Search Results for "Eczema"
Gillian K. Weston MD,a Jette Hooper,b Bruce E. Strober MD PhDa| |
J Drugs Dermatol. 2018;17(3):355-356.
Angelo Landriscina BA,a Tagai Musaev BA,a Bijal Amin MD,b and Adam J. Friedman MDa,c| |
J Drugs Dermatol. 2014;13(12):1491-1493.
Steroid-Free Over-the-Counter Eczema Skin Care Formulations Reduce Risk of Flare, Prolong Time to Flare, and Reduce Eczema Symptoms in Pediatric Subjects With Atopic Dermatitis
Teresa M. Weber PhD,a Frank Samarin MD,b Michael J. Babcock MD,c
Alexander Filbry PhD,d and Frank Rippke MDd
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.
April W. Armstrong MD MPH, C.T. Harskamp BA, S. Cheeney MS, and C.W. Schupp PhD| |
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.
The Use of an Over-the-Counter Hand Cream With Sweet Almond Oil for the Treatment of Hand Dermatitis
Joshua A. Zeichner MD,a Diane Berson MD,b Kavita Mariwalla MD,c and Angela Donald ND MScd| |
J Drugs Dermatol. 2018;17(1):78-82.
Topical Corticosteroid Treatment Choice: A Clinical and Practical Discussion of Clocortolone Pivalate Cream
Combined Antibiotic/Corticosteroid Cream in the Empirical Treatment of Moderate to Severe Eczema: Friend or Foe?
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.
Teresa M. Weber PhD,a Michael J. Babcock MD,b James H. Herndon Jr. MD,c Alexander W. Filbry PhD,d Ulrich Scherdin PhD,d and Frank Rippke MDd| |
J Drugs Dermatol. 2014;13(5):589-595.
J. Mark Jackson MD, Joseph F. Fowler Jr. MD, Jeffrey P. Callen MD, Douglas J. Lorenz MA MSPH| |
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.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Alitretinoin (BAL4079) in the Treatment of Severe Chronic Hand Eczema Refractory to Potent Topical Corticosteroid Therapy
Joseph F. Fowler MD,a Ole Graff MD,b Abbas G. Hamedanib| |
J Drugs Dermatol. 2014;13(10):1198-1204.
Seung Yoon Lee MD, Doo Rak Lee MD, Chung Eui You MD, Mi Youn Park MD PhD, Sook Ja Son MD PhD| |
Danielle Tartar PhD,a Tina Bhutani MD,b Monica Huynh BA,c Timothy Berger MD,b and John Koo MDb| |
J Drugs Dermatol. 2014;13(5):564-568.
Melvin Lee, John Koo MD| |
Lisa Prussick BSc,a,b Natalia Plotnikova MD,a and Alice Gottlieb MD PhDa,b| |
J Drugs Dermatol. 2016;15(6):715-718.
Joseph F. Fowler Jr. MD FAAD| |
J Drugs Dermatol. 2014;13(10):1180-1183.
Jeffrey M. Weinberg, MD; James G. Bowerman, MD; Stuart M. Brown, MD; David Gerstein, MD; Kay S. Kane, MD; James Selevan, MD and Sat Virdee, MD| |
Ted Rosen MD| |
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.
Ted Rosen MD| |
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.
Christine M. Pennesi BS,a John Neely MD,b Ames G. Marks Jr. MD,b and S. Alison Basak MD MAb,c| |
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.
Neal Bhatia MD| |
J Drugs Dermatol. 2013;12(7):796-798.
Gina R. Chacon MD, David J. Wolfson MD, Carlos Palacio MD, Animesh A. Sinha MD PhD| |
Craig G. Burkhart, MPH,MD and Heidi R. Burhart, BA| |
Magdalene Dohil MD, Leslie Baumann MD, Hema Sundaram MD, Jason Emer MD| |
Providing optimal patient outcomes continues to be a challenge in the treatment and management of dermatologic conditions. Most physicians and patients are interested in doing everything possible to optimize the treatment of their skin disease. This is especially important in treating patients with chronic disorders such as eczema, acne, psoriasis, rosacea, photodamage and the negative effects of aging. Physicians and patients often explore the therapeutic benefits of natural ingredients as alternative or complementary treatments to conventional methods. It is important that dermatologists remain up-to-date on the research and new advances in skin care products with natural ingredients.
This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 1 category 1 CME Credit.
William Abramovits MD, Alan B. Fleischer Jr MD, Eileen Jaracz Pharm D, Debra Breneman MD| |
A Multicenter, Randomized, Vehicle-Controlled Clinical Study to Examine the Efficacy and Safety of MAS063DP (Atopiclair™) in the Management of Mild to Moderate Atopic Dermatitis in Adults
William Abramovits MD, Mark Boguniewicz MD| |
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.
Anh N. Tran MSa,b and John Y. Koo MDa| |
J Drugs Dermatol. 2014;13(9):1118-1122.
Shivani S. Patel BS,a Karen E. Huang MS,a Alan B. Fleischer Jr. MD,a and Steven R. Feldman MD PhDa,b,c| |
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.
Anti-Inflammatory Activities of Colloidal Oatmeal (Avena sativa) Contribute to the Effectiveness of Oats in Treatment of Itch Associated With Dry, Irritated Skin
Kurt A. Reynertson PhD, Michelle Garay MS, Judith Nebus MBA, Suhyoun Chon PhD, Simarna Kaur PhD,
Khalid Mahmood PhD, Menas Kizoulis BA, Michael D. Southall PhD
METHODS: Four extracts of colloidal oatmeal were made with various solvents and tested in anti-inflammatory and antioxidant assays. In addition, an investigator blind study was performed with twenty-nine healthy female subjects who exhibited bilateral mild to moderate itch with moderate to severe dry skin on their lower legs. Subjects were treated with a colloidal oatmeal skin protectant lotion.
RESULTS: Extracts of colloidal oatmeal diminished pro-inflammatory cytokines in vitro and the colloidal oat skin protectant lotion showed significant clinical improvements in skin dryness, scaling, roughness, and itch intensity.
CONCLUSIONS: These results demonstrate that colloidal oat extracts exhibit direct anti-oxidant and anti-inflammatory activities, which may provide the mechanisms for observed dermatological benefits while using the colloidal oatmeal skin protectant lotion.
J Drugs Dermatol. 2015;14(1):43-48.
Olha Ilnytska PhD, Simarna Kaur PhD, Suhyoun Chon PhD, Kurt A. Reynertson PhD, Judith Nebus MBA,
Michelle Garay MS, Khalid Mahmood PhD, and Michael D. Southall PhD
J Drugs Dermatol. 2016;15(6):684-690.
A Novel Multifactorial Approach to Developing Mild Laundry Detergents and Assessing Their Relative Mildness
Joseph F. Fowler Jr. MD,a Matthew J. Zirwas MD,b Lisa Napolitano BS,c Meghan Russell BS,c and Janet Coope-Epstein PhDc| |
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.
J Drugs Dermatol. 2012;11(7):804-807.
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.
Cost-Effectiveness Study of Pediatric Atopic Dermatitis in Asia: Atopiclair vs. Regular Emollient (AD-ATOP)
Mark B.Y. Tang FRCP MRCP MMed MBBS,1 Kin Fon Leong MRCPCH MBBS,2 Liang-Shiou Ou MD,3
Zakiudin Munasir MD,4 Pankaj R. Parekh MD DCH,5 Soraya Azmi MPH MBBS,6
Wilson H.H. Low MSc BSc,6 and Adrian Goh MEc BEc6
J Drugs Dermatol. 2015;14(2):169-175.
A Phase 2, Open-Label, Investigator-Initiated Study to Evaluate the Safety and Efficacy of Apremilast in Subjects With Recalcitrant Allergic Contact or Atopic Dermatitis
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.
Efficacy and Tolerability of Retapamulin 1% Ointment for the Treatment of Infected Atopic Dermatitis: A Pilot Study
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.
A 1% Colloidal Oatmeal Cream Alone is Effective in Reducing Symptoms of Mild to Moderate Atopic Dermatitis: Results from Two Clinical Studies
Toni Anne Lisante BA,a Chris Nunez PhD,b Paul Zhang PhD,c and Barbara M. Mathes MDd| |
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.
Deborah S. Sarnoff MD| |
Patrick M. O’Shea BS and Aída Lugo-Somolinos MD| |
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.
Kendra Gail Bergstrom MD| |
Staci Brandt PA-C MBA MS,a Matthew H. Meckfessel PhD,a and Peter A. Lio MDb| |
J Drugs Dermatol. 2014;13(9):1108-1111.
Leon H. Kircik MD FAAD| |
J Drugs Dermatol. 2014;13(6):725-728.
Program Spotlight: The Unified Division of Dermatology Residency Program of Albert Einstein College of Medicine
Adam Friedman MDa and Steven Cohen MD MPHa| |
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 firstname.lastname@example.org
Stephanie Kao BA,a Ramsin Yadgar BS,a Thomas Enelow MD,b Adam Friedman MDc,d| |
A Randomized, Double-Blind Phase 4 Study of the Efficacy and Safety of Ethanol-Free Clobetasol Propionate Foam, 0.05%, vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis
Leon H. Kircik MD,a-c William J. Eastman MD,d and Jennifer Gwazdauskas MBAe| |
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.
Comparative Trial of 5% Dexpanthenol in Water-in-Oil Formulation With 1% Hydrocortisone Ointment in the Treatment of Childhood Atopic Dermatitis: A Pilot Study
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.
Treatment of Mild-to-Moderate Chronic Hand Dermatitis With Clobetasol Propionate 0.05% EF Foam: Results From an Open-Label Study
Leon H. Kircik MDa,b and Cathy Tropmann RPhc| |
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.
Treatment of Atopic Dermatitis in the United States: Analysis of Data from the National Ambulatory Medical Care Survey
Sean P. McGregor DO PharmD, Michael E. Farhangian MD, Karen E. Huang MS, and Steven R. Feldman MD PhD| |
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.
Lyn C. Guenther MD FRCPC,a Anneke Andriessen PhD,b Charles W. Lynde MD FRCPC,c John W. P.Toole BSc MD FRCPC,d Gary R. Sibbald MD FRCPC MACP FAAD M.Ed DSc (Hons),e James N. Bergman MD FRCPC,f Marc Bourcier MD FRCPC,g and Ian D.R. Landells MD FRCPCh| |
Anna Kurayev MD and Alice B. Gottlieb MD PhD| |
J Drugs Dermatol. 2016;15(10):1267-1269.
Robert A. Swerlick MD aand Caren F. Campbell MD b| |
J Drugs Dermatol. 2013;12(1):99-102.
A Study to Assess the Occlusivity and Moisturization Potential of Three Topical Corticosteroid Products Using the Skin Trauma After Razor Shaving (STARS) Bioassay
Leon H. Kircik MD FAAD| |
J Drugs Dermatol. 2014;13(5):582-585.
Resident Rounds. Part III B: Tumor Necrosis Factor-α Antagonists and Alopecia Areata: A Class-Wide Adverse Effect
James L. Griffith MS,a Johnathan J. Ledet MD,b Boni E. Elewski MDb| |
Aikaterini I. Liakou MD,a Michael J. Theodorakis MD,b Bodo C. Melnik MD PhD,c
Apostolos Pappas PhD,d and Christos C. Zouboulis MD PhDa
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.
Anthony Chiaravalloti MD,a Ali Banki DOb,c,d| |
Amelanotic melanoma (AM) is one of the great masqueraders in dermatology. It is a very difficult clinical diagnosis to make because these tumors are devoid of pigment and other clues of melanoma. They are commonly misdiagnosed clinically as other benign and malignant conditions. We present a new case of AM in an 84-year-old woman with a history of non-melanoma skin cancer. She had a thin pink plaque that was initially misdiagnosed as a basal cell carcinoma. We also discuss dermoscopy and its valuable role to improve diagnostic accuracy. A review of dermoscopic features that favor and oppose the clinical diagnosis of AM is discussed. Even with dermoscopy, it is still important to have a high index of suspicion and a low threshold to biopsy when the clinical diagnosis is unclear.
J Drugs Dermatol. 2017;16(11):1164-1165.
A New Body Moisturizer Increases Skin Hydration and Improves Atopic Dermatitis Symptoms Among Children and Adults
Eric Simpson MD MCRa and Yves Dutronc MDb| |
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.
J Drugs Dermatol. 2012;11(10):1158-1165.
Leon H. Kircik MD| |
Transepidermal Water Loss (TEWL) and Corneometry With Hydrogel Vehicle in the Treatment of Atopic Dermatitis: A Randomized, Investigator-Blind Pilot Study
Leon H. Kircik MD| |
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.
The Integration of Physiologically-Targeted Skin Care in the Management of Atopic Dermatitis: Focus on the Use of a Cleanser and Moisturizer System Incorporating a Ceramide Precursor, Filaggrin Degradation Products, and Specific “Skin-Barrier–Friendly” Excipients
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2013;12(7 suppl 1):s85-s91
Anti-Pruritic Efficacy of Itch Relief Lotion and Cream in Patients With Atopic History: Comparison With Hydrocortisone Cream
Matthew J. Zirwas MD FAADa and Sylvia Barkovic BAb| |
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.
Post Hoc Analyses of the Effect of Crisaborole Topical Ointment, 2% on Atopic Dermatitis: Associated Pruritus from Phase 1 and 2 Clinical Studies
Zoe Diana Draelos MD,a Linda F. Stein Gold MD,b Dedee F. Murrell MD,c Matilda H. Hughes CCRA,d and Lee T. Zane MDd| |
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.
The Role of a Midpotency Topical Corticosteroid and the Clinical Relevance of Formulation Characteristics in the Management of Commonly Encountered Eczematous and Inflammatory Dermatoses in Adults and Children:Focus on the Pharmacologic Properties of Clocortolone Pivalate 0.1% Cream
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2013;12(2)(suppl):s5-s10.
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.
Transitioning From Brand to Generic With Topical Products and the Importance of Maintaining the Formulation and Therapeutic Profiles of the Original Product: Focus on Clocortolone Pivalate 0.1% Cream
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2014;13(suppl 7):s77-s83.
Matthew C. Matsunaga MDa and Paul S. Yamauchi MD PhDb| |
J Drugs Dermatol. 2016;15(8):925-929.
Magdalene A. Dohil MD| |
J Drugs Dermatol. 2013;12(suppl 9):s128-s132.
Joy Makdisi BS,a Bijal Amin MD,b and Adam Friedman MDa,c| |
J Drugs Dermatol. 2013;12(9):1050-1051.
Objective and Methods:Our objective was to examine the features of discoid lupus erythematosus on reflectance confocal microscopy. Two patients presenting with discoid lupus erythematosus were imaged using RCM. Features seen in RCM were correlated with those seen in histopathology.
Results:Reflectance confocal microscopy images of discoid lupus erythematosus yielded features characteristically seen in histopathological samples including inflammatory cells, inflammation at the dermo-epidermal junction, pigment incontinence, and vacuolar degeneration.
Conclusion:Reflectance confocal microscopy is a useful tool in the diagnosis of discoid lupus erythematosus. Features described in these two cases as well as prior research have yielded sufficient data to allow for the formulation of useful RCM diagnostic algorithms. Further studies with a larger patient population will help in confirming and describing new features of DLE on RCM.
J Drugs Dermatol. 2012;11(9):1111-1113.
Linda Stein Gold MD,a Jerry Tan MD,b and Leon Kircik MDc| |
OBJECTIVES: We evaluated differences in outcome measures and definition of success in acne trials; and their impact on FDA approval and indications for acne medications.
METHODS: Review of acne clinical trial literature, prescribing information and regulatory guidelines for currently approved acne medications in the United States.
RESULTS: Numerous IGA scales exist with variations in specific categorical definitions. There are also differences in definitions of global success. Outcome success may not be accurately translated into corresponding terminology for indications.
CONCLUSIONS: Variability in IGA scales and definitions of success confound comparison of trial results for acne treatments. Harmonization and standardization of these factors will facilitate meta-analytics and treatment selection in patient care. Outcome measure success has not consistently been incorporated into acne medication indications.
J Drugs Dermatol. 2016;15(1):79-86.
J Drugs Dermatol. 2012;11(10):1174-1178.
Geraldine Cheyana Ranasinghe BS and Adam J. Friedman MD| |
J Drugs Dermatol. 2018;17(1):118-120.
Managing Occupational Irritant Contact Dermatitis Using a Two-Step Skincare Regimen Designed to Prevent Skin Damage and Support Skin Recovery
Erika C. von Grote PhD, Kiruthi Palaniswamy PharmD, and Matthew H. Meckfessel PhD| |
Urticaria After Methyl Aminolevulinate Photodynamic Therapy in a Patient With Nevoid Basal Cell Carcinoma Syndrome
J Drugs Dermatol. 2012;11(11):1364-1365.
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.
An Over-the-Counter Moisturizer Is as Clinically Effective as, and More Cost-Effective Than, Prescription Barrier Creams in the Treatment of Children With Mild-to-Moderate Atopic Dermatitis: A Randomized, Controlled Trial
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.
Mark A. Strom BS,a Girish C. Mohan MD,b and Peter A. Lio MDa| |
J Drugs Dermatol. 2016;15(10):1203-1207.
Jason Chouake and Adam Friedman| |
Autoimmune Progesterone Dermatitis: A Diagnosis to Consider in a Patient With Cyclical Cutaneous Eruptions
Alexa B. Steuer MPH,a,b Sharon Scherl MD,c and Robin Ashinoff MDb,d| |
J Drugs Dermatol. 2017;16(10):1040-1042.
A Bilateral Comparison Study of Pimecrolimus Cream 1% and a Topical Medical Device Cream in the Treatment of Patients With Atopic Dermatitis
Jason J. Emer MD, Amylynne Frankel MD, Andrew Sohn BS, Mark Lebwohl MD| |
J Drugs Dermatol. 2011;10(7):735-743.
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.
Adam J. Luber BA, Shaheen H. Ensanyat BS, and Joshua A. Zeichner MD| |
J Drugs Dermatol. 2014;13(2):130-134.
Kristin Totoraitis BS,a Cynthia M. Magro MD,b Adam Friedman MDc| |
J Drugs Dermatol. 2017;16(10):1036-1038.
Patient Awareness of Local Drug Price Variation and the Factors That Influence Pharmacy Choice: A Cross-sectional Survey Study
Spencer D. Brodsky BS,a Olabola D. Awosika MD MS,b Misty G. Eleryan MD,a,b Monica Rengifo-Pardo MD,a,b Xiangyu Kuang MS,b Richard L. Amdur PhD,a,b and Alison Ehrlich MD MHSa,b| |
Background: High out-of-pocket drug expenditures are increasingly common in dermatology. Patients may not be aware that prices vary among pharmacies and consequently may not shop for the lowest cost.
Objective: To determine what factors influence pharmacy choice and the effect of providing local prescription prices on pharmacy selection. We hypothesized that patients do not “shop around” due to lack of knowledge of price variation and would choose a pharmacy based on costs if educated on price disparity.
Methods: Between July and August 2016, we administered a cross-sectional anonymous survey to adults visiting four outpatient clinics at an academic tertiary care center in Washington, D.C. Participants answered questions before and after viewing a list of prescription drug prices from local pharmacies.
Results: 287 surveys were administered to a convenience sample of adults (age ≥ 18 and literate in English). Of the 287 participants, 218 fully completed the survey; 55.1% were women and 40.5% were over age 40. When considering a cost savings of $10-25, 65% would switch pharmacies if the distance were the same, and 21.3% would switch if the distance were 45-minutes further. After price education, fewer participants felt that drug price knowledge would ultimately influence pharmacy choice (P less than 0.0001). However, respondents’ intended frequency of researching price online, calling a pharmacy to ask about price, and comparing price between pharmacies before filling a prescription all increased, compared to prior self-reported frequencies (P less than 0.001). Specifically, participants with $75,000-$99,999 income were more likely to compare prices than those with income below $45,000 (odds ratio [OR], 4.62; 95% confidence interval [CI], 1.24-17.28)
Conclusion: In this study, pharmacy choice was more influenced by convenience than cost prior to drug price education. However, price education ultimately impacted intent to research prescription drug prices before selecting a pharmacy. Thus, knowledge of drug pricing may be useful in creating cost savings for patients.
J Drugs Dermatol. 2017;16(12):1274-1280.
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.
A Randomized Controlled Clinical Study to Evaluate the Effectiveness of an Active Moisturizing Lotion With Colloidal Oatmeal Skin Protectant Versus Its Vehicle for the Relief of Xerosis
Amer N. Kalaaji, MDa and Warren Wallo, MSb| |
J Drugs Dermatol. 2014;13(10):1265-1268.
Tejaswi Mudigonda BS, William Kaufman MD, and Steven R. Feldman MD PhD| |
J Drugs Dermatol. 2016;15(1):114-115.
Ryan R. Bogner,a Elizabeth K. Blixt MD,b Alison J. Bruce MB ChB,b,c and Gabriel F. Sciallis MDb,c| |
J Drugs Dermatol. 2015;14(11):1358-1359.
Scott A. Elman AB,a Joseph F. Merola MD MMSc,a,b April W. Armstrong MD MPH,c Kristina Callis Duffin MD,d John Latella,e Amit Garg MD,f Alice B. Gottlieb MD PhDg| |
The International Dermatology Outcome Measures (IDEOM) group, comprising patients, physicians, health economists, industry partners, payers, and regulatory agencies, was established to develop unified and validated patient-centered outcome measures in dermatology in response to increasing demand to quantify effectiveness of treatments and performance outcomes among providers. IDEOM has chosen to start with psoriasis outcome measures, and then apply its methodology to other dermatologic diseases. In this paper, we review the background and progress to date of IDEOM, including an update of IDEOM activities as of our 2016 meeting in Washington DC, USA. Briefly, the progress-to-date of a Delphi process to create outcome measures for psoriasis was reviewed, including preliminary data from the first round of Delphi voting. Updates were also heard from industry partners including the National Psoriasis Foundation (NPF) and the US Food and Drug Administration (FDA). Furthermore, plans to establish outcome measures for hidradenitis suppurativa (HS) were discussed.
J Drugs Dermatol. 2017;16(2):119-124.
Management of Rosacea-Prone Skin: Evaluation of a Skincare Product Containing Ambophenol, Neurosensine, and La Roche-PosayThermal Spring Water as Monotherapy or Adjunctive Therapy
Sophie Seité PhD,a Florence Benech PharmD,b Sandrine Berdah PhD,b Muriel Bayer PharmD,b Sophie Veyrat PharmD,b Evelyne Segot PharmD PhD,b Marcela Sakalikova Mgr,c Lucia Gibejova Mgr,c Hana Zelenkova MD PhDc| |
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.
Heather C. Woolery-Lloyd MD, Jonette Keri MD, and Stefan Doig MD| |
J Drugs Dermatol. 2013;12(4):434-437.
Alice He BS,a Steven R. Feldman MD PhD,a,b,c and Alan B. Fleischer Jr. MDd| |
Ross Brothers MD, Rawn E. Bosley MD, and Steven Daveluy MD| |
J Drugs Dermatol. 2014;13(8):960-966.
Efficacy of a Moisturizing Foam in Skin Barrier Regeneration and Itch Relief in Subjects Prone to Atopic Dermatitis
Peter A. Lio MD| |
Efficacy of a Hand Regimen in Skin Barrier Protection in Individuals With Occupational Irritant Contact Dermatitis
Laura Jordan DO MS| |
Bilateral Comparison Study of Pimecrolimus Cream 1% and a Ceramide-Hyaluronic Acid Emollient Foam in the Treatment of Patients With Atopic Dermatitis
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.
Efficacy of Benzoyl Peroxide (5.3%) Emollient Foam and Benzoyl Peroxide (8%) Wash in Reducing Propionibacterium acnes on the Back
James J. Leyden MD| |
Objectives: To evaluate the effectiveness of BP (5.3%) emollient foam and BP (8%) wash in reducing P. acnes levels on the back.
Methods: Five-week open-label single-center study of 20 healthy subjects (>18 years old), colonized with P. acnes on their backs (>10,000 colonies per cm2). Subjects were treated once daily with BP (5.3%) foam for two weeks; no treatment in week 3, and BP (8%) wash once daily for two further weeks. Quantitative bacteriologic cultures obtained at baseline and weeks 1, 2, 3, 5 and 6. Results: Nineteen evaluable patients. Total P. acnes counts were reduced by 1.9 log (one week) and 2.1 log (two weeks) with BP (5.3%) emollient foam. BP (8%) wash did not reduce P. acnes counts after two weeks.
Discussion: BP (5.3%) emollient foam was superior to BP (8%) wash in reducing P. acnes on the back. The lack of effect of BP (8%) wash is surprising in view of the demonstrated results on the face and warrants further study.
Microbiome of Affected and Unaffected Skin of Patients With Atopic Dermatitis Before and After Emollient Treatment
Gilberto E. Flores PhD,a Sophie Seité PhD,b Jessica B. Henley MS,c Richard Martin MS Ing,d
Hana Zelenkova MD,e Luc Aguilar PhD,f Noah Fierer PhDa,c
J Drugs Dermatol. 2014;13(11):1365-1372.
A Randomized, Double-Blind, Placebo-Controlled Study of the Vasoconstrictor Potency of Topical 0.25% Desoximetasone Spray: A High to Super High Range of Potency (Class I to Class II) Corticosteroid Formulation
Elias Oussedik BS,a Mohammed D. Saleem MD,a Steven R. Feldman MD PhDa,b,c| |
J Drugs Dermatol. 2017;16(10):972-975.
Logan W. Thomas MS4, Ashley Elsensohn MD MPH, Terese Bergheim MD, Jessica Shiu MD PhD, and Anand Ganesan MD PhD| |
J Drugs Dermatol. 2018;17(3):323-329.
David Schairer BA and Adam Friedman MD| |
Safety and Efficacy of Two Anti-Acne/Anti-Aging Treatments in Subjects With Photodamaged Skin and Mild to Moderate Acne Vulgaris
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
Leflunomide: An Immune Modulating Drug That May Have a Role in Controlling Secondary Infections With Review of Its Mechanisms of Action
Kathleen J. Smith MDa and Marguerite Germain MDb| |
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.
Crisaborole Topical Ointment, 2%: A Nonsteroidal, Topical, Anti-Inflammatory Phosphodiesterase 4 Inhibitor in Clinical Development for the Treatment of Atopic Dermatitis
Kurt Jarnagin PhD,a Sanjay Chanda PhD,b Dina Coronado BS,a Vic Ciaravino PhD,a Lee T. Zane MD,a Emma Guttman-Yassky MD PhD,b and Mark G. Lebwohl MDb| |
J Drugs Dermatol. 2016;15(4):390-396.
A Comparison of Physicochemical Properties of a Selection of Modern Moisturizers: Hydrophilic Index and pH
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.
Pimecrolimus Cream and Tacrolimus Ointment in the Treatment of Atopic Dermatitis: A Pilot Study on Patient Preference
Neh Onumah MDa and Leon Kircik MDb,c| |
J Drugs Dermatol. 2013;12(10):1145-1148.
Peter A. Lio MD| |
Adam J. Friedman MD FAAD,a Erika C. von Grote PhD,b Matthew H. Meckfessel PhDb| |
J Drugs Dermatol. 2016;15(5):633-639.
Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study
Ulrike Blume-Peytavi MD,a Jerry Shapiro MD,b Andrew G. Messenger MD,c Maria K. Hordinsky MD,d Paul Zhang PhD,e Carlos Quiza MD,e Uday Doshi PhD,e and Elise A. Olsen MDf| |
OBJECTIVE: Determine noninferiority of once-daily 5% MTF versus twice-daily 2% minoxidil topical solution (MTS) based on the change from baseline in target area hair count (TAHC) at 24 weeks. METHODS: In a randomized, phase III trial, women with female pattern hair loss received once-daily 5% MTF (n=161) or twice-daily 2% MTS (n=161) for 52 weeks. Primary endpoint was change from baseline in TAHC at 24 weeks. Secondary endpoint was change from baseline in TAHC at 12 weeks. Exploratory endpoints included change in total unit area density and change in overall scalp coverage.
RESULTS: Once-daily 5% MTF increased TAHC from baseline (adjusted mean ± standard error) by 23.9 ± 2.1 hairs/cm2 at week 24. Twice-daily 2% MTS increased TAHC 24.2 ± 2.1 hairs/cm2 at week 24. The treatment difference was –0.3 hairs/cm2 (95% CI = –6.0, 5.4). Since the lower bound of the 95% CI was less than –5.0, the prespecified noninferiority goal was not met. Both treatments were well tolerated.
CONCLUSIONS: Once-daily 5% MTF and twice-daily 2% MTS induced hair regrowth in female pattern hair loss, but prespecified noninferiority criteria were not met.
ClinicalTrials.gov identifier: NCT01145625
J Drugs Dermatol. 2016;15(7):883-889.
Improvement in Signs and Symptoms of Plaque Psoriasis After 1 Week of Treatment With Clobetasol Propionate 0.05% Spray
Robert Brodell MDa,b and Norman Preston PhDc
aDivision of Dermatology, University of Mississippi Medical Center, Jackson, MS bDepartment of Dermatology, University of Rochester School of Medicine and Dentistry, Rochester, NY cGalderma Laboratories, L.P., Fort Worth, TX| |
J Drugs Dermatol. 2012;11(12):1455-1459.
Andrew Mamalis*,a,b Natallia Fiadorchanka MD*,c Lauren Adams MD,b Melissa Serravallo MD,c
Edward Heilman MD,c Daniel Siegel MD MS,c Neil Brody MD PhD,c and Jared Jagdeo MD MSa,b,c
J Drugs Dermatol. 2014;13(5):574-578.
A Double-Blind, Randomized, Bilateral Comparison of Skin Irritancy Following Application of the Combination Acne Products Clindamycin/Tretinoin and Benzoyl Peroxide/Adapalene
Renato Goreshi MD, Aman Samrao MD, and Benjamin D. Ehst MD PhD| |
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.
Emily C. Milam BA and Evan A. Rieder MD| |
J Drugs Dermatol. 2016;15(4):452-456.
Carlos Galzote,a Mini Thomas PhD,b and Mukta Sachdev MDc| |
J Drugs Dermatol. 2016;15(10):1244-1248.
Shedding Light on the “Hidden Psoriasis”: A Pilot Study of the Inverse Psoriasis Burden of Disease (IPBOD) Questionnaire
Jeffrey M. Cohen BA,1,* Kareem Halim AB,1,* Cara J. Joyce MS,2 Mital Patel MD,3 Abrar A. Qureshi MD MPH,4 and Joseph F. Merola MD MMSc3,5| |
J Drugs Dermatol. 2016;15(8):1011-1016.
Biophysical Evaluation of Fractional Laser Skin Resurfacing With an Er:YSGG Laser Device in Japanese Skin
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 FractionalTM , 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.
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.
Christina C. Patrone BAa and Larisa J. Geskin MD FAADb| |
Mycosis Fungoides and Sézary Syndrome, the two most common types of Cutaneous T-Cell Lymphoma (CTCL), present many management challenges for dermatologists. Here, we provide a comprehensive review of up-to-date literature, guidelines, and expert clinical insights. We highlight the updates in the World Health Organization Classification of Cutaneous Lymphomas; we summarize the epidemiology, including a recently observed stabilization of increasing incidence of CTCL in the past decade and increased incidence in males, blacks, and veterans; we also provide the most recent updates on prognostic factors for CTCL. Utilization of Next-Generation Sequencing and other novel technologies has shed light on pathogenic mechanisms of CTCL, including immune dysregulation, antigen stimulation, and genomic alterations. CTCL management still remains a significant challenge due to lack of standardization of therapies for every stage of the disease. We provide a straightforward approach to clinical evaluation, diagnostic workup via immunophenotyping and molecular studies, staging guidelines, and select treatment strategies in Mycosis Fungoides and Sézary Syndrome. CTCL patients require individualized, holistic, and multidisciplinary care, for whom addressing management in different skin types and prioritizing quality of life issues are essential.
J Drugs Dermatol. 2017;16(5):405-412.
The Effect of Benzoyl Peroxide 9.8% Emollient Foam on Reduction of Propionibacterium acnes on the Back Using a Short Contact Therapy Approach
Benzoyl peroxide (BP) exerts its therapeutic effect for acne vulgaris through reduction of Propionibacterium acnes. A 1.0 to 2.0 log reduction in P acnes has been demonstrated primarily on the face with use of “leave-on” BP formulations, but also with some BP cleansers. In addition to use for facial acne vulgaris, cleanser formulations of BP are commonly used for truncal acne vulgaris due to ease of use on a large body-surface area and to avoid bleaching of fabric. To date, evaluation of P acnes reduction on the trunk has not been well studied with BP formulations, especially with the use of recognized and standardized methods to accurately determine P acnes colony counts. A previous study demonstrated that a BP 8% cleanser did not reduce counts of P acnes on the back when subjects were instructed to apply the cleanser in the shower, allow it to dry for 20 seconds on the skin, and then rinse off the cleanser. Evaluation of specified time intervals between application on the back and rinsing with BP formulations would help to better define the necessary skin contact time associated with high reductions of P acnes (>90%), recognizing also the potential roles of BP concentration and vehicle. This 2 week study using quantitative bacteriologic cultures evaluates the effectiveness of BP 9.8% emollient foam in reducing P acnes levels on the back with 2 minutes of skin contact time and compares results with a BP 5.3% “leave-on” emollient foam formulation. Short contact therapy utilizing a 2 minute skin contact time with BP 9.8% emollient foam used once daily over a 2 week duration was highly effective in reducing the quantity of P acnes organisms on the back and provided comparable colony count reduction to “leave on” therapy using BP 5.3% emollient foam.
J Drugs Dermatol. 2012;11(7):830-833.
Peter W. Hashim MD MHS,a Mark G. Lebwohl MD,a Leon H. Kircik MDa,b,c| |
The Phototoxic and Photoallergy Potential of Clindamycin Phosphate 1.2%/ Tretinoin 0.025% Gel for Facial Acne: Results of Two Single-Center, Evaluator-Blinded, Randomized, Vehicle-Controlled Phase 1 Studies in Healthy Volunteers
John Murray MDa and Aaron Potts BScb| |
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.
News, Views, and Reviews. Less May Be More for MRSA: The Latest on Antibiotics, the Utility of Packing an Abscess, and Decolonization Strategies
Kendra Gail Bergstrom MD FAAD| |
J Drugs Dermatol. 2014;13(1):89-92.
Asthma and Atopic Dermatitis: A Review of Targeted Inhibition of Interleukin-4 and Interleukin-13 As Therapy for Atopic Disease
Catherine D. Buzney MA,a Alice B. Gottlieb MD PhD,a,b David Rosmarin MDa,b| |
J Drugs Dermatol. 2016;15(2):165-171.
Theresa N. Canavan MD and Boni E. Elewski MD| |
J Drugs Dermatol. 2015;14(suppl 10):s42-s47.
News, Views & Reviews. A Biopsy Diagnosis? Clinical Clues and Patterns to Help Distinguish Cutaneous Metastases: Part I of II
Karin Blecher BA and Adam Friedman MD| |
Mio Nakamura MD,a Michael Abrouk MD,b Henry Zhu MD,c Benjamin Farahnik MD,d John Koo MD,a and Tina Bhutani MDa| |
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.
Introduction: Acitretin is a systemic retinoid drug used in the treatment of severe psoriasis. It has also been used for a spectrum of
other difficult-to-treat dermatoses, including hyperkeratotic and inflammatory dermatoses and non-melanoma skin cancers. Here we
review the available data regarding both FDA-approved and off-label uses of acitretin, clinically relevant adverse events, precautions
Methods: A PubMed literature search was conducted utilizing the search term "acitretin," which yielded 714 hits. Results were further limited to English language clinical trials in human subjects. Of 78 articles evaluated for relevance, 60 were included for review.
Results: Acitretin is effective as monotherapy and in multidrug therapeutic regimens for the treatment of psoriasis and other hyperkeratotic and inflammatory disorders, as well as for malignancy chemoprevention. Its use is limited by its teratogenic potential and other adverse effects, including mucocutaneous effects and hepatotoxicity. Potential adverse effects may be reduced or avoided by using lower doses of acitretin or in combination with other therapies.
Limitations: The reviewed studies include many small trials and case reports of the use of acitretin for psoriasis. Studies of acitretin therapy for the treatment of other cutaneous disorders are limited.
Conclusion: Acitretin is a beneficial treatment for psoriasis, and should be considered when not contraindicated. Particularly when used in combination with ultraviolet (UV) phototherapy, is a safe and cost effective therapeutic strategy.
J Drugs Dermatol.2011;10(7):772-782.
Suzanne Bruce MD,a Jwala Karnik MD,b Laurence Dryer PhD,c and David Burkholder PhDd| |
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.
Melissa B. Hoffman MD,a Rachna A. Bhandari MD,b and Animesh A. Sinha MD PhDc| |
J Drugs Dermatol. 2016;15(7):821-829.
Adalimumab Plus Narrowband Ultraviolet B Light Phototherapy for the Treatment of Moderate to Severe Psoriasis
Jerry Bagel MDa,b| |
Background: Combining systemic agents with phototherapy is becoming a standard of care for patients with moderate to severe
psoriasis. The combination of adalimumab and phototherapy has not been previously explored.
Methods: In this 24-week single-arm open-label study, adults with moderate to severe psoriasis received adalimumab 40 mg every other week and narrowband (NB)-UVB phototherapy three times a week for 12 weeks and then were followed for 12 weeks without treatment. Response to therapy was determined using the Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA) affected and Physician’s Global Assessment (PGA) of psoriasis.
Results: Twenty patients were enrolled with mean baseline scores of 17.0 for PASI, 21.2 for BSA and 3.5 for PGA. Half (10/20) of the patients achieved PASI 75 response by week 4. At the end of treatment at week 12, 19 (95%) patients achieved PASI-75, 15 (75%) patients achieved PASI-90 and 11 (55%) patients achieved PASI-100. Seventeen (85%) patients were clear or almost clear (PGA score ≤1). Mean baseline PASI, BSA and PGA scores improved by 95 percent, 93 percent and 80 percent, respectively. Disease improvement was observed through the end of follow up period at week 24. No serious adverse events were noted.
Conclusion: Concurrent use of adalimumab and NB-UVB phototherapy was clinically effective and well tolerated in patients with moderate to severe psoriasis. This combination regimen represents a new treatment option for clinical practice and warrants further investigation in controlled clinical trials.
J Drugs Dermatol. 2011;10(4):366--371.
Halobetasol Propionate Lotion, 0.05% Provides Superior Hydration Compared to Halobetasol Propionate Cream, 0.05% in a Double-Blinded Study of Occlusivity and Hydration
Gary Grove PhD,a Charles Zerweck PhD,a Tim Houser MS,a Anthony Andrasfay BS,b Bob Gauthier MS,b Charles Holland PhD,b and Daniel Piacquadio MDb| |
J Drugs Dermatol. 2017;16(2):140-144.
Anjana Ray PhD,a,* Breanne Mordorski BA,b,* Angelo Landriscina BA,b Jamie Rosen BA,b Joshua Nosanchuk MD,a,c and Adam Friedman MDd| |
J Drugs Dermatol. 2016;15(7):836-840.
Amy S. Paller MD,a Rakesh Singh PhD,b Martin Cloutier MSc,c Marjolaine Gauthier-Loiselle PhD,c Bruno Emond MSc,c Annie Guérin MSc,c and Arijit Ganguli MBA PhDb| |
Efficacy and Safety of Naftifine HCl Cream 2% in the Treatment of Pediatric Subjects With Tinea Corporis
Michael Gold MD,a Sunil Dhawan MD,b Amit Verma DrPH MPH,c Michael Kuligowski MD PhD MBA,c and David Dobrowskic| |
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.
Cost-Effectiveness Analysis of Ixekizumab vs Etanercept and Their Manufacturer-Recommended Dosing Regimens in Moderate to Severe Plaque Psoriasis
Jeremy Udkoff MA MAS and Lawrence F. Eichenfield MD| |
J Drugs Dermatol. 2017;16(10):964-970.
Atopic Dermatitis, and the Role for a Ceramide-Dominant, Physiologic Lipid-Based Barrier Repair Emulsion
Leon Kircik MD,a,b Firas Hougeir MD,c and Joseph Bikowski MDd| |
J Drugs Dermatol. 2013;12(9):1024-1027.
Evaluation of Moisturizing Effect of Methanolic Extract of Five Medicinal Plants Incorporated Into Cream Bases Using Impedance and Extensiometry Methods
Background: Skin moisturizing is an important issue due to its impact on skin function. Adverse reactions to herbal extracts have been rarely reported and can be used in moisturizers. This study was conduct to evaluate moisturizing effect of a methanolic extract of five medicinal plants incorporated into cream bases.
Methods: Methanolic extract of five medicinal plants including olive, burdock, licorice, mallow and marsh horsetail was prepared. The extracts were dissolved in distilled water completely and freeze-dried to a dry powder. These extracts were added separately to the cream based formulation that has been suggested to be appropriate for adding herbal extracts. Moisturizing effects of these creams with herbal extracts were assessed using the impedance method on 12 rats equally divided into six groups (one control and five cases), as well as the extensiometry method on 25 mice divided into five groups (in each group one cream with herbal extract and control cream were tested concurrently). Obtained results were compared with the control cream based.
Results: The maximum moisturizing effect was observed with the marsh horsetail. Other creams with herbal extracts, except the one with the licorice, also exerted significantly higher moisturizing effect compared to the controls (P<0.05). Regarding the force for skin tearing, the differences were statistically significant in all groups when compared to the control group (P<0.05) and the highest difference was seen in the marsh horsetail group (2.0832 ± 0.6811 kgN).
Conclusions: The highest moisturizing activity was observed using marsh horsetail extract that can be explained by flavonoids content of marsh horsetail.
J Drugs Dermatol. 2011;10(10):1116-1121.
Skin Microbiome in Patients With Psoriasis Before and After Balneotherapy at the Thermal Care Center of La Roche-Posay
Richard Martin MSc,a Jessica B. Henley PhD,b Patrick Sarrazin MD,c and Sophie Seité PhDd| |
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.
Zain Husain MD,a Joyce K. Ho,b and Basil M. Hantash MD PhD c| |
OBJECTIVE: Two cases of rapid SK eruptions, one the sign of Leser-Trélat (SLT) and one PLT, are presented, and the literature on SLT and PLT is reviewed.
METHODS: A literature review of SLT/PLT was performed by searching the PubMed database for all related English published cases.
RESULTS: We identified 109 cases of SLT and 12 cases of PLT, with a mean patient age of 61.8 years. SK eruptions were observed before (68.3%), after (22.1%), and at the time of (9.6%) malignancy diagnosis. The malignancy most frequently associated with SLT was gastric adenocarcinoma. The most common anatomical location of SK eruptions was the trunk (18.9%). Frequently reported associated signs and symptoms included pruritus (52%) and acanthosis nigricans (38.7%). The most common treatment included surgery (35.8%), chemotherapy (26.9%), and radiation therapy (26.9%). Treatment resulted in clinical improvement (45%), no change (30%), exacerbation (15%), or initial improvement followed by exacerbation of SKs. Patient outcomes included disease stability/ improvement (48.4%), recurrence (9.7%), exacerbation/metastasis/new malignancy (4.8%), and death (37.1%).
LIMITATIONS: This was a retrospective study and excluded non-English published cases.
CONCLUSION: This review updates the existing SLT literature and emphasizes the presence of PLT. Clinicians should be aware that SK eruptions may be early manifestations of an internal malignancy or other pathology. To our knowledge, this is the first review examining both SLT and PLT.
J Drugs Dermatol. 2013;12(5):e79-e87.
Linda Stein Gold MD,a William P. Werschler MD,b Jennifer Mohawk PhDc| |
BACKGROUND: Acne vulgaris affects a diverse group of people, and there is an increasingly wide variety of acne treatments. Because of the many options, clinicians have a better ability to individualize treatment; however, achieving optimal results relies on understanding how various agents perform in specific population segments. Fixed-combination adapalene plus benzoyl peroxide (A/BPO) is a first-line recommended acne therapy and is available in two adapalene concentrations (0.1% and 0.3%) combined with BPO 2.5%. This analysis investigated whether gender and age have an impact on either the efficacy or safety of topical A/BPO 0.3%.
METHODS: A post-hoc subanalysis was performed on data from a multicenter, randomized, double-blind, parallelgroup, 12-week study of A/BPO gel 0.3%/2.5% or vehicle gel in subjects ≥ 12 years old with moderate to severe acne vulgaris (Investigator global assessment [IGA] of 3 or 4). Efficacy measurements included achievement of an IGA of clear (0) or almost clear (1), and change in lesion counts from baseline to week 12. Safety measures included adverse events and cutaneous tolerability. The intent to treat (ITT) and safety populations were analyzed.
RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 217 subjects. Among the subjects, 111 were 12-17 years old and 106 were ≥ 18 years old; 104 were male and 113 were female. A/BPO 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle in success rates (IGA 0 or 1) and reduction of inflammatory/noninflammatory lesions (P≤0.05) across both age groups and genders.
CONCLUSIONS: A/BPO 0.3%/2.5% treatment achieved success and was equally effective and safe in younger vs older subjects and in males vs females. These results support the use of A/BPO 0.3%/2.5% in all subjects 12 and older.
Clinicaltrials.gov registry: (NCT01880320)
J Drugs Dermatol. 2017;16(6):582-589.
Whitney P. Bowe MDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2014;13(suppl 7):s89-s94.
Nicole D. Cresce BS,a Scott A. Davis MA,a William W. Huang MD MPH,a Steven R. Feldman MD PhDa,b,c| |
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.
David A. Sanchez BS,a,e Joshua D. Nosanchuk MD,b,c and Adam J. Friedman MDa,d,| |
J Drugs Dermatol. 2015;14(2):127-130.
Julia G. Hobson MD, Michael J. Cunningham MD, Kendra Lesiak MD MEd, Elizabeth B. Lester MD, Andrew R. Tegeder MD MS, Elizabeth Zeeck MD, Jeremy M. Hugh MD, and Julie H. Lin MD| |
BACKGROUND: Isotretinoin is an effective treatment for nodulocystic acne. Outside of required pregnancy testing, laboratory monitoring suggested by the manufacturers is vague. Dermatologists, therefore, monitor a variety of tests with variable frequency. Despite intense monitoring, the majority of patients do not have gross laboratory abnormalities that warrant changes in management.
OBJECTIVE: To survey US dermatologists regarding laboratory monitoring practices while prescribing isotretinoin.
METHODS: An online survey sent via e-mail to members of the American Academy of Dermatology.
RESULTS: 12,396 surveys were sent with a response rate of ~19%. At baseline >60% of responders check a CBC, LFTs, and a lipid panel. 74% check a monthly lipid panel and LFTs, while 57% check a monthly CBC. 75% report stopping isotretinoin when AST or ALT values reach 3 times normal; 89% report stopping at 4 times normal. When triglycerides reach 4 times normal, 72% stop the medication.
CONCLUSIONS: There is no consensus on isotretinoin monitoring tests and frequency, though the majority of dermatologists surveyed monitor a lipid panel and LFTs.
J Drugs Dermatol. 2017;16(6):557-564.
Julie Harper MD,a James Q. Del Rosso DO,b Ilia L. Ferrusi PhDc| |
Efficacy of Early Initiation of a Gel Containing Extractum Cepae, Heparin, and Allantoin for Scar Treatment: An Observational, Noninterventional Study of Daily Practice
Gunter H. Willital MDa and Jeannette Simon MDb| |
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.
A Randomized, Double-Blind, Vehicle-Controlled Crossover Study to Determine the Anti-Pruritic Efficacy, Safety and Local Dermal Tolerability of a Topical Formulation (SRD174 Cream) of the Long-Acting Opiod Antagonist Nalmefene in Subjects With Atopic Dermatitis
Jo Lynne Herzog MD,a James A.Solomon MD PhD,b Zoe Draelos MD,c Alan Fleischer Jr. MD,d Dow Stough MD,e David I.Wolf MD,f William Abramovits MD,g William Werschler MD,h Emma Green BSc,i Maeve Duffy PhD,i Alan Rothaul PhD,i Robert Tansley MBBSi| |
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 (SPID0-4) 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 SPID0-4 (±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.
Infliximab-Induced Psoriasis in Treatment of Crohn's Disease-Associated Ankylosing Spondylitis: Case Report and Review of 142 Cases
Shannon Famenini BSa and Jashin J. Wu MDb| |
J Drugs Dermatol. 2013;12(8):939-943.
DFD-01, a Novel Medium Potency Betamethasone Dipropionate 0.05% Emollient Spray, Demonstrates Similar Efficacy to Augmented Betamethasone Dipropionate 0.05% Lotion for the Treatment of Moderate Plaque Psoriasis
Joseph F. Fowler Jr. MD,a Adelaide A. Hebert MD,b Jeffrey Sugarman MD PhDc| |
OBJECTIVE: To compare the efficacy and safety of medium potency DFD-01 with super potent augmented betamethasone dipropionate 0.05% lotion (Diprolene) for the topical treatment of moderate plaque psoriasis.
METHODS: Adults with moderate plaque psoriasis (Investigator Global Assessment [IGA]=3; 10–20% BSA) were randomized 2:1:1 to DFD-01, Diprolene, or Vehicle. Products were applied twice daily to affected areas for 14 days. Treatment success was defined as IGA=0 or 1 and ≥2-grade improvement from baseline. IGA and target lesion Total Sign Score (TSS; sum of erythema, scaling, and plaque elevation scores) were assessed at baseline and at days 4, 8, and 15. Adverse events (AEs) were recorded.
RESULTS: 351 subjects with moderate psoriasis were randomized to DFD-01 (n=174), Diprolene (n=90), or Vehicle (n=87). Mean BSA was 13–14%. Treatment success was achieved in 19.0% DFD-01, 18.9% Diprolene, and 2.3% Vehicle (P<0.001 DFD-01 vs Vehicle) at day 15. Treatment success at day 8 was 10% DFD-01, 6.7% Diprolene, and 1.2% Vehicle (P=0.003 DFD-01 vs Vehicle). TSS was significantly reduced with DFD-01 compared with Vehicle at days 4, 8, and 15 (P≤0.006) and compared with Diprolene at day 4 (P=0.010). DFD-01 relieved signs of erythema and scaling earlier than Diprolene or Vehicle, showing significant improvements on day 4 (P≤0.048). All products were well tolerated. Significantly more burning/stinging was reported with Diprolene than DFD-01 (13.6% vs 4.1%, P=0.006).
CONCLUSION: Medium potency DFD-01 was efficacious for the treatment of moderate psoriasis. DFD-01 demonstrated similar efficacy to super potent Diprolene lotion. Results at 4 and 8 days indicate that DFD-01 shows early improvement in some subjects. DFD-01 was well tolerated and had an excellent safety profile.
J Drugs Dermatol. 2016;15(2):154-162.
Skin Barrier Health: Regulation and Repair of the Stratum Corneum and the Role of Over-the-Counter Skin Care
Thomas Lee MD and Adam Friedman MD| |
J Drugs Dermatol. 2016;15(9):1047-1051.
Varun Kalhana and Neil Sadick MDb| |
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
J Drugs Dermatol. 2012;11(9):e10-e17.
Combination of Essential Oil of Melaleuca alternifolia and Iodine in the Treatment of Molluscum Contagiosum in Children
Molluscum contagiosum is a common childhood viral skin condition and is increasingly found as a sexually transmitted disease in adults. Current treatment options are invasive, requiring tissue destruction and attendant discomfort. Fifty-three children (mean age 6.3+5.1 years) with the diagnosis of molluscum contagiosum were treated with twice daily topical application of either essential oil of Melaleuca alternifolia (TTO), a combination of TTO and organically bound iodine (TTO-I), or iodine alone. At the end of 30 days, 48 children were available for follow up. A greater than 90% reduction in the number of lesions was observed in 16 of 19 children treated with TTO-I, while 1 of 16 and 3 of 18 children met the same criteria for improvement in the iodine and TTO groups (P<0.01, ANOVA) respectively by intention-to-treat analysis. No child discontinued treatment due to adverse events. The combination of essential oil of M. alternifolia with organically bound iodine offers a safe therapeutic alternative in the treatment of childhood molluscum. Clinical Trial Registry ACTRN12610000984099.
J Drugs Dermatol. 2012;11(3):349-354. 2012;11(3):349-354.
Viral M. Patel BS, Robert A. Schwartz MD MPH DSc (Hon), and W. Clark Lambert MD PhD| |
J Drugs Dermatol. 2016;15(7):830-834.
Maggie Chow MD PhD,a Kevin Lai MS,b Richard Ahn PhD,b Rashmi Gupta PhD,b Sarah Arron MD PhD,b and Wilson Liao MDb| |
METHODS: Thirty adult subjects with > 10% body surface area of chronic plaque psoriasis were recruited for the study. Lesional skin and peripheral blood mononuclear cell samples prior to and one month following treatment with adalimumab were collected. The skin samples were analyzed using genome-wide RNAseq, and the blood samples were analyzed using genome-wide Affymetrix microarrays. Data preprocessing and analysis were conducted using the EdgeR and Affy packages in R/Bioconductor.
RESULTS: In the skin, paired analysis before and after treatment revealed changes in pathways important to epidermal development and keratinocyte differentiation. Such important genes as keratin 6A and 6B, tubulin B6, desmocollin, and desmoglein 3 were among the top differentially expressed genes. In peripheral blood, pathways involved in hematopoetic cell lineage and immune response were found to be differentially expressed, including genes such as the Fc receptor-like A and 5, as well as immunoglobulin heavy chains. Using a principal components approach, we show that expression of genes in post-treatment skin more closely resembles that of healthy controls.
CONCLUSION: Treatment of psoriasis with adalimumab appears to be associated with modulation of keratinocyte and epidermal proliferation in the skin and with immunologic changes in the blood. We discuss the ramifications of these findings for the treatment for psoriasis.
J Drugs Dermatol. 2016;15(8):988-994.
The projections of increases in the number of skin of color patients over the next several decades, necessitates expertise in cultural competence for health care providers. Acquiring competency begins with practitioners reflecting on their self identity and personal beliefs. Additionally, understanding African-American cultural habits and practices and their impact on disease is critically important. We review, in this article, the fundamentals of becoming cultural competent. Patients are best served when their physician embraces their culture, their view of the health care system as well as habits and practices.
J Drugs Dermatol. 2012;11(4):460-465.
Clinical Relevance of Skin Barrier Changes Associated With the Use of Oral Isotretinoin: The Importance of Barrier Repair Therapy in Patient Management
James Q. Del Rosso DO FAOCD| |
J Drugs Dermatol. 2013;12(6):626-631.
Consuelo V. David BA,a Hong Nguyen BS,b Gary Goldenberg MDc| |
The immunomodulatory characteristics and topical application of imiquimod (IQ), a toll-like receptor 7 agonist, have lead to extensive off-label therapeutic trials. Off-label use is not uncommon in dermatology. However, clinicians must make informed decisions to ensure safe and effective implementation when standardized protocols are lacking. We present the highest level of clinical evidence for each off-label application of IQ, summarize management steps, treatment regimens, and results. We hope consolidation of this information will facilitate implementation of informed and evidence-based clinical decisions. Forty-six off-label applications were reported. Treatments were generally applied in the same manner, tailored to induce an inflammatory response and reduced with the development of adverse reactions. The efficacy of imiquimod ranged from promising to suboptimal compared to standard treatments and protocols. Clinicians who choose to use IQ off-label should have a firm understanding of the extent an application has been studied and how to manage adverse events.
J Drugs Dermatol. 2011;10(11):1300-1306.
Brandon L. Adler BA and Adam J. Friedman MD| |
Katelyn Mariko Updyke BS,a Amor Khachemoune MD FAAD FACMSbc| |
Port-wine stain (PWS) is the second most common congenital vascular malformation characterized as ectatic capillaries and venules in the dermis that clinically appears as a deep red to purple patch on the skin. Typically, PWS progressively darken and may become hypertrophic or nodular without treatment. There are several treatment options available for PWS from topical antiangiogenic agents to laser therapies. Vascular-specific lasers are the gold standard in treating PWS and classically pulsed dye lasers are usually the treatment of choice. However, some patients with PWS are recalcitrant to PDL and may require a combination of treatment methods. Nonetheless, even with the advancements in laser therapies utilized today, it is can be difficult to achieve complete clearance of the PWS. Thus, new innovations for treating recalcitrant PWS are underway in order to improve overall patient treatment outcomes.
J Drugs Dermatol. 2017;16(11):1145-1151.
Omid Hamid MDa and Gary Goldenberg MDb| |
J Drugs Dermatol. 2013;12(11):1246-1252.
Hilary E. Baldwin MD,a Neal D. Bhatia MD,b Adam Friedman MD,c Richard Martin Eng,d and Sophie Seité PhD e| |
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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Ted Rosen MD| |
J Drugs Dermatol. 2016;15(Suppl 2):s49-55.
Wm. Philip Werschler MD FAAD FAACS,a Julius W. Few Jr. MD,b Carolyn I. Jacob MD FAAD,c
John H. Joseph MD,d James M. Spencer MD MS,e and Amy Forman Taub MDf
J Drugs Dermatol. 2016;15(5):518-525.
Patricia K. Farris MD,a Nicole Rogers MD,a Amy McMichael MD,b Sophia Kogan MDc| |
Hair loss is a complicated problem that causes significant concern for those who are affected. Patients seeking medical treatment have limited options that include topical minoxidil and oral finasteride. While these treatments are backed by long term clinical use and research outcomes, many patients find topical minoxidil difficult to incorporate into their daily routine and some are concerned with the side effects associated with finasteride. In the office setting, patients may be treated with more invasive procedures such as platelet-rich plasma injections (PRP) and hair transplantation, treatments that often must be repeated and can lead to a costly investment. Consumers are increasingly interested in natural treatments for hair loss. Many turn to basic supplements only to be disappointed when they fail to deliver due to lack of standardization and efficacy. In this paper we review the benefits of a nutraceutical containing a specific blend of highly purified, standardized, bio-optimized, and bioavailable botanical extracts to treat hair loss. These phytoactives were selected because of their diverse multi-modal biologic activity against inflammation, DHT, stress mediators, oxidative damage, and intermediary signaling cascades. This supplement represents a paradigm shift as it addresses not only the factors that trigger hair loss but the downstream mediators of inflammation as well. Multi-center clinical studies are currently underway to confirm the efficacy and benefits of this unique nutraceutical.
J Drugs Dermatol. 2017;16(11 Suppl):s141-148.
Ted Rosen M.D.| |
Within a relatively short period of time after the first antimicrobial drugs were introduced, bacteria began exhibiting varying degrees of resistance. The excessive use (and abuse) of antibiotics in agriculture, and in both human and veterinary medicine, has played a critical causative role in the development of antibiotic resistance, which is now recognized as a global public health threat. Increasing concern over this issue should impact the practice of cutaneous medicine and surgery, as dermatologists can easily adopt new healthcare delivery patterns that might reduce the development of antibiotic resistance and still achieve acceptable treatment outcomes. Dermatologists should seriously consider any and all alternative therapies before committing to an extended course of antibiotic therapy for disease entities that are almost certainly not infectious. Conversely, dermatologists should carefully and closely adhere to dosage and duration recommendations when using antibiotics to treat a bona fide infectious disorder.
J Drugs Dermatol.2011;10(7):724-733.
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