Volume 12 | Issue 3
Evaluation of the Efficacy, Tolerability, and Safety of an Over-the-Counter Acne Regimen Containing Benzoyl Peroxide and Salicylic Acid in Subjects With Acne
Leon H. Kircik MD,a-c Lawrence J. Green MD,d Joseph Eastern MD,e Victoria Butners BSc,f and Jennifer Gwazdauskas MBAf|Benzoyl peroxide (BPO) is a widely used over-the-counter (OTC) topical acne treatment often used in combination with salicylic acid (SA) to achieve better comedone control than that achieved with BPO alone. MaxClarity™ is an OTC acne treatment system comprising BPO and SA in an aqueous foam delivery vehicle, VersaFoam AF™. This paper describes 2 open-label, single-arm studies conducted to assess the efficacy, safety, tolerability, and patient preference of MaxClarity in the treatment of mild, moderate, and severe acne. Subjects applied MaxClarity twice daily for 8 weeks in study 402 and for 12 weeks in study 405. Reductions in all lesion types were seen throughout both studies. At week 8 (study 402), there was a mean reduction from baseline of –56.9 ± 32.7% in total lesions in subjects with mild, moderate, or severe acne. At week 12 (study 405), there was a reduction from baseline of –61.6 ± 22.0% in total lesions in subjects with moderate or severe acne. Overall, both studies demonstrated that MaxClarity is a generally well tolerated and effective treatment for mild, moderate, and severe acne.
J Drugs Dermatol. 2013;12(3):259-264.
Comparison of Clindamycin 1% and Benzoyl Peroxide 5% Gel to a Novel Composition Containing Salicylic Acid, Capryloyl Salicylic Acid, HEPES, Glycolic Acid, Citric Acid, and Dioic Acid in the Treatment of Acne Vulgaris
Leslie S. Baumann MD, CPI,a Kristian Figueras MS,a Amanda Dahl BS CCRA,b Margarita Yatskayer MS,b and Christian Oresajo PhDb|This study evaluated the tolerance and efficacy of 2 facial skin products in subjects with acne using the following acne treatments: 1) treatment A, a combination of salicylic acid, capryloyl salicylic acid, HEPES, glycolic acid, citric acid, and dioic acid, and 2) treatment B (BenzaClin®, clindamycin 1% and benzoyl peroxide 5% gel). The treatment design included the split-face application of treatment A and treatment B and the full-face application of the cleanser, moisturizer, and sunscreen. Data were collected through physician visual assessments, subject irritation questionnaires and assessments, along with clinical photography. Results showed similar tolerance and efficacy for both treatments.
J Drugs Dermatol. 2013;12(3):266-269.
Comparison of a Skin-Lightening Cream Targeting Melanogenesis on Multiple Levels to Triple Combination Cream for Melasma
Gary D. Monheit MDa and Frank Dreher PhDb|The safety and efficacy of a novel skin-lightening cream (SLC) with 4% hydroquinone (HQ), which additionally contains 4 skin-brightening actives, was compared with a triple combination cream (TCC) with 4% HQ, 0.05% tretinoin, and 0.01% fluocinolone acetonide for the treatment of melasma under measures of sun protection. The study was a randomized, investigator-blinded, split-face study including 20 Caucasian females with at least mild epidermal or mixed melasma. Evaluations were made before treatment, after 4 and 8 weeks, and after 12 weeks at the end of the once-daily treatment period with the creams. The evaluations included the investigator's tolerability assessments, the Investigator's Global Assessment, the Melasma Area and Severity Index (MASI), and a participant questionnaire. Under the conditions of the present study, the SLC was comparable in both efficacy and tolerability with the well-established TCC treatment for facial melasma. The MASI reduction became significant for both creams after 4 weeks and reached -77% for SLC and -79% for TCC cream after 12 weeks of once-daily use under measures of sun protection. None of the subjects discontinued treatment because of an intolerability or adverse event. About one-third of the subjects experienced at least one local intolerability (eg, erythema, dryness, or peeling) with both creams over the entire study period, while the remaining subjects did not experience any intolerabilities.
J Drugs Dermatol. 2013;12(3):270-274.
Efficacy and Safety of Tretinoin 0.025%/Clindamycin Phosphate 1.2% Gel in Combination With Benzoyl Peroxide 6% Cleansing Cloths for the Treatment of Facial Acne Vulgaris
Joshua A. Zeichner MD, Madelaine Haddican MD, Rita V. Linkner MD, and Vicky Wong BS|Combination therapy using medications with complementary mechanisms of action is the standard of care in treating acne. We report results of a clinical trial evaluating the use of a fixed-dose tretinoin 0.025%/clindamycin phosphate 1.2% (T/CP) gel in combination with a benzoyl peroxide 6% foaming cloth compared with T/CP alone for facial acne. At week 12, the combination therapy group showed a trend toward greater efficacy compared with T/CP alone. There was a high success rate observed in the study, which may be attributable to the large percentage of adult female acne patients enrolled. Cutaneous adverse events were not statistically different in using combination therapy compared with T/CP alone.
J Drugs Dermatol. 2013;12(3):277-282.
Scoping Scalp Disorders: Practical Use of a Novel Dermatoscope to Diagnose Hair and Scalp Conditions
Nicole E. Rogers MD|BACKGROUND: Dermoscopy has been widely implemented to diagnose various skin and scalp disorders. However, existing devices that call for direct scalp contact may alter the appearance of hair features or perifollicular structures.
OBJECTIVE: This paper will show how the Canfield DermScope can quickly and easily identify various nonscarring and scarring scalp disorders. Its open design does not change the direction of affected hairs or blanch certain features such as erythema. Features like perifollicular hyperkeratosis and loss of follicular orifices are still easily visible.
METHODS and MATERIALS: The author prospectively photographed patients with hair and scalp disorders in private practice between 2011 to 2012 using the handheld Canfield DermScope device.
RESULTS: The presence of scale, erythema, tufting, miniaturized or broken hairs, and loss of follicular orifices were quickly identified to make a diagnosis.
CONCLUSION: The diagnosis of hair and scalp disorders can be greatly facilitated by the use of the DermScope device.
J Drugs Dermatol. 2013;12(3):283-290.
Efficacy of Extended-Release 45 mg Oral Minocycline and Extended-Release 45 mg Oral Minocycline Plus 15% Azelaic Acid in the Treatment of Acne Rosacea
J. Mark Jackson MD,a Douglas J. Lorenz PhD,b and Leon H. Kircik MDc-e|Rosacea is one of the most commonly occurring dermatoses treated by dermatologists. There are multiple therapeutic options available for the treatment of papulopustular rosacea. Rosacea is an inflammatory condition, classically presenting with flushing and/or blushing along with erythema, edema, telangiectasia, papules, pustules, and nodules of the face. Minocycline, a member of the tetracycline family, has demonstrated benefit in the treatment of inflammatory lesions in patients with rosacea. This manuscript highlights the use of a new sustained-release low-dose minocycline 45 mg tablet, with or without azelaic acid, for the treatment of papulopustular rosacea.
J Drugs Dermatol. 2013;12(3):292-298.
A Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Calcipotriene Foam, 0.005%, vs Vehicle Foam in the Treatment of Plaque-type Psoriasis of the Scalp
Steven R. Feldman MD PhD,a William J. Eastman MD,b Thomas Brundage MS,b and Mary Mills BSb|BACKGROUND: Calcipotriene ointment and cream are effective treatments for psoriasis, but many patients with scalp psoriasis prefer lighter, less messy vehicles.
OBJECTIVES: To evaluate the efficacy and safety of calcipotriene foam, 0.005%, for plaque-type psoriasis of the scalp.
METHODS: Subjects (n=363) were randomized into an 8-week, multicenter, double-blind, vehicle-controlled, parallel-group, phase 3b study of calcipotriene foam, 0.005% (NCT01139580). Primary end point was the proportion of subjects with an Investigator's Static Global Assessment (ISGA) score of 0 (clear) or 1 (almost clear) at week 8 for scalp involvement. Body involvement, target lesion score, and improvement for erythema, scaling, and plaque thickness were also assessed.
RESULTS: At week 8, more subjects in the calcipotriene foam, 0.005% group (40.9%) met the primary end point vs the vehicle foam group (24.2%; intent-to-treat [ITT] population; P<.001); a significant difference between groups was also observed at weeks 2 (P=.041) and 4 (P<.001). No significant difference was observed between treatment groups for ISGA of body psoriasis (ITT population; P=.544). In the per-protocol population, but not the ITT population, more subjects in the calcipotriene foam, 0.005%, group than the vehicle foam group met the secondary end points for scaling (P=.019) and plaque thickness (P=.027). Incidence of adverse events in both treatment groups was low; calcipotriene foam, 0.005%, was associated with erythema. Limitations: An 8-week study provides limited safety and efficacy data.
CONCLUSION: Calcipotriene foam, 0.005%, was more effective than vehicle foam for improving scalp psoriasis over an 8-week period, with improvements evident from week 2, and had a similar safety profile to vehicle foam.
J Drugs Dermatol. 2013;12(3):300-306.
Topical Amitriptyline Combined With Ketamine for the Treatment of Erythromelalgia: A Retrospective Study of 36 Patients at Mayo Clinic
Timothy J. Poterucha BS,a Sinead L. Murphy BS,b Mark D. P. Davis MD,c Paola Sandroni MD PhD,d Richard H. Rho MD,e Roger A. Warndahl RPh,f and William T. Weiss RPhf|BACKGROUND: Erythromelalgia is an uncommon neurovascular disorder characterized by redness, increased skin temperature, and pain that usually occurs in the extremities. Treatment remains challenging because of its varying response to medical therapy. The objective of this study was to assess the response of erythromelalgia to compounded topical amitriptyline-ketamine.
METHODS: We retrospectively evaluated 36 patients with erythromelalgia who were treated with compounded topical amitriptyline-ketamine from January 1, 2004, through January 31, 2011.
RESULTS: Thirty-two patients (89%) were female. Mean (standard deviation) age was 44.7 (15.8) years (range, 5-74 years). Patients applied the medication 1 to 6 times per day (median, 5 times). One patient (3%) had complete relief from symptoms, 14 (39%) had substantial relief, 12 (33%) had some relief, 7 (19%) had no relief, and 2 (6%) had local worsening of symptoms. No patients had systemic adverse effects.
CONCLUSIONS: A majority of patients with erythromelalgia (75%) reported improvement in pain with topical application of a compounded amitriptyline-ketamine formulation. The medication was well tolerated.
J Drugs Dermatol. 2013;12(3):308-310.
Efficacy of Topical 4% Quassia amara Gel in Facial Seborrheic Dermatitis:A Randomized, Double-Blind, Comparative Study
Christian Diehl MDa and Alicia Ferrari MDb|BACKGROUND: Seborrheic dermatitis (SD) is a chronic mild skin disorder with high prevalence. Various treatment options are available, including topical antifungals and anti-inflammatories. Antifungal and anti-inflammatory properties of Quassia amara have been reported.
AIM: To check the efficacy and safety of a topical gel with 4% Quassia amara extract and compare it with topical 2% ketoconazole and 1% topical ciclopiroxolamine in the treatment of facial SD.
METHODS: A group of 60 patients displaying facial SD were randomly distributed in 3 groups and given either a topical gel with 4% Quassia amara extract, a topical gel with 2% ketoconazole, or a topical gel with 1% ciclopirox olamine for 4 weeks. Disease severity was assessed at the start and weekly along treatment, as well as 4 weeks after the end of treatment. In each selected area, severity of erythema, scaling, pruritus, and papules were scored from 0 to 3, the sum of these values representing the score of SD on the face. This evaluation was conducted at each visit. The decrease in SD score with all 3 products was compared at each visit. At each stage, overall improvement, safety, and tolerability were also assessed.
RESULTS: Of the 60 patients, 54 (90%) completed the study. The 3 therapeutic options resulted to be very effective, with a significant advantage in efficacy for 4% Quassia extract. For the other 2 drugs, the results were in line with those previously published in the literature.
CONCLUSION: Topical gel with 4% Quassia extract represents a new, safe, and effective treatment for facial SD.
J Drugs Dermatol. 2013;12(3):312-315.
Shannon Famenini BSa and Jashin J. Wu MDb|Psoriasis is an immune-mediated cutaneous disease affecting 2% of the worldwide population. While topical therapy, phototherapy, oral systemic therapy, and biologic agents have been used, the treatment of psoriasis still remains a challenge. Ustekinumab is a biologic therapy that provides a novel avenue for management by blocking interleukin-12/23. The purpose of this article is to review the mechanism of action of ustekinumab and its efficacy in psoriatic patients. The use of ustekinumab in other immune-mediated diseases is also discussed. It is our goal to provide dermatologists with the knowledge to enable them to incorporate ustekinumab into their practice.
J Drugs Dermatol. 2013;12(3):317-320.
Hernan Pinto MDa and Luis G. Garrido MDb,c|Since ancient times, humans have fought a still-unwinnable battle against aging and time. The possibility of processing our own blood in order to obtain certain precious substances for a particular purpose has opened the gates for the development of new treatments, indications, and techniques. In this study, we obtained an autologous serum with very high concentrations of some growth factors and anti-inflammatory cytokines using a special syringelike device that exposed the blood to medical-grade glass spheres in a closed system. The application of this autologous conditioned antiaging serum achieved local beauty enhancement results by improving skin hydration, smoothness, and elasticity.
J Drugs Dermatol. 2013;12(3):322-326.
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|BACKGROUND: Chronic hand dermatitis may have a significant detrimental effect on daily home-related and work-related activities, and quality of life (QOL). Clobetasol propionate foam, 0.05%, is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged 12 years and older.
OBJECTIVES: To demonstrate superior efficacy, similar safety, and superior QOL outcomes in subjects with moderate to severe chronic hand dermatitis following treatment with clobetasol propionate foam, 0.05%, compared with vehicle foam.
METHODS: In this randomized, double-blind, vehicle-controlled, parallel-group, multicenter study (ClinicalTrials.gov identifier NCT01323673), subjects aged 12 years and older with moderate to severe chronic hand dermatitis and an Investigator's Static Global Assessment (ISGA) score of 3 or 4 at baseline were randomized 1:1 to receive clobetasol propionate foam, 0.05%, or vehicle foam, twice daily over 15 days. The primary end point was the proportion of subjects who achieved treatment success, defined as improvement from baseline of ≥2 ISGA grades for the target hand at day 15.
RESULTS: In total, 125 subjects were enrolled: 62 subjects were randomized to the clobetasol propionate foam group and 63 subjects were randomized to the vehicle foam group. The proportion of subjects with treatment success at day 15 did not differ significantly between treatment groups. Adverse events (AEs) were reported in 18% of subjects in the clobetasol propionate foam group and 8% of subjects in the vehicle foam group. No serious AEs, AEs resulting in discontinuation of study product, or severe AEs were reported in the clobetasol propionate foam group.
CONCLUSIONS: Clobetasol propionate foam, 0.05%, was not significantly more efficacious than vehicle foam at improving chronic hand dermatitis on investigator-assessed end points. Emollient properties of the study product vehicle may be a confounder in the study.
J Drugs Dermatol. 2013;12(3):328-334.
Topical Formulation Engendered Alteration in p53 and Cyclobutane Pyrimidine Dimer Expression in Chronic Photodamaged Patients
James M. Spencer MD MS,a Summer D. Moon BS,b Kara M. Trapp BA,c and Michael B. Morgan MDd-f|While the clinical attributes of photoaging are well characterized in the literature, the pathogenic mechanisms that underlie these changes are incompletely elucidated. At the molecular level, p53 tumor-suppressor gene product mediated excision repair of ultraviolet (UV)-induced DNA damage is a critical effector in xeroderma pigmentosum (XP) and potentially in conventional photoaging. We examined p53 activity and measured UV-induced DNA damage via cyclobutane pyrimidine dimers (CPDs) quantitatively in 20 volunteers before and after an 8-week, open-label prospective topical application of a proprietary DNA recovery serum (Celfix). There was a statistically significant decrease in immunohistochemically determined p53 and CPD levels. While these data are preliminary, the findings lend support to the theoretical possibility of a topical agent reversing the effects of photodamage at the molecular level and, potentially, an ameliorative outcome clinically.
J Drugs Dermatol. 2013;12(3):336-340.
Xi Tan PharmD,a Steven R. Feldman MD PhD,b and Rajesh Balkrishnan PhDa|Tumor necrosis factor (TNF)-α inhibitors have been shown to increase the risks of overall infection and serious infection in rheumatoid arthritis. However, it is uncertain whether we can draw the same conclusion in the psoriatic population. This article focuses on the 3 most commonly used TNF-α inhibitors in psoriasis: adalimumab, etanercept, and infliximab. In order to assess the risks of overall infection and serious infection in patients with psoriasis, we reviewed the underlying mechanism of the potential infection risk, different types of serious infection associated with TNF-α inhibitors, and current evidence in the psoriatic population. Results from 11 randomized controlled trials and open-label extension studies showed that there was no apparent significant association between the use of TNF-α inhibitors and increasing risks of overall infection and serious infection. Becasue of the limitations of current evidence, large, long-term follow-up studies with appropriate control groups using real-life data, such as postmarket surveillance, are warranted.
J Drugs Dermatol. 2013;12(3):e41-e45.
The Evaluation of Hyaluronic Acid, With and Without Lidocaine, in the Filling of Nasolabial Folds as Measured by Ultrastructural Changes and Pain Management
Josefina Royo de la Torre MD, Paloma Cornejo MD, Gema Pérez MD, Irene Cruz MD, Estefania Muñoz BSc, Maria J. Isarría MD, and J. Moreno-Moraga MD|BACKGROUND: Pain management is an important objective in procedures involving dermal fillers composed of hyaluronic acid (HA).
OBJECTIVE: To compare the 1-year clinical results of filling the nasolabial fold with 2 types of filler: large-gel particle HA and large-gel particle HA plus 0.3% lidocaine (HA+L). We compared the level of pain during treatment and 10 minutes after treatment and assessed the safety and efficacy profile, satisfaction, and histological findings (using reflectance confocal microscopy [RCM]).
MATERIALS and METHODS: We performed a comparative, parallel-group, double-blind trial with an external observer (blinded to the type of treatment administered). The filler was applied to the nasolabial fold in 119 patients (HA in 62 patients and HA+L in 57). Patients were followed at months 3, 9, and 12. Pain was evaluated using a visual analog scale. Efficacy and satisfaction were evaluated using the Wrinkle Severity Rating Scale and the Global Aesthetic Improvement Scale. RCM images (n=32) were taken at baseline and at months 3 and 12.
RESULTS: Pain: The severity of pain was decreased in patients treated with HA+L on application (P<.001) and 10 minutes later (P=.008). Efficacy and satisfaction: No significant differences existed between the 2 groups at months 3, 9, and 12. RCM: Skin rejuvenation occurred with a 32% increase in the height of the dermoepidermal junction at month 12 (P<.001), which was similar in both groups. Adverse events: At month 3, the most common adverse events (AEs) were erythema (68%) and hematoma (11%). No AEs were recorded at months 9 or 12.
CONCLUSION: The use of HA+L provides pain relief without affecting efficacy, satisfaction, safety, or the duration of results. RCM showed that the changes in the dermoepidermal junction represented a histological improvement in the skin with similar results in both groups.
J Drugs Dermatol. 2013;12(3):e46-e52
Assessment of Syndecan-1 (CD138) and Ki-67 Expression for Differentiating Keratoacanthoma and Squamous Cell Carcinoma
Lorena Lammoglia-Ordiales MD,a Judith Dominguez-Cherit MD,a Samantha Rivera-Macías DDM,b Alma A. Rodriguez-Carreón MD,a Verónica Fonte-Avalos MD,a Martha Contreras-Barrera MD,a and Sonia Toussaint-Caire MDa|BACKGROUND: There is a major controversy over the natural behavior of keratoacanthoma (KA). KAs have been described as benign lesions, but also as variants of squamous cell carcinoma (SCC). Microscopic differentiation between these 2 entities is problematic, and sometimes impossible. Syndecan-1 (CD138) is an adhesion molecule whose expression appears to be inversely correlated with tumor invasiveness. Elevated Ki-67 expression is indicative of a high proliferation index, a feature of malignant tumors.
METHODS: Syndecan-1 and Ki-67 expression were assessed in 22 KA skin samples and in 17 SCC skin biopsies.
RESULTS: Syndecan-1 expression was diminished in the SCC specimens compared with the KA specimens (P=.000). Ki-67 expression was increased in the SCC specimens compared with the KA specimens, with mean values of 9 and 0.08, respectively (P=.000).
LIMITATIONS: Further studies that compare intermediate risk KAs to typical KAs and SCCs are required to corroborate these findings.
CONCLUSION: The assessment of syndecan-1 and Ki-67 expression in skin biopsies is a helpful tool for differentiating KA and SCC.
J Drugs Dermatol. 2013;12(3):e53-e58.
Pterygium Inversum Unguis: Report of an Extensive Case With Good Therapeutic Response to Hydroxypropyl Chitosan and Review of the Literature
Roberta Marinho Falcão Gondim MD PhD,a,b Pedro Bezerra da Trindade Neto MD PhD,a and Robert Baran MDc|Pterygium inversum unguis is a rare but not exceptional dermatological condition, with few descriptions in literature. It occurs more frequently in females and may be associated with several clinical conditions. About 50% of cases are concurrent with collagen diseases such as systemic lupus erythematosus and scleroderma. Severe cases are accompanied by moderate morbidity caused by discomfort when the patient has to perform minor tasks. The treatment has been considered complex, regardless of its underlying cause, with poor response to the topical therapies such as keratolytics and corticosteroids. This paper reports a case of pterygium inversum unguis with a good therapeutic response to hydroxypropyl chitosan and includes a review of the literature.
J Drugs Dermatol. 2013;12(3):344-346.
Sustained Clinical Resolution of Acquired Epidermodysplasia Verruciformis in an Immunocompromised Patient After Discontinuation of Oral Acitretin With Topical Imiquimod
Rajiv I. Nijhawan MD,a Jeremy M. Hugh MD,b and Achiamah Osei-Tutu MDa|Increased cases of acquired epidermodysplasia verruciformis (EDV) have been reported in patients with human immunodeficiency virus (HIV). With regard to management, there are no randomized controlled trials in either immunocompetent or immunocompromised patients, and only a limited number of anecdotal treatment options. Systemic retinoids, either independently or in combination with other treatment modalities, have been used with limited success, demonstrating transient clinical response and recurrence of lesions after cessation of therapy. We report a case of an HIV-positive patient with acquired EDV who achieved sustained clinical resolution even after discontinuation of oral acitretin by applying topical imiquimod to prevent recurrence of his lesions.
J Drugs Dermatol. 2013;12(3):348-349.
Ralph Fiore II DO, Sarah M. Coffman DO MSc, and Richard Miller DO|The emphasis on the preservation of youth is ever apparent as new antiaging products, cosmetic procedures, and advertising campaigns aim to address new ways to prevent the natural aging process. Many individuals prefer noninvasive surgical procedures involving minimal downtime and a speedy recovery. Although these cosmetic procedures are considered minor, complications do arise and infections can occur. While many species of bacteria can cause these infections, one such species that is usually over looked and can cause these infections are the atypical mycobacteria. Early diagnosis is important, as these infections can rapidly progress into more serious skin manifestations. We present a 31-year-old female with a 3-month history of a nonhealing ulcer on her cheek that started approximately 2 weeks following a cosmetic procedure with an injectable filler. This patient represents an uncommon complication that may occur in patients subjected to multiple facial injections, as their susceptibility to infection and secondary biofilm formation increases with their current and future injections. This case review highlights the growing number of cosmetic procedures in our society, the most common complications of these treatments, an emerging complication concerning the formation of biofilms, as well as a review of the literature on atypical mycobacteria infections.
J Drugs Dermatol. 2013;12(3):353-357.
Hannah Liu BS, Rachel Schleichert MD, and Anthony A. Gaspari MD|Prurigo nodularis is a chronic, relapsing neurodermatitis that is often resistant to standard therapies with topical corticosteroids and oral antihistamines. Thalidomide, while efficacious in treating recalcitrant cases of prurigo nodularis, causes significant toxicity. Thalidomide-induced peripheral neuropathy frequently results in drug discontinuation. Lenalidomide (Revlimid; Celgene Corporation, Summit, NJ) is a derivative of thalidomide with less neurotoxicity approved for the treatment of multiple myeloma and myelodysplastic syndromes that has not been widely studied in dermatologic disorders. Here, we report a case of refractory prurigo nodularis effectively treated with lenalidomide. Given its favorable side-effect profile, lenalidomide may offer a superior alternative to thalidomide in the treatment of this condition.
J Drugs Dermatol. 2013;12(3):360-361.
Surgical Corner:A Poliglecaprone 25-Only Approach to Wound Closure:Cosmetic and Financial Advantages
Jesse M. Lewin MD,a Jeremy A. Brauer MD,b and Ariel Ostad MDa|The primary concerns when performing surgical excisions include adequate control of surgical margins and cosmetic outcome. The ideal repair combines perfect wound approximation, tensile strength, and minimal scarring. Various techniques and suture materials are utilized by dermatologic surgeons to achieve this goal. We describe a Monocryl-only bilayered repair, which can lead to excellent cosmetic results and may reduce the burden of return visits for patients. In this paper, we describe the technique used to place deep Monocryl sutures, as well as a running subcuticular suture, and illustrate this technique with photographs.
J Drugs Dermatol. 2013;12(3):341-342.
Resident Rounds: Part I. Program Spotlight: Pennsylvania State University Dermatology Residency Program
Charlene Lam MD MPH, Jeffrey J. Miller MD MBA, and Joslyn S. Kirby MD|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 Pennsylvania State University Dermatology Residency Program. The editor of Resident Rounds is Omar A. Ibrahimi MD PhD. He is currently the Founding and Medical Director of the Connecticut Skin Institute. Dr. Ibrahimi is also a Visiting Assistant Professor of Dermatology Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at OIbrahimi@jddonline.com.
Charlene Lam MD MPH, Jeffrey J. Miller MD MBA, and Joslyn S. Kirby MD|No abstract details for the moment.
Charlene Lam MD MPH, Jeffery J. Miller MD MBA, and Joslyn S. Kirby MD|No abstract details for the moment.
No abstract details for the moment.
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.
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.
C. Stanley Chan MDa and Jeffrey S. Dover MDa-c aSkinCare Physicians, Chestnut Hill, MA bDepartment of Dermatology, Yale University School of Medicine, New Haven, CT cDepartment of Surgery, Dartmouth Medical School, Hanover, NH|Safe and effective laser treatments are crucial, especially in darker-skinned individuals. Herein, we report our experience treating Fitzpatrick skin types IV to VI with a long-pulsed, 1,064-nm neodymium-doped yttrium aluminum garnet laser. With the right treatment settings, darkly pigmented individuals can undergo laser hair removal effectively.
J Drugs Dermatol. 2013;12(3):366-367.
Allergan's Tazorac is at the Vanguard of the Next Generation of Topical Retinoids
Over the last 4 decades, topical retinoids have become standard therapy for the treatment of acne vulgaris. Although the market currently encompasses multiple formulations of next-generation topical retinoids, Tazorac is unique among them due to its dual role as a treatment option for both acne vulgaris and psoriasis vulgaris. Tazorac has also demonstrated that it is highly effective for the treatment of acne vulgaris as a monotherapy or in combination with other agents. Recent studies show that Tazorac can be combined effectively with dapsone 5% gel or with a benzoyl-peroxide - containing formulation to augment efficacy. Additionally, Tazorac does not have a generic substitution, so physicians can be assured that their patients will receive exactly what they have been prescribed.
The Future is Now With SkinMedica’s Lytera™
The gold standard for the treatment of abnormal melanin accumulation has long been 4% hydroquinone, but, given the proliferating safety concerns posed by hydroquinone, the search for novel skin brighteners has been ongoing. Several studies have demonstrated that the future for skin brighteners is now, because of the skin brightening efficacy of SkinMedica’s Lytera™, a hydroquinone-free skin-brightening complex. Lytera includes a series of formulations that utilize a multi-modal treatment approach, and it is as effective as hydroquinone over the course of 24 weeks for the treatment of facial hyperpigmentation without the concomitant toxicities of the latter.
Leon H. Kircik MD|No abstract details for the moment.
James Q. Del Rosso DO FAOCDa and Emil Tanghetti MDb|Tazarotene is a synthetic retinoid that, depending on the concentration and vehicle, is approved by the US Food and Drug Administration for the topical treatment of acne vulgaris (AV) and plaque psoriasis. Tazarotene is also used as adjunctive treatment for specified clinical manifestations of chronically photodamaged skin (facial fine wrinkling, mottled facial hypopigmentation and hyperpigmentation, and benign facial lentigines), along with comprehensive skin care and photoprotection from sunlight. The gel formulation was released in the United States in 1997, with the cream formulation made available in 2000. Multiple studies are available supporting the effective and safe use of topical tazarotene for each of its indications. This article provides an overview of the pharmacology of topically applied tazarotene, discussing in particular up-to-date information on the efficacy, tolerability, and safety of topical tazarotene for AV, including monotherapy and combination therapy studies. Topical tazarotene 0.1% in both formulations is highly effective in reducing both inflammatory and noninflammatory acne lesions, and can be used in combination with other topical agents, including formulations containing benzoyl peroxide or dapsone 5% gel. Although many patients tolerate the use of topical tazarotene without significant issues or concerns, some patients experience application-site tolerability reactions, which can usually be managed with proper skin care and are less frequent with the cream formulation.
J Drugs Dermatol.2013;12(3 suppl 2):s53-s58.
Evaluation of a Hydroquinone-Free Skin Brightening Product Using In Vitro Inhibition of Melanogenesis and Clinical Reduction of Ultraviolet-Induced Hyperpigmentation
Elizabeth T. Makino BS CCRA MBA,a Sujatha Sonti PhD,a Monya L. Sigler PhD,b Piyush Jain PhD,c Ajay Banga PhD,c and Rahul C. Mehta PhDa|BACKGROUND and OBJECTIVE: Skin lightening preparations are used by people all over the world for a diverse range of dermatologic indications. Hydroquinone (HQ) is the gold standard and remains the only prescription product available in the United States for the treatment of generalized facial hyperpigmentation. Irritation and the risk of exogenous ochronosis are the main adverse effects for concern. Therefore, there has been a constant search for new treatment alternatives. Understanding the molecular mechanisms involved in pigmentation has resulted in the development of a series of formulations that utilize a multimodal treatment approach. These proprietary formulas combine skin lightening agents that act via different mechanisms of action. The actives included 4-ethoxybenzaldehyde (anti-inflammatory and prostaglandin E2 suppressor), licorice extract (tyrosinase inhibitor), tetrahexyldecyl ascorbate (antioxidant), niacinamide (melanosome transport inhibitor), ethyl linoleate (tyrosinase inhibitor; enhances turnover of epidermis), hexylresorcinol (tyrosinase inhibitor), and retinol (tyrosinase transcription inhibitor; enhances turnover of epidermis).
METHODS: Select formulations were tested in several studies using the MelanoDerm™ Skin Model (MatTek Corporation, Ashland, MA) to assess the ability of the product to reduce melanin production and distribution. A single-center, double-blind comparison clinical study of 18 subjects was conducted to evaluate the efficacy of the product in reducing ultraviolet-induced hyperpigmentation. Test sites were irradiated with 1.0, 1.5, 2.0, and 2.5 minimal erythema doses. After 5 days, to allow for pigmentation development, the product or 4% HQ cream was applied to the respective test sites, once daily for 4 weeks. Chroma Meter measurements (L* brightness) and standardized digital photographs were taken of the test sites twice a week.
RESULTS: The test product resulted in greater reduction in melanin as measured by melanin content and histological staining compared with the positive control in the MelanoDerm Skin Model. The product also demonstrated statistically significant reductions in pigmentation compared with baseline (all P≤.0001) at the end of the clinical study, and produced greater increases in L*, compared with 4% HQ. Results from these studies indicate that a product designed to affect multiple pathways of melanogenesis and melanin distribution may provide an additional treatment option beyond HQ for hyperpigmentation.
J Drugs Dermatol. 2013;12(3 suppl 1):s16-s20.
Clinical Efficacy and Safety of a Multimodality Skin Brightener Composition Compared With 4% Hydroquinone
Elizabeth T. Makino BS CCRA MBA,a James H. Herndon Jr. MD,b Monya L. Sigler PhD,b Vincent Gotz MS MBA,c John Garruto BS,a and Rahul C. Mehta PhDa|There are numerous common skin disorders involving hyperpigmentation, including solar lentigines, postinflammatory hyperpigmentation, melasma, freckles, and dyschromia from photoaging. While these conditions are of an aesthetic nature, there is great interest in newer, safer, and more effective treatment modalities. Topical hydroquinone (HQ) has been the gold standard of skin lighteners for many years. However, regulatory authorities around the world are now questioning its safety. A randomized, double-blind, half-face study was conducted in females with moderate to severe facial hyperpigmentation to assess the efficacy and tolerability of 3 new skin brightener formulations containing SMA-432, a prostaglandin E2 inhibitor, compared with 4% HQ. Each subject was assigned 2 of the 4 test materials and was instructed to apply the product on the assigned side of the face twice daily for 12 weeks. Evaluation visits were conducted at baseline and at 4, 8, and 12 weeks. At each visit, subjects were evaluated by a blinded investigator for clinical efficacy and tolerability using grading scales. Standardized digital photography and Chroma Meter assessments were also taken. Self-assessment questionnaires were completed at weeks 4, 8, and 12. Sixty-eight Caucasian subjects (136 half faces) completed the study. All test materials significantly reduced Overall Hyperpigmentation and improved the Investigator's Global Hyperpigmentation Improvement rating at weeks 4, 8, and 12 compared with baseline. SMA-432 exhibited a dose-dependent improvement in hyperpigmentation. There were no major tolerability issues with any of the test materials. Self-assessments were generally favorable for all test materials. At the completion of the trial, subjects rated one of the tested multimodality brightener compositions as the most favorable product and 4% HQ as the least favorable. This study demonstrated that the new non-HQ-containing skin brightener formulations were as effective and equally well tolerated as the gold standard, 4% HQ, in females with facial hyperpigmentation.
J Drugs Dermatol. 2013;12(3 suppl 1):s21-s26.
Suzanne Bruce MD|BACKGROUND: Abnormal accumulation of melanin is a common aesthetic skin concern. For years, the gold standard for the treatment of hyperpigmentary disorders has been 4% hydroquinone (HQ). Due to regulatory agencies around the world questioning the safety of HQ, there has been interest in developing new HQ-free skin brightening/lightening products. A multimodality product (skin brightening complex) addressing various pathways for melanogenesis was developed as an alternative to HQ.
OBJECTIVE: The skin brightening complex was studied for efficacy and tolerability in subjects with moderate to severe facial hyperpigmentation.
METHODS: Subjects were instructed to apply skin brightening complex to the entire face twice daily and to follow a standard skin care regimen (facial cleanser, moisturizer, and sunscreen) during the course of the study. The study was conducted over a 12-week period and consisted of evaluation visits at baseline and at weeks 4, 8, and 12. At each visit, subjects were evaluated by an investigator for clinical efficacy and tolerability using grading scales. Standardized digital photographs and spectrophotometric assessments were also taken. Self-assessment questionnaires were completed at weeks 4, 8, and 12. To assess longer-term safety and efficacy, 10 subjects elected to continue treatment for an additional 12 weeks (24 weeks total), with evaluations at weeks 18 and 24.
RESULTS: Twenty-six subjects completed the 12-week study, and 8 subjects completed treatment for an additional 12 weeks (24 weeks in total). In the 12-week study, the skin brightening complex was shown to be effective and significantly improved Overall Hyperpigmentation at weeks 4, 8, and 12 compared with baseline. The skin brightening complex also significantly improved the Mottled Pigmentation Area and Severity Index ([MoPASI], a modified Melasma Area and Severity Index [MASI] scale) at weeks 8 and 12 compared with baseline. These efficacy benefits continued at 24 weeks. The product was well tolerated at all evaluation visits. Subject questionnaires showed 80% or more of the subjects reporting pigmentation improvement and satisfaction with the skin brightening complex at all evaluation visits.
CONCLUSION: This HQ-free skin brightening complex was effective and well tolerated in subjects with facial hyperpigmentation who were treated for as long as 24 weeks.
J Drugs Dermatol. 2013;12(3 suppl 1):s27-s31.
Comparative Study of Hydroquinone-Free and Hydroquinone-Based Hyperpigmentation Regimens in Treating Facial Hyperpigmentation and Photoaging
Sabrina G. Fabi MD and Mitchel P. Goldman MD|BACKGROUND: Photoaged skin, characterized by mottled, irregular areas of pigmentation, is a common skin condition that is often difficult to treat. The areas of hypermelanosis are an aesthetic concern to subjects and may lead to social distress and quality of life issues. There are many commercial hyperpigmentation regimens marketed to lighten dark spots and improve overall skin dyschromia. However, data to support efficacy of such kits are often lacking.
OBJECTIVE: This investigator-blinded, randomized trial was conducted to compare a new hydroquinone (HQ)-free hyperpigmentation regimen against a leading HQ-based hyperpigmentation regimen for the treatment of facial hyperpigmentation and photoaging.
METHODS: Subjects with mottled pigmentation and photodamaged facial skin were randomized to treatment with either the new 4-product (HQ-free) SkinMedica® Hyperpigmentation System (SKM; SkinMedica, an Allergan Company, Carlsbad, CA) kit or the 7-product (HQ-containing) Obagi Nu-Derm System (OMP; Obagi Medical Products, Long Beach, CA) kit. Subjects were evaluated by a blinded investigator for clinical efficacy and tolerability using grading scales at baseline and at weeks 4, 8, and 12. Standardized digital photographs were taken at baseline and week 12. Self-assessment questionnaires were completed at week 12.
RESULTS: Thirty-six female subjects (16: SKM; 20: OMP) completed the 12-week comparative study. Both hyperpigmentation regimens significantly reduced Overall Hyperpigmentation, Mottled Pigmentation Area and Severity Index (MoPASI), global photoaging, and sallowness at week 12 compared to baseline. Significant reductions in tactile roughness were seen with the OMP regimen at week 12. In these investigator-blinded assessments, there were no significant differences between treatment groups, nor was there a difference in global response to treatment. Investigator assessments of tolerability showed mean scores were mild or below for all parameters with both treatment regimens.
CONCLUSION: A new 4-product (HQ-free) regimen was shown to be as effective and tolerable as a 7-product (HQ-based) regimen in reducing facial hyperpigmentation and photoaging in females with mottled pigmentation and photodamaged facial skin.
J Drugs Dermatol. 2013;12(3 suppl 1):s32-s37.
Assessment of a Superficial Chemical Peel Combined With a Multimodal, Hydroquinone-Free Skin Brightener Using In Vivo Reflectance Confocal Microscopy
Lisa T. Goberdhan BA, Lora Colvan BA, Elizabeth T. Makino BS CCRA MBA, Caroline Aguilar RN BSN, and Rahul C. Mehta PhD|The combination of in-office procedures such as chemical peels with topical maintenance therapies has been shown to provide greater efficacy than either treatment by itself in the management of melasma. A series of 3 case studies were conducted to evaluate the efficacy and tolerability of one superficial chemical peel (containing a proprietary blend of resorcinol, lactic acid, salicylic acid, and retinol) combined with a topical multimodal, hydroquinone-free skin brightener as postpeel maintenance therapy. Patients presented with moderate to severe facial hyperpigmentation. At baseline, subjects received the superficial chemical peel treatment followed by a standard postpeel skin care regimen (cleanser, moisturizer, and SPF 30+ sunscreen). Approximately 1 week after the peel procedure, subjects initiated twice-daily application of the skin brightener. Subjects were then evaluated for Global Improvement in Hyperpigmentation by the investigator for up to 7 weeks postpeel. Standardized digital photographs of the subjects facial skin and in vivo reflectance confocal microscopy (RCM) images were taken of a target hyperpigmented lesion at baseline and at follow-up. Standardized photography and in vivo RCM images at baseline and at postpeel show the improvements observed by the investigator. Results from these case studies suggest that the combination of a superficial chemical peel with topical maintenance and the multimodal skin brightener may provide an effective treatment approach for subjects with moderate to severe facial hyperpigmentation.
J Drugs Dermatol. 2013;12(3 suppl 1):s38-s41.
Mona S. Foad MD and Erin Winters BA|To assess the treatment of hyperpigmentation, a series of 5 case studies were conducted to evaluate the efficacy and tolerability of a novel hydroquinone-free treatment regimen combining a multimodal skin brightener with a cleanser, high strength retinol product and sunscreen SPF 30+. Patients presented with moderate to severe facial hyperpigmentation as determined by a score of 4 to 8 on the Overall Hyperpigmentation scale. Physician-graded Overall Hyperpigmentation, Global Improvement in Hyperpigmentation, and standardized photography were conducted at weeks 3, 6, and 12. At week 12, the majority of patients demonstrated Global Improvements in Hyperpigmentation of at least 50%, with at least a 2-grade reduction in Overall Hyperpigmentation scores, as assessed by the physician. Standardized photographs also support the physician and patient findings. Results from these case studies demonstrate that this unique 12-week treatment regimen can provide an effective and simple option for patients with facial hyperpigmentation.
J Drugs Dermatol. 2013;12(3 suppl 1):s42-s44.