chemotherapeutic medications; however, a review of literature implicates increasing numbers of nonchemotherapeutic agents and supplements in RRD. Although the pathophysiology of RRD has yet to be elucidated, the implication of more nonchemotherapeutic agents may favor a drug hypersensitivity etiology. To our knowledge, this is the first report of RRD secondary to levofloxacin.

Ciclopirox is a hydroxylated pyridone, a unique substance in our tropical treatment armamentarium. It first came to market in Europe and has been in use for a number of years¹. Worldwide it is or has been available as a spray, vaginal cream, powder, solution, cream, lotion, gel, and nail lacquer. The latter four are available in the United States at the time of this article. Ciclopirox gel differs from other formulations. It contains ciclopirox as a free acid, as opposed to an olamine salt. Superficial fungal infections and seborrheic dermatitis are two of the most common disorders seen in dermatology and indeed in medicine in general; ciclopirox is active against both, and literally may be used head to foot.

Topical tacrolimus has been observed to induce granulomatous rosacea (GR) in prior case reports and series. In most cases, patients recover fully after withdrawing tacrolimus and initiating doxycycline or minocycline. Herein, we describe a case of severe GR, which required further therapy. Clinicians should be aware of this rare complication because of the frequent use of topical tacrolimus.

J Drugs Dermatol. 2015;14(6):628-630.

Human hair has been classified into 3 major groups, as determined by ethnic origin. In these populations, significant structural and biochemical variations of the hair follicle and shaft are seen, as well as unique hair grooming practices. These structural variations of the hair are closely linked to the common disorders of the hair and scalp, such as acquired trichorrhexis nodosa, seborrheic dermatitis, traction alopecia, central centrifugal cicatricial alopecia, dissecting cellulitis, frontal fibrosing alopecia, and pseudofolliculitis barbae.

J Drugs Dermatol. 2013;12(4):420-427.

Topical fluorouracil is widely used for the treatment of precancerous and cancerous lesions of the skin. The most common side effect of this medication is localized irritant dermatitis. The authors report a case of dysgeusia with metallic taste as a side effect of this medication. While not previously seen with topical use, this is not an uncommon side effect seen with systemic administration of 5-fluorouracil. The etiology of dysgeusia from chemotherapeutic agents and systemic absorption of fluorouracil is discussed. J Drugs Dermatol. 2011;10(10:1201-1203

The most common subepidermal blistering disorder, bullous pemphigoid (BP) typically occurs in the elderly without any obvious inciting event.1 Anti-basement membrane zone antibodies are typically detected on direct and indirect immunofluorescence studies.2 A flu-like prodromal phase with a non-specific urticarial dermatitis may herald the development of the more characteristic tense bullae.3 Obtaining a thorough medication history is important as a number of pharmacological agents have been reported to trigger this same phenomenon. We report a case of generalized BP induced by hydrochlorothiazide therapy in a 32-year-old male.

J Drugs Dermatol. 2014;13(3):360-362.

Riehl melanosis is a rare cause of skin hyperpigmentation that typically occurs on the face and neck and is characterized by the rapid onset of gray-brown reticular pigmentation. It is theorized to be a pigmented contact dermatitis or a lichenoid immune reaction that may be caused by intrinsic as well as extrinsic factors. Treatment is challenging; laser and intense pulsed light (IPL) therapy is a common treatment for other pigmented skin conditions. IPL has been reported twice for the treatment of Riehl melanosis and we report a case of Riehl melanosis successfully treated with q-switched Nd:YAG after proving recalcitrant to IPL treatment.

J Drugs Dermatol. 2014;13(3):356-358.

Topical corticosteroids are the most commonly prescribed agents in the treatment of dermatologic conditions. They are used primarily as monotherapy or in combination with other agents for enhanced efficacy. Several stronger preparations are now available since their first introduction. They are also available in various vehicles altering the potency and giving the option of tailoring them for use based on specific anatomic locations, area of involvement, age of the patient, and most importantly, severity of the condition. Several local and systemic side effects have been associated with their inadvertent use. Allergic contact dermatitis to most of the preparations has also been noticed. Judicious use with reinforced patient education lowers such risk for side effects, and can be of great use in treating dermatologic conditions.

Targeted phototherapy has been utilized in the past few years for the treatment of various dermatoses. In this article, we summarize the experience of using 308-nm excimer laser at Henry Ford Hospital, Detroit, MI, for the treatment of psoriasis, vitiligo, palmoplantar psoriasis, and hand dermatitis. A total of 34 patients were treated between January 2003 and February 2005. Of the 28 patients with psoriasis, over 80% had greater than 75% improvement after an average of 12 treatments. While the number of patients was small, excimer laser showed promising results for palmoplantar psoriasis. Possibly due to patient selection bias, we have not had the same success as other studies for the treatment of vitiligo with this modality.

BACKGROUND: Topical products with epidermal lipids in a ceramide-dominant ratio were originally developed to address atopic dermatitis. They have been used by extension to address the barrier deficits of aging skin, and after laser resurfacing and other barrier-disrupting procedures. The purpose of this study was to evaluate efficacy, tolerability, and safety of a novel formulation containing high levels of physiological barrier lipids, in a unique cholesterol-dominant ratio hypothesized to directly address the specific epidermal lipid imbalances of aging skin. METHODS: An 8-week, single-center study was conducted on females aged 55 to 75 with mild to moderate fine lines and wrinkles, and other stigmata of facial photodamage. Evaluations were performed at baseline, immediately after rst use of the cholesterol-dominant test formulation, and at weeks 4 and 8. Efficacy evaluations comprised blinded expert grading of 9 skin attributes, bioinstrumental measurements of trans-epidermal water loss (TEWL) and stratum corneum hydration, standardized digital imaging, and self-assessment questionnaires. Tolerability was scored objectively and subjectively, and by grading of skin dryness. Adhesive tape extracts were analyzed biochemically for epidermal lipids, and by double-staining to detect mature vs. immature corneocytes. In a separate study, the effects of pre- or post-treatment with the test formulation on barrier recovery following traumatic tape stripping of forearm skin were assessed via measurements of TEWL and stratum corneum hydration. RESULTS: Statistically significant improvements occurred in all facial skin attributes (weeks 4 and 8), TEWL (week 8), and stratum cor- neum hydration (weeks 4 and 8). There were significant increases in total ceramides and cholesterol, including ceramide isoforms not present in the test formulation itself; and a statistically significant increase in the ratio of mature to immature corneocytes at week 8. Forearm skin treated with the test formulation after traumatic tape stripping recovered barrier function significantly faster than untreated skin. Pre-treatment for 1 week prior to traumatic tape stripping had a significant protective effect. Tolerability and safety of the test formulation were excellent. CONCLUSIONS: This cholesterol-dominant lipid formulation offers a new paradigm of primary skin barrier repair specifically targeted to- ward aging skin. Correction of age-related epidermal lipid deficits directly addresses the underlying cause and the profound sequelae of barrier dysfunction in aging skin. This may also be of utility to optimize skin tolerance, response and recovery from aesthetic procedures and other topical treatments, and for dermatoses associated with barrier dysfunction, such as rosacea. The formulation achieved sustained improvements in barrier function throughout the course of the 8-week study, had a protective effect when applied prior to barrier insult, and mediated more rapid recovery when applied after barrier insult. Significant increases in total epidermal ceramides, cholesterol and triglycerides, and in mature versus immature corneocytes, indicated both structural and functional normalization of the skin barrier, and possibly a broader-based stimulation of ceramide synthesis. The formulation had excellent tolerability and safety profiles, even in subjects with sensitive skin. J Drugs Dermatol. 2016;15(12):1513-1523.

Benzoyl peroxide (BP) has been a standard and effective topical treatment for acne vulgaris for the past 35 years. Previous studies and case reports have documented benzoyl peroxide to be a strong irritant and a weak allergen, with many cases of tolerance induced with repeat use of this irritant. While less common, numerous cases of BP-induced allergic contact dermatitis (delayed type hypersensitivity reaction) have been reported in the literature. We report here an individual with an incipient edematous reaction to topical BP used for acne therapy. This under-recognized presentation is discussed in the context of published literature on BP-induced hypersensitivity and irritation.

The authors report a case of a 68-year-old Caucasian female with type 2 diabetes mellitus who experienced an acute exacerbation of her rosacea 2 weeks after self-initiating cinnamon oil pills to lower her blood sugar levels. Historically, cinnamon oil has been used for a variety of medicinal purposes, but recently the use of cinnamon oil in lowering blood glucose and cholesterol levels in patients with type 2 diabetes is being investigated and gaining popularity amongst the general population. The use of cinnamon has commonly produced cutaneous side effects of irritant or allergic contact dermatitis and been reported to have vasodilatory effects. Yet, there are no reports of cinnamon use triggering a rosacea exacerbation in the literature.

Topical antifungal treatment is a mainstay of therapy for Seborrehic Dermatitis (SD). Although the amidazole and ciclopyridine antifungals have been extensively studied, few clinical efficacy data are available for topical allylamine therapy in SD. The objective of this open-label exploratory study was to evaluate the efficacy and safety of natifine HCl 1% gel applied twice daily for 4 weeks, as topical treatment of moderate SD of the scalp. Nine subjects (5 men, 4 women) with a mean age of 56 (33-81) years with SD of the scalp were enrolled and made 4 visits to the site. At Visit 1 (Week 0), subjects were screened, enrolled, baseline efficacy data were obtained, and treatment was initiated. Subjects returned at Week 2, Week 4 (end of treatment), and Week 6 for efficacy and safety assessments. Efficacy was evaluated by changes from baseline in investigator-rated scores on 0-5-grade scales: (1) SD Global Evaluation Scale (SDGES), (2) Erythema Severity Scale, (3) Scaling Severity Scale, (4) % Scalp Involvement Scale, and subject-rated scores on the (4) Itching Severity Scale, and (5) Global Improvement Scale, where 0=none and 5=most severe. Mean severity scores for the SDGES and % Scalp Involvement scales progressively declined (improved) 66% and 54% from respective baseline levels at Week 6. Mean erythema rating decreased 38% from baseline and scaling decreased 50% from baseline by Weeks 4 and 6. Itching improved in 5 of 9 (56%) subjects by the end of treatment. A total of 8 of 9 (89%) subjects rated their symptoms as improved from baseline at the end of treatment and Week 6. There were no treatment-related adverse events during the study. These results suggest that naftifine 1% gel applied twice daily for 4 weeks is effective and safe topical treatment for moderate SD of the scalp.

J Drugs Dermatol.2012;11(4):514-518.

Alopecia areata (AA) is a common, non-scarring, autoimmune hair-loss disorder with a complex genetic and environmental etiology. A higher incidence rate of AA in the female population is well described. It is unclear why females are more likely to be diagnosed with AA and what, if any, differences in disease phenotype exist between males and females. The identification of gender specific characteristics of disease may help clinical management and patient education in cases of AA. Accordingly, we recruited 481 North-American Caucasian AA patients (336 female, 145 male) to assess age of onset, autoimmune and atopic co-morbidity, nail involvement, family history of AA and autoimmune disease, and disease subtype. There was a female predominance (female to male ratio 2.3:1) in this AA study population. We found that male AA patients are more likely to be diagnosed in childhood (age <10 years, P= 0.067) and have a family history of AA (P= 0.004). On the other hand, female AA patients are more likely to be diagnosed in adolescence (age 10-20 years, P= 0.083), have co-morbid nail involvement (P= 0.0257), and have concomitant autoimmune disease (P= 0.014), particularly thyroid disease (P= 0.058). The clinical implications of disease heterogeneity between males and females remains to be determined.

J Drugs Dermatol. 2014;13(4):409-413.

Topical retinoids are an important class of drugs for treating several dermatoses occurring more frequently in patients with pigmented skin, such as melasma, post-inflammatory hyperpigmentation, pseudofolliculits barbae and keloids. They also play a role in managing acne, psoriasis, photoaging, cutaneous T-cell lymphoma, Kaposi sarcoma and disorder of hyperkeratosis in this demographic as well. In general, topical retinoids are well tolerated in pigmented skins. There is little evidence to suggest that patients with darker skin are at increased risk of irritation. However, retinoid dermatitis can induce post-inflammatory hyperpigmentation and attempts should be made to reduce its occurrence by modifying treatment regimens in patients with pigmented skins.

J Drugs Dermatol. 2011;10(5):483-489.

Dermatologic surgery is advancing at a very rapid pace. New procedures are being introduced and older techniques are being used for new applications every day, for both therapeutic and cosmetic purposes. Complications in dermatologic surgery are rare, but as in all surgical procedures, there is always the risk of associated side effects.

These potential side effects can be divided into intraoperative and postoperative complications. Intraoperative complications include bleeding, damage to vital organs, nerve injuries, allergic reactions to anesthetics, and electrocautery-associated complications. Postoperative complications include contact dermatitis, infection, chondritis, wound dehiscence, necrosis of the skin, suture spitting, suture tracking, excessive granulation tissue, non-healing wounds, pigment change, and scars/keloids. In this article, these surgical complications and their management will be covered.

Contact sensitizers are a major cause of inflammatory skin disease and as topical immunomodulators also have the potential for treat- ing cancer, viral diseases and certain autoimmune disorders. In the present study, the authors identify the upregulation of the TH17 lymphocyte subset transcription factor retinoid orphan receptor gamma T (RORγT) and the CD70 costimulatory pathway in human contact sensitivity (CS) using molecular techniques. Identification of this important new subset of T lymphocytes and a recognized costimulatory pathway offers potential for ameliorating CS and insight into antitumor and antiviral mechanism of haptens as topical immunomodulators.

Corticosteroids have been combined with other agents in the treatment of melasma for years. In early studies by Kligman and Willis, topical dexamethasone as monotherapy produced little depigmentation even after 3 months of therapy. A significant concern is that topical corticosteroids used alone in this setting, especially on the face, may result in epidermal atrophy, telangiectasia, rosacea-like erythemas, acne, and perioral dermatitis.

Topical corticosteroids, however, including low-potency fluocinolone acetonide, also exert an anti-metabolic effect, resulting in decreased epidermal turnover, and, thus, may produce a mild depigmenting effect. When used in combination with tretinoin and hydroquinone in the treatment of melasma, fluocinolone acetonide 0.01% suppresses biosynthetic and secretory functions of melanocytes, and thus melanin production, leading to early response in melasma, synergy among the three agents, and no significant side effects over an 8-week period.

Pityriasis rosea (PR) is a relatively common, benign skin disease of unknown etiology. In rare cases, medications can induce a morphologically similar eruption. We present a case of a PR-like drug eruption caused by the atypical antipsychotic asenapine. The clinical presentation consisted of a rapidly progressive, disseminated, and severely pruritic dermatitis comprised of ovoid, scaly, pink-violaceous plaques. The initial histopathologic specimen was consistent with PR, but upon re-sampling a week later, the findings favored a drug eruption. PR-like drug eruptions, though rare, can occur in response to a wide variety of medications. Because the findings may be only subtly different than those of typical PR, careful clinical and histopathological correlation must be sought. To our knowledge, this is the first reported case of a PR-like drug eruption to asenapine.

J Drugs Dermatol. 2013;12(9):1050-1051.

Cutaneous reactions to interferon, including a lichenoid drug reaction, are most commonly reported in patients undergoing treatment for hepatitis C virus (HCV) infection. There have been case reports of interferon-induced lichen planus in seronegative HCV patients with lymphoproliferative disorders and melanoma. We report the case of a 71-year-old man undergoing treatment with interferon for metastatic renal cell carcinoma (RCC) who developed an eruption 2 months after starting interferon. Clinical and histological findings from biopsies supported a diagnosis of interferon-induced lichen planus. To our knowledge, this is the first known case of a lichenoid drug eruption from interferon in a seronegative HCV patient with metastatic RCC.

J Drugs Dermatol. 2017;16(7):714-716.

Darier’s disease is a rare disorder of keratinization of the epidermis, nails, and mucous membranes. Patients usually present with pruritus and pain along with multiple small, red-brown papules on the seborrheic areas. Other cutaneous signs include punctate keratotic pits of the palms and soles and dystrophy of the nails. Darier’s disease is the result of a mutation in the ATP2A2 gene. A case which was difficult to diagnose because its presentation resembled more commonly seen skin conditions is reported. The patient was misdiagnosed with acne, eczema, and seborrheic dermatitis, and was treated without improvements. This case highlights the fact that skin disorders that do not respond to conventional therapy should lead physicians to suspect an uncommon or even serious cutaneous disorder. The diagnosis of Darier’s disease, based on family history, clinical appearance, and histopathology, expedited the appropriate treatment.

Basal cell carcinoma (BCC) is the most common human malignancy, which often occurs as a result of ultraviolet light on sun-exposed areas. A more rare location for the presentation of BCC is the non-sun−exposed genital area, where squamous cell cancer occurs frequently in the setting of human papilloma virus and chronic inflammatory lesions (ie, lichen sclerosus et atrophicus). Consequently, such tumors may escape detection by the dermatologist and be mistaken by the gynecologist for an inflammatory condition. A delay in diagnosis can result in wider surgical margins and potential recurrences. We present a case of BCC of the vulva with involvement of the clitoris presenting with unilateral pruritus and treated as an allergic contact dermatitis with topical corticosteroids. The patient was treated with Mohs micrographic surgery in conjunction with topical imiquimod to spare surrounding tissue.

An exact vertical approximation of epidermal edges during wound suturing allows rapid reepithelialization of the sutured wound and may reduce scar formation. Over 20 patients have been treated with a unique suturing technique for woundedge approximation using a sterile polyurethane adhesive dressing as an epidermal scaffolding, Some of these procedures and results were documented using intraoperative and postoperative photos to help evaluate potential benefits to wound healing. The polyurethane dressing acts as a barrier to microbes, water, and irritants. Postoperative wound care was found to be cost-effective and virtually maintenance-free, as the wound does not require daily dressing changes. The patients treated with this technique demonstrated well-approximated wound edges and excellent cosmesis. The authors have not found cases of contact dermatitis or wound infection as a result of treatment using this suturing technique.

Systemic glucocorticoids are widely used in dermatologic practice for various conditions including connective tissue and immunobullous diseases, vasculitis, dermatitis, neutrophilic and other dermatoses, and androgen excess syndromes. Long-term use of systemic glucocorticoids has been associated with substantial and rapid bone loss, which places patients at increased risk for bone fractures. Therefore, bone density measurements and the timely initiation of lifestyle modifications and pharmacotherapy are essential for future bone health. The use of several Food and Drug Administration–approved agents to prevent and treat corticosteroid-induced bone loss has been inconsistent among many specialties. In this review, the authors summarize guidelines on the prevention and treatment of corticosteroid- induced bone loss published by the American College of Rheumatology and supplement these guidelines with descriptions of the latest approved pharmacologic therapies and user-friendly flow algorithms. This summary should aid dermatologists in providing education and recommendations regarding bone health for their patients on systemic glucocorticoids.

INTRODUCTION: Bevacizumab is a recombinant humanized antibody against vascular endothelial growth factor (VEGF). It is approved by the Food and Drug Administration (FDA) for metastatic colorectal cancer, advanced non-small cell lung cancer, metastatic renal cell cancer and glioblastoma. Bevacizumab has also been used off label in ophthalmology for age-related macular degeneration, diabetic retinopathy, retinal vein occlusions, retinopathy of prematurity, and other chorioretinal vascular disorders. Numerous case reports have described various cutaneous reactions in response to bevacizumab therapy including acneiform eruptions and exfoliative dermatitis.
CASE PRESENTATION: We report a case of a 63 year-old Caucasian female who presented with subacute cutaneous lupus erythematosus six weeks after initiating two intravitreal injections of bevacizumab for central serous choroidopathy.
CONCLUSION: We report the first documented case of a cutaneous lupus erythematosus eruption following bevacizumab administration as a monotherapy.

J Drugs Dermatol. 2013;12(9):1052-1055.

Despite their beneficial effects on the treatment of acne vulgaris, topical and oral retinoids may cause severe local irritation (retinoid dermatitis) due to their mechanism of action, thereby jeopardizing patient adherence, and thus compromising treatment efficacy. Alleviating dryness and improving skin comfort by using a moisturizer concomitantly to retinoids could enhance efficacy. In the present study, 30 subjects receiving either oral isotretinoin for at least 2 months or topical tretinoin for at least one month applied a moisturizing cream (Cetaphil® Moisturizing Cream) twice daily for 15 days on one half of the face while the other side remained untreated. Clinical assessments, confirmed by biophysical measurements, showed that the moisturizer provided a significant improvement in skin dryness, roughness, and desquamation. Skin properties and skin discomfort were also greatly improved and subjects were very satisfied with the product. Retinoid-induced skin irritation can be relieved by the regular use of a gentle moisturizing cream as an adjunctive treatment.

Background: Scalp hyperkeratosis and/or alopecia are common pediatric dermatologic findings. In Caucasian children, scalp hyperkeratosis of childhood is most often associated with atopic and seborrheic dermatides. Recent data is lacking on the clinical meaning of scalp hyperkeratosis and alopecia in children of color.
Objective: To determine diagnosis associated with scalp hyperkeratosis and/or alopecia in a predominately Black and Hispanic pediatric patient population.
Methods: A retrospective chart review was conducted for all children (0-17 years of age) seen at our institution who had a scalp fungal culture for the evaluation of scalp hyperkeratosis and/or alopecia from January 2007 to September 2009. Fungal culture was performed using cotton swab technique, plating onto Sabouraud's and Mycosel media. Demographic features, fungal culture results, clinical symptoms, physical findings and final diagnosis were reviewed.
Results: 164 children were identified who were eligible for inclusion in the study, 75 of whom were Black and 56 Hispanic/Latino. Scalp hyperkeratosis was noted in 106 patients and alopecia was noted in 71 subjects. Tinea capitis was the final diagnosis in 50 out of 80 children who had hyperkeratosis without alopecia (60%), 16 of 43 children with alopecia alone (37.2%) and 23 of 28 children with both hyperkeratosis and alopecia (82.1%, P=0.0007). The odds ratio of tinea capitis in the presence of hyperkeratosis with alopecia was 7.49 with a 95 percent confidence limit of 2.19-25.70.
Conclusion: Scalp hyperkeratosis, especially when accompanied by alopecia, is usually associated with tinea capitis in Black and Hispanic children. Fungal culture and empirical anti-fungal therapy are warranted in children of color with scalp hyperkeratosis.

J Drugs Dermatol. 2011;10(5):511-516.

Acute graft-versus-host disease (GVHD) is a rare and life threatening complication after solid organ transplantation. The diagnosis can be made with clinical and laboratory evidence of skin, liver, or intestinal involvement. The role of skin biopsy in confirming acute GVHD is debatable. However, it is proposed that the skin biopsy is a valuable tool in confirming the diagnosis in low prior probability settings. An atypical case of acute GVHD following orthotopic liver and small bowel transplantation in a 2-year-old male is presented. Seven weeks posttransplantation, the patient developed a bullous eruption limited to the buttocks and upper thighs. A skin biopsy was performed which showed interface dermatitis and epidermal necrosis consistent with acute GVHD. Prompt treatment with daclizumab and intravenous corticosteroids was given and the patient survived without evidence of systemic GVHD. This case highlights the importance of skin biopsy in establishing the prompt diagnosis of GVHD in low prior probability settings.

INTRODUCTION: Irritation, such as burning and stinging, on the site of application, is a common side effect of topical dermatologic products including creams, lotions, sprays, and foams. This effect may be more pronounced when applying products to atopic or psoriatic skin. The composition of the vehicle may affect the extent of the irritation. This study compared the irritation and erythema potential of 7 different topical dermatologic products to determine the products with the least likelihood of causing discomfort when applied.
METHODS: Seven sites on the anterior leg of 30 subjects were dry shaven with 10 upward strokes. Subjects rated the stinging of petrolatum (negative control), isopropyl alcohol (positive control), Cetaphil Lotion, triamcinolone 0.1% cream, triamcinolone 0.2% spray, betamethasone foam, and clobetasol 0.05% spray, 1 minute after product application, using a scale of 0 (no symptoms) to 10 (intolerable stinging/burning). The investigator assessed erythema at the sites 30 minutes after application of the products using a scale of 0 (none) to 4 (severe).
RESULTS: Stinging rating score of each product was statistically significant from one another. Petrolatum produced the least stinging (0) and isopropyl alcohol the most (10). Stinging with triamcinolone spray, Cetaphil Lotion, and triamcinolone cream ranked in the lower half of the rating scale (all below 5). Betamethasone foam and clobetal spray ranked the highest at >7. When corrected for the erythema caused by shaving, triamcinolone spray and Cetaphil Lotion produced the least amount of erythema of all the products tested.
DISCUSSION: Rapid evaporation of the volatile vehicle of triamcinolone spray and the non-irriating nature of the medication left behind may contribute to its low erythema and stinging. This product may be an appropriate choice for patients with compromised skin but who require the advantages and conveniences of a spray vehicle.

J Drugs Dermatol. 2016;15(7):870-873.

BACKGROUND: Topical corticosteroids are the standard-of-care treatment for dermatitis, mild psoriasis, and other inflammatory skin diseases. Prescribing practices rely on knowledge of topical corticosteroid potency, as well as potential side effects including steroid allergies.
PURPOSE: The primary aim of this study is to determine how dermatologists classify particular topical corticosteroids according to potency, and which products they prefer in cases when allergenicity is a concern.
METHODS: The data were collected and analyzed from 105 US-based dermatologists surveyed at the 2011 Summer American Academy of Dermatology meeting.
RESULTS: The majority of dermatologists were in agreement on the potency ranking of many commonly prescribed topical corticosteroids. Two thirds of the surveyed dermatologists expressed concern about allergy to topical corticosteroids. In cases of a suspected allergy, desoximetasone was the leading product dermatologists would choose to prescribe.
LIMITATIONS: The survey was limited to attendees of an educational conference, possibly leading to an overestimation of dermatologist knowledge of topical steroids.
CONCLUSIONS: This study shows that dermatologists are generally knowledgeable about group classifications of corticosteroids in terms of potency and that they can appropriately select a topical product with low potential for allergy.

J Drugs Dermatol. 2013;12(7):786-789.

This study was a multicenter, double-blind, placebo-controlled, parallel-group pilot study of efficacy and tolerability of a nonsteroidal cream (Promiseb® Topical Cream; Promius Pharma, LLC, Bridgewater, NJ) for treatment of cradle cap when applied topically twice daily for up to 14 days in 42 pediatric subjects. Both treatments were similarly effective in reducing disease severity, as measured by success with Investigator's Global Assessment scores at day 7 or end of treatment, with 96% of subjects achieving success in the nonsteroidal cream group and 92% of subjects achieving success in the placebo cream group. Both treatments resulted in significant reductions from baseline in terms of erythema, crusting, scaling, and oiliness (P<.05), with no significant difference between treatments. There was a significant difference (P=.03) between treatment groups for percent reduction in scaling at the end of treatment, with a 90% reduction in the nonsteroidal cream group compared with a 58% reduction in the placebo cream group. All subjects in both groups had an overall safety score of excellent, and there were no adverse events related to treatment for either group.

J Drugs Dermatol. 2013;12(4):448-452.

Background: Alefacept has an established efficacy and safety profile for 12 weeks of treatment of severe chronic plaque type psoriasis. The effectiveness and safety of longer-term continuous use is not well characterized. Methods: Fifteen subjects with moderate-to-severe chronic plaque type psoriasis were given weekly 15 mg alefacept injections for 16 consecutive weeks followed by monthly 15 mg injections for up to eight consecutive months, along with clobetasol propionate spray 0.05% twice daily for the first four weeks. Disease severity was measured using the Psoriasis Area and Severity Index (PASI) and the Investigator Global Assessment (IGA). Results: Mean PASI scores improved 33 percent overall during the first month with combination treatment. There was an overall 21 percent worsening in PASI scores after the transition from weekly to monthly medication administration. Of the 15 initially enrolled patients, 27 percent achieved PASI 75 by end of study. No patients achieved an IGA of 0 or 1 by end of study. Two major adverse events were reported: low CD4 count and severe allergic dermatitis. Conclusion: Topical clobetasol propionate 0.05% was only partially effective at augmenting the early treatment effect of alefacept. The authors did not observe marked benefit or major side effects by continuing additional monthly alefacept treatments beyond 16 weeks of weekly treatment.

BACKGROUND: The treatment of hyperpigmentation in darker-skinned patients (Fitzpatrick skin phototypes III-VI) has remained challenging for dermatologists. No studies have been conducted on hyperpigmentation under the eyes, axilla, and neck in darker-skinned patients. This survey was designed to assess current treatments of hyperpigmentation in these areas.
MATERIALS/METHODS: With approval from the institutional review board at the University of California, Irvine, an electronic survey was sent to practicing dermatologists that contained 18 questions regarding the approach to evaluating and treating hyperpigmentation under the eyes, in the axilla, and along the neck.
RESULTS: Fifty dermatologists completed the survey, and 46 (92%) reported treating patients with darker skin. The ethnic groups treated were Latino (97.8%), African American (97.8%), Middle Eastern (77.6%), and Asian (88.9%). Thirty-six reported treating patients with hyperpigmentation under the eyes, and 22 (61.1%) thought the hyperpigmentation was a result of idiopathic increase in melanin deposition. Forty-two responded to treating hyperpigmentation in the axilla, most of whom thought it was related to acanthosis nigricans (69.0%) or contact dermatitis (59.5%). Forty responded to treating hyperpigmentation on the neck, most of whom treated the condition with hydroquinone (66%). Treatments for these 3 areas were not found to be effective.
CONCLUSIONS: Hyperpigmentation under the eyes, under the arms, or on the neck is a significant problem in darker-skinned patients that is refractory to currently available treatments, highlighting the necessity of developing treatment approaches directed toward this population. Two cases of hyperpigmentation on the neck are presented, describing a new entity that primarily affects dark-skinned individuals.

J Drugs Dermatol. 2013;12(5):563-567.

Background: Since July 2004, the United States (U.S.) Army has operated a forward-deployed dermatology clinic in Baghdad, Iraq. This paper outlines the prevalence of skin disease among deployed service men and women in Operation Iraqi Freedom.

Methods: A cross-sectional study was performed for all dermatology visits presenting to the Combat Dermatology Clinic, Ibn Sina, Iraq, between January 15, 2008 and July 15, 2008.

Results: In the six-month period reviewed, 2,696 total patients were evaluated. The most prevalent diagnoses included eczematous dermatitis [17%, n=462] and benign neoplasms [14%, n=375]. Eight percent (n=205) of the total visits were for skin cancer. This included: basal cell carcinoma, squamous cell carcinoma both in-situ and invasive, mycosis fungoides and melanoma. Actinic keratosis comprised 5% of the total visits (n=129). Bacterial infections comprised 6% (n=158) of the total visits and 31 of these cases were community acquired methicillin resistant Staphylococcus aureus (MRSA).

Limitations: Cross-sectional study with referral bias.

Conclusion: This is the largest publication of the prevalence of skin disease in an exclusively dermatologic clinic in a combat setting. For the first time the presence of skin cancer is noted in a combat setting. The prevalence of MRSA is noted and was exclusively seen in U.S. soldiers. There was a statistically significant rise in the prevalence of eczematous dermatitides when compared with previous conflicts. Dermatologists can have a significant and strategic impact on deployed military medicine.

Background: Topical corticosteroids (TCS) are the mainstay of psoriasis treatment. Safety concerns may limit use. Combination with tazarotene may optimize efficacy and minimize safety and tolerability concerns. Objective: Investigate safety and efficacy of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis. Methods: Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=418). Subjects randomized (2:1) to HP/TAZ lotion or vehicle once-daily for 8 weeks, 4-week follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in IGA score and ‘clear’ or ‘almost clear’). Safety and treatment emergent AEs evaluated throughout. Results: HP/TAZ lotion demonstrated statistically significant superiority over vehicle as early as week 2 (P equals 0.002). By week 8, 40.6% of subjects were treatment successes compared with 9.9% on vehicle (P less than 0.001). A third of subjects remained treatment successes post-treatment. HP/TAZ lotion was also superior in reducing psoriasis signs and symptoms, and Body Surface Area (BSA) involvement. Most frequently reported treatment related AEs were contact dermatitis (6.3%), application site pain (2.6%), and pruritus (2.2%). Limitations: No data were collected beyond the 4-week follow-up. Conclusions: HP/TAZ lotion provides synergistic efficacy that is both rapid and sustained, with good tolerability and safety over 8 weeks use. J Drugs Dermatol. 2018;17(8):855-861.

Background: Eczema is a common atopic disease associated with pruritus, sleep disturbance, and impaired quality of life. Staphylococcus aureus colonization/infection is important in its pathophysiology.
Aim: To evaluate the prevalence of S aureus colonization/infection and the efficacy and acceptability of a combined antibiotic/corticosteroid cream in the empirical treatment of eczema.
Methods: Consecutive patients with moderate to severe eczema were recruited. Swab and cultures from the right antecubital fossa and the worst eczematous area, disease severity (SCORAD) and quality of life (Children's Dermatology Life Quality Index, CDLQI), skin hydration (SH), and transepidermal water loss (TEWL) were obtained prior to and following a two week twice-daily course of treatment with a fucidin/corticosteroid cream. General acceptability of treatment (GAT) was documented at completion.
Results: Thirty-five patients (63% males; mean age 13.5, standard deviation 3.6 years; with 21 moderate and 14 severe disease) were recruited. At start, S aureus was isolated from the right antecubital fossa and the worst affected areas in 66% and 71% of these patients, respectively. At completion, S aureus was isolated in 23% and 40% at the antecubital fossae and worst affected areas (P=0.001 and P=0.003, respectively). No methicillin-resistant S aureus was isolated in this series, but the percentage of fucidin-resistant S aureus increased from 8% to 58% (P<0.001). Disease severity and quality of life were significantly improved (pre-Objective SCORAD and post-Objective SCORAD were 38.4±13.7 and 29.7±14.2, P<0.001; pre-CDLQI and post-CDLQI were 9.4±5.2 and 7.1±4.8, P<0.001). At the right antecubital fossa, skin hydration improved from 30.8±14.2 to 36.7±15.2 (P=0.015); and TEWL from 10.7±2.3 to 9.4±2.2 (P<0.001). Eighty percent of patients found the treatment good or very good, and only one (3%) patient found it unacceptable.
Conclusions: The most prevalent organism in moderate to severe eczema was S aureus. Usage of the combined fucidin/corticosteroid cream is convenient and associated with a reduction in disease severity, improvement in quality of life, SH, and TEWL, but caution has to be taken with emergence of fucidin-resistant S aureus.

J Drugs Dermatol. 2012;11(7):861-864.

Consumers are increasingly interested in over-the-counter skin care products that can improve the appearance of photodamaged and aging skin. This 10-week, open-label, single- center study enrolled 25 subjects with mild to moderate hyperpigmentation and other clinical stigmata of cutaneous aging including fine lines, sallowness, lack of clarity, and wrinkling. Their mean age was 53.4±7.7 years. The test product contained retinol 0.5% in combination with niacinamide 4.4%, resveratrol 1%, and hexylresorcinol 1.1% in a moisturizing base. Subjects were provided a skin care regimen including a cleanser, hydrating serum, moisturizer, and an SPF 30 sunscreen for daily use. The test product was applied only at night.

The use of this skin brightening/anti-aging cosmeceutical was found to provide statistically significant improvements in all efficacy endpoints by study end. Fine lines, radiance, and smoothness were significantly improved as early as week 2 (P<.001). By week 4, hyperpigmentation, overall skin clarity, evenness of skin tone, and wrinkles showed statistically significant improvement compared to baseline. Mild retinoid dermatitis including flaking and redness occurred early in the study as reflected by tolerability scores. By week 10, subjects reported no stinging, itching, dryness, or tingling.

The results of this open-label clinical study suggest that a topical cream containing retinol 0.5% in combination with niacinamide, resveratrol, and hexylresorcinol is efficacious and tolerable for skin brightening/anti-aging when used with a complementary skin care regimen including SPF 30 sun protection.

J Drugs Dermatol. 2016;15(7):863-868.

Periorbital hyperpigmentation (POH) is a common worldwide problem. It is challenging to treat, complex in pathogenesis, and lacking straightforward and repeatable therapeutic options. It may occur in the young and old, however the development of dark circles under the eyes in any age is of great aesthetic concern because it may depict the individual as sad, tired, stressed, and old. While “dark circles” are seen in all skin types, POH is often more commonly seen in skin of color patients worldwide.1 With a shifting US demographic characterized by growing number of aging patients as well as skin of color patients, we will encounter POH with greater frequency. As forecasted by the US Census, by 2030 1 in 5 Americans will be 65 plus years old and greater than 50% of the population will possess ethnic skin of color.2 The disparity in the medical community’s understanding of POH versus popular demand for treatment is best illustrated when you have only 65 cited articles to date indexed on PubMed line3 compared to the 150,000,000 results on Google search engine.4 Most importantly POH may be a final common pathway of dermatitis, allergy, systemic disorders, sleep disturbances, or nutritional deficiences that lends itself to medical, surgical, and cosmeceutical treatments. A complete medical history with ROS and physical examination is encouraged prior to treating the aesthetic component. Sun protection is a cornerstone of therapy. Safety issues are of utmost concern when embarking upon treatments such as chemical peeling, filler injection, and laser therapy as not to worsen the pigmentation. Without intervention, POH usually progresses over time so early intervention and management is encouraged. The objective of this study was to review the current body of knowledge on POH, provide the clinician with a guide to the evaluation and treatment of POH, and to present diverse clinical cases of POH that have responded to different therapies including non-ablative fractional photothermolysis in two skin of color patients.

J Drugs Dermatol. 2014;13(4):472-482.

An unmet need exists for a safe, tolerable, effective treatment for moderate to severe persistent facial erythema in patients with rosacea. This pivotal phase 3, multicenter, double-blind study evaluated the efficacy and safety of topical oxymetazoline in patients with facial erythema associated with moderate to severe rosacea. Patients were randomly assigned to treatment with oxymetazoline hydrochloride cream 1.0% or vehicle applied once daily for 29 days, and were followed for 28 days posttreatment. The primary efficacy outcome was having at least a 2-grade decrease from baseline on both the Clinician Erythema Assessment (CEA) and the Subject Self-Assessment for rosacea facial redness (SSA) scales (composite success) at 3, 6, 9, and 12 hours postdose on day 29. Safety assessments included treatment-emergent adverse events (TEAEs) and posttreatment worsening of erythema (composite CEA/SSA increase of 1-grade severity from baseline; rebound effect). A total of 440 patients (mean age, 49.5 years; 78.9% females) were randomized (oxymetazoline, n=222; vehicle, n=218); most had moderate erythema. On day 29, significantly greater proportions of oxymetazoline recipients achieved the primary efficacy outcome at each time point (P less than 0.02) and overall (P less than 0.001) compared with vehicle recipients. The incidence of discontinuation due to TEAEs was low in both groups (oxymetazoline group, 1.8%; vehicle group, 0.5%). The most common TEAEs reported during the entire study period were application-site dermatitis, application-site erythema, and headache in the oxymetazoline group (1.4% each), and headache (0.9%) in the vehicle group. Following cessation of treatment, low proportions of patients experienced rebound effect (oxymetazoline group, 2.2%; vehicle group, 1.1%). Oxymetazoline applied to the face once daily for 29 days was effective, safe, and well tolerated in patients with moderate to severe persistent facial erythema of rosacea.

J Drugs Dermatol. 2018;17(1):97-105.

Objective: Naftifine HCl 2% cream (NAFT-2%) is a topical allylamine antifungal preparation under development in the U.S. The objective of this randomized, double-blind, vehicle-controlled study was to evaluate the efficacy and safety of a two-week course of once-daily NAFT-2% vs. vehicle in the treatment of Tinea cruris ("jock itch"). Methods: A total of 334 subjects with T. cruris were enrolled and randomly assigned to NAFT-2% (n=166) or vehicle (n=168), which was applied once daily for 14 days. Efficacy and safety were evaluated at week 2 (end of treatment) and week 4. Efficacy measures included complete cure, treatment effectiveness, mycological cure, clinical cure, and clinical success and were analyzed only in subjects with a positive potassium hydroxide (KOH) and dermatophyte culture at baseline (n=75, naftifine; n=71, vehicle). Safety was assessed by adverse events and changes from baseline in clinical status and laboratory studies. Results: At week 4, 25 percent of naftifine-treated subjects achieved complete cure vs. three percent of vehicle subjects and 72 percent achieved mycological cure vs. 16 percent of vehicle treated subjects (one-sided, P<0.001). Treatment effectiveness was achieved in 60 percent of NAFT-2% subjects vs. 10 percent of vehicle subjects (one-sided, P<0.001). Clinical cure rate and clinical success rate were 33 percent and 84 percent in NAFT-2% subjects, respectively vs. 10 percent and 46 percent in vehicle subjects (both P<0.001, 2-sided). Week 2 efficacy response rates in NAFT-2% subjects were all lower than at week 4 but were significantly higher than week 2 vehicle-treated counterparts (P<0.025). Treatment-related AE occurred in 11 subjects (7 NAFT-2%, 4 vehicle) during the study. The most common AE in both groups were contact dermatitis (2 NAFT-2%), pruritus (2 vehicle), and application site reaction (1 per group). Conclusion: NAFT-2% applied once daily for two weeks (one-half the treatment duration for naftifine 1% cream) is efficacious and safe for the treatment of T. cruris. J Drugs Dermatol. 2011;10(10):1142-1147.

Background: Many therapeutic modalities for scabies were available, topical sulfur ointment is a cost-effective and safe therapeutic agent. It is often applied for the whole body for three successive days.
Objective: To evaluate their therapeutic regimen of 8% and 10% topical precipitated sulfur in petrolatum ointment for single day, three successive nights or three successive days in management of scabies.
Patients and Methods: This single-blinded, comparative study was conducted in the Department of Dermatology-Baghdad Teaching Hospital from April 2008 through October 2009. A total of 97 patients with scabies were enrolled in this study. The diagnosis was established on clinical basis. The patients treated with 8% and 10% topical sulfur in petrolatum ointment were divided randomly into three groups: Group A: 33 patients treated for single day (24 hours); Group B: 32 patients treated for three successive nights (from 6 p.m. to 8 p.m. to 6 a.m. to 8 a.m. and bathing every day); and Group C: 32 patients treated for three successive days (bathing every 24 hours). The patients were seen regularly every two weeks for the duration of four weeks.
Results: Study included 58 (59.8%) males and 39 (40.2%) females, with a male to female ratio 1.4:1. The age range of males at presentation from 3 to 64 (26.74±15.98) years, while the females age ranged at presentation from 3 to 60 (24.05±14.53) years of age. At the end of the study, the response to treatment was: Group A, response in 14 (42.4%) patients and no response in 19 (57.6%); Group B, response in 29 (90.6%) patients and no response in 3 (9.4%); and Group C, response in 31 (96.9%) patients and no response in 1 (3.1%). There is significant statistical difference among the response of 3 groups with (P=0.00000011), but no statistically significant difference between the response of Group C and Group B, (P=0.6055). Mild burning sensation and irritating (sulfur) dermatitis were the only side effects of 8% and 10% sulfur. Pruritic rash occurred in Group C mainly, in 11 (34.4%) patients, 8 (25%) in Group B and 4 (12.1%) in Group A, with no significance (P=0.1058). Recurrence or relapse occurred in Group A mainly, with 4 (12.1%) patients, and in Group B, 1 patient, (3.1%), with no recurrence in group C, with significance (P=0.0060).
Conclusion: Three successive days and three successive nights of 8% and 10% sulfur ointment were effective regimens with no statistical difference in favor of three successive days, while single-day application was much less effective but with fewer side effects.

J Drugs Dermatol. 2012;11(3):357-364.

Background: Side effects may limit the use of current tetracycline-class antibiotics for acne. Objective: Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne. Methods: Patients 9–45 years with moderate to severe facial acne (Investigator’s Global Assessment [IGA] score ≥ 3, 20–50 inflammatory and ≤ 100 noninflammatory lesions, and ≤ 2 nodules) were randomized 1:1 to sarecycline 1.5 mg/kg/day or placebo for 12 weeks in identically designed phase 3 studies (SC1401 and SC1402). Results: In SC1401 (sarecycline n=483, placebo n=485) and SC1402 (sarecycline n=519, placebo n=515), at week 12, IGA success (≥ 2-grade improvement and score 0 [clear] or 1 [almost clear]) rates were 21.9% and 22.6% (sarecycline), respectively, versus 10.5% and 15.3% (placebo; P less than 0.0001 and P equals 0.0038). Onset of efficacy in inflammatory lesions occurred by the first visit (week 3), with mean percentage reduction in inflammatory lesions at week 12 in SC1401 and SC1402 of −51.8% and −49.9% (sarecycline), respectively, versus −35.1% and −35.4% (placebo; P less than 0.0001). Onset of efficacy for absolute reduction of noninflammatory lesion count occurred at week 6 in SC1401 (P less than 0.05) and week 9 in SC1402 (P less than 0.01). In SC1401, the most common TEAEs (in ≥ 2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting (2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). Most were not considered treatment-related. Vestibular (dizziness, tinnitus, vertigo) and phototoxic (sunburn, photosensitivity) TEAEs both occurred in ≤ 1% of sarecycline patients. Gastrointestinal TEAE rates for sarecycline were low. Among females, vulvovaginal candidiasis (SC1401: 1.1% [sarecycline] and 0 [placebo]; SC1402: 0.3% and 0) and mycotic infection (0.7% and 0; 1.0% and 0) rates were low. Conclusion: The narrow-spectrum antibiotic sarecycline was safe, well tolerated, and effective for moderate to severe acne, with low rates of side effects common with tetracycline antibiotics. J Drugs Dermatol. 2018;17(9):987-996.

Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

No abstract details for the moment.

No abstract details for the moment.

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

No abstract details for the moment.

No abstract details for the moment.

No abstract details for the moment.

No abstract details for the moment.

Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.

No abstract details for the moment.

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

Squaric acid dibutyl ester (SADBE) is a commonly used treatment for verruca vulgaris of childhood. Few studies, however, have examined the role of SADBE in combination with other topical therapies for warts. We sought to determine if trichloroacetic acid 50% (TCA) and/or cantharidin 0.7% improve therapeutic response to SADBE. A retrospective chart review of 74 patients who were treated for warts at a pediatric dermatology practice in 2010 was performed. Cox regression analysis was used to identify determinants of 100% response to SADBE and found that number of warts was most important (P=0.002). Trichloroacetic acid + SADBE resulted in 100% clearance of warts in all subjects with the shortest time-to-clearance (hazard ratio [HR]: 2.45, 95% confidence interval [CI]: 1.14-5.25, P=0.02). In contrast, addition of cantharidin did not improve response to SADBE (HR: 1.13, 95% CI: 0.60-2.13, P=0.59) or TCA + SADBE (HR: 1.16, 95% CI: 0.65-2.07, P=0.61). These results suggest that combination treatment with TCA 50% and SADBE significantly improves the consistency and speed of SADBE-induced clearance of warts.

J Drugs Dermatol. 2012;11(10):1228-1230.

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

No abstract details for the moment.

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

Resident Rounds is a section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds includes three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the Department of Dermatology, Oregon Health & Science University. The editor of Resident Rounds is Omar A. Ibrahimi MD PhD. He is currently the Director of Cutaneous Laser and Cosmetic Surgery and a Mohs surgeon at the University of Connecticut. Dr. Ibrahimi is also a Visiting Scientist at the Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at OIbrahimi@jddonline.com.

Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.

Background: Vitiligo vulgaris is a chronic autoimmune depigmenting disorder affecting individuals of all skin colors. Lesions are commonly noted in the periorificial face and over the upper and lower extremities in areas of friction. Although there have been many published reports of successful therapies for vitiligo, few have assessed differential response based on skin color.
Objective: To determine if topical tacrolimus is more effective at treating vitiligo in individuals of color.
Methods: An IRB-approved chart review of patients with a diagnosis of vitiligo was conducted including patients seen between May 2001 and April 2006. Patients with vitiligo were treated with tacrolimus 0.03% for children ages 2-15 years of age and tacrolimus 0.1% ointment for individuals 16 years of age or older, applied twice-daily to all hypopigmented or depigmented lesions. A review of clinical features, Fitzpatrick skin type and response to topical tacrolimus were recorded.
Results: Topical tacrolimus was effective in all Fitzpatrick skin types, with superior efficacy on body lesions in individuals of Fitzpatrick types 3-4 (Fisher exact test, P=0.03). Further, individuals with Fitzpatrick type 3-4 skin had shorter interval to >75 percent improvement of lesions on the body (Kaplan-Meier Log-rank, P=0.03) and head and neck (P=0.016).
Conclusion: Topical tacrolimus is an effective treatment for vitiligo irrespective of skin tone, with greatest benefit in Fitzpatrick type 3-4 skin. Repigmentation of lesions on the head and neck is superior to repigmentation of the body and extremities in all racial subgroups.

J Drugs Dermatol. 2011;10(5):507-510.

No abstract details for the moment.

Phototherapy is often used to treat inflammatory skin conditions such as psoriasis and eczema. Much progress has recently been made in understanding the mechanisms underlying the local, cutaneous immune effects induced by phototherapy. Unlike many immunosuppressive drugs used in the management of inflammatory skin disease, phototherapy not only targets effector immune cells but also appears to up-regulate regulatory T cells (Tregs). Additionally, phototherapy reverses epidermal barrier abnormalities common in these diseases, allowing for restoration of cutaneous homeostasis.

J Drugs Dermatol. 2014;13(5):564-568.

Polymorphic light eruption (PMLE) is the most common of the immunologically mediated photodermatoses.¹ Onset is typically within the first three decades of life and affects females two to three times more than males.^2,3 It occurs 30 minutes to 1-3 days after sun exposure and usually resolves in 7 to 10 days.² Lesions present as non-scarring, erythematous and minimally pruritic papules, vesicles, papulovesicles, plaques or nodules.³
A pinpoint papular variant of PMLE has been reported in individuals with skin phototype IV-VI,⁴ characterized by the development of pinpoint papules, 1 to 2 mm, on sun-exposed areas after ultraviolet radiation.⁵ PMLE has a predilection for the arms, forearms, hands, head and neck region, usually with sparing of the face.^2,4 We report two cases of American-American males who presented with the pinpoint papular variant of PMLE involving the face.

J Drugs Dermatol. 2013;12(11):1285-1286.

Surgical procedures are an important piece of a dermatologist’s daily practice. Therefore, the optimization of post-surgical wound healing is an area of utmost importance and interest. Although low risk, one notable barrier to proper wound healing is surgical site infection.

In an attempt to mitigate this risk and improve surgical outcomes, multiple topical products continue to be used both pre- and postprocedure. Traditionally, this includes both topical antibiotics and antiseptics. However, these products are not without consequence.

The overuse of topical antibiotics as prophylaxis for infection has contributed to increased bacterial resistance, and in fact is no longer recommended by the American Academy of Dermatology in clean post surgical wounds. Topical antiseptics, including chlorhexidine and povidone-iodine, can have a cytotoxic effect on keratinocytes and may actually impede wound healing as a result. In addition, chlorhexidine in particular can produce both otologic and ocular toxic effects when used on the face. Emerging products, such as hypochlorous acid, may be a potential alternative to the more commonly used agents, as it has effective antimicrobial actions and minimal adverse effects. Therefore, the purpose of this review is to highlight several topical products used to optimize post-surgical wound healing and discuss both their efficacy and safety.

J Drugs Dermatol. 2017;16(3):209-212.

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.

BACKGROUND: Topical corticosteroids (TCS) are the mainstay of psoriasis treatment; long-term safety concerns limiting consecutive use of potent TCS to 2-4 weeks. OBJECTIVE: Investigate safety and efficacy of halobetasol propionate 0.01% lotion in moderate-to-severe plaque psoriasis. METHODS: Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Subjects randomized (2:1) to halobetasol propionate 0.01% lotion or vehicle once-daily for 8 weeks, 4-week posttreatment follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in Investigator Global Assessment [IGA] score and ‘clear’ or ‘almost clear’) at week 8. Safety and treatment emergent adverse events (AEs) evaluated throughout. RESULTS: Halobetasol propionate 0.01% lotion demonstrated statistically significant superiority over vehicle as early as week 2. By week 8, 36.5% (Study 1) and 38.4% (Study 2) of subjects were treatment successes compared with 8.1% and 12.0% on vehicle (P less than 0.001). Halobetasol propionate 0.01% lotion was also superior in reducing psoriasis signs and symptoms, body surface area (BSA), and improving quality of life. Halobetasol propionate 0.01% lotion was well-tolerated with no treatment-related AEs greater than 1%. LIMITATIONS: Study did not include subjects with BSA greater than 12. CONCLUSIONS: Halobetasol propionate 0.01% lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, without the safety concerns of a longer treatment course. J Drugs Dermatol. 2018;17(10):1062-1069.

Midpotency topical corticosteroids (TCSs) are frequently used for the treatment of common eczematous and inflammatory skin disorders in both adults and children. There are several commercially available products in this category, and many vehicles and formulations for the clinician to choose from. Clocortolone pivalate 0.1% cream is a midpotency TCS formulated in an emollient formulation that has been shown to be effective and well tolerated when used appropriately in the management of several corticosteroid-responsive dermatoses. This article discusses the physiochemical properties of the compound; the characteristics of its emollient cream formulation; the functions of individual excipients; and the efficacy, tolerability, and safety data supporting its use in adults and children, including for facial involvement.

J Drugs Dermatol. 2013;12(2)(suppl):s5-s10.

BACKGROUND: Changes in the composition of microbial communities that colonize skin have been linked to several diseases including psoriasis. Nevertheless, the intra-individual dynamics and how these communities respond to balneotherapy remain poorly understood.
METHODS: This open label study was conducted between July and September 2012. Microbial communities of patients with psoriasis vulgaris were characterized prior and post a 3-week selenium-rich water balneotherapy treatment at the thermal care center La Roche-Posay (La Roche-Posay, France). Balneotherapy consisted of high-pressure filiform showers, baths, facial, and body spray treatments as well as La Roche-Posay thermal spring water (LRP-TSW) consumption. Swabs were taken from affected and proximal unaffected skin and the 16S rRNA bacterial gene was used to analyze the composition of bacterial communities. Using the same 16S rRNA gene tool, we tried to describe the LRP-TSW bacterial landscape.
RESULTS: This study included 54 patients diagnosed with moderate to severe forms of psoriasis vulgaris. After eliminating individuals lacking paired samples from both visits, 29 individuals were analyzed for their microbiome profile. Shannon Diversity Index and global bacterial landscape indicate similar microbial communities on both unaffected and adjacent affected skin. PASI values decreased post-balneotherapy implying improvement of disease severity. No significant change in the Shannon Diversity Index was noticed at the end of the third week. The average taxonomic composition of skin microbial communities associated with unaffected and affected skin of psoriatic patients post-balneotherapy shows that treatment with LRP-TSW significantly increased the level of Xanthomonas genus and, to a lesser extent, Corynebacterium genus. The Xanthomonas genus belongs to the main Xanthomonadaceae family found in LRP-TSW and also on healthy skin.
CONCLUSIONS: In psoriatic patients, a poor bacterial biodiversity was noticed and the bacterial communities were similar on unaffected and affected adjacent skin. Family analysis identified, for the first time, Xanthomonadaceae belonging to Proteobacteria phylum and known to be keratolytic, associated with the clinical improvement observed after a 3-week balneotherapy treatment. This data supports the interest of selenium-rich thermal spring water in the treatment of psoriasis vulgaris.

J Drugs Dermatol. 2015;14(12):1400-1405.

An acute inflammatory nodule of unknown etiology can pose a formidable diagnostic challenge. Here, we highlight the importance of including Mycobacterium avium intracellulare complex (MAC) and other atypical mycobacterial infections in the differential diagnosis of a cutaneous nodule in an immunocompetent individual. We also explore the implications of eczema in the development of a mycobacterial infectious process. We report a case of MAC skin infection in an immunocompetent individual. The patient is a 49-year-old male with a history of dyshidrotic eczema presenting with a fluctuant, non-draining nodule on his right forearm for 2 to 3 weeks, identified by tissue DNA probe to be a cutaneous MAC infection without systemic complications, as serologies and chest X-ray were unremarkable. MAC should be included in the broader differential diagnosis of deep fungal vs atypical mycobacterial skin infections. Nucleic acid-based assays are an important tool in making a definitive diagnosis, allowing for utilization of appropriate therapy for the specific etiologic pathogen. Given the patient’s preceding diagnosis of eczema, it is possible that the compromised skin barrier and dampened cytotoxic Th1 activity predisposed the patient to this infection, typically appreciated in the immunosuppressed, warranting further investigation into the relative risk for atypical mycobacterial infections in the setting of eczema.

J Drugs Dermatol. 2014;13(12):1491-1493.

Acne vulgaris (AV) is a very common inflammatory facial disorder that is complex in its pathophysiology, heterogenous in clinical presentation, and affects children and adults of all ethnicities, races, and skin types.

No abstract details for the moment.

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

BACKGROUND: Topical corticosteroids (TCS) are typically used for extended periods of time for chronic skin conditions, including psoriasis. Chronic TCS use may result in side effects similar to those of systemic corticosteroids. Patients may have subclinical adrenal suppression and be unaware of their risk in the case of serious trauma.
OBJECTIVE: The objective of this study was to investigate the real world effects of chronic TCS use and its effects on adrenal suppression in a chronic disease such as psoriasis.
MATERIALS: This retrospective study utilized data from screening visits of a psoriasis clinical trial in which subjects had been on chronic TCS.
RESULTS: In this study, subjects with moderate to severe psoriasis affecting 16-20% of total body surface area (BSA) and using high-potency TCS at screening had a lower post-cosyntropin cortisol level (18.83 mcg/dL) compared to those with moderate psoriasis involving 10-15% of total BSA and using lower potency TCS at screening (23.22 mcg/dL; P=0.03). Both subject groups had lower post-cosyntropin cortisol levels compared to normal, healthy adults (P<0.001 for both).
CONCLUSION: This suggests that real world chronic use of high potency TCS over a larger BSA may result in silent adrenal suppression.

J Drugs Dermatol. 2016;15(8):945-948.

Flagellate erythema occurs following the consumption of raw or undercooked shitake mushrooms, in associated with autoimmune disease, and after bleomycin treatment. A dramatic case of shitake mushroom-induced flagellate erythema is presented, highlighting the presence of dermatographism in this patient.

Taurine is present abundantly in various tissues, especially in leukocytes embattled to foreign invaders such as microorganisms or oxidants. Taurine-chloramine (Tau-Cl) is produced from taurine at the site of inflammation via the myeoloperoxidase-halide pathway in leukocytes induced by oxidants and/or infectious materials. Previously, our data demonstrated that Tau-Cl inhibited nitric oxide (NO) production and TNF-α secretion induced by lipopolysaccharide (LPS), a Toll-like receptor 4 (TLR-4) ligand or lipoarabinomannan (LAM), a TLR-2 ligand plus interferon-γ (IFN-γ) in peritoneal macrophages or RAW 264.7 cells. Zymosan, a β-glucan of yeast cell wall, is a ligand for TLR-2 and dectin-1 and stimulates macrophages to produce proinflammatory mediators such as NO and TNF-α. Based on our previous data, we examined the effect of zymosan and IFN-γ induced production of NO and TNF-α in the absence or presence of Tau-Cl or taurine using RAW 264.7 cells. Production of NO and secretion of TNF-α is increased when zymosan is combined with IFN-γ. Tau-Cl inhibited production of NO and secretion of TNF-α in zymosan plus IFN-γ activated RAW 264.7 cells in a dose-dependent manner (99% vs. 48% using 0.8mM Tau-Cl). Taurine was without effect. Nitric oxide synthase protein (iNOS), induced by zymosan plus IFN-γ, was inhibited by Tau-Cl (0.8mM) as measured using western blot analysis. NOS mRNA was inhibited by Tau-Cl at four, eight and 16 hours post activation, but not at 24 hours. TNF-α mRNA was inhibited at four hours and eight hours, but not at 16 and 24 hours. These data suggest that expression of both iNOS and TNF-α mRNAs are inhibited by treatment with Tau-Cl within four and eight hours, but not at later time points. Transient suppression of activation of RAW 264.7 cells induced by zymosan may play a critical physiological role for taurine in protecting against tissue injury from initial overt inflammation. This study indicates that tropical treatment of taurine may ameliorate inflammatory dermatoses caused by an environmental yeast or abnormal immune function.

J Drugs Dermatol. 2011;10(6):659-665.

No abstract details for the moment.

Objective: Some literature reported that topical calcineurin inhibitors (TCIs) did not accelerate photocarcinogenesis in hairless mice after long-term simulated solar radiation. In this work, we investigate the effects of topical pimecrolimus 1% on long-term suberythemal ultraviolet B (UVB)—irradiated epidermal Langerhans cells (LCs) in mice.
Methods:Thirty female mice were randomly divided into two groups, including four subgroups: (1A) control, (1B) pimecrolimus 1% only, (2A) 25 mJ/cm2 UVB only, (2B) UVB plus pimecrolimus. After being treated for 60 days, the dorsal skin was collected and given immunohistochemical staining of active caspase 3, and immunofluorescence staining for cluster of differentiation 1a (CD1a).
Results:Our results show that, compared with the control subgroup, the CD1a+ LC number in the epidermal sheet of the UVB-only subgroup decreased substantially from 578.6 per mm² to 227 per mm² (P<.001). Compared with the UVB-only subgroup, the UVB plus pimecrolimus subgroup significantly restored the LC number from 227 per mm² to 475.7 per mm² (P<.001). Compared with other subgroups, the LC morphology of the UVB-only subgroup became rounder, and the LC dendrites became shorter. There were no significant active caspase 3-positive cells in the epidermis in any of the four subgroups.
Conclusion:Our results show that topical pimecrolimus 1% reverses long-term UVB-induced epidermal LC reduction and morphologic changes in mice, where the exact mechanism is likely not related to apoptosis.

J Drugs Dermatol. 2012;11(9):e25-e27.

Excipients are defined as inert substances added to a drug or food to confer a suitable consistency, appearance, or form. They may be added for bulk, to change dissolution or the kinetics of absorption, to improve stability, to influence palatability, or to create a distinctive appearance. The last function may depend heavily on the use of coloring agents, especially when there are multiple dosages (such as with warfarin), and dose confusion may result in profound complications. While described as inert, excipients have been associated with triggering immunological reactions, although this is almost never considered in common practice when patients have reactions to medications, even when they appear to react to many different and distinct drugs. We have found a cohort of 11 patients with chronic, unexplained pruritic skin disorders that have responded to medication changes centered around avoidance of coloring agents, particularly FD&C Blue No. 1 (bright blue) and Blue No. 2 (indigo carmine). We believe that reactions to agents that color medications and foods may be more common than previously appreciated and that recognition of this phenomenon may provide therapeutic alternatives to patients with intractable pruritic disorders.

J Drugs Dermatol. 2013;12(1):99-102.

Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.

Sensitive skin is a common skin complaint frequently associated with skin diseases or adverse reactions to cosmetic products. Manufacturers have produced numerous products targeted for patients with sensitive skin and frequently label these products as being hypoallergenic. This term implies that the product may be less likely to cause an allergic reaction and be better suited for those with sensitive skin. However, there is no federal regulatory definition of this term and products may not have clinical support of their claim. Patch testing ingredients is frequently done to identify potential irritants; however, patch-testing product formulations may provide more realistic expectations about potential skin sensitivity and help support claims of hypoallergenicity. Ten skincare products were assessed for their sensitizing potential and hypoallergenicity in 14 repeat insult patch test clinical studies, involving over 2,000 subjects. In these studies, the products were deemed to be hypoallergenic if there was no evidence of sensitization or allergic reactions. The results from these trials demonstrated that all ten products were well tolerated, showed no sensitization or allergic reactions, and support claims of hypoallergenicity.

J Drugs Dermatol. 2014;13(3):264-266.

Patients under two years old comprise a small fraction of the population of patients seen in general dermatology clinics. Newborns and infants have immature skin barriers and immune systems, and as a result may be afflicted with different cutaneous diseases than adults. Additionally, common conditions may present differently in this population and may not be as easily recognized. This may make evaluation and diagnosis challenging for dermatologists. We provide a comprehensive review of rashes seen in neonatal and infantile patients to aid with proper diagnosis and treatment of this population. This review may also serve as a useful reference for board preparation.

BACKGROUND: Limited options are available for the treatment of brittle nail syndrome.
OBJECTIVE: To assess the efficacy and safety of topical cyclosporine emulsion (CsAE) versus emulsion (vehicle) alone in the treatment of brittle nail syndrome.
RESULTS: Twenty-four patients were randomized to topical CsAE emulsion or emulsion (vehicle) for 24 weeks. Four fingernails of each patient were included; the 2 most severe brittle nails and the second most normal nail were treated with the same medication. The fourth nail, the most normal nail, remained untreated and was used to assess nail growth. The prespecified primary endpoint was change from baseline in Physician Global Assessment (PGA) score (0 to 5 scale) at each follow-up visit. Safety evaluations were conducted at each visit.
RESULTS: In the intent-to-treat population (n=12 for each treatment arm), the PGA score for treated nails improved from baseline (CsAE, 0.7 to 1.4; emulsion, 0.7 to 1.5; P<0.05 for each), with no significant between-group differences. Untreated nails did not improve in overall appearance (0.0 to 0.3 grade; P>0.05). Statistically and clinically significant improvement from baseline was reported for nail length/appearance in both CsAE and vehicle groups.
LIMITATIONS: Sample size was relatively small. The difference in PGA between treated and untreated nails was not analyzed. Baseline disease severity may have been too mild, limiting detection of efficacy.
CONCLUSIONS: Both CsAE and emulsion vehicle applied topically appeared to improve signs and symptoms of brittle nail syndrome and were well tolerated. These findings warrant corroboration in a larger population and inclusion of comparison with an inactive control and a higher concentration of CsAE, the former which may help in distinguishing the efficacy of vehicle emulsion from CsAE.

J Drugs Dermatol. 2014;13(10):1232-1239.

Down syndrome (DS) is the most common chromosomal disorder and a major cause of mental retardation. Down syndrome phenotype is complex and may present a combination of dysmorphic features, congenital heart disease and immunological deficiency. Psoriasis it has been noted to be 0.5%-8% in patients with DS and numerous factors can limit the use of therapeutic options, in particular long-term organ-specific toxicity, and the risk of opportunistic infections. It is still debated whether the use of biologics in the treatment of DS-related psoriasis is safe. We have valuated the efficacy and safety of ustekinumab treatment in-patient with DS suffering from plaque type psoriasis. A 31-year-old patient suffering from plaque type psoriasis since the age of 14, showed a PASI score of 12 after the failure of anti-TNF agents. We switched the patient to ustekinumab treatment at the standard dose of 45 mg subcutaneously initially and 4 weeks later, followed by 45 mg every 12 weeks. The patient showed a significant improvement of the PASI score already after 4 weeks of treatment and further improvements were observed throughout the treatment. We report the first case of DS-correlated psoriasis patient treated for a long-term period with various biologics, showing a satisfactory safety profile undergoing treatment. In our experience, ustekinumab has demonstrated a high efficacy, relatively rapid onset of action, favorable safety profile, and can be considered a good treatment option even after failure to respond to other biologic therapies in patient with DS.

J Drugs Dermatol. 2012;11(8):1000-1002.

The stratum corneum (SC) is the skin’s outermost layer and serves the primary function of acting as a shield to keep foreign matter out and to essential elements, such as moisture and water, in. Maintenance of this skin barrier is crucial to healthy functioning skin. A damaged or diseased skin barrier is vulnerable to infection, irritants, and allergens. The cornerstone of skin barrier regulation and repair is through the use of moisturizers. While healthcare providers and patients may underestimate the importance of moisturizers due to their lack of active ingredients, the benefit of a well-planned moisturizer regimen for skin barrier regulation should not be discounted. Dermatologists should be comfortable prescribing and educating about over-the-counter moisturizers to patients with skin barrier is- sues. A general understanding of basic moisturizer ingredients and formulations will aid the dermatologist in providing a personalized moisturizer regimen to their patients. J Drugs Dermatol. 2016;15(11):1289-1294.

Background: Periocular "dark circles" fall among the most difficult chief complaints to address. In most cases, we have little information regarding etiology and no gold-standard treatment option. The extent of the problem is reflected in the sheer number of products on the market advertised to either lighten or cover the pigmentation.
Objective/Methods: To present dermatologists with a complete review of the literature with regard to anatomy, definition, etiology, and treatment of periocular hyperpigmentation.
Conclusions: Our understanding of the causes and treatment of periocular hyperpigmentation continues to advance. Nevertheless, we are in need of additional controlled clinical trials and novel therapeutic options. Individual patients will likely benefit most from a combination of approaches. Although more randomized clinical studies are necessary, Pfaffia paniculata/Ptychopetalum olacoides B.⁄Lilium candidum L. - associated compound cream seems to be a promising option, with 90% improvement. For patients with increased melanin deposition, quality-switched ruby laser therapy could offer a better treatment option. In the hands of experienced professionals, a surgical option might be suitable, either by autologous fat transplantation or hyaluronic acid filler.

J Drugs Dermatol. 2013;12(2):154-157.

No abstract details for the moment.

The skin is constantly exposed to various endogenous and exogenous factors that may impact its barrier function at the physical, mechanical, immunological, and microbial levels. These factors have the potential to initiate or exacerbate a variety of inflammatory skin conditions, especially those associated with barrier dysfunction. The barrier function of the skin depends upon a symbiotic relationship between resident microbial communities and host tissue. This symbiosis results from complex signals involved in both the innate and adaptive immune responses. Recent research indicates that both bacterial diversity and the relative abundance of different microbes present on and in the skin, may contribute to skin barrier stability or dysfunction. The objectives of this review are to discuss the relationship between the skin microbiota and skin barrier function and to consider mechanisms that may help its preservation.

J Drugs Dermatol. 2017;16(1):12-18.

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Background: The use of topical medications for acne vulgaris is often limited by their irritant properties. Newer combination preparations are available and offer convenience, but irritant potential may still be a hindrance, perhaps more so with the combination of 2 agents. Few studies have compared these formulations directly for tolerability.
Objective: We sought to compare the tolerability of 2 combination topical acne products, clindamycin 1.2%-tretinoin 0.025% (CLIN/RA) gel and benzoyl peroxide 2.5%-adapalene 0.1% (BPO/ADA) gel.
Methods: CLIN/RA and BPO/ADA were applied daily to opposite sides of a subject's face for 21 days in a double-blinded fashion. Investigators' Global Assessments and study subject self-assessments of burning/stinging, itching, erythema, and dryness/scaling were collected. Transepidermal water loss (TEWL) was also measured as an objective measure of skin irritation. A mixed model analysis and repeated-measures analysis of variance were used to compare outcomes for both acne formulations.
Results: CLIN/RA produced significantly less burning/stinging than BPO/ADA (P<.001) as well as significantly less pruritus than BPO/ADA (P<.001). BPO/ADA caused significantly more TEWL than CLIN/RA (P=.005). There was no significant difference in the amount of erythema or the amount of dryness/scaling caused by either formulation.
Conclusion: CLIN/RA produced significantly less skin irritancy and TEWL than BPO/ADA.

J Drugs Dermatol. 2012;11(12):1422-1426.

Interferon- α has been associated with a wide range of adverse events (AEs). A lupus-like reaction at the injection site of subcutaneous (SC) interferon-α is exceptionally rare. A 60-year-old woman with recurrent metastatic melanoma repeatedly developed cutaneous lupus-like reactions at the SC interferon-α-2b injection sites on her thighs. Known features of lupus-like reactions at SC interferon-α injection sites are reviewed, and cutaneous injection site reactions to SC interferon-α are summarized.

J Drugs Dermatol. 2012;11(3):393-398.

The objective of this 6-week clinical study was to demonstrate the effectiveness of a natural ingredient-based moisturizing cream versus a colloidal oatmeal moisturizing cream in improving the hydration, barrier function, appearance, and feel of dry leg skin. Thirty-two subjects completed the study. After a 5-day washout, subjects used the natural ingredient-based moisturizing cream and oatmeal-containing cream on randomly-assigned legs twice a day for a period of three weeks. For the following two weeks subjects did not use any moisturizer on their legs. Skin moisture measurements showed a statistically significant increase in hydration for both products at all time points during the treatment phase of the study. Both products reduced transepidermal water loss measurements during the treatment phase of the study, showing their abilities to improve stratum corneum barrier function. Clinical evaluations showed that both products significantly decreased visual dryness and tactile roughness during the treatment phase. Improvements in the assessed clinical parameters persisted even after treatment cessation. In conclusion, the natural ingredient-based moisturizing cream was highly effective in providing moisturization and improving the skin barrier of subjects with very dry leg skin. It also produced significant improvements in visual dryness and tactile roughness that persisted during regression. Overall, these results show that the natural ingredient-based moisturizing cream delivers comparable benefits to that of a colloidal oatmeal-containing benchmark product and is an option for health care providers and consumers who seek relief from dry skin and prefer a product with all-natural ingredients. J Drugs Dermatol. 2018;17(7):758-764.

Various extracts of polypodium leucotomos (PLE) applied topically or taken orally have been shown to have several beneficial antioxidant, photoprotectant, antimutagenic, and immunoregulatory effects. Modern studies have evaluated the efficacy of PLE orally as a photoprotective agent and for use in several photo-aggravated dermatologic disorders such as polymorphous light eruption, other photodermatoses, and melasma. No articles have been published evaluating the safety of PLE. We performed a PUBMED search for any randomized clinical trials related to PLE, or anapsos, a synonym. The primary safety endpoint of the review was any mention of an adverse event, side effect, or toxicity. Overall, 19 human and 6 basic science studies were included spanning over 40 years of research. Oral PLE was administered at daily doses ranging from 120 mg to 1080 mg. No adverse effects were reported in laboratory studies. In humans, side effects (gastrointestinal complaints and pruritus) were mild to moderate and found only in very small numbers of patients overall (16/1016 [2%]). This review concludes PLE is well tolerated at all doses administered and associated with a negligible risk of side effects.

J Drugs Dermatol. 2015;14(3):254-259.

Herpes Labialis results from reactivation of latent herpes simplex virus (HSV-1 or HSV-2) harbored in the trigeminal ganglion during times of psychological stress, cutaneous injury or photo exposure. Following reactivation, the virus is anterogradely transported through axonal termini to the skin where the virus is released and replicates causing a clinical outbreak. Botulinum neurotoxin A (BoNTA) is known to inhibit presynaptic neuropeptide and neurotransmitter release. Whether it has the capacity to interfere with viral shedding and delivery into the skin remains unclear. We were interested in determining whether BoNTA could serve as a potential therapeutic or prophylactic treatment approach for frequent and severe HSV recurrences. We describe a clinical case report in which a patient successfully maintained a sustained absence of HSV outbreaks in regions where BoNTA was intradermally administered. BoNTA may offer a novel therapeutic approach for preventing recurrent HSV disease. J Drugs Dermatol. 2018;17(10):1127-1129.

Oral isotretinoin is a non-aromatic oral retinoid that is highly effective for the treatment of severe inflammatory acne vulgaris that is refractory and/or prone to scarring, and has also been used successfully to treat several other disorders in selected cases. Since its introduction into the United States marketplace in 1982, it has been well recognized that cutaneous side effects characterized by xerotic and desquamative changes are very common, and appear to be related to epidermal dyscohesion, and to some extent the sebosuppressive effects of the drug. Additionally, increased susceptibility to staphylococcal colonization has also been observed. The epidermal barrier impairments that have been associated with oral isotretinoin are reviewed in this article along with clinical implications. Strategies to mitigate the altered effects of epidermal barrier functions are reviewed including the importance of topical barrier repair therapy.

J Drugs Dermatol. 2013;12(6):626-631.

BACKGROUND: This study measured skin hydration and occlusivity of two test products [halobetasol propionate lotion, 0.05% (HBP Lotion) and Ultravate® (halobetasol propionate) cream, 0.05% (HBP Cream)] at 2, 4, and 6 hours after application to skin test sites previously challenged by dry shaving, which was performed to compromise the integrity of the stratum corneum barrier. METHODS: Trans-epidermal water loss (TEWL), an indicator of skin barrier function, was measured using cyberDERM, inc. RG-1 evaporimeter. Skin hydration was evaluated using IBS SkiCon-200 conductance meter. Test products were applied bilaterally on dry-shaved sites on the volar forearm sites, according to a randomization scheme, with two test sites untreated to serve as “dry-shaved” controls. TEWL and conductance were measured at 2, 4, and 6 hours post-treatment. RESULTS: HBP Lotion displayed a significant increase in skin hydration at 2, 4, and 6 hours post-treatment compared to the baseline values and dry-shaved controls (each, P less than 0.001). However, HBP Cream produced statistically significant increased skin hydration only after 6 hours (P less than 0.05). HBP Lotion was significantly more effective than HBP Cream in increasing skin hydration at 2 and 4 hours post-treatment (each, P less than 0.001), and had a directional advantage (not statistically significant) at 6 hours. Neither test product had a significant occlusive effect as measured by TEWL at 2, 4, and 6 hours post-application. CONCLUSION: Both formulations of HBP (Lotion and Cream) contributed to skin moisturization, as measured by skin conductance. HBP Lotion produced a significantly more rapid onset and higher level of moisturization at 2 and 4 hours post-application compared to HBP Cream. The TEWL results indicate that neither HBP Lotion nor HBP Cream provided any significant occlusivity to the skin.

J Drugs Dermatol. 2017;16(2):140-144.

BACKGROUND: Although botulinum toxin type A (BoNT-A) has been used effectively and safely to reduce facial dynamic wrinkles, few studies assessed patients' quality of life and satisfaction after treatment.
OBJECTIVE: To assess the quality of life and satisfaction of patients treated with full-face injections of variable doses of abobotulinum toxin A (ABO).
METHODS: Ninety subjects were randomized into 3 different groups, receiving 120-165 U, 166-205 U and 206-250 U, respectively. WHOQOL- BREF and Satisfaction and Self-assessment Questionnaire (SSQ) were completed by subjects up to 6 months after treatment.
RESULTS: Most of the subjects were women (96.5%). For the physical domain in WHOQOL, a difference was observed between baseline and visit 2 (p = 0.036). There was no difference between groups for mean grades regarding amount of wrinkles, beauty, harmony and symmetry. However, there was a significant difference in the mean grades between visits. Patients' opinions also showed an improvement in their self-image up to four months after treatment, according to the self-grading.
CONCLUSION: The results presented in this study show improvements in patients' quality of life during the peak of action of BoNT-A treatment, regarding the physical aspect. In addition, patients reported good satisfaction after a full-face approach.

J Drugs Dermatol. 2013;12(12):1363-1367.

Topical treatment is a pillar of dermatologic practice. The delivery of drug by a topical vehicle is dependent on complex physical chemistry and on how well patients apply the product. The potency of topical agents is not solely dependent on the concentration of active drug in the vehicle. A corticosteroid molecule may have vastly different potency depending on what vehicle is used to deliver it. Similarly, a new gel vehicle is able to deliver considerably more active antifungal than an older vehicle technology and may represent a promising vehicle for other novel formulations. The use of new vehicles can provide more effective means for treating patients with skin disease.

J Drugs Dermatol. 2014;13(4):423-427.

The epidermis functions as a physical barrier that separates the inner body from the outside environment. The outermost layer of the epidermis, the stratum corneum, plays a key role in maintaining this barrier. There are numerous biochemical changes that take place to and in the keratinocyte as it migrates from the bottom, or startum basale, to the top layer of the epidermis in order for this barrier to function appropriately. In addition, external and internal factors, such as irritants and underlying medical diseases, can also affect the stratum corneum, both of which can potentially lead to disruption of barrier function and ultimately skin pathology. In this article, we will review keratinocyte biology as it relates to the formation and function of the stratum corneum. We will also review stratum corneum structure, physiology, and the impact of chemical agents and defective stratum corneum components that can lead to skin disease. Finally, we will briefly discuss how moisturizers repair defects in the stratum corneum and restore barrier function.

J Drugs Dermatol. 2016;15(9):1047-1051.

No abstract details for the moment.

The human microbiome has recently gained prominence as a major factor in health and disease. Here we review the literature regarding the microbiome and cancer and suggest how the microbiome may be manipulated for improved health outcomes. The gut microbiome has been relatively well studied, and the mechanisms of how it may increase or decrease the risk of certain cancers may apply to the skin microbiome. Additionally, the gut microbiome may directly impact the risk of cancer in the skin and other organs by promoting systemic inflammation. The skin microbiome itself is as diverse as the gut microbiome, but research has just begun to unravel its influence on the host. Like the gut microbiome, it affects the risk for several diseases, including cancer. By using healthpromoting strains from the microbiome in oral or topical probiotics, it may be possible to reduce the risk of skin cancer and perhaps even increase the likelihood of successful treatment.

J Drugs Dermatol. 2015;14(5):461-465.

Leuprolide acetate, a gonadotropin-releasing hormone agonist, is used in the treatment of prostate cancer. We report a unique case of a disseminated papular rash following leuprolide acetate injections in a 65-year-old man that shares clinical and histopathological features of papuloerythroderma of Ofuji. Leuprolide-induced papuloerythroderma, as well as a limited number of other disseminated cutaneous eruptions caused by this drug, is extremely rare, with only one case previously reported. Our case calls attention to this uncommon side effect in a commonly used hormonal therapy.

J Drugs Dermatol. 2014;13(6):755-757.

No abstract details for the moment.

No abstract details for the moment.

Objectives: To assess the benefit of adjunctive use of a SPF 30 moisturizing lotion in reducing local side effects associated with atopical tretinoin cream.
Methods:This was a randomized, investigator/evaluator-blinded, split-face comparison in subjects with healthy skin. Subjects applied tretinoin cream 0.05% once daily to the whole face and Cetaphil^® Dermacontrol Moisturizer (CDM) once daily to one side of the face based on randomization. Tolerability, perference and skin hydration were evaluated at each week, and a cosmetic acceptability questionnaire regarding CDM was completed at the end of the study.
Results: The majority (about 83% to 86%) of subjects experienced skin irritations on both sides of their face, though predominantly mild for the CDM + tretinoin treated side. Tolerability preferences favored the CDM+tretinoin sides. Adjunctive use of CDM with a topical tretinoin cream improves tolerance of the treatment.

J Drugs Dermatol. 2012;11(9):1104-1107.

Resident Rounds is a section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds includes three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features The Unified Division of Dermatology Residency Program of Albert Einstein College of Medicine. The editor of Resident Rounds is Omar A. Ibrahimi, MD, PhD. He is currently the Director of Cutaneous Laser and Cosmetic Surgery and a Mohs surgeon at the University of Connecticut. Dr. Ibrahimi is also a Visiting Scientist at the Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at omar.ibrahimi@gmail.com

The proposed terminology Generational Dermatology encompasses prevention and involves medical, cosmetic, surgical and oncologic strategies over the decades to optimize skin performance throughout the course of a lifetime. Organ failure is the inability of the organ to perform its determined function as a part of normal physiology and it may be possible to take a Generational preventive approach toward reducing morbidities associated with the failure of our largest organ, the skin. Outside of skin cancer prevention efforts we have as a specialty primarily worked on the tertiary prevention realm. I advocate that we can increase our focus on the primary and secondary tiers where we as Dermatologists have the training and education to identify risk factors and detect early symptoms of skin disease. I appeal to the house of Dermatology to embrace this concept of Generational Dermatology as preventive medicine for the evolving aging patient. The practice of Generational Dermatology will decrease patient morbidity and bring down the cost of healthcare. Our global increased longevity increases the number of elderly worldwide. Longer lifespan means dermatologic needs will increase as the skin must perform its basic function longer. There are also new unknowns and skin issues which arise from large numbers of people in the 9th and 10th decades. Generational Dermatology is well suited to be a model for prevention as our patient's age and we can intervene at any decade. I believe the specialty will increasingly focus on how the skin can optimally perform for a longer period. Lastly, the practice of Generational Dermatology unifies the house of Dermatology as we need the innovations and input of every subspecialty to contribute to the health of the people we serve.

J Drugs Dermatol. 2013;12(12):1396-1399.

No abstract details for the moment.

Background: Ingenol mebutate gel 0.015% provides high clearance rates for actinic keratosis (AK) on the face and scalp but causes transient local skin responses (LSRs).

Objective: This study sought to determine whether the application of 1% dimethicone would decrease ingenol mebutate–associated LSRs and/or affect efficacy during the treatment of multiple AKs on the face.

Methods: Ingenol mebutate gel 0.015% was applied for 3 days to two 25 cm2 areas, each containing 3 to 8 AKs on the face of each subject, followed by application of 1% dimethicone lotion in an investigator-blinded manner to one randomly selected AK-containing area until LSRs were no longer present.

Results: In total, 20 subjects were enrolled and completed the study. Topical 1% dimethicone lotion applied during and after treatment of facial AK with ingenol mebutate gel 0.015% reduced mean total LSR scores at days 8 and 15 compared with ingenol mebutate gel only, although the difference was not statistically significant. Efficacy was equivalent between the two treatment arms.

Limitations: The study evaluated a relatively small number of subjects, all of whom were white.

Conclusions: The application of 1% dimethicone following ingenol mebutate gel 0.015% produced a trend toward lower severity of some LSRs, with no difference in efficacy.

J Drugs Dermatol. 2017;16(5):432-436.

The management of skin infections has evolved over time and new evidence suggests that less acute intervention may be as good or better. For acute treatment, evidence from the emergency medicine literature shows that empiric oral antibiotics may not improve outcomes relative to incision and drainage alone. The use of packing material for wounds after draining does not lead to a decreased rate of recurrence, more rapid healing, or fewer physician visits, but does cause more pain. For patients with multiple or recurrent skin and soft tissue infections, a comprehensive decolonization or eradication strategy is the most effective at preventing further recurrences. Several decolonization approaches exist and can be tailored to find the most appropriate for a particular individual.

J Drugs Dermatol. 2014;13(1):89-92.

No abstract details for the moment.

Tinea pedis is a frequently encountered dermatophytosis affecting the superficial skin of the feet, primarily of adults. The prevalence of tinea pedis has increased over the last several decades due to an increase in multiple risk factors. Infection from dermatophytes is most common, but infection from other fungi can also result in tinea pedis. Four distinct clinical presentations occur: interdigital, moccasin, vesicular, and acute ulcerative types. A variety of physical exam findings can help the clinician identify patients with tinea pedis.

J Drugs Dermatol. 2015;14(suppl 10):s42-s47.

We retrospectively reviewed the records of 195 patients with suspected cutaneous reactions from NSAIDs. Two hundred and six different non-steroidal anti-inflammatory drugs (NSAIDs) were suspected of causing cutaneous reactions, and the most frequent suspected causative NSAID was ibuprofen (25.7%). Angioedema and/or urticaria were the most frequent cutaneous reactions (54.4%), and the foremost suspected causative drug for these reactions was ibuprofen. The second most frequently found cutaneous reaction was maculopapular eruption (26.2%), and celecoxib was the most commonly suspected causative NSAID for it. The primary suspected NSAIDs causing fixed drug eruption were in enolic acid group. Furthermore, drug hypersensitivity syndrome was diagnosed in five patients, and Stevens-Johnson syndrome and toxic epidermal necrolysis were detected in five patients. J Drugs Dermatol. 2011;10(10):1160-1167.

Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.

An appropriate selection of topical agents for wound care is important to promote uncomplicated healing. Petrolatum-based ointments, such as Aquaphor Healing Ointment (AHO) and white petroleum jelly, are commonly employed to keep wounds moist postoperatively. While they have beneficial properties for wound healing, they also may cause wound redness and swelling. We decided to evaluate for wound reactivity postoperatively for these 2 commonly used petrolatum-based ointments. We found that surgical wounds treated with AHO had a higher incidence of wound redness (52%) than those treated with plain white petrolatum (12%).

J Drugs Dermatol. 2013;12(2):163-164.

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

BACKGROUND: Poly-ureaurethane has been previously described for the management of dry, brittle, and in general, dystrophic nails. The polymer yields a waterproof, breathable barrier to protect the nail plate and prevent further damage to the nail, while regulating transonychial water loss (TOWL). Because nail dystrophy and dessication are contributing factors to onychomycosis, a barrier that protects the nail but also allows a topical antifungal to permeate its shield is potentially an advantageous combination. Oral antifungals such as terbinafine, itraconazole, and fluconazole, as well as the newer topical antifungals efinaconazole and tavaborole (although formulated to penetrate the nail unit and work with the porosity and inherent electrical charge of the nail plate), do not take into account nail damage that has been created from years of harboring a dermatophyte infection. Up to 50% of cases presumed to be onychomycosis are in fact onychodystrophy without fungal infection, and laboratory testing for fungus should be obtained prior to initiating antifungal treatment. Whether a nail has onychomycosis, or onychodystrophy due to other causes, barrier function and structural integrity are compromised in diseased nails, and should be addressed. A poly-ureaurethane barrier that protects against wetting/drying, fungal reservoirs, and microtrauma, followed by the addition of oral or topical antifungals after laboratory fungal confirmation may optimize outcomes in the treatment of onychomycosis.
OBJECTIVE: The purpose of this work was to determine through in vitro release testing (IVRT) whether poly-ureaurethane 16% allows for penetration of efinaconazole 10% or tavaborole 5%. Results could spur subsequent clinical studies which would have implications for the addition of an antifungal based on fungal confirmation, after addresssing the underlying nail dystrophy primarily.
METHODS: A vertical diffusion cell system was used to evaluate the ability of efinaconazole 10% and tavaborole 5% to penetrate across poly-ureaurethane 16%. The diffusion cells had a 1.0 cm² surface area and approximately 8 mL receptor volume. Poly-ureaurethane 16% was applied to a 0.45 μm nylon membrane and allowed to dry before use. Efinaconazole 10% or tavaborole 5% was then applied to the poly-ureaurethane 16% coated membrane, and samples were pulled from the receptor chamber at various times. Reverse phase chromatography was then used to assess the penetration of each active ingredient across the membrane.
RESULTS: The flux and permeability of efinaconazole or tavaborole across poly-ureaurethane 16% were determined from efinaconazole 10% or tavaborole 5%, respectively. The flux and permeability of efinaconazole were determined to be 503.9 +/- 31.9 μg/cm²/hr and 14.0 +/- 0.9 nm/sec. The flux and permeability of tavaborole were determined to be 755.5 +/- 290.4 μg/cm²/hr and 42.0 +/- 16.1 nm/sec.
CONCLUSION: In addition to the treatment of onychoschizia, onychorrhexis, and other signs of severe dessication of the nail plate, a barrier that regulates TOWL should be considered in the management onychomycosis to address barrier dysfunction and to promote stabilization of the damaged nail. Previously published flux values across the nail are reported to be 1.4 μg/cm²/day for efinaconazole and 204 μg/cm²/day for tavaborole. These values are substantially lower than the herein determined flux for both molecules across poly-ureaurethane 16%. A comparison of the data suggests that poly-ureaurethane 16%, if used prior to efinaconazole or tavaborole, would not limit the ability of either active ingredient to access the nail, and therefore, would be unlikely to reduce their antifungal effect. Onychodystrophy is inherent in, and often precedes onychomycosis, and consideration should be given for initiation of treatment in the same sequence: stabilizing and protecting the nail plate barrier primarily, and subsequently adding oral or topical antifungals after laboratory confirmation. Future clinical studies will be needed to determine combination efficacy for in vivo use.

J Drugs Dermatol. 2016;15(9):1116-1120.

A new classification of melanocytic nevi is presented that may incorporate 1 of 3 anatomic patterns, 1 of 12 architectural patterns, and 1 of 3 cellular patterns in the diagnosis. In this scheme, the patterns are easy to understand, logical, and the end result is an unambiguous descriptive diagnosis. A pattern diagnosis for melanocytic nevi allows for an understandable and reproducible interpretation by the physician. The nosology of a pattern diagnosis is familiar to physicians. It is common to have a variety of histopathologic patterns for a clinical condition alone or in combination and to be portrayed in the clinical diagnosis. There are countless examples in the literature, such as squamous cell carcinoma (superficial, spindle cell, atypical fibroxanthomatous, pseudovascular types) and basal cell carcinoma (superficial, nodular, pigmented, cystic, morpheaform, fibroepithelial types) to mention but a few. Our classification emphasizes the benignancy of the melanocytic nevus and makes it feasible for the physician to picture it. A pattern diagnosis thus results in a bona fide service to the patient resulting in less confusion, misinterpretation, or fear of malignancy, as well as unnecessary surgery.

In December of 2013 the Food and Drug Administration announced it would look further into the safety and efficacy of the biocide triclosan and requested further safety data as part of a new review with the Environmental Protection Agency. The use of triclosan has increased exponentially since its introduction in in 1972, to the point that 75% of commercial soap brands contain triclosan and 76% of a nationwide sample of adults and children excrete triclosan in the urine. This announcement raised an important dialog about the appropriate use of all over the counter biocides. Particular concerns include whether these biocides are more effective than regular soaps, whether they may create new drug resistant bacteria, and whether they may also act as hormone disruptors in humans or the environment.

BACKGROUND: Currently available treatment options for impetigo are limited by either systemic side effects (for oral therapy) or lack of ease of use (for topical ointment). A novel foam formulation of minocycline for topical use may improve convenience and treatment utilization for pediatric patients with impetigo. OBJECTIVE: To evaluate the safety and efficacy of topically applied minocycline foam (FMX-102 1% and 4%) in the treatment of impetigo and to determine the optimal therapeutic active ingredient concentration. METHODS: In this randomized, parallel-group, double-blind, comparative clinical trial, 32 subjects aged ≥2 years with a clinical diagnosis of pure impetigo, impetigo contagiosa, or uncomplicated blistering impetigo were randomized to treatment with FMX-102 1% or 4%, twice daily for 7 days. Subjects were followed for up to 7 days post-treatment. RESULTS: Clinical cure, defined as ≥80% cured lesions (fully recovered lesions, visually determined by investigators), was achieved by 57.1% and 50.0% of FMX-102 1% and 4% subjects, respectively, at the end of treatment (visit 3). Clinical success, defined as the absence of lesions, or the drying or improvement of treated lesions (decrease in size of affected area, lesion number, or both), was demonstrated in 81.3% and 78.6% of FMX-102 1% and 4% subjects, respectively, following 3 days of treatment (visit 2), in 92.3% and 100% of the respective subjects at the end of treatment, and in 100% in both groups at follow-up (visit 4). Bacteriologic success rates at the end of treatment, defined as complete pathogen eradication, were 85% and 74% in the FMX-102 1% and 4% groups, respectively. The bacteriologic success rate for MRSA infections was 100% (11/11), with no recurrences. Both FMX-102 1% and 4% were considered well tolerated and safe. CONCLUSION: Topical minocycline foam may be a safe and effective new treatment option for impetigo in children, including those with MRSA.

J Drugs Dermatol. 2016;15(10):1238-1243.

Background: Even though proton pump inhibitors (PPIs) are commonly used in clinical practice, a limited number of studies are available about cutaneous adverse reactions from PPIs, and most of these are case reports.
Objective: To demonstrate the pattern of cutaneous reactions related to PPI usage and to evaluate the risk of developing PPI drug eruptions among adult patients.
Methods: We reviewed the spontaneous reports of any adverse events associated with PPI use, as reported from January 2005 through May 2010 to the Adverse Drug Reaction Center at Siriraj Hospital in Thailand. Each control was sampled from 15 patients who had consecutive hospital numbers from each study case.
Results: The prevalence of cutaneous reactions to PPIs varied, ranging from three to 20 per 100,000 of the treated population. Sixty-four patients with a history of reaction to PPIs, and 65 controls were enrolled. Most cutaneous reactions were attributed to omeprazole (n=50; 78.1%), and the most frequently observed cutaneous reaction was maculopapular rash (43.8%). None of the patients experienced a cross-reaction between individual PPIs.
Conclusion: Cutaneous adverse reactions to PPIs range from minor drug rashes to a severe, life-threatening reaction. Individuals with a history of adverse drug reaction have an increased risk of cutaneous reaction to PPIs.

J Drugs Dermatol. 2012;11(10):e43-e47.

Lichen striatus (LS) is an uncommon linear dermatosis that is primarily seen in children from 4 months to 15 years of age. While some of these eruptions are asymptomatic, others can be quite pruritic. In darker-skinned individuals, post-inflammatory hypopigmentation can be significant and may provide a cause for concern for the patients and/or their parents. In our case series of 4 patients, we observed rapid resolution of LS by combining a topical retinoid with a topical steroid. To our knowledge, this is the first report of successful treatment with this kind of combination therapy in the English literature. The patients not only achieved satisfying cosmesis, but also complete resolution of their pruritus. The most common side effect of topical tazarotene is localized irritation at treatment sites, but the patients in this particular series tolerated the treatment well.

J Drugs Dermatol. 2012;11(7):872-875.

Skin care products are recognized by dermatologists as critical adjunctive therapeutic modalities for patients suffering from acne vulgaris (AV). Prescribing an acne medication without reviewing a patient’s skin care regimen can lead to poor compliance, intolerable side effects, and resulting patient and physician frustration. Striking that delicate balance between maintaining the skin barrier while controlling oil and shine has always been a challenge when treating this chronic inflammatory condition, and it necessitates a unique set of ingredients and formulation. Cetaphil® DermaControl™ Moisturizer SPF 30 (Galderma Laboratories, L.P., Fort Worth, Texas) is a new generation of skin care specifically designed for acne-prone skin and acne-affected skin. Both Cetaphil® DermaControl™ Foam Wash and Cetaphil DermaControl Moisturizer SPF 30 incorporate pharmacologically tested, state-of-the-art ingredients and technologies that studies have shown impart substantial benefits to AV patients.

J Drugs Dermatol. 2014;13(suppl 7):s89-s94.

IMPORTANCE: While psoriasis (Ps) is mainly characterized as an adult disease, it can also develop during childhood. However, prevalence estimates of pediatric psoriasis in the United States (US) are lacking. OBJECTIVE: To assess the 2015 annual prevalence of Ps and moderate-to-severe Ps in pediatric individuals in the US. DESIGN: This is a retrospective study based on a large administrative insurance claims database in the US. SETTING: Data were extracted from the Truven Health Analytics MarketScan® Commercial Claims and Encounters database, which covers over 60 million individuals with employer-provided health insurance across the US. PARTICIPANTS: Over 4.3 million of individuals continuously enrolled in their healthcare plan in 2015 and under 18 years of age were included in the study. Intervention(s) for Clinical Trials or Exposure(s) for Observational Studies: Not applicable. Main Outcome(s) and Measure(s): Ps was defined based on medical claims with a diagnosis of Ps (ICD-9-CM: 696.1); moderate-to-severe Ps was defined based on medical or pharmacy claims for a systemic treatment (biologic, conventional systemic, or phototherapy) for Ps. Overall and age- and gender-stratified prevalence was estimated for both Ps and moderate-to-severe Ps. RESULTS: The prevalence of Ps was estimated at 128 cases per 100,000 individuals (95% CI: 124-131), that of moderate-to-severe Ps at 16 cases per 100,000 individuals (95% CI: 15-17) in 2015. For both Ps and moderate-to-severe Ps, prevalence estimates were numerically higher in females than in males (146 per 100,000 vs. 110 per 100,000 and 17 per 100,000 vs. 15 per 100,000) and increased with age, ranging from 30 per 100,000 in the 0-3 year old group to 205 per 100,000 in the 12-17 year old group. CONCLUSION AND RELEVANCE: This study provides robust estimates of the prevalence of pediatric Ps that can inform decisions pertaining to the management of pediatric patients with Ps. J Drugs Dermatol. 2018;17(2):187-194.

Objective: To characterize the prevalence of psychiatric disorders in patients with moderate-to-severe psoriasis and compare health care costs between patients with and without psychiatric comorbidities.
Methods: In a retrospective, matched case-control study, data for services from nearly 75 health care plans in the United States (U.S.) were collected from PharMetrics Patient Centric Database using International Classification of Diseases, Ninth Revision Clinical Modification codes, identifying a total of 39,855 adults with moderate-to-severe psoriasis (n=7,971) and without (controls; n=31,884). Patients with psoriasis had at least one psoriasis health care claim and received at least one medical/prescription treatment claim within two consecutive years. Psychiatric comorbidities and treatments among patients and controls were determined by claims. Annual inpatient, outpatient, emergency room, and prescription costs for those with and without psoriasis and those with and without psychiatric disorders were compared.
Results: Patients had significantly higher prevalence of anxiety (6.9% versus 4.4%), depression (9.2% versus 5.3%), bipolar disorder (1.1% versus 0.5%), or delirium (0.3% versus 0.1%; P<0.05) than controls (others P<0.0001). Significantly higher proportions of patients with psoriasis received antidepressants (6.1% versus 0.9%), anxiolytics (5.0% versus 0.8%), or antipsychotics (5.9% versus 0.9%) compared with controls (each P<0.0001). Total health care costs for patients with psoriasis (US $11, 369.47) were significantly higher than for controls ($3,427.60; P<0.001). Psoriasis patients with psychiatric disorders had significantly higher health care costs ($17,637.66) than those without psychiatric disorders ($10,362.80; P<0.001).
Conclusion: The prevalence of psychiatric disorders is higher in patients with moderate-to-severe psoriasis than in controls. Annual health care costs are higher in psoriasis patients with psychiatric disorders than in those without psychiatric disorders.

J Drugs Dermatol. 2011;10(8):843-850.

Chemical burn is a rare complication of topical polyvinylpyrrolidone-iodine (PVP-I), commonly called povidone-iodine (trade name Betadine, Purdue, Stamford, NJ). This adverse reaction occurred on the buttocks of an eight-year-old male after undergoing a laparoscopic appendectomy involving antiseptic skin preparation using a 10% PVP-I solution. This case is consistent with previous reports in which a chemical burn develops when PVP-I does not adequately dry, pools beneath a dependent body part during surgery, or is placed under an occlusive device. Symptoms develop immediately to one day after surgery. The proposed mechanism is irritation from iodine coupled with maceration, pressure and friction. While patients typically heal without significant scarring, the burn subjects the patient to unnecessary pain, prolongs hospitalization and increases the risk for infection. Physicians should be aware of this complication and therefore take preventative measures. These include allowing PVP-I to completely dry, preventing dripping and pooling and avoiding occlusion.

J Drugs Dermatol. 2011;10(4):414-417.

Rituximab, an anti CD20 monoclonal antibody leading to transitory B cell depletion, is used to treat a wide variety of immune system tumors and immune mediated diseases. While most of data supporting the efficacy and safety of rituximab in treating autoimmune patients is focused on the adult population, the utilization of rituximab (RTX) for a wide range of pediatric conditions is also increasing. While there are a number of published case reports, a comprehensive review of the various uses for rituximab in pediatric dermatology is lacking. To better assess the therapeutic role of rituximab in the management of skin disease in children, here we comprehensively document reported cases of use including details regarding specific treatment regimens, efficacy and safety profile. Evaluation of the data supports consideration for the initiation of rituximab at early time points in the treatment ladder, before certain diseases become refractory to conventional treatment.

J Drugs Dermatol. 2016;15(7):821-829.

No abstract details for the moment.

Bleomycin is an antibiotic with antineoplastic properties. It is used in the treatment of different tumors in oncology. The mucocutaneous side effects of this drug include ulcers, scaly erythematous and bullous lesions, sclerosis, stomatitis, and pigmentary alterations. Flagellate erythema is a characteristic hyperpigmentation of bleomycin. We report a case of flagellate erythema following the administration of bleomycin in a 34-year-old woman with ovarian teratoma. She developed linear lesions two weeks after the first injection of bleomycin. Flagellate erythema is a specific reaction to bleomycin therapy, which occurs in susceptible individuals independently of dose, route of administration, and type of malignant disease treated.

J Drugs Dermatol. 2014;13(8):983-984.

Background: South Asians represent a rapidly growing part of the U.S. population, increasing 188 percent from 1990 to 2000 (0.27% to 0.78%). Studies investigating the epidemiology of skin disorders in South Asian Americans are lacking.
Objective: We sought to determine common skin conditions and concerns among this population.
Methods: This was a community-based survey study. The IRB-approved survey tool was distributed to South Asians adults in the New York City area. All data was self-reported.
Results: 190 surveys were completed. 54 percent of responders were female and 46 percent were male. The age of participants ranged from 18-74 years. The respondents were predominantly foreign born (76%), but a large minority (32%) reported living in the U.S. for over 20 years. Nearly half (49%) of the study population reported having visited a dermatologist in the past. The five most common dermatologic diagnoses included: acne (37%), eczema (22%), fungal infection (11%), warts (8%) and moles (8%). The five most common concerns included: dry skin (25%), hair loss (22%), uneven tone (21%), dark spots (18%) and acne (17%).
Conclusions: Our results suggest that the leading skin conditions and concerns in South Asian Americans are similar to those reported in other populations with skin of color.

J Drugs Dermatol. 2011;10(5):524-528.

Introduction: Epidermodysplasia verruciformis (EV) is a rare inherited dermatosis characterized by increased susceptibility to human papilloma virus infection. Acquired EV occurs in patients with compromised cell-mediated immunity, such as patients with HIV and transplant recipients. Optimal management of acquired EV has not yet been established, as cases are rare and are due to a variety of underlying conditions. Additionally, no distinctions have been made between different immunosuppressive medications and their respective link to EV. Methods and Results: We report a patient with systemic lupus erythematosus who developed EV while on azathioprine and prednisone. The patient’s lesions resolved completely after she was switched from azathioprine to mycophenolate mofetil. Her lesions recurred when her immunosuppressive regimen was again changed from mycophenolate mofetil to methotrexate. A review of the literature revealed azathioprine to be related to other cases of acquired EV. Discussion: This case indicates a possible link between specific immunosuppressive drugs and the development of EV, allowing for new EV treatment considerations. In this case and previous cases, azathioprine is indicated as being particularly linked with the development of EV, while mycophenolate mofetil may be an immunosuppressive option that is less likely to induce EV in patients predisposed to this condition. J Drugs Dermatol. 2017;16(7):701-704.

The cosmeceutical industry is a multi-billion dollar, consumer-driven market. Products promise highly desirable anti-aging benefits, but are not subject to regulation. We present an introduction to cosmeceuticals for the general and cosmetic dermatologist, including definitions and explanations of key terms, an approach to the evidence base, a dissection of chamomile and green tea, two paradigmatic cosmeceutical products, and a window into the underlying psychology of this vast marketplace.

J Drugs Dermatol. 2016;15(4):452-456.

Introduction: The multikinase inhibitors sorafenib (SO) and sunitinib (SU) have shown benefit in a wide range of solid tumors. Although these agents are generally well tolerated, they may be associated with dermatologic adverse events, particularly hand-foot skin reaction (HFSR). The aim of this study is to evaluate the impact of HFSR associated with these multikinase inhibitors on patient health-related quality of life (HRQOL).
Methods: Twenty-three patients with HFSR related to SO or SU were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for clinical severity and for impact on HRQOL through completion of the patient self-administered Skindex-16 (SK-16). Clinical severity scores were compared to HRQOL assessments.
Results: Of the 23 patients with HFSR, clinical severity was grade 1 in 17.4%, grade 2 in 74%, and grade 3 in 8.6%. Median SK-16 scores were reported for symptoms (53.3), emotions (30.6), and functioning subscales (33.3). Median symptoms and emotions scores positively correlated with HFSR clinical severity grade.
Conclusions: These findings demonstrate that HFSR related to SO or SU negatively impacts HRQOL, with the symptoms domain being most significantly affected. In addition, CTCAE toxicity grading correlates with HRQOL.

J Drugs Dermatol. 2012;11(11)e61-e65.

Severe chronic hand eczema (sCHE) is a persistent, disfiguring disease that responds poorly to conventional treatment and causes substantial physical and psychological disability. The objective of this study was to evaluate efficacy and safety of oral alitretinoin in sCHE in a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing alitretinoin with placebo. Efficacy was assessed every 4 weeks during treatment and 4 weeks after end of treatment (EOT, 24 weeks); responders were assessed every 4 weeks for a further 48 weeks after EOT. The study was conducted at academic and private dermatology centers. The participants were 596 patients with sCHE refractory to potent topical corticosteroids. Patients were treated with daily oral alitretinoin 30 mg or placebo for up to 24 weeks. Primary endpoint was proportion of responding patients based on Physician Global Assessment (PGA) of “clear” or “almost clear” at EOT. Key secondary endpoints: Patient Global Assessment (PaGA), change in modified Total Lesion Symptom Score (mTLSS), time to response (TTR), extent of disease at EOT, and duration of response (DOR). At EOT, 40% of alitretinoin-treated patients were responders vs 15% placebo-treated patients (odds ratio [OR] = 3.78; P < .001); a greater proportion of alitretinoin-treated patients achieved a PaGA of “cleared” or “almost cleared” (OR = 4.05; P < .001). A greater decrease in mTLSS occurred from baseline to EOT in alitretinoin- vs placebo-treated patients (treatment difference −24% P < .001). Median TTR for responders at EOT was shorter with alitretinoin vs placebo (65 vs 117 days; P < .001). Greater decreases in extent of disease at EOT were observed with alitretinoin vs placebo (treatment difference −22%; P < .001). The most common treatment-emergent adverse event was headache. Alitretinoin significantly improved signs/symptoms of sCHE, was well tolerated in patients refractory to potent topical corticosteroids, and may provide benefit to this population.

J Drugs Dermatol. 2014;13(10):1198-1204.

INTRODUCTION: The potential for systemic effects due to percutaneous absorption of superpotent topical steroids has been a longstanding concern. The Food and Drug Administration currently recommends limiting the use of superpotent topical steroids to 50g per week for 2 or 4 consecutive weeks depending on the formulation, which is mostly based on the exact duration with which phase 3 clinical trials were allowed to be conducted per the FDA. This article reviews all published clinical incidence of adrenal adverse effects in the medical literature, specifically Cushing’s syndrome (CS) and pathologic adrenal suppression (PAAS), to try to ascertain a more realistic limit for the safe use of superpotent topical steroids as it pertains to its potential systemic effects.

METHODS: Literature search was conducted using PubMed. Only cases of CS and PAAS secondary to the use of Class I superpotent topical steroids were included. Pediatric cases and full articles unavailable in English were excluded.

RESULTS: There were a total of 14 cases of CS and 5 cases of subsequent PAAS found in the current literature.

DISCUSSION: From our review of these cases, if the amount used per week is within FDA guidelines, it appears that patients needed to use superpotent topical steroids for far greater than 2 or 4 weeks to develop CS or PAAS. CS did not necessarily predict occurrence of PAAS, but in all cases CS appeared to be a prerequisite for developing PAAS. All cases of CS and all but one case of PAAS were reversible. If excessive amount of greater than 50g per week is avoided, it appears that superpotent topical steroids may be safe to use consecutively for months, perhaps even years, without causing systemic effects.

J Drugs Dermatol. 2017;16(7):643-648.

Econazole nitrate topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older. The symptom of itch or pruritus was evaluated in two randomized, double-blind, parallel-group, vehicle-controlled, multicenter Phase III studies in which econazole foam was compared with foam vehicle in subjects with interdigital tinea pedis. A thin, uniform layer of study treatment was applied once daily to all clinically affected interdigital regions of both feet for four weeks. At baseline, at least 69% of all subjects had moderate to severe itch. Throughout the duration of both studies, numerically econazole foam was numerically superior to vehicle in achieving absence of itch. After the cessation of treatment, from day 29, itching continues to improve until day 43 in the active treatment group, whereas there is no evident continued improvement within the vehicle foam groups. At day 43, in the active treatment groups, 83% in Study 1 and 71% in Study 2 achieved complete absence of itching. Using less stringent criteria, for the econazole nitrate foam arm, achieving no itch or mild itch (0 or 1), in Study 1, 95% and 86.8% in Study 2 achieved this outcome. Tolerability of the products was excellent with few treatment-related adverse events. In summary, econazole foam decreased the burden of itch as early as day 8 in patients with interdigital tinea pedis, and this improvement continued after cessation of treatment.

J Drugs Dermatol. 2016;15(9):1111-1114.

BACKGROUND/OBJECTIVE: Many topical formulations include antioxidants to improve the antioxidant capability of the skin. This study evaluated the ability of a unique combination of antioxidants including resveratrol, green tea polyphenols, and caffeine to reduce facial redness.
METHODS: Subjects (n=16) presenting with facial redness applied the resveratrol-enriched product twice daily to the entire face. Reduction in redness was evaluated by trained staff members and dermatology house staff officers. Evaluators compared clinical photographs and spectrally enhanced images taken before treatment and at 2-week intervals for up to 12 weeks.
RESULTS: 16 of 16 clinical images showed improvement and 13 of 16 spectrally enhanced images were improved. Reduction in facial redness continued to evolve over the duration of the study period but was generally detectable by 6 weeks of treatment. Adverse effects were not observed in any subject.
CONCLUSION: The skin product combination of resveratrol, green tea polyphenols, and caffeine safely reduces facial redness in most patients by 6 weeks of continuous treatment and may provide further improvement with additional treatment.

J Drugs Dermatol. 2013;12(7):770-774.

Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.

BACKGROUND: Acne and rosacea cause significant negative impact on quality of life. There is limited information comparing the health-related quality of life (HRQL) impact associated with acne and rosacea to other patient populations.
PURPOSE: We review available literature to assess the HRQL impact of acne and rosacea and compare them with major medical conditions.
METHODS: A PubMed search identified studies that utilized the Short Form 36 (SF-36), the Dermatology Life Quality Index (DLQI), and the willingness-to-pay (WTP) metric to assess the HRQL impact of acne and rosacea. These data were compared to HRQL values for other diseases.
RESULTS: The HRQL impact of acne is similar to asthma, epilepsy, diabetes, back pain, arthritis, and coronary heart disease using SF-36 data. DLQI scores for acne ranged from 2 to 17.7 and for rosacea ranged from 4.3 to 17.3; the DLQI scores for psoriasis ranged from 1.7 to 18.2. WTP data identified ranged widely for both acne and rosacea.
LIMITATIONS: There was limited broadly generalizable data for acne and rosacea.
CONCLUSIONS: Acne and rosacea impact HRQL to a similar degree as other major medical conditions by indirect comparison to psoriasis, a skin condition causing significant disability, and by direct comparison for acne. In the setting of limited health care resources, allocation should be grounded in the evidence that acne and rosacea are not trivial in their effects.

J Drugs Dermatol. 2014;13(6):692-697.

While burden of disease (BOD) data exists for plaque psoriasis, and to a lesser extent other phenotypes of psoriasis, there is no published data on the impact of inverse (intertriginous) psoriasis. We sought to assess the overall BOD among patients with inverse psoriasis (IP). We introduce the Inverse Psoriasis Burden of Disease (IPBOD) questionnaire and compare it to the Dermatology Life Quality Index (DLQI). In this cross-sectional pilot study, we administered the IPBOD and the DLQI to 16 patients. We present the initial psychometric properties of the IPBOD survey. We used Spearman’s correlation coefficients to compare the two questionnaires on overall performance and in specific domains. Our cohort had an average age of 55.6 (SD 16.6) years, was predominantly female (68.8%), and white (87.5%). 87.5% of patients had a second psoriasis subtype. A majority of patients reported some effect of IP on pain (n=14, 87.5%). Thirteen (81.3%) patients reported some effect on depressed mood or anxiety/worry. Overall, the largest effect was on body self-image (93.8% reporting an effect). The average DLQI score was 8.5/30, higher than average DLQI scores reported in patients with plaque psoriasis or psoriatic arthritis. Average IPBOD score was 4.9/10. The reliability of IPBOD was good (overall Cronbach’s alpha = 0.89, individual items’ range 0.88 – 0.91). Correlations between IPBOD and DLQI were: overall (Spearman’s P=0.650, P=0.006), symptoms (P=0.462, P=0.072), daily activities (P=0.507, P=0.045), leisure (P=0.633, P=0.008), interpersonal function (P=0.728, P=0.001), and work and school (P=0.427, P=0.100). IP has a profound impact on patients’ lives and the results of this pilot study suggest that the IPBOD questionnaire may be a useful disease-specific tool for measuring the BOD of IP.

J Drugs Dermatol. 2016;15(8):1011-1016.

BACKGROUND: A novel lotion formulation of halobetasol propionate, 0.05% (HBP Lotion) with enhanced vehicle characteristics of a cream while preserving the ease of use and cosmetic elegance of a lotion has been developed to treat plaque psoriasis. OBJECTIVE: Determine the safety and effectiveness of HBP Lotion in patients with plaque psoriasis. METHODS: Two prospective, randomized, vehicle-controlled clinical studies were conducted in 443 adult subjects with moderate-severe plaque psoriasis. Subjects applied the test article to psoriatic plaques within the treatment area twice daily for 14 days. Efficacy data are based upon treatment “success” defined as those subjects that achieved scores of 0=clear or 1=almost clear with at least a two-grade improvement relative to baseline for an Investigator’s Global Assessment (IGA) and clinical signs (plaque elevation, erythema, scaling). Safety data are presented as adverse events and local skin reactions. RESULTS: After two weeks of treatment with HBP Lotion, 44.5% of the HBP Lotion treated subjects in each study achieved (a) treatment “success” (ie, an IGA score of 0=clear or 1=almost clear and >2 grade improvement compared to baseline) and (b) a notable reduction in plaque elevation, erythema, scaling, and pruritus. In contrast, only 6.3% and 7.1% of VEH subjects in Studies 1 and 2, respectively, achieved treatment success and the reduction of disease related signs was materially lower. Statistically, at day 15 in both Phase 3 studies, treatment success with HBP Lotion was superior to VEH (P less than 0.001). From a safety perspective the outcomes were in general unremarkable with similar findings in the HBP Lotion and VEH treatment groups. CONCLUSIONS: The results demonstrate the safety and effectiveness of HBP Lotion in the treatment of plaque psoriasis. Furthermore, this novel HBP lotion formulation is also distinguished by its moisturization qualities and ease of use.

J Drugs Dermatol. 2017;16(3):234-240.

The Food and Drug Administration approved Ruxolitinib in 2011 for the treatment of primary myelofibrosis. Five-year safety data showed a higher incidence of skin cancer in patients treated with Ruxolitinib compared to best available therapy for myelofibrosis. This report presents a series of five patients with history of myelofibrosis treated with Ruxolitinib who subsequently developed numerous skin cancers with aggressive biological behavior. Each patient in this report was treated by a Mohs surgeon affiliated with an academic institution. All patients had a history of myelofibrosis and were exposed to Ruxolitinib. Some patients were exposed to other immunomodulatory medications such as Hydroxyurea and Rituximab. The total number of skin cancers and skin cancers with particularly aggressive behavior were noted. All five patients in this series developed numerous skin cancers with aggressive biological behavior during or after therapy with Ruxolitinib. Also, one patient developed lentigo maligna melanoma and another developed metastatic undifferentiated pleomorphic sarcoma. The repeat observation of skin cancers with aggressive features during JAK inhibitor treatment suggests that these medications may promote cutaneous malignant transformation in at risk patients. Further surveillance and testing of JAK kinases regarding the risk of skin cancers is indicated.

J Drugs Dermatol. 2017;16(5):508-511.

Background: Papulopustular acne rosacea is a chronic inflammatory condition which can be difficult to treat. Many patients are unwilling to use systemic medications, and single topical agents alone may not address all the symptoms of rosacea. A combination topical clindamycin phosphate 1.2% and tretinoin 0.025% gel is efficacious for acne vulgaris, and may be helpful for rosacea, since acne vulgaris and rosacea shares many similar clinical and histologic features.
Objective: To assess the preliminary efficacy and safety of a combination gel consisting of clindamycin phosphate 1.2% and tretinoin 0.025% on papulopustular rosacea after 12 weeks of usage.
Methods: Randomized, double-blind, placebo controlled two site study of 79 participants with moderate to severe papulopustular acne rosacea using both physician and subjects' validated assessment tools. Primary endpoint consisted of statistically significant reduction in absolute papule or pustule count after 12 weeks of usage.
Results: There was no significant difference in papule/pustule count between placebo and treated groups after 12 weeks (P=0.10). However, there was nearly significant improvement in physicians' assessments of the telangiectasia component of rosacea (P=0.06) and erythematotelangiectatic rosacea subtype (P=0.05) in treated versus placebo group after 12 weeks. The only significant adverse event different was facial scaling, which was significantly increased in treated group (P=0.01), but this did not result in discontinuation of study drug.
Conclusions: A combination gel of clindamycin phosphate 1.2% and tretinoin 0.025% may improve the telangiectatic component of rosacea and appears to better treat the erythemotelangiectatic subtype of rosacea rather than papulopustular subtype. Our preliminary study suggests that future studies with much larger sample size might confirm our findings. Clinical Trials: NCT00823901.

J Drugs Dermatol. 2012;11(3):333-339.

Ustekinumab is effective in the treatment of a variety of autoimmune conditions including psoriasis. As a relatively new therapeutic agent, its long-term effects are still under investigation. Short-term studies, however, have revealed ustekinumab to be generally well tolerated and safe. This article provides a comprehensive review of the pharmacokinetics of ustekinumab, its safety profile, adverse effects, and use in pregnancy. The effect of diabetes and prior immunosuppressant therapy is also addressed.

J Drugs Dermatol. 2012;11(8):907-910.

Background and Objective: Many tinea inguinalis infections are characterized by pronounced inflammatory lesions and pruritus. Therefore, a therapy with a topical corticosteroid in addition to a topical antimycotic agent might be beneficial. In this multicenter, retrospective study, we compared the mycological and clinical efficacy and tolerability of isoconazole nitrate alone vs isoconazole nitrate and diflucortolone valerate in 58 adult patients with tinea inguinalis.
Patients and Methods: Treatment duration was three weeks. The efficacy of the treatment was based on the assessment of several signs and symptoms, which were collected on a 4-point scale. All patients were examined clinically before the beginning of the treatment, one week later, two weeks later, and at the end of the treatment. Mycological examinations were performed before the beginning of the treatment and at the end of the study.
Results: Treatment results with the combination of isoconazole nitrate and diflucortolone valerate were superior regarding erythema and pruritus. Both erythema and pruritus resolved in a larger percentage of patients and more quickly. Both regimens were well tolerated. Mycological cure rates were similar in both groups of patients.
Conclusions: Combination therapy with isoconazole nitrate and diflucortolone valerate is an effective and well-tolerated regimen in adult patients with tinea inguinalis.

J Drugs Dermatol. 2012;11(11)e70-e73.

Tumor necrosis factor-α (TNF-α) inhibitors, such as adalimumab, are often used to treat psoriasis and psoriatic arthritis. While it is well known that these agents increase the risk of reactivation tuberculosis, recent evidence suggests that the risk of other nontuberculous mycobacterial (NTM) infections is on the rise. We report cutaneous Mycobacterium fortuitum in a 60-year-old woman with psoriasis who had been receiving adalimumab therapy for psoriatic arthritis for six months. No other risk factors were identified. M. fortuitum was cultured from a lesion on the right leg. Following resolution of the lesion, the patient has been successfully treated with infliximab infusions and subsequently certalizumab without complication for the past three years. To our knowledge, this is the first report of M. fortuitum occurring in a patient receiving adalimumab with successful subsequent treatment without complication while on another TNF-α inhibitor.

J Drugs Dermatol. 2011;10(8):927-929.

Tattoo reactions can be clinically challenging to diagnose and treat. We present a case of a biopsy-proven granulomatous reaction to purple tattoo ink that clinically mimicked lichen planus. This reaction was successfully treated with one course of intralesional kenalog (ILK), with no recurrence six months after treatment. To our knowledge, this is the first report of a granulomatous tattoo reaction appearing clinically like lichen planus, and one of the few reports of a reaction to purple tattoo pigment. It highlights the importance of biopsying tattoo-related dermatoses prior to treatment in order to confirm the diagnosis. It also illustrates how a minimally invasive technique utilizing ILK to treat a granulomatous tattoo reaction can result in excellent dermatologic, cosmetic, and symptomatic outcomes. Based on this therapeutic success, we believe treatment with ILK injections should be attempted before more invasive modalities such as excision or laser therapy.

J Drugs Dermatol. 2015;14(6):638-640.

Fixed drug eruptions often have a characteristic appearance, which, when correlated with the clinical history, can be easily identified. However, multifocal fixed drug eruptions, especially the non-pigmenting variety, can present a diagnostic challenge, especially in the absence of a complete medication history. We present such a case, in which the patient was taking two over-the-counter medications, both of which contain uncommon causes of multifocal fixed drug eruptions.

J Drugs Dermatol. 2012;11(2):244-246.

BACKGROUND: A fixed-dose combination of clindamycin phosphate 1.2% and tretinoin 0.025% gel (VELTIN® (clindamycin phosphate and tretinoin) 1.2%/0.025% Gel [VELTIN]) (clindamycin/tretinoin gel) is currently available for the once-daily topical treatment of acne.
OBJECTIVES: Two-phase I studies were conducted to evaluate the phototoxic and photoallergic potential of clindamycin/tretinoin gel.
METHODS: Study 1 (phototoxic) (n=37) and Study 2 (photoallergic) (n=58) were single-center, evaluator-blinded, randomized, vehicle-controlled, phase 1 studies conducted in healthy volunteers. In Study 1, clindamycin/tretinoin gel patches, vehicle gel patches and blank patches (no gel) were applied concurrently for 24 hours to naïve sites. After patch removal, sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) then 0.75 minimal erythema dose (MED) of UVA/ultraviolet B light (UVB), the same irradiation protocol followed by 15 joules/cm2 of visible light (VIS), or served as non-irradiated controls. Study 2 examined the effect of repeated drug exposure and involved an induction period (6 repeat phases at the same body sites during which clindamycin/tretinoin gel and vehicle gel patches were applied for 24 hours, removed and sites irradiated with UVB +/- VIS), followed by a rest period (10 to 17 days), then a challenge period that used the protocol described for Study 1. In both studies, inflammatory responses and other cutaneous effects were evaluated at 1, 24, 48, and 72 hours after patch removal.
RESULTS: No subject experienced any adverse events in Study 1 (phototoxic). One subject in Study 2 (photoallergic) experienced AEs (diffuse erythema; mild application site irritation at one each of UV/VIS-irradiated clindamycin/tretinoin gel and vehicle gel patch sites) considered definitely related to study product that resulted in discontinuation from the study. Data from Study 1 and the challenge phase from Study 2 showed most subjects had no visible inflammatory reaction to clindamycin/tretinoin gel after irradiation.
CONCLUSIONS: Clindamycin/tretinoin gel has a favorable safety profile following UV/visible irradiation and a low potential for phototoxicity and photoallergenicity.

J Drugs Dermatol. 2014;13(1):16-22.

Cutaneous Crohn’s is a rare extra-intestinal manifestation of inflammatory bowel disease seen in a select group of patients, in which cutaneous lesions similar to those of the intestinal illness appear distant from the gastrointestinal tract. Oral findings may be found in up to 60% of patients with extra-intestinal Crohn’s and may appear as the initial symptom underlying disease. We present a case of a 17-year-old male presenting with granulomatous chelitis of the lower lip who was unaware of the underlying diagnosis of Crohn’s disease (CD).

INTRODUCTION: A number of diagnoses in clinical dermatology are currently histopathologically confirmed and this image recognition–based confirmation generally requires surgical biopsies. The increasing ability of molecular pathology to corroborate or correct a clinical diagnosis based on objective gene expression, mutation analysis, or molecular microbiome data is on the horizon and would be further supported by a tool or procedure to collect samples non-invasively. This study characterizes such a tool in form of a ‘bladeless’ adhesive patch-based skin biopsy device. METHODS: The performance of this device was evaluated through a variety of complementary technologies including assessment of sample biomass, electron microscopy demonstrating the harvesting of layers of epidermal tissue, and isolation of RNA and DNA from epidermal skin samples. Samples were obtained by application of adhesive patches to the anatomical area of interest. RESULTS: Biomass assessment demonstrated collection of approximately 0.3mg of skin tissue per adhesive patch and electron microscopy confirmed the nature of the harvested epidermal skin tissue. The obtained tissue samples are stored in a stable fashion on adhesive patches over a wide range of temperatures (-80oC to +60oC) and for extended periods of time (7 days or more). Total human RNA, human genomic DNA and microbiome DNA yields were 23.35 + 15.75ng, 27.72 + 20.71ng and 576.2 + 376.8pg, respectively, in skin samples obtained from combining 4 full patches collected non-invasively from the forehead of healthy volunteers. DISCUSSION: The adhesive patch skin sampling procedure is well tolerated and provides robust means to obtain skin tissue, RNA, DNA, and microbiome samples without involving surgical biopsies. The non-invasively obtained skin samples can be shipped cost effectively at ambient temperature by mail or standard courier service, and are suitable for a variety of molecular analyses of the skin microbiome as well as of keratinocytes, T cells, dendritic cells, melanocytes, and other skin cells involved in the pathology of various skin conditions and conditions where the skin can serve as a surrogate target organ.

J Drugs Dermatol. 2017;16(10):979-986.

There are many over-the-counter products used to treat dermatological conditions. Patients are inundated with information about these products. Dermatologists often encounter questions about the usefulness of over-the-counter products as anecdotal data about such products is often adapted as common practice in the medical field. Modern dermatology training does not include pharmacological education on many of the over-the-counter products commonly used by patients. In this current age when patients have increasing interest in using “natural” remedies, it is important that dermatologists can provide guidance to patients regarding some of the most common products that they may encounter. This article is designed to provide introductory information on the common uses for several over-the-counter products as well as to display any evidence in support of these products for dermatological diseases.

J Drugs Dermatol. 2014;13(8):960-966.

Lichen planopilaris (LPP) is a variant of lichen planus that affects the scalp causing scarring hair loss. Patients also frequently experience symptoms of scalp itch, pain, and burning. To date, there are no long-term remittive nor curative therapies available. Low-dose naltrexone has anti-inflammatory properties and has recently been described in the context of treating autoimmune conditions. This retrospective medical record review describes four LPP patients treated with low-dose (3 milligrams per day) naltrexone. This medication provided benefit in these four patients including reduction in symptoms of pruritus, clinical evidence of inflammation of the scalp, and disease progression. All patients tolerated naltrexone without adverse effects. This is the first case series demonstrating the beneficial effects of low-dose naltrexone for patients with LPP. This medication was well-tolerated by the patients and is cost-effective.

J Drugs Dermatol. 2017;16(11):1140-1142.

Stratum corneum (SC) abnormalities are associated with disease-affected skin conditions such as inflammatory acne. Current topical acne treatment options including benzoyl peroxide and retinoids can worsen the barrier dysfunctions by increasing transepidermal water loss, depleting SC vitamin E levels, and relatively decreasing SC thickness. However, strategies exist to employ these treatments in a more effective manner and lessen barrier function disruption including use of less irritating vehicles or concomitant application of moisturizers. Patients also play a role in the outcome of their skin barrier function based on their compliance and administration technique. By increasing patient compliance and proper application of treatments, patient skin barrier function can improve. Additionally, future treatments are on the horizon that may customize acne therapy at a molecular level.

J Drugs Dermatol. 2016;15(10):1170-1173.

Introduction: Genital psoriasis is a common but frequently overlooked manifestation of psoriasis with a considerable impact on patients’ quality of life. Currently no validated clinical trial outcome measures exist to assess genital psoriasis severity that meet regulatory agency requirements.

Methods: This study describes the development of the static Physician’s Global Assessment of Genitalia (sPGA-G) scale, a clinical outcome measure for the assessment of genital psoriasis severity that accounts for the erythematous clinical presentation of genital psoriasis. The reliability of the sPGA-G was evaluated using scores collected from clinician assessments of photographs of genital psoriasis cases. Scores were collected from 10 academic and clinical experts in genital psoriasis and 95 clinician assessors who participated in either in-person (n=28) or online (n=67) sPGA-G training modules.

Results: The sPGA-G had a high inter-rater reliability (IRR, measured by Kendall’s W) for expert raters (W=0.856, P less than 0.0001), in-person assessors (W=0.822, P less than 0.0001), and online assessors (W=0.678, P less than 0.0001). IRR was also high for all clinical assessors combined, (W=0.714, P less than 0.0001).

Discussion: This study demonstrates that the sPGA-G is an intuitive and reliable clinical outcome measure that specifically measures the severity of genital psoriasis.

J Drugs Dermatol. 2017;16(8):793-799.

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No abstract details for the moment.

BACKGROUND: Econazole nitrate is a broad-spectrum topical antifungal with activity against a variety of dermatophytes and yeasts. A new topical dosage form, econazole nitrate topical foam 1%, utilizing patented Proderm Technology® has been developed for treatment of interdigital tinea pedis.
OBJECTIVE: To evaluate econazole nitrate foam 1% versus foam vehicle for treatment of interdigital tinea pedis.
METHODS: Two randomized, double-blind, parallel-group, vehicle-controlled, multicenter studies enrolled males and females ≥12 years old with a clinical diagnosis of interdigital tinea pedis and baseline fungal culture positive for a dermatophyte. Subjects applied econazole nitrate foam 1% (n=246) or foam vehicle (n=249) once daily for 4 weeks. The primary endpoint was proportion of subjects achieving a complete cure (negative KOH, negative fungal culture, complete resolution of all signs and symptoms) at 2 weeks post-treatment (Day 43). Secondary endpoints included mycologic cure (negative KOH and negative culture) and effective treatment (mycologic cure + no or mild erythema and/or scaling and all other signs and symptoms absent).
RESULTS: The complete cure rate at Day 43 was 24.3% for econazole nitrate foam 1% vs 3.6% for foam vehicle. In addition, higher rates of mycologic cure (67.6% vs 16.9%) and effective treatment (48.6% vs 10.8%) were observed with econazole nitrate foam 1% versus the foam vehicle. There were few adverse events and only nasopharyngitis and headache were experienced by >1% of subjects. No serious adverse events were reported for econazole nitrate foam 1%.
CONCLUSIONS: Econazole nitrate foam 1% exhibited superiority over foam vehicle for the primary and secondary endpoints with a high mycologic cure rate for all pathogens evaluated. Econazole nitrate foam 1% was safe and well tolerated with a safety profile comparable with the foam vehicle. Econazole nitrate foam 1% presents a novel alternative for the management of tinea pedis.

J Drugs Dermatol. 2014;13(7):803-808.

Lawrence transfer factor (TF) is defined as dialyzable leukocyte extract (DLE) that can transfer antigen-specific cell-mediated immunity from a person testing positive for the antigen in a delayed type hypersensitivity skin test manner to a person negative for the same antigen.

A recent article by Myles et al1 has identified a DLE isolated from an established CD8+ T cell line capable of transferring antigen-specific immunity. The DLE contains a portion of the beta chain of the T cell receptor and additional nucleotide and protein factors that are being subjected to further modern biochemical analysis.

After months of study that included interviews of TF physician-scientists, we conclude that an antigen-specific TF exists for most, if not all, antigens. By working from a CD8+ T cell line with modern biochemical technology, it should be possible to identify and patent products capable of treating infectious diseases, antigen-responsive cancers, and autoimmune disorders.

J Drugs Dermatol. 2017;16(12):1198-1206.

Acne vulgaris (AV) is an inflammatory skin disease characterized by the presence of comedones, papules, pustules, and nodules. Consensus guidelines recommend the use of combination therapy using different drugs with complementary mechanisms of action to best address as many acne pathogenic factors as possible at the same time. Topical acne medications exist as individual agents that may be combined in physician-recommended regimens or as pre-formulated fixed-dose combination products. In addition, there are several new and promising topical therapies currently being developed that work by different mechanisms of action from traditionally used acne therapies. The following review will cover commonly used drugs, newcomers to the market, and what the future holds for the topical treatment of AV.

J Drugs Dermatol. 2016;15(1 Suppl 1):s11-s16.

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BACKGROUND: The jasmonates are a novel class of plant-derived anti-aging compounds. Among these, LR2412-Cx (tetrahydrojasmonic acid, Visionnaire) has been demonstrated to reduce photoaging and the appearance of wrinkles, as well as to upregulate collagens, hyaluronic acid and fibrillin.
OBJECTIVE: To clinically study the cosmetic effects of a novel jasmonate complex LR2412-Cx in the treatment of visible skin aging.
METHODS: LR2412-Cx was evaluated in a 15-subject open-label prospective clinical trial for the treatment of fine wrinkle appearance, texture, and pores. Subjects were evaluated by an investigator at baseline, day 1, day 3, and week 6 with the Alexiades comprehensive grading scale of skin aging, and introducing a novel pore-grading scale and subject quality of life assessments.
RESULTS: The mean (SEM) at baseline and at week 6 following twice-daily application were: for the appearance of wrinkles 2.91 (0.12) and 2.70 (0.10); for texture 2.91 (0.10) and 2.55 (0.10); and for pores 3.29 (0.08) and 2.46 (0.09), respectively. The differences in all 3 categories at all follow-up intervals were statistically significant (P<.005). The percentage improvement in investigator-assessed grades relative to baseline at day 1, day 3, and week 6 were: 2.3%, 4.9%, and 7.4% for the appearance of wrinkles, 5.7%, 9.4%, and 12.4% for texture, and 14.2%, 21.6% and 25.2% for pores, respectively. No significant untoward effects were reported.
CONCLUSION: Visionnaire LR2412-Cx is a novel jasmonate-containing compound that is safe and effective for the cosmetic treatment of fine wrinkle appearance, texture, and pores of the facial skin.

J Drugs Dermatol. 2016;15(2):209-215.

Capecitabine is emerging as an important drug in the treatment of metastatic breast and colorectal cancers. Marketed as Xeloda ®, this prodrug is taken orally and readily absorbed. It is novel in its increased convenience for patients, similar efficacy to the intravenous form of its active metabolite and its increased tolerability.¹ We present a woman with metastatic breast cancer who presented with cutaneous abnormalities two months after starting treatment with capecitabine. Various dermatologic side effects have been attributed to capecitabine, often requiring cessation of the offending drug. We describe an unreported dermatological side effect of capecitabine therapy, systemic lupus erythematosus concurrent with palmoplantar erythrodysesthesia. As the use of this chemotherapeutic agent becomes more prevalent, it is important to recognize the range of its cutaneous side effects.

J Drugs Dermatol. 2012;11(6):769-771.

PURPOSE: Fractionated carbon dioxide (CO2) laser resurfacing uses fractional photothermolysis with an ablative 10,600-nm wavelength for treatment of rhytides and photodamage. Although associated with reduced side effect profile from traditional ablative lasers, fractionated lasers can lead to significant erythema, edema, crusting, and exudation for 14 days. Post-care includes regular distilled water soaks and healing ointment. This study evaluated efficacy and patient satisfaction of a novel plant-based hypoallergenic ointment (Doctor Rogers RESTORE®Healing Balm; Product 1) compared to petroleum-based lanolin-containing ointment (Aquaphor® Healing Ointment; Product 2) to accelerate wound healing post-laser resurfacing of the face. DESIGN: This was a single-center, prospective randomized, double-blinded, split-face comparative study of 10 subjects with photo-aging and rhytids who received treatment with fractionated CO2 laser between September 2017 and January 2018. Product 1 and Product 2 were randomized to each half of the face and applied from days 0 to 7 with an option to continue to day 14. The primary outcome measures were Investigator-rated degree of erythema, edema, crusting, exudation, and percentage healing, with follow-up evaluations performed at days 2, 4, 7, 14, and 30. The secondary outcome measure was patient satisfaction. SUMMARY: Based on investigator post-resurfacing scores, day 4 showed improved erythema (50%), edema (50%), crusting (40%), and percentage healing (60%) on the Product 1-treated side compared to Product 2, with the majority of remaining patients scoring the same as Product 2. On day 14, Product 1 demonstrated improvement in erythema (50%), edema (30%), and percentage healing (30%) compared to Product 2, with all remaining patients scoring the same as Product 2. Crusting was the same between the two products on day 14. Ninety percent of patients preferred Product 1 over Product 2, found it easier to use, and were more likely to use it in the future. CONCLUSION: Product 1 is a plant-based hypoallergenic ointment that is safe and effective post-laser treatment and is associated with high patient satisfaction and preference. J Drugs Dermatol. 2018;17(11):1178-1182.

Background: Actinic keratoses (AKs) are proliferations of abnormal keratinocytes, which may progress into non-melanoma skin cancers. Although multiple treatment modalities exist for AKs, their incidence continues to rise, making new methods of both prevention and treatment necessary. DNA repair enzymes have been shown to reverse sun-damage, resulting in reduced rates of AKs and non-melanoma skin cancer (NMSC) in specific patient populations. Objective: We investigated the efficacy of a topical DNA repair enzyme lotion as a field therapy for AKs. Methods: In a single center, randomized double-blind study, we randomly assigned 15 patients with AKs on their face or scalp to receive topical DNA repair enzyme lotion or placebo (Eucerin Professional lotion). Lotion was self-applied to a treatment field twice daily for 8 consecutive weeks. Complete clearance (primary outcome) was assessed at week 8, and local reactions were quantitatively measured. Follow-up at week 12 assessed for continued clearance of AKs. Results: Thirteen subjects completed the trial. Compared to baseline, patients who used the repair enzyme had significantly fewer AKs than those using the control lotion after 8-weeks treatment. Specifically, there was a 46.6% percent decrease in AKs the DNA repair enzyme lotion group compared to a 32.7% decrease in the placebo group. Significance between the two groups was noted at the12 week follow-up, where there was an additional 29.2% decrease in AK percentage in the DNA repair enzyme group, while the placebo group had a 31.4% increase in AKs (P=0.0026). On final self-assessment, 85% of subjects reported being at least “satisfied” with the ability of the medication to decrease their AK burden. No side effects were reported. Conclusion: These results suggest that topical DNA repair enzymes may help reduce the number of AKs in individuals with moderate-to-severe photodamaged skin. Additionally, there may be a lasting effect of the DNA repair if application is discontinued. Further, cutaneous malignancies were not detected in any of the subjects during the study period. Despite the brevity of the study, these preliminary results suggest the role of DNA repair enzymes for not only treatment, but also skin cancer prevention. Further study and more objective evaluation measures are required for definitive conclusions to be drawn.

J Drugs Dermatol. 2017;16(10):1030-1034.

Crusted scabies (CS) is a highly infectious hyperinfestation variant of scabies with up to millions of Sarcoptes scabiei mites present on the skin surface. Diagnostic clues include intense itching and thick crusting especially on the face, groin, and buttocks, although variable presentations may mimic other dermatoses. CS has been associated with immunosuppression including the human immunodeficiency virus (HIV) and lymphoreticular malignancies.1-3 A long latency period from symptom onset to diagnosis and appropriate treatment is often reported. Clinical suspicion is required to obtain a mineral oil preparation or biopsy. We report a patient treated for eczema with 9 months of progressive immunosuppression who was found to have crusted scabies. J Drugs Dermatol. 2018;17(10):1131-1133.

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No abstract details for the moment.

Facial redness is a common difficult to control cosmetic problem representing various phases of rosacea. Using anti-inflammatory/antioxidant botanicals in moisturizer formulations is a possible approach to minimizing the erythema. This research utilized a common facial cleanser, but only applied the botanically based moisturizer to one half face to properly assess efficacy. 30 female subjects Fitzpatrick skin types I-IV 30-55 years of age with mild to moderate chronic facial redness, defined as a redness score of 3-6 on a 10-point scale, were enrolled. By the end of week 4, statistically significant improvement was seen on the cleanser/mask treated side in scaling (P less than 0.001), flaking (P less than 0.001), tactile smoothness (P less than 0.001), textural smoothness (P less than 0.001), firmness (P less than 0.001), radiance (P less than 0.001), luminosity (P less than 0.001), and overall appearance (P less than 0.001). Thus, cosmetic moisturizers may be useful in reducing facial redness. J Drugs Dermatol. 2018;17(6):671-676.

No abstract details for the moment.

Inverse or intertriginous psoriasis commonly involves skin fold areas including the axillae, perianal skin, intergluteal cleft, inframammary, genital/inguinal, abdominal, and retroauricular folds. After reviewing the literature for new treatments, a task force was convened to update a consensus on inverse psoriasis therapy. Short-term treatment continues to be low-potency topical steroids. In order to avoid steroid-induced adverse effects, long-term therapy includes topical immunomodulators, calcitriol, and calcipotriene. Second and third-line therapies include antimicrobials, emollients, and tar-based products. Inverse psoriasis resistant to topical therapy has been shown to respond to botulinum toxin injections, excimer laser therapy, and certain systemic agents (such as anti-TNF and anti-IL12/IL23 therapy). Based on promising results from case reports and prior clinical experience, these systemic agents should be strongly considered in inverse psoriasis resistant to topical therapy. However, they need further evidence-based evaluation. The use of randomized trials and objective severity indices may allow for more robust therapeutic data.

J Drugs Dermatol. 2017;16(8):760-766.

Onychomycosis is the most common fungal skin infection, and it is frequently seen in the setting of other concomitant fungal infections, the most common being tinea pedis. Infected nails become a reservoir of fungal organisms that may infect the skin, and vice versa. Early, effective treatment of the nails is necessary for preventing not only permanent structural damage but also the spread and superinfection of the surrounding skin and soft tissue. Moreover, treatment of the skin is important for preventing re-infection of the nails.

J Drugs Dermatol. 2015;14(suppl 10):s32-s34.

BACKGROUND: Ethnic differences in skin sensitivity suggest that greater emphasis be focused on understanding a product’s effect in diverse populations. OBJECTIVE: The irritation and/or sensitization potential of 8 baby skin care products in Indian adults were evaluated using cumulative irritation tests (CIT) and human repeat insult patch testing (HRIPT) protocols. PATIENTS/MATERIALS/METHODS: Healthy males or females aged 18 to 65 years of Indian ethnicity were treated with each of 6 products (cream, hair oil, lotion, body wash, shampoo, and baby soap) using CIT (n = 25) and HRIPT (n = 200). Baby powder and baby oil were evaluated by CIT (n = 25) and HRIPT (n = 107) in separate studies. CITs were conducted over 14 days; HRIPTs were conducted over 10 weeks. RESULTS: In both CIT and HRIPT, most products were considered mild, with no irritation. Baby soap and powder elicited reactions in the HRIPT induction phase, with positive challenge phase reactions (3 subjects), but were affirmed to be nonallergenic in the rechallenge phase. CONCLUSIONS: In these studies, 8 baby skin care products were evaluated by both CIT and HRIPT in Indian adults. The results of the studies indicated that all of the tested products were nonallergenic and nonirritating.

J Drugs Dermatol. 2016;15(10):1244-1248.

Gemcitabine, a pyrimidine nucleoside analogue, is an oncologic agent used in the treatment of cutaneous T-cell lymphoma (CTCL). Common dermatologic reactions associated with gemcitabine include alopecia, mild skin rash, and mucositis but skin necrosis is exceptional. Herein we present an unusual case of widespread skin necrosis mimicking toxic epidermal necrolysis in a 45-year-old woman receiving gemcitabine therapy for stage IIIA cutaneous T-cell lymphoma. This is the first reported case of a TEN-like reaction subsequent to gemcitabine treatment. J Drugs Dermatol. 2018;17(5):582-585.

We propose rituximab as a first-line therapy for pemphigus vulgaris and steroid-dependent bullous pemphigoid with or without systemic steroids. A brief review of the literature substantiates the significant risk associated with the use of long term, high-dose prednisone, mycophenolate mofetil (MMF), and azathioprine. No head-to-head studies are available with respect to safety and efficacy of rituximab versus these therapies. When comparing the side effects of rituximab to MMF, both are found to be mild when used as monotherapy in dermatologic patients. The most severe side effects of rituximab include fatal infusion reactions and hypersensitivity, pancytopenia, infection and organ dysfunction. With MMF, malignancy, pancytopenia, infection, and organ dysfunction are the most concerning side effects. The frequencies of these observed adverse events are difficult to compare, but the side effect profiles of rituximab and MMF are clearly similar. Therefore, there is equipoise whether to use rituximab before rather than after MMF and/or systemic corticosteroids.

J Drugs Dermatol. 2012;11(5):622-625.

No abstract details for the moment.

OBJECTIVE: The objective of these studies was to investigate whether a skincare product containing Ambophenol, Neurosensine, and La Roche-Posay thermal spring water formulated in a highly protective packaging can have an impact in the management of rosacea-prone skin subjects.
METHODS: Several studies were performed to evaluate the efficacy of this product in the management of rosacea prone skin, as either monotherapy or adjunctive therapy or to maintain the efficacy of a Metronidazole treatment. The first study was performed on 37 women aged 18-45 with added stage 2 erythro-couperosis, who applied test formula as monotherapy twice a day for 4 weeks. During a second study, a dermatological evaluation was performed on patients with stage I or II rosacea, a questionnaire containing information about patient characteristics, tolerance, clinical signs, symptoms and skin reactivity to “trigger factors” was completed by dermatologists at baseline and 2 months after treatment with the test formula as either monotherapy or adjunctive therapy. Finally, in a third study, 65 patients finishing a Metronidazole treatment applied once daily and the tested formula twice daily were divided into 2 groups using the test formula or vehicle control, twice a day for 8 weeks for the evaluation of efficacy as adjunctive therapy.
RESULTS: We noted that the test formula, as an adjunctive therapy, helped prolong the efficacy of a Metronidazole treatment. In monotherapy, there was a significant efficacy of the test formula associated with an excellent tolerance. A significant improvement of all the clinical signs and symptoms of rosacea and a reduction of the skin reactivity to "trigger factors" were shown.
CONCLUSIONS: These studies highlight the interest value and impact of a skincare product containing Ambophenol, Neurosensine, and La Roche-Posay thermal spring water formulated in a highly protective packaging in monotherapy or in combination with or after a therapeutic treatment in the management of patients suffering from rosacea.

J Drugs Dermatol. 2013;12(8):920-924.

Background: Although reliable prevalence data are not available, adult acne is thought to be somewhat common, and it is not unusual for patients to have acne as well as early signs of skin aging. A novel anti-acne/anti-aging formulation (Treatment A) has been developed for daily use by patients to address both signs of skin aging and facial acne vulgaris. The novel, non-prescription formulation includes several ingredients shown to target factors underlying the pathogenesis of acne vulgaris while also addressing multiple components in the pathophysiology of skin aging.
Methods: A blinded, randomized, split-face study was conducted to evaluate and compare the tolerability and efficacy of the novel anti-acne/ anti-aging product in subjects with photodamaged skin and acne vulgaris relative to tretinoin cream 0.025% (Treatment B). All subjects also were given supportive skincare, consisting of a cleanser, moisturizer, and sunscreen. Each treatment was assessed for its effects on subjects' appearance, lesion count reductions, and tolerability.
Results: Treatment A produced statistically significantly greater improvements in skin tone evenness, skin tone clarity, and blemishes and blotchiness. There were also statistically greater reductions in total lesion count for acne patients on the side of the face treated with Treatment A compared to Treatment B; Treatment A was also associated with early (day 2) improvement in skin tone evenness and clarity, tactile skin smoothness, and blemishes and blotchiness. Both treatments demonstrated favorable tolerability.
Conclusion: The novel topical anti-aging/anti-acne therapy (Treatment A) within a comprehensive skin care regimen of cleanser, moisturizer, and sunscreen may maximize efficacy and tolerability and contribute to our armamentarium for treating both photodamage and acne at the same time.

J Drugs Dermatol. 2012;11(6):737-740

No abstract details for the moment.

Resident Rounds is a new section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds will feature three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the University of California, Irvine Department of Dermatology Residency Training Program. The editor of Resident Rounds is Omar A. Ibrahimi, MD, PhD. Dr. Ibrahimi is a recent graduate of the Harvard Combined Program in Dermatology and currently a fellow in Mohs, Laser and Cosmetic Surgery at the University of California Davis. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at omar.ibrahimi@gmail.com

Background: Contractubex^® (Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a gel containing extractum cepae, heparin, and allantoin with proven efficacy in the prevention of excessive scarring and promotion of physiological scar formation.
Aim: To investigate the efficacy of early initiation of Contractubex in the prevention of excessive scarring and promotion of physiological scar formation.
Methods: In total, 1,268 patients were included in this observational, noninterventional study. Patients were assessed at visit 1 (within 3 weeks of the injury), when treatment was initiated, with subsequent assessments after 2 to 3 months of treatment, and at the end of the study (after 4 to 5 months of treatment). Parameters measured included scar size, color, and pliability (consistency/hardness), as well as patients' and physicians' subjective assessments of treatment efficacy and tolerability.
Results: After 2 to 3 months of treatment, there were statistically significant improvements in color and pliability of the scar, sensation of pain, tension, and pruritus compared with visit 1 (P<.0001). By the end of the study, further statistically significant improvements compared with visit 1 were observed for all parameters. Only about 1% of scars were rated as markedly red or markedly hardened at the final visit. In addition, there was a reduction of 31.5% in mean scar width and of 47.8% in mean scar height at the end of the observation period. A high percentage of patients (85.8%) and physicians (86.6%) rated the treatment as good or very good with respect to prevention of excessive scarring and promotion of physiological scar development. Tolerability was described as good or very good by 92.0% of physicians and 91.5% of patients.
Conclusions: The results of this study suggest that the scar gel is effective in preventing excessive scarring and promoting physiological scar formation when treatment is initiated early. In addition, the treatment was well tolerated.

J Drugs Dermatol. 2013;12(1):38-42.

In recent years, new topical antifungals have emerged for the treatment and management of tinea pedis, but all have been investigated and approved for the treatment of interdigital tinea pedis. Moccasin tinea pedis has not been recognized by governing bodies as a definable and treatable disease entity separate from interdigital tinea pedis at this time. Thus, creating randomized, controlled clinical trials to investigate moccasin tinea pedis is a challenge without an agreed upon definition of the disease state, treatment regimen, and treatment course. Considering systemic therapy issues and the lack of data from large trials demonstrating safety and efficacy in the topical management of this clinical presentation, an unmet need has been created for a topical antifungal agent that can treat moccasin tinea pedis. Naftifine 2% gel, an allylamine, was studied in a clinical trial that enrolled patients who had interdigital or both interdigital and moccasin-type tinea pedis. In the moccasin group, the primary efficacy endpoint of complete cure at week 2 (end of treatment) was 1.7% (gel) vs 0.9% (vehicle) and week 6 (four weeks post-treatment) was 19.2% (gel) vs 0.9% (vehicle). Naftifine 2% cream in combination with urea 39% also showed improvement in hyperkeratotic moccasin tinea pedis.

J Drugs Dermatol. 2016;15(Suppl 2):s56-59.

Androgenic alopecia (AGA) is the most common type of hair loss in men, characterized by hair miniaturization, hairline recession, and vertex balding. It affects approximately 50% of men, negatively affecting self-esteem and sociability. Topical minoxidil formulations are approved up to a 5% concentration for men, but patient adherence to treatment is challenged by gradual results that may be perceived as a lack of initial benefit. Herbal extracts, which are also believed to promote healthier-looking hair, have a long history of use in hair care formulations. The safety and efficacy of a twice-daily regimen of 5% minoxidil foam used in combination with a novel botanical hair solution was evaluated in a 12-week, multicenter, single-arm, open label study in 56 subjects with mild to moderate AGA. Assessments included investigator ratings of improvement and subject self-ratings of satisfaction. Investigator ratings indicated significant improvement in scalp hair coverage and perception of overall treatment benefit in as early as 4 weeks (P<.001). Subject self-ratings were significant for improved hair growth and hair appearance in as few as 4 weeks (P<.05). The regimen was well tolerated, and subjects indicated a high degree of satisfaction. Investigator and subject-assessed efficacy and subject satisfaction with this novel regimen provide clinicians with an effective treatment option for AGA that also provides a high level of patient satisfaction, which may help promote patient adherence to long-term treatment.

J Drugs Dermatol. 2016;15(4):406-412.

BACKGROUND: Topical dapsone gel, 5% is approved for treatment of acne vulgaris but has not been studied specifically in women with skin of color (SOC; Fitzpatrick skin types IV, V, or VI).
OBJECTIVE: Evaluate safety and efficacy of dapsone gel, 5% applied topically twice daily for 12 weeks in women with SOC.
METHODS: Females with SOC aged 18 years and older with facial acne participated in a multicenter, open-label, single-group, 12-week pilot study of twice-daily monotherapy with dapsone gel, 5%. The investigator-rated 5-point Global Acne Assessment Score (GAAS) was used to assess efficacy. The impact of acne on subjects was assessed using the validated Acne Symptom and Impact Scale (ASIS).
RESULTS: The study enrolled and treated 68 women with SOC and facial acne. GAAS decreased significantly from baseline to week 12 (mean, -1.2 [95% CI, -1.4, -1.0]; P<.001), a 39.0% improvement. Overall, 42.9% of subjects were responders based on a GAAS of 0 or 1 at week 12. Subjects also experienced significant reductions in mean total lesions (52% decrease), inflammatory lesions (65%), and comedo counts (41%; all P<.001). Dapsone gel, 5% monotherapy was associated with significant improvement in subject-assessed acne signs (P<.001) and impact on quality of life (QOL; P<.001), based on ASIS. Dapsone gel, 5% used twice daily was well tolerated, with no treatment-related adverse events. The local dermal tolerability scores tended to remain stable or decrease from baseline to week 12.
CONCLUSIONS: Monotherapy with dapsone gel, 5% administered twice daily was safe and effective for treatment of facial acne in women with SOC. Significant improvement in overall acne severity and both inflammatory lesions and comedones was observed. Further, study subjects reported considerable improvement in both acne signs and impact on QOL.

J Drugs Dermatol. 2016;15(2):197-204.

BACKGROUND AND OBJECTIVES: The etiology of aging human skin includes intrinsic physiologic changes greatly accelerated by photoaging, predominantly through exposure to UV light. Consumer interest and demand for anti-aging skin care products is extremely high especially in light of aging populations. Prenatal (fetal) tissue has been shown to possess healing characteristics and regenerative effects. A proprietary tissue engineering technology has been developed to produce a soluble human extracellular matrix material with growth factors and proteins. Neonatal cells are cultured on microbeads under conditions of low oxygen tension. This human cell-conditioned media (hCCM) contains a variety of growth factors and cytokines similar to those found in fetal cells and has been incorporated into a topical preparation for use in facial wound healing (after laser resurfacing procedures) and improving the appearance of aging skin. The objective of this study was to observe the effects of an MRCxTM-containing topical skincare regimen on subjects with demonstrated aging skin damage (photodamage) when used consistently over a 3 month time period.
METHODS: Female subjects age 35-65 with Fitzpatrick Skin Type I-IV and mild to moderate amounts of photodamage, fine lines, and wrinkles used Regenica® Replenishing Crème and Regenica® Renew SPF 15 for 3 months. At each visit, photos were taken of subjects while investigators completed skin grading assessments and subjects completed self-assessments. Investigator assessments included evaluation of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance, and translucence on a 5-point scale. Subjects’ self-assessments included assessment of fine lines and wrinkles, firmness, evenness of skin tone, brightness, resilience, clarity, and radiance. Changes from baseline were evaluated for each parameter and P values for changes from baseline to each study visit for investigator’s assessments and to end-of-study for self-assessments were calculated.
RESULTS: Eighteen of 21 enrolled female subjects completed the study. Three subjects chose to drop from the study. Statistically significant improvements in investigator assessments of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance and translucency compared to baseline were observed at weeks 4, 8, and 12 after initiating treatments. Progressive improvement was seen through the last study visit (visit 5, week 12). Similar statistically significant improvements in subjects’ self-assessments were seen comparing the first post-baseline visit (visit 2, week 2) to subsequent visits. 93.5 % subjects agreed (somewhat or strongly) with all of the positive subject assessment statements at week 12. Importantly, 100 % of subjects indicated at the end of the study that they would recommend the product to a friend and would want to purchase the product. No treatment-related adverse events were recorded during the study.
CONCLUSIONS: Regenica was safe and clinically effective in reducing anti-aging effects in this group of female subjects aged 35-65 years as measured by both investigator assessments and subjects’ self-assessments.

J Drugs Dermatol. 2014;13(9):1074-1081.

Numerous cutaneous manifestations have been associated with use of BRAF inhibitors, including two previously reported cases of granuloma annulare (GA) eruptions associated with vemurafenib therapy. Both of these patients were being treated for metastatic melanoma. In this report, we describe the case of a 71-year-old man who developed classic GA lesions while being treated with vemurafenib monotherapy for nonmelanoma cancer, specifically metastatic lung adenocarcinoma positive for BRAF V600 mutation.

J Drugs Dermatol. 2017;16(10):1050-1052.

Boxed, or “black box” warnings are issued by the United States Food and Drug Administration (US FDA) as a means to label drugs associated with serious adverse events. However, there is no clear metric to determine how and when the boxed warning is applied. Inconsistencies in the review process, language, timing, and dissemination of these warnings impact dermatologists and their patients. Appropriate patient selection and monitoring can help minimize risk to patients when prescribing drugs with boxed warnings. Future changes in the manner in which the boxed warning is issued and in its subsequent clinical application may improve the utility of these warnings for dermatologists and ultimately, patient safety.

Female pattern hair loss (FPHL), also known as female androgenic alopecia, affects over 21 million women in the United States with devastating effects on self-esteem and psychosocial functioning. Topical minoxidil 2% and 5% formulations are the only US Food and Drug Administration-approved treatments for FPHL. The length of time it typically takes to observe the benefits is a challenge for many patients, and may affect adherence to treatment. Herbal extracts, which are also believed to promote healthier-looking hair, have a long history of use in hair care formulations. The safety and efficacy of a twice-daily regimen of 2% minoxidil solution used in combination with the botanical hair solution for 12 weeks in 54 subjects was evaluated in a multicenter, single-arm, open-label study. Assessments included investigator and subject ratings of improvement and subject satisfaction. Investigator ratings indicated significant improvement in hair growth and overall treatment benefits in as early as 6 weeks (P<.001). Subject self-ratings indicated significant satisfaction with hair volume and quality improvement at week 6 (P<.001). Subjects also indicated an increase in self-confidence and attractiveness at week 12 (P<.001). The investigator and subject-assessed efficacy and subject satisfaction with this regimen provides clinicians with an effective treatment option for FPHL that also provides a high level of patient acceptance, which ultimately may help promote minoxidil treatment adherence.

J Drugs Dermatol. 2016;15(4):398-404.

IMPORTANCE: Intramuscular (IM) steroids can be used to treat a wide variety of dermatologic diseases. Although seemingly effective and safe, this form of corticosteroid therapy may be underused amongst dermatologists. OBJECTIVE: The objective of this review is to determine the evidence regarding the efficacy and side effect profile of intramuscular triamcinolone in the treatment of dermatologic disease. EVIDENCE REVIEW: A PubMed search engine was used for this study. Inclusion criteria were studies that examined human subjects, reported clinical outcomes and side effects of intramuscular steroids for the treatment of dermatologic disease, cutaneous disease where steroids remain an accepted standard of care, studies published after 1980, and English language articles. FINDINGS: A total of 62 papers were reviewed. Six papers met criteria. They looked at alopecia areata, (2) systemic lupus erythematosus (1), Behcets disease (1), and nail lichen planus (2). Collectively, the studies included 342 patients. Study types included case series (1), retrospective observational (2), randomized prospective (2), and double-blind placebo controlled (1) studies. In this systematic review, intramuscular steroids were found to have comparable efficacy and side effect profile alone or in comparison with other steroid modalities for the select number of dermatoses investigated. CONCLUSIONS AND RELEVANCE: We conclude that intramuscular steroids can be regarded as having comparable efficacy to other steroid modalities in the treatment of steroid responsive dermatoses; and also appear to be safer in most instances with the exception of dysmenorrhea in females. Additional studies are greatly needed.

J Drugs Dermatol. 2018;17(3):323-329.

BACKGROUND: Combining narrowband UVB (NB-UVB) phototherapy with biologics has been shown to enhance the therapeutic response of plaque psoriasis patients. The objective of this study was to evaluate the effectiveness of apremilast combined with NB-UVB in patients with moderate to severe plaque psoriasis. METHODS: This was a 12-week, open-label study of 29 patients diagnosed with moderate to severe psoriasis. Patients received apremilast 30 mg twice daily, and increasing doses of NB-UVB (310-312 nm) 3 times per week for 12 weeks. RESULTS: Twenty-two of 29 patients (76%) completed the 12-week apremilast and NB-UVB combination therapy; 73% (16 of 22 completers) achieved a PASI 75 response at week 12. Mean scores for PASI, VAS pain, VAS itch, DLQI, and PGA improved by 77%, 77%, 69%, 70%, and 67%, respectively, at week 12. The most commonly reported adverse events (AEs) were mild and moderate first-degree burns related to NB-UVB (n=11 [38%] patients). A second-degree NB-UVB burn was reported (likely due to an underlying photosensitivity) and was considered a serious AE. CONCLUSION: The combination of apremilast with NB-UVB was effective for the treatment of moderate to severe plaque psoriasis, without any unexpected safety signals. Apremilast combined with NB-UVB provided a high treatment response in patients with moderate to severe plaque psoriasis, and may be an option for patients to enhance a patient’s initial therapeutic response.

J Drugs Dermatol. 2017;16(10):957-962.

The eutectic mixture of lidocaine and prilocaine (EMLA, APP Pharmaceuticals, LLC.) is an anesthetic cream frequently used by dermatologists. Although side effects of EMLA are usually mild local skin reactions (ie, edema, pallor, erythema), more severe complications can be encountered including methemoglobinemia, central nervous system toxicity, and cardiotoxicity. This article reviewed the literature regarding risk of systemic toxicity associated with use of EMLA in the pediatric and adult population. All 12 clinical trials evaluating the safety of EMLA in either the pediatric or adult population generally followed dosing and administration guidelines set by the manufacturer and reported clinically insignificant plasma levels of methemoglobin, lidocaine, prilocaine, and their respective metabolites. To date, nine pediatric cases and three adult cases of systemic toxicity associated with EMLA have been published. Possible factors that contributed to the development of systemic toxicity include excessive amount of EMLA, large application area, prolonged application time, diseased and/or inflamed skin (eg, vascular malformations, molluscum contagiosum, eczema, previously abraded skin), age less than 3 months, prematurity, and concomitant use of a methemoglobin-inducing agent. Recommendations are provided on how to safely use EMLA to minimize the risk of systemic toxicity.

J Drugs Dermatol. 2014;13(9):1118-1122.

Background: Wound healing is a dynamic and complex process affected by tissue hydration, the presence of bacteria, inflammation, and other variables. Oregano has potent antibacterial, antifungal, antioxidant, and anti-inflammatory properties. Studies of oregano ointment on wound healing are lacking.
Objective: To determine the efficacy of 3% oregano extract ointment on wound healing.
Methods: An investigator initiated, randomized, double-blind, petrolatum-controlled study was performed to determine the effects of oregano ointment on wound healing. Forty patients who underwent surgical excision were enrolled and randomized. Cultures were obtained on day 12 and scars were evaluated using the Patient and Observer Scar Assessment tool on day 12, 45, and 90.
Results: The oregano ointment group had 19 percent of cultures test positive for Staphlococcus aureus compared to 41 percent in the petrolatum group. One patient in the oregano ointment group developed a cellulitis compared to three patients in the petrolatum group. The oregano group had a statistically significant improvement over petrolatum in scar color, pigmentation, and pliability.
Conclusion: Oregano extract ointment decreased bacterial contamination and subsequent infection on post-surgical wounds and had equivalent overall scar appearance compared to petrolatum.

J Drugs Dermatol. 2011;10(10):1168-1172.

BACKGROUND: Tinea corporis is fungal infection of body surfaces other than the feet, groin, scalp, or beard. Naftifine hydrochloride is a topical antifungal of the allylamine class used to treat tinea corporis, displaying fungicidal activity and clinically significant anti-bacterial and anti-inflammatory effects.
OBJECTIVE: To evaluate the efficacy and safety of two-weeks once daily application of naftifine cream 2% in the treatment of tinea corporis among pediatric subjects.
METHODS: At baseline, 231 subjects were randomly assigned 1:1 to naftifine cream 2% (n=116) and vehicle (n=115). Treatment effect consisting of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity was evaluated at baseline, week 2 (end of treatment) and week 3. Efficacy was analyzed in 181 subjects (n=88, naftifine; n=93, vehicle) with a positive baseline dermatophyte culture and KOH for whom week 3 assessments were available. Safety was evaluated by adverse events (AE) and laboratory values in 231 subjects (n=116, naftifine; n=115, vehicle).
RESULTS: Children with tinea corporis treated with naftifine cream 2% demonstrated significantly greater improvements from baseline over vehicle for mycological cure (P<0.0001) and treatment effectiveness (P=0.003) as early as 2 weeks (end of treatment). Response rates continued to increase post-treatment and were the highest 1-week after completion of the therapy (P=0.003 for complete cure; and P<0.001 for mycological cure and treatment effectiveness). Treatment related adverse events were minimal.
CONCLUSIONS: Treatment with naftifine cream 2% applied once daily for two weeks was well-tolerated and was effective in treating tinea corporis in children. Further improvement was observed 1-week after treatment completion for all key outcome measures (complete cure, mycological cure, treatment effectiveness, clinical cure, and clinical success) and clinical signs and symptoms (erythema, induration, and pruritus).

J Drugs Dermatol. 2016;15(6):743-748.

INTRODUCTION: Response to etanercept therapy in patients who have failed apremilast therapy has not been well characterized. METHODS: In this multicenter, open-label, single-arm, phase 4, estimation study, subjects with moderate to severe plaque psoriasis received etanercept 50 mg SC twice weekly for 12 weeks, followed by etanercept 50 mg SC once weekly for an additional 12 weeks. Subjects had BSA greater than equal to 10%, PASI greater than equal to 10, and sPGA greater than equal to 3 at screening and baseline; and had failed apremilast—because of either failure to achieve or loss of adequate clinical response, or intolerability to apremilast in the opinion of the investigator. Primary endpoint was PASI 75 at week 12. Secondary endpoints included PASI 75 at week 24, PASI 90 at weeks 12 and 24, and patient-reported outcomes: Psoriasis Symptom Inventory (PSI) score (total and individual items) at baseline and weeks 12 and 24, and over time; DLQI responder analysis (5-point improvement in DLQI from baseline or score of 0) at weeks 12 and 24; and patient assessment of treatment satisfaction at baseline and weeks 12 and 24. RESULTS: Among 80 patients, PASI 75 at weeks 12 and 24 was 41.6% (95% CI, 30.4%-53.4%) and 45.5% (34.1%-57.1%), respectively; PASI 90 was 13.0% (6.4%-22.6%) and 22.1% (13.4%-33.0%), respectively. Mean total PSI score (LOCF) improved from 16.6 (95% CI, 15.1-18.0) at baseline to 8.8 (7.3-10.2) and 9.6 (7.9-11.4) at weeks 12 and 24, respectively; improvements in item PSI scores were similar. The percentage of DLQI responders was 66.2% (95% CI, 54.3%-76.8%) and 57.3% (45.4%-68.7%) at weeks 12 and 24, respectively. The percentage of subjects who were satisfied/very satisfied with their psoriasis treatment improved from 5.0% at baseline to 60.8% and 53.3% at weeks 12 and 24, respectively. During the 24-week study, 23.8% and 2.5% of subjects reported an adverse event and serious adverse event, respectively; there were no new safety signals in this study. DISCUSSION: In patients who have failed apremilast, etanercept may represent an effective therapeutic option. Trial Registration: ClinicalTrials.gov: NCT02749370 J Drugs Dermatol. 2018;17(10):1078-1082.

Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.

The human circadian clock ensures that biochemical and physiological processes occur at the optimal time of day. In addition to a central pacemaker in the body, recent evidence suggests that peripheral mammalian tissues also possess autonomous circadian oscillators, which are regulated by genes linked to distinct tissue-specific functions. The skin is situated in a position naturally exposed to diurnal environmental changes. The skin's chronobiological functioning influences skin aging, cell repair and development of skin cancers, as well as optimal timing of drug delivery to the skin. An understanding of circadian skin-related functions and the impact of their disruption allow clinicians to improve therapeutic decision-making and maximize the effectiveness of prescribed treatments.

J Drugs Dermatol. 2014;13(2):130-134.

Pityriasis rubra pilaris (PRP) is a rare idiopathic papulosquamous eruption. Few cases of PRP have been reported in association with malignancies. We report a case of an 83-year-old Caucasian male who presented with recalcitrant paraneoplastic PRP as the presenting manifestation of metastatic squamous cell carcinoma with unknown primary. Treatment with chemotherapy and radiation led to temporary radiologic and symptomatic regression of the cancer as well as resolution of cutaneous findings. This suggests a direct relationship between the PRP and the underlying malignancy in this patient. This case highlights a rare, but important phenomenon in which PRP may act as a harbinger for underlying malignancy.

J Drugs Dermatol. 2014;13(5):610-612.

Complementary and alternative medicine (CAM) therapies are increasing in popularity in the field of dermatology. Natural products and holistic approaches are in high demand among patients and research has begun to support their roles in acne and rosacea pathophysiology. In this article, commonly utilized biologically based complementary and alternative therapies for acne and rosacea are reviewed from an evidence-based perspective. Therapies discussed include vitamin C, nicotinamide, zinc, tea tree oil, green tea, resveratrol, curcumin, feverfew, licorice, chamomile, polypodium leucotomos, and nutrition-based approaches. J Drugs Dermatol. 2018;17(6):611-617.

Resident Rounds is a section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds includes three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the St. Joseph Mercy Health System Dermatology Residency Program. The editor of Resident Rounds is Omar A. Ibrahimi MD PhD. He is currently the Founding and Medical Director of the Connecticut Skin Institute. Dr. Ibrahimi is also a Visiting Assistant Professor of Dermatology Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at OIbrahimi@jddonline.com.

Resident Rounds is a section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds includes three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the University of Massachusetts Medical School Dermatology Residency Program. The editor of Resident Rounds is Omar A. Ibrahimi, MD, PhD. He is currently the Director of Cutaneous Laser and Cosmetic Surgery and a Mohs surgeon at the University of Connecticut. Dr. Ibrahimi is also a Visiting Scientist at the Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at omar.ibrahimi@gmail.com

Background: Ablative fractional laser skin resurfacing (FLSR) has recently been used for the amelioration of acne scars, and previous studies have shown clinical effectiveness. Despite its extensive use, few studies have focused on the associated changes in biophysical properties of the epidermis. Herein, we evaluate transepidermal water loss, sebum levels, skin hydration, and skin elasticity, following FLSR treatments with an Er:YSGG laser device (Pearl Fractional^TM , Cutera Inc., Brisbane, CA), employing non-invasive measurements.
Methods: Five Japanese patients with facial acne scars underwent one FLSR session. Some acne scars appeared to become less obvious as a consequence of the treatment. All patients were aware of a feeling of skin tightness in treated areas.
Results: Objective measurements on the lower lateral angle of the eye and on the inner cheeks were evaluated at baseline and at 3 days, 1 week, and 4 weeks after FLSR. Transepidermal water loss showed a significant two-fold (100%) increase at day 3, but had returned to almost the baseline level at week 4 in both areas. Sebum secretion showed a 50% increase at day 3, but had returned to the baseline level after day 7. Skin hydration showed a significant decrease at day 3, but had returned to the baseline level by day 7, and showed significant improvement at the end of the study. Skin elasticity (R2) was still at baseline on day 3, but showed some improvement—an increase of at least 30%—at the end of the study.
Conclusions: Based on our findings, we believe that FLSR should be performed no more than once a month to allow sufficient time for the damaged skin to recover its barrier function in most areas of the face.

J Drugs Dermatol. 2012;11(5):637-642.

No abstract details for the moment.

Resident Rounds is a section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds includes 3 sections: (1) a program spotlight highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the Department of Dermatology, University Hospitals Case Medical Center. The editor of Resident Rounds is Dr. Ali Alikhan. If you are interested in highlighting your training program in a future issue, please contact Dr. Alikhan at alialikhan1@yahoo.com.

Resident Rounds is a new section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds will feature three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the Eastern Virginia Medical School Dermatology Residency Program. The editor of Resident Rounds is Omar A. Ibrahimi, MD, PhD. Dr. Ibrahimi is a recent graduate of the Harvard Combined Program in Dermatology and currently a fellow in Mohs, Laser and Cosmetic Surgery at the University of California Davis. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at omar.ibrahimi@gmail.com

Introduction: Air pollution continues to be a global health concern and recent studies have shown that air pollutants can cause skin damage and skin aging through several pathways that induce oxidative stress, inflammation, apoptosis, and skin barrier dysfunction. Preventive measures need to be considered to retain optimal skin health, and topical skincare products may be able to alleviate the negative effects of air pollution on skin. A randomized, double-blind, placebo-controlled clinical usage study was conducted to assess the efficacy and tolerability of a novel two-part skincare system (LVS) that was developed to provide protection against environmental skin aggressors including air pollution. After 8 weeks of use in subjects exposed to extremely high levels of pollution, LVS provided significant improvements compared to placebo in all clinical efficacy parameters including crow’s feet wrinkles, overall skin damage, skin tone evenness, tactile roughness, and visible redness. Subject self-assessment questionnaires showed that the treatment product was highly rated in self-perceived efficacy. Decreased SQOOH and MDA content in skin swab samples suggest that LVS helped to reduce oxidative stress in patients’ skin. Histological analyses of biopsy samples using biomarkers related to skin structure, damage and function (collagen IV, MMP1, CPD, and CD1a) further support the clinical benefits of LVS. Altogether, the presented study is among the first to show that topical skincare products can help to reduce pollution-induced skin damage and improve skin quality, especially when specifically formulated with active ingredients that combat the harmful effects of air pollutants. J Drugs Dermatol. 2018;17(9):975-981.

Resident Rounds is a section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds includes three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the Mayo Clinic Dermatology Residency Training Program. The editor of Resident Rounds is Omar A. Ibrahimi MD PhD. He is currently the Director of Cutaneous Laser and Cosmetic Surgery and a Mohs surgeon at the University of Connecticut. Dr. Ibrahimi is also a Visiting Scientist at the Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at OIbrahimi@jddonline.com.

Two Phase 3, double-blind, randomized, vehicle-controlled parallel studies evaluated the efficacy and safety of desoximetasone spray 0.25%, a super-potent topical corticosteroid, twice daily vs vehicle spray twice daily for 28 days in adult patients with moderate to severe plaque psoriasis. At baseline and throughout the study, the severity of disease for the psoriatic lesions was assessed using the Physician Global Assessment (PGA) score and a target lesion was assessed using the Total Lesion Severity Score (TLSS). A designated psoriatic plaque lesion was selected as the target lesion upon enrollment and evaluated throughout the study to determine the TLSS. To qualify for study entry, the subject needed to exhibit a PGA score of 3 (moderate) or 4 (severe) for overall disease severity, and a target lesion with an area of at least 5 cm2 that achieved a combined score TLSS of >=7, with a plaque elevation score of >=3 (at least moderate). The mean % BSA affected by psoriasis ranged from 13%-17% at baseline.

In both Phase 3 studies, a statistically significantly greater percentage of subjects in the desoximetasone spray 0.25% compared to vehicle group achieved both Clinical Success and Treatment Success at Day 28. These results, which were the primary efficacy variables, demonstrated superior efficacy in the active study group for both overall improvement of plaque psoriasis (by PGA) and in the individual psoriasis lesion (by TLSS) designated at baseline as the most severely involved plaque (target lesion). Assessment of secondary efficacy variables in both Phase 3 studies showed that subjects receiving desoximetasone Spray 0.25% twice daily exhibited statistically significantly mean changes from Baseline to Day 28 in PGA, TLSS, and % BSA affected when compared to subjects receiving vehicle spray twice daily.

Tolerability and safety were assessed at all study visits. No statistically significant differences were observed between study arms and no major safety signals related to AEs were noted. No stinging and burning were reported with the spray formulation. This Class I topical corticosteroid has shown to be safe and efficacious in moderate to severe plaque psoriasis.

J Drugs Dermatol. 2013;12(12):1404-1410.

BACKGROUND: Current studies have demonstrated the efficacy and safety of laser intervention in the treatment of onychomycosis. The objective of this study was to compare the efficacy of long-pulsed Nd:YAG 1064 nm laser for treatment of toenails onychomycosis with fingernails onychomycosis.
METHODS: One hundred and twelve affected fingernails or toenails in 37 patients with onychomycosis were randomized into Group 1 (22 patients with 50 affected fingernails) and Group 2 (15 patients with 62 affected toenails). These patients were further classified into three subgroups (Grade II, III, and IV) according to Scoring Clinical Index of Onychomycosis. All the affected nails were treated with long-pulse Nd:YAG 1064 nm laser intervention, once weekly, for continuous weeks, and were followed up for 24 weeks.
RESULTS: The response rates at weeks 8, 16, and 24 were 0, 0 and 52%, respectively, for Group 1, and 10, 32 and 71% for Group 2. The inter-group difference in efficacy was statistically significant (P<0.05). Even in the same subgroup, the response rate of Group 2 was higher than that of Group 1.
CONCLUSIONS: The efficacy of long-pulsed Nd:YAG 1064 nm laser intervention against affected toenails is superior to that against fingernails. It is also effective for treatment of onychomycosis with different severity.

J Drugs Dermatol. 2014;13(10):1258-1263.

Background: Toreforant is a selective histamine H4 receptor antagonist. H4 receptor activation may play a role in immune-mediated inflammation in psoriasis. Objective: To evaluate Toreforant efficacy and safety in patients with moderate-to-severe psoriasis. Methods: Biologic-naïve patients were to be treated (30, 60, or 3 mg Toreforant or placebo) for 12 weeks and followed through week 16. In this adaptive-design study, assignments were guided by interim analyses. Primary and major secondary efficacy endpoints, evaluated using Bayesian analyses, were the proportions of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI) from baseline and achieving Investigator’s Global Assessment (IGA) of cleared (0) or minimal (1), respectively, at week 12. Results: Per interim analyses results, patients were randomized to 30 (n = 30) or 60 mg (n = 26) Toreforant or placebo (n = 6). The estimated mean difference in the PASI 75 response rate at week 12 from the posterior distributions compared to placebo was 14.1% (95% credible interval [CI], -0.1% to 30.9%) and 8.9% (95% CI, -5.0% to 24.3%) with 30 and 60 mg Toreforant, respectively. The posterior probabilities of 30 and 60 mg Toreforant inducing a greater response rate than placebo were 97.4% and 90.3%, respectively; neither met the 97.5% predefined success criterion. Results for the IGA 0/1 endpoint were similar. Toreforant was generally safe and well tolerated. No deaths, serious or opportunistic infections, active tuberculosis, or malignancies were reported. Conclusions: Toreforant efficacy at 30 and 60 mg was greater than placebo but did not meet predefined success criterion. J Drugs Dermatol. 2018;17(8):873-879.

Vitiligo is an acquired condition resulting in patches of depigmented skin that is cosmetically disfiguring and can subsequently be psychologically disturbing. For patients seeking to mask their vitiligo, camouflage options have historically been limited and been designated as a cosmetic, rather than a medical, concern. As research has indicated that proper concealment of vitiligo lesions can vastly improve quality of life, we believe it is essential that dermatologists become aware of all the options available to their patients and that discussions of camouflage options be broached from the first visit. Methods for concealment include cosmetic tattoos, dihydroxyacetone, general cosmetics, and various topical camouflage agents, including the newest product, Microskin™. We conducted a literature review of all of the available options for vitiligo concealment and evaluated their advantages and disadvantages. Ultimately, temporary methods of concealment are recommended; but the particular agent used can come from discussion with the patient based on the location of the lesions, degree of concealment desired, cost, and availability.

J Drugs Dermatol. 2016;15(4):384-387.

BACKGROUND: Pityriasis (tinea) versicolor is a superficial fungal infection of the stratum corneum caused by Malassezia species. The diagnosis is made clinically by its classic appearance of round or oval macules with fine scale that may be hyperpigmented or hypopigmented. Diagnosis may also be confirmed with microscopic evaluation of skin scrapings that reveal both short, stubby hyphae, and spores under KOH preparation. Ketoconazole is an important treatment of pityriasis versicolor but is primarily used in cream formulas. A foam vehicle has been shown to improve drug absorption through the stratum corneum and distribution in the skin. This study has assessed the safety and efficacy of ketoconazole 2% foam in treatment of pityriasis versicolor.
METHODS: Ketoconazole 2% foam was evaluated in a single-center, open-label, one-arm pilot study which enrolled eleven subjects to gain 10 evaluable subjects aged 21 years and older with a clinical diagnosis of tinea versicolor and positive KOH using calcofluor. The subjects came for 4 scheduled visits (baseline, week 1, week 2, and week 4) and were instructed to apply ketoconazole 2% foam to all affected areas twice daily for 2 weeks. At each visit, mycological and clinical assessment of a target area was done, along with static global assessment and body surface area estimation of the disease in each subject. Patient questionnaires were given at baseline and at week 2 to rate pruritus and satisfaction with the foam.
RESULTS: At the week 2 visit, following the treatment period, three out of ten evaluable subjects had negative skin samples prepared with KOH/calcifluor. Of these three, one subject later showed recurrence of fungal elements consistent with tinea versicolor at the week 4 follow-up visit. The other negative subjects remained negative and four additional subjects tested negative at week 4. Three subjects with positive samples at week 4 had only yeast forms without hyphae present. Investigator ratings of the target area were averaged for each clinical feature and demonstrated improvement in scale, hyper- or hypopigmentation, erythema, and induration throughout the study. Average pruritus score increased slightly 1 week after the baseline visit, but then improved steadily over the remaining visits. The investigator’s static global assessment rating showed improvement from mild to moderate disease at baseline to minimal or no disease at week 4 in 7 subjects. The remaining subjects showed neither improvement nor progression of the disease throughout the study. One out of the eleven subjects enrolled did not complete the study. One subject noted mild skin burning sensation after application of medicine. Post-treatment patient questionnaires indicated overall satisfaction with the foam vehicle.
LIMITATIONS: This was a single-arm, open-label, noncomparative trial.
Conclusion: Ketoconazole 2% foam improved overall clinical assessment and microscopic evidence of pityriasis versicolor in all subjects with favorable patient feedback regarding the novel foam vehicle.

J Drugs Dermatol. 2014;13(7):855-859.

Q-switched lasers, such as the neodymium:yttrium-aluminum-garnet (Nd:YAG) laser, are the gold standard for tattoo removal. Allergy to tattoo pigment is well-documented, but adverse allergic reactions during or shortly after laser tattoo removal are rare with few reports in the medical literature. Here we describe an intraoperative, localized urticarial reaction that developed during treatment of a tattoo using a 1064-nm Nd:YAG laser. As laser tattoo removal becomes increasingly popular amongst our patients, it is important for dermatologists to be aware of urticarial allergic reactions as well as their management. We outline our recommendations for medical management of this condition and hope that these guidelines will facilitate patient care by dermatologists who encounter this immune skin reaction to laser tattoo removal.

J Drugs Dermatol. 2015;14(3):303-304.

This is a case report of a 69-year-old female with Parkinson's disease who developed an asymptomatic eruption on her legs bilaterally. Clinical and histologic examination was consistent with livedo reticularis, which was temporally associated with initiation of rasagiline. The pathogenesis of livedo reticularis is discussed along with the possible mechanisms for both rasagiline and amantidine causing drug-induced livedo reticularis in patients.

J Drugs Dermatol.2012;11(6):764-765.

BACKGROUND: The Internet is a commonly utilized health information resource that provides access to information of varying quality.
OBJECTIVE: We sought to evaluate the use of the Internet as a health information resource within a keloid patient population and the effects of an educational intervention on patient knowledge about keloids.
METHODS: A consecutive convenience sample of subjects completed a questionnaire on keloid-related Internet use and on personal and family history of keloids. Participants listened to a short educational intervention on keloid-related topics followed by assessment of relevant knowledge at baseline, immediately postintervention, and 3 months after the intervention.
RESULTS: Among 40 participants, 55% reported having used the Internet to obtain keloid-related information. Subjects who had used the Internet to obtain keloid-related information had baseline knowledge similar to those who had not. When subjects were assessed immediately and 3 months postintervention, the intervention improved knowledge that not all raised scars are keloids, that keloids are not cancerous, and that certain areas of the body are more prone to keloid formation. The proportion of subjects who reported being less likely to obtain piercings or tattoos because of the intervention was 80% and 75%, respectively.
LIMITATIONS: This study was performed at a single academic center.
CONCLUSION: The Internet is a commonly used information resource for keloid-prone individuals, but keloid-related knowledge was not greater among Internet keloid-related information seekers. A very short educational intervention benefits keloid-prone individuals by improving knowledge about keloid prevention and treatment and by discouraging them from obtaining piercings and tattoos.

J Drugs Dermatol. 2013;12(4):397-402.

Objective: Naftifine HCl 2% cream (NAFT-2) is a topical allylamine antifungal agent under development in the United States. This randomized, double-blind, vehicle-controlled, phase 3 trial evaluated the efficacy and safety of two weeks of NAFT-2 treatment in subjects with tinea pedis. Naftifine 1% cream (NAFT-1) treatment for four weeks and vehicle were also evaluated as a positive control.
Methods: 709 subjects were randomly assigned 2:1:2:1 to one of four treatment groups: (i) NAFT-2 (n= 235), (ii) two-week vehicle (n=118), (iii) NAFT-1 (n=237), or (iv) four-week vehicle (n=119). Efficacy was evaluated at baseline, week 2, week 4, and week 6 and consisted of mycology determination (KOH and dermatophyte culture) and scoring of clinical symptom severity (erythema, scaling, and pruritus). Efficacy was only analyzed in 425 subjects with positive baseline dermatophyte culture. Safety was evaluated by adverse events (AE) and laboratory values in 707 subjects.
Results: At week 6, NAFT-2 subjects achieved 18 percent complete cure rate, 67 percent mycological cure rate, 57 percent treatment effectiveness, 22 percent clinical cure rate, and 78 percent clinical success rate compared to respective vehicle rates of seven percent (one-sided, P<0.01), 21 percent (P<0.001), 20 percent (P<0.001), 11 percent (P=0.04) and 49 percent (P<0.001). Week 6 efficacy responses in NAFT-1-treated subjects were significantly higher than vehicle subjects and almost identical to NAFT-2 subjects. Mycological cure and clinical response rates in both NAFT-2 and NAFT-1 increased from week 2 to week 6. Treatment-related AEs occurred in five percent of NAFT-2 subjects, seven percent of vehicle subjects, four percent of NAFT-1 subjects and eight percent of vehicle subjects. The most common AEs for all groups were application site pruritus and skin irritation.
Conclusion: Topical NAFT-2 for two weeks is safe and provides significantly superior antifungal treatment than vehicle in tinea pedis subjects. NAFT-2 produces equivalent efficacy responses to four weeks of NAFT-1 treatment. The fungicidal activity of naftifine continues to increase for at least one month after treatment is completed. (Clinical Trials Identification Numbe=NCT00750139).

J Drugs Dermatol. 2011;10(11):1282-1288.

Resident Rounds is a section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds includes three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the University of Texas Southwestern Medical Center Dermatology Residency Program. The editor of Resident Rounds is Omar A. Ibrahimi, MD, PhD. He is currently the Director of Cutaneous Laser and Cosmetic Surgery and a Mohs surgeon at the University of Connecticut. Dr. Ibrahimi is also a Visiting Scientist at the Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at OIbrahimi@jddonline.com

Fungal infection of the nails is an increasingly recognized disease in infants and children. However, it can be difficult to distinguish clinically from other nail dystrophies. In addition, many mistakenly believe that onychomycosis does not occur in childhood. Under-recognition of this infectious disorder therefore occurs. Although many consider “nail fungus” a trivial cosmetic concern, it can lead to discomfort, risk of secondary infection, and a more significant health threat in immunocompromised or diabetic individuals. It should always be considered in the differential diagnosis of nail plate disorders in children as it is one of the more common causes.

Here we review the latest data on prevalence of the disease, reasons for its relatively low incidence compared with adults, and important predisposing factors. It is important to confirm the clinical diagnosis of onychomycosis in children, and affected individuals should be examined for concomitant tinea pedis. As familial disease often occurs, it is important to check parents and siblings as well for onychomycosis and tinea pedis.

Treatment of onychomycosis is challenging, and recurrence appears to be more common in children than in adults. Prolonged systemic antifungal therapy is commonly required. However, pediatric practitioners and parents alike hesitate when asked to treat young children with a systemic drug that requires laboratory monitoring and can have systemic toxicities. Due to their thinner, faster-growing nails, children are theoretically more likely to respond to topical monotherapy than adults, and therefore good candidates for topical antifungal therapy.

The clinical data on the use of topical antifungals in pediatric onychomycosis is scarce. We review data that exist from case reports and small clinical trials. New topical antifungals are now available that afford better nail penetration and additional delivery routes to the site of infection. Pediatric trials are now on-going, and should clarify the usefulness of these agents in children.

J Drugs Dermatol. 2017;16(2):105-109.

Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.

Resident Rounds is a section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds includes three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the USF Department of Dermatology and Cutaneous Surgery Residency Training Program. The editor of Resident Rounds is Omar A. Ibrahimi MD PhD. He is currently the Director of Cutaneous Laser and Cosmetic Surgery and a Mohs surgeon at the University of Connecticut. Dr. Ibrahimi is also a Visiting Scientist at the Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at OIbrahimi@jddonline.com.

Erythema dyschromicum perstans (EDP), or ashy dermatosis, is characterized by oval, blue-gray macules, which are completely asymptomatic. In adults, the condition is primarily seen in patients of color, most commonly those of Hispanic descent, and typically follows a chronic course. We describe a pediatric case of EDP in a Caucasian patient. In the pediatric population, EDP is more commonly observed in Caucasian patients and often shows significant recovery or complete resolution in a matter of years. This case report outlines the differences in EDP between adult and pediatric patients.

J Drugs Dermatol. 2013;12(7):819-820.