Search Results for "Atopic Dermatitis"
Tejaswi Mudigonda BS, William Kaufman MD, and Steven R. Feldman MD PhD| |
J Drugs Dermatol. 2016;15(1):114-115.
Effect of Skin Barrier Emulsion Cream vs a Conventional Moisturizer on Transepidermal Water Loss and Corneometry in Atopic Dermatitis: A Pilot Study
Leon H. Kircik MD| |
J Drugs Dermatol. 2014;13(12):1482-1484.
Arta Farshidi BS, Parrish Sadeghi MD| |
Kendra Gail Bergstrom MD| |
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.
J Drugs Dermatol. 2012;11(10):1158-1165.
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.
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.
The Role of a Novel Daily Cleansing and Moisturizing Regimen in the Management of Atopic Dermatitis: A Clinical Review
The efficacy of Galderma’s Cetaphil® and Restoraderm® support the emerging and available data that epidermal barrier function and its repair are a crucial element in treating patients with atopic dermatitis and several other common dermatoses. The Galderma Restoraderm products are novel formulations that support the epidermal barrier by enhancing filaggrin expression, which restores natural moisturizing factors in the skin and helps to rebuild a healthy skin barrier. The Restoraderm products are over-the-counter, widely available, and competitively priced, making them accessible to a large majority of the patient population.
Lisa Prussick BSc,a,b Natalia Plotnikova MD,a and Alice Gottlieb MD PhDa,b| |
J Drugs Dermatol. 2016;15(6):715-718.
Lauren K. Hoffman BSa and Leon Kircik MDb| |
J Drugs Dermatol. 2017;16(9):919-922.
Matthew C. Matsunaga MDa and Paul S. Yamauchi MD PhDb| |
J Drugs Dermatol. 2016;15(8):925-929.
Evidence-Based Skincare: The Importance of Offering Moisturization, Relief, and Protection in Common Skin Disorders
Leon H. Kircik MD FAAD| |
J Drugs Dermatol. 2014;13(6):725-728.
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| |
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.
Joanna L. Chan, AB; Linda Davis-Reed, MD and Alexa Boer Kimball, MD, MPH| |
Joseph Bikowski MD| |
J Drugs Dermatol. 2012;11(7):804-807.
Marita Zimmermann MPH PhD,a David Rind MD MSc,b Rick Chapman PhD, MS,b Varun Kumar MBBS MPH MSc,b Sonya Kahn MPH,b Josh Carlson PhD MPHa| |
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.
Alice He BS,a Steven R. Feldman MD PhD,a,b,c and Alan B. Fleischer Jr. MDd| |
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.
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.
Good Adherence and Early Efficacy Using Desonide Hydrogel for Atopic Dermatitis:Results From a Program Addressing Patient Compliance
Brad A. Yentzer MD, Fabian T. Camacho MS, Trudye Young MD, Julie M. Fountain CCRC,Adele R. Clark PA-C, Steven R. Feldman MD PhD| |
Purpose: To assess adherence to and efficacy of a multifaceted program for atopic dermatitis using a lightweight, easy-to-apply medication and more frequent return visits.
Methods: Forty-one subjects with mild-to-moderate atopic dermatitis were instructed to use desonide hydrogel 0.05% twice daily. Disease severity was measured at baseline and weeks 1, 2 and 4. Subjects also received a follow-up phone call on day 3. Adherence was assessed using electronic monitors. At the end of the study, subjects sampled and rated the vehicle attributes of six different topical corticosteroid formulations.
Results: Mean adherence to twice-daily application slowly declined over time, from 81% on day 1 to 50% by day 27. An improvement in pruritus was observed as early as day 3, and by week 4, mean pruritus and EASI scores improved from baseline by 60% and 61%, respectively. Mean SGA scores also improved to marked improvement/almost clear by week 4. In vehicle attribute surveys, the hydrogel was consistently rated higher than the other vehicles in all categories.
Conclusion: Subjects responded very well to treatment, and adherence to desonide hydrogel 0.05% was much better than previously reported with ointments. The early efficacy, favorable attributes of the hydrogel vehicle and judicious follow up likely increased adherence to topical therapy. The use of ointments or more potent topical steroids as a first choice may be counterproductive in the treatment of atopic dermatitis.
Topical Corticosteroid Treatment Choice: A Clinical and Practical Discussion of Clocortolone Pivalate Cream
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.
Peter Rullan MD and Jenny Murase MD| |
Anna Kurayev MD and Alice B. Gottlieb MD PhD| |
J Drugs Dermatol. 2016;15(10):1267-1269.
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.
William Abramovits MD, Alan B. Fleischer Jr MD, Eileen Jaracz Pharm D, Debra Breneman MD| |
Adelaide A. Hebert MD and Fran E. Cook-Bolden MD for the Desonide Hydrogel Study Group, Sarmistha Basu PhD, Barry Calvarese MS, Ronald J. Trancik PhD| |
Gillian K. Weston MD,a Jette Hooper,b Bruce E. Strober MD PhDa| |
J Drugs Dermatol. 2018;17(3):355-356.
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.
A Multiple-Domain Framework of Clinical, Economic, and Patient-Reported Outcomes for Evaluating Benefits of Intervention in Atopic Dermatitis
Mark Boguniewicz MD, William Abramovits MD, Amy Paller MD, Diane L. Whitaker-Worth MD, Mary Prendergast MBA, J. Wang Cheng, Patrick Wang, Kuo B. Tong MS| |
Scott A. Davis MA,a Hsien-Chang Lin PhD,b Cheng-Han Yu MA,c
Rajesh Balkrishnan PhD,d and Steven R. Feldman MD PhDa,e,f
PURPOSE: To characterize the timing of first follow-up visits in US dermatologic practice.
Methods: Patients with a diagnosis of psoriasis, acne, or atopic dermatitis were identified in the 2003-2007 MarketScan Medicaid database. Factors affecting the length of time before first follow-up were assessed using a Cox proportional hazards model.
RESULTS: Mean length of time to the first follow-up visit was 153 days for adults and 142 days for children with psoriasis; 151 days for adults and 218 days for children with acne; and 161 days for adults and 209 days for children with atopic dermatitis. Black and those other than white patients were less likely than whites to receive early follow-up in psoriasis and acne, but more likely in atopic dermatitis. Dermatologists were more likely to schedule early follow-up visits than nondermatologists.
LIMITATIONS: The database includes only Medicaid patients. The rate of non-attendance at scheduled visits could not be determined.
CONCLUSIONS: Most physicians are missing the opportunity to maximize patient adherence by scheduling early follow-up visits. Contact by email or phone may be beneficial for physicians who cannot schedule early follow-up.
J Drugs Dermatol. 2014;13(7):833-836.
Over-the-Counter Product Role in the Daily Management of Atopic Dermatitis: Achieving Success With Advanced Technology
Leon H. Kircik MD| |
Joseph F. Fowler Jr. MD FAAD| |
J Drugs Dermatol. 2014;13(10):1180-1183.
Stefano Veraldi MD PhD, Paolo De Micheli MSc, Rossana Schianchi MD, Luisa Lunardon MD| |
Pharmacokinetics of Tacrolimus Following Topical Application of Tacrolimus Ointment in Adult and Pediatric Patients with Moderate to Severe Atopic Dermatitis
Gerald G. Krueger MD, Lawrence Eichenfield MD, J. John Goodman MD, Bernice R. Krafchik MD, Christopher S. Carlin MD, Mei-Lin Pang MD, Richard Croy MA, Mary Elizabeth Holum MS, Eileen Jaracz PharmD, Taiji Sawamoto PhD, James Keirns PhD| |
Methods: Tacrolimus ointment 0.03% or 0.1% was applied twice daily. In the adult and pediatric pharmacokinetic studies, serial blood samples were obtained after single and repeated topical application. During the 12 clinical efficacy trials of tacrolimus ointment, single blood samples were obtained at various times relative to tacrolimus ointment application.
Results: In the pharmacokinetic studies, 89% to 95% of tacrolimus whole blood concentration samples were less than 1 ng/mL; mean maximum concentrations ranged from 0.2 to 1.6 ng/mL and mean area under the blood concentrationtime curves (0-12 hours) ranged from 1.4 to 13.1 ng·hr/mL. Likewise, in the clinical efficacy trials, the majority (85%- 99%) of tacrolimus concentration samples were less than 1 ng/mL.
Conclusions: Tacrolimus ointment is associated with minimal systemic absorption and no evidence of systemic accumulation in patients with moderate to severe atopic dermatitis and extensive disease.
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.
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.
Topical Clofibrate Improves Symptoms in Patients With Atopic Dermatitis and Reduces Serum TARC Levels: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
Mototsugu Fukaya MDa and Hajime Kimata MD PHDb| |
METHODS: This study was conducted as a double-blind design to investigate the effects of random administration of topical clofibrate and base (placebo) on skin manifestation and blood parameters of patients for 2 weeks. Severity was digitized using severity scoring systems for atopic dermatitis by the Japanese Dermatological Association (SSS-JDA) before and after two weeks. Subjective severity of patients was evaluated using visual analog scale (Pt-VAS). Serum thymus and activation-regulated chemokine (TARC) and immunoglobulin E (IgE) were also investigated.
RESULTS: Twenty patients were enrolled, and 19 of 20 patients completed the study. In 19 patients, the value of severity score using SSS-JDA was decreased significantly after administration of topical clofibrate (P=0.001). Subjective evaluation using Pt-VAS (P=0.008) and serum TARC levels (P=0.03) were also significantly decreased after two weeks of topical clofibrate. There was not a significant difference in serum IgE levels. No adverse effect was observed.
CONCLUSIONS: Topical clofibrate is useful for patients with AD especially who are reluctant to use topical steroids.
J Drugs Dermatol. 2014;13(3):259-263.
Efficacy of a Lipid-Based Barrier Repair Formulation in Moderate-to-Severe Pediatric Atopic Dermatitis
Jeffrey L. Sugarman MD PhD and Lawrence Charles Parish MD| |
Methods: In a five-center, investigator-blinded, randomized trial, EpiCeram was compared to fluticasone (Cutivate®) cream in 121 patients with moderate-to-severe AD. Primary outcome measures were: 1) reduction in disease severity, assessed as SCORAD (Severity Scoring for Atopic Dermatitis) scores; 2) improvement in pruritus; and 3) improvements in sleep habits.
Results: EpiCeram reduced clinical disease severity, decreased pruritus and improved sleep habits both 14 and 28 days after initiation of therapy. Although the fluticasone-treated group showed significantly greater improvement at 14 days, SCORAD, pruritus and sleep habit scores for EpiCeram did not differ significantly from the fluticasone-treated group by 28 days.
Conclusion: The ceramide-dominant, physiological-lipid based formulation could represent an effective stand-alone or ancillary therapy for many pediatric patients with AD.
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.
Winning Poster: A Phase 2, Open-Label, Investigator-Initiated Study to Evaluate the Safety and Efficacy of Apremilast in Subjects with Recalcitrant Contact or Atopic Dermatitis
Eva Volf MD| |
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.
Crisaborole Topical Ointment, 2% in Adults With Atopic Dermatitis: A Phase 2a, Vehicle-Controlled, Proof-of-Concept Study
Dedee F. Murrell MD FRCP,a Kurt Gebauer MD,b Lynda Spelman MBBS FACD,c and Lee T. Zane MDd| |
METHODS: This phase 2a, randomized, double-blind, bilateral, 6-week study of crisaborole topical ointment, 2% was conducted in adult patients with mild to moderate AD with 2 comparable target AD lesions. Patients were randomly assigned to twice-daily application of crisaborole topical ointment, 2% or vehicle, each to 1 of the 2 target lesions. The primary efficacy endpoint was change from baseline in Atopic Dermatitis Severity Index (ADSI) score at day 28. Safety assessments included local tolerability and incidence of adverse events (AEs).
RESULTS: A total of 25 enrolled patients received study medication. At day 28, 17 patients (68%) experienced a greater decrease in ADSI score in the active-treated lesion than in the vehicle-treated lesion; 5 patients (20%) had a greater decrease in ADSI score in the vehicle-treated lesion than in the active-treated lesion. Local application-site reactions were reported in 3 patients (12%). A total of 29 AEs were reported in 11 patients; most (90%) were mild in intensity and unrelated to study medication. No serious or severe AEs were reported, and no patient discontinued due to an AE.
CONCLUSIONS: These findings provide preliminary evidence of the efficacy and safety of treatment with crisaborole topical ointment, 2% in adults with mild to moderate AD.
The study is registered on ClinicalTrials.gov (identifier NCT01301508).
J Drugs Dermatol. 2015;14(10):1108-1112.
A Nonsteroidal Lamellar Matrix Cream Containing Palmyitoyethanolamide for theTreatment of Atopic Dermatitis
Leon Kircik MD| |
Seung Yoon Lee MD, Doo Rak Lee MD, Chung Eui You MD, Mi Youn Park MD PhD, Sook Ja Son MD PhD| |
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.
An Approach to Pruritus in Atopic Dermatitis: A Critical Systematic Review of theTacrolimus Ointment Literature
Alan B. Fleischer Jr. MD and Mark Boguniewicz MD| |
Rino Cerio MD, Magdalene Dohil MD, Jeanine Downie MD FAAD, Sofia Magina MD, Emmanuel Mahé MD, Alexander J. Stratigos 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.
Efficacy of a Moisturizing Foam in Skin Barrier Regeneration and Itch Relief in Subjects Prone to Atopic Dermatitis
Peter A. Lio MD| |
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.
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.
Leon Kircik MD, James Del Rosso DO FAOCD| |
J Drugs Dermatol. 2012;11(10):1174-1178.
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
Clobetasol Propionate 0.05% Lotion in the Treatment of Moderate to Severe Atopic Dermatitis: A Randomized Evaluation versus Clobetasol Propionate Emollient Cream
Debra Breneman MD, Alan B Fleischer Jr. MD, David Kaplan MD, Mark G. Lebwohl MD, Bruce Miller, MD, David Pariser, MD, Toivo Rist MD, L. Swinyer MDh, Yin Liu PhD, Valerie Foley PharmD| |
A Phase 2, Randomized, Controlled, Dose-Ranging Study Evaluating Crisaborole Topical Ointment, 0.5% and 2% in Adolescents With Mild to Moderate Atopic Dermatitis
Linda F. Stein Gold MD,a Lynda Spelman MBBS FACD,b Mary C. Spellman MD,c Matilda H. Hughes CCRA,d and Lee T. Zane MDd| |
METHODS: In this multicenter, randomized, double-blind, dose-ranging, phase 2 study, adolescent patients 12 to 17 years of age with mild to moderate AD and 2 distinct target AD lesions were randomized to once-daily (QD) or twice-daily (BID) treatment with crisaborole topical ointment. For each patient, 2 target lesions were randomized to receive 29 days of treatment with 0.5% or 2% crisaborole topical ointment. The primary endpoint was change from baseline in AD severity index (ADSI) score for each lesion. Exploratory efficacy endpoints and safety were also assessed.
RESULTS: A total of 86 patients were enrolled and received crisaborole topical ointment 0.5% or 2% QD (n=44) or BID (n=42). All dosing regimens produced dose-related improvements in ADSI as well as in all 5 component signs and symptoms of AD (erythema, excoriation, exudation, lichenification, and pruritus). The greatest improvements were consistently observed with crisaborole topical ointment, 2% applied BID. With this regimen, ADSI improved from baseline by 71%, and total or partial clearance of target lesions (ADSI ≤2) was achieved by 62% of patients after 29 days of treatment. Both doses of crisaborole topical ointment were well tolerated; mild application site reactions were the only treatment-related adverse events (QD, n=3; BID, n=1).
CONCLUSION: These results provide preliminary evidence of the efficacy and safety of crisaborole topical ointment, 2% applied topically BID in adolescents with mild to moderate AD.
J Drugs Dermatol. 2015;14(12):1394-1399.
Crisaborole Topical Ointment, 2%: 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.
Charu Taneja MPH, Richard J. Antaya MD, Ariel Berger MPH, Thomas S. Marshall PharmD,Raafat Seifeldin PhD, Gerry Oster PhD| |
Objective: To assess the cost-effectiveness of tacrolimus versus pimecrolimus in adults with AD.
Methods: Using a Markov cohort model, the authors projected clinical and economic outcomes over six weeks in adults receiving tacrolimus versus pimecrolimus. Cost-effectiveness was assessed in terms of the ratio of the expected cost of AD-related care to the expected number of days with resolved AD.
Results: Patients receiving tacrolimus had an estimated 4.9 fewer days with active AD over six weeks (30.0 versus 34.9 for pimecrolimus). Expected costs (per patient) of AD-related care also were lower for tacrolimus patients ($501.27 versus $546.14, respectively).
Limitation: While pimecrolimus is indicated for use solely in patients with mild-to-moderate AD, the trial on which this study was based included some patients with severe AD.
Conclusion: In adults with AD, tacrolimus 0.1% may yield better clinical outcomes and lower costs of care than pimecrolimus 1.0%.
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.
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.
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.
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| |
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.
Sari Weinstein, MD and Ronald R. Branacaccio, MD| |
An Evidence-based Review of the Efficacy of Coal Tar Preparations in the Treatment of Psoriasis and Atopic Dermatitis
Jordan B. Slutsky MD, Richard A. F. Clark MD, Alexander A. Remedios MD, Peter A. Klein MD| |
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.
Ann R. Tucker BA,a Ashley N. Emerson MD,a Julie P. Wyatt MD,b Robert T. Brodell MDc| |
Aditya k. Gupta, MD;, PhD, FRCP(C) and Karyn A. Nicol, HBMSc| |
Amy L. Gosnell BS, Susan T. Nedorost MD| |
Objective: To determine whether amlodipine therapy is more common among patients with stasis dermatitis than age-matched controls.
Methods: In this retrospective chart review study, the medication lists of all subjects with stasis dermatitis from a single practice site over the past 2 years were compared to alphabetically consecutive charts of patients with basal cell carcinoma to determine the relative usage of amlodipine.
Results: Patients with stasis dermatitis (n = 43) are more likely to take amlodipine than are basal cell carcinoma patients (n = 117) of similar age (19% vs. 5%, P < .02), even when controlled for the use of any antihypertensive medications (25% vs. 10%, P = .05).
Conclusion: Amlodipine therapy is associated with stasis dermatitis and discontinuing amlodipine should be considered when stasis dermatitis is diagnosed.
Background: Some dermatologic disorders are known to be much more common in patients of color, but the leading dermatologic
disorders in patients of color have not yet been described on the basis of nationally representative data.
Purpose: To determine the leading dermatologic disorders for each major racial and ethnic group in the United States.
Methods: We queried the National Ambulatory Medical Care Survey (NAMCS) for the leading diagnoses in patient visits to U.S. dermatologists from 1993 to 2009. The leading diagnoses were tabulated for each racial and ethnic group, and the top conditions were compared between groups. In a separate analysis, visits for skin conditions regardless of physician specialty were analyzed for leading diagnoses in each racial and ethnic group.
Results: The top five diagnoses for African-American patients in dermatology clinics were acne, unspecified dermatitis or eczema, seborrheic dermatitis, atopic dermatitis, and dyschromia. For Asian or Pacific Islander patients, the top five were acne, unspecified dermatitis or eczema, benign neoplasm of skin, psoriasis, and seborrheic keratosis. By contrast, in Caucasian patients, the top five were actinic keratosis, acne, benign neoplasm of skin, unspecified dermatitis or eczema, and nonmelanoma skin cancer. In Hispanic patients of any race, the leading diagnoses were acne, unspecified dermatitis or eczema, psoriasis, benign neoplasm of skin, and viral warts. When the leading dermatologic diagnoses across all physician specialties were assessed, the top diagnoses for African-Americans were unspecified dermatitis or eczema, acne, dermatophytosis of scalp and beard, sebaceous cyst, and cellulitis or abscess; for Asians or Pacific Islanders were unspecified dermatitis or eczema, acne, atopic dermatitis, urticaria, and psoriasis; and for Caucasians were acne, unspecified dermatitis or eczema, actinic keratosis, viral warts, and sebaceous cyst. For Hispanics of any race, they were unspecified dermatitis or eczema, acne, sebaceous cyst, viral warts, and cellulitis or abscess. For a sole diagnosis of a dermatologic condition, only 28.5% of African-Americans' visits and 23.9% of Hispanics' visits were to dermatologists, as compared to 36.7% for Asians and Pacific Islanders and 43.2% for Caucasians.
Limitations: The data are based on numbers of ambulatory care visits rather than numbers of patients. Data on race or ethnicity were not collected for some patients.
Conclusions: Several dermatologic disorders are much more commonly seen in patients of color. Acne and unspecified dermatitis or eczema are in the top five for all major U.S. racial and ethnic groups. There may be an opportunity to improve the care of patients of color by ensuring they have equal access to dermatologists.
J Drugs Dermatol. 2012;11(4):466-473.
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.
Robert Matheson MD, Steven Kempers MD, Debra Breneman MD, Zoe Draelos MD, Candice E. Johnson MD PhD,Robert Loss MD, Daniel J. Hogan MD, Robert Schoenfeld MD, Scott Checketts MD, Leon Kircik MD,David Fivenson MD, Adelaide A. Hebert MD, Judith Williams MD, Regina Hamlin MD, Daniel Groisser MD,Dan Piacquadio MD| |
Objective: The objective of this study was to evaluate the efficacy and safety of HCB 0.1% lotion compared to the vehicle in subjects aged 3 months to less than 18 years with mild to moderate atopic dermatitis (AD).
Methods: In this multicenter double-blind study, 284 subjects with mild to moderate AD were randomized 1:1 to receive HCB 0.1% lotion or the vehicle for a duration of 4 weeks. “Treatment success” was defined as those subjects with a final Physician Global Assessment (PGA) score of 0 or 1 that had at least a 2-point reduction in the PGA score from baseline to day 29. Safety was assessed by monitoring adverse events.
Results: Analyses of the final PGA score showed a significant treatment effect (P<.001) in favor of the HCB 0.1% lotion group. The safety profile of the HCB 0.1% lotion was also favorable.
Limitations: The study did not assess the durability of the treatment effects (ie, safety and efficacy) after completion of the 4-week treatment period nor the potential need for longer term therapy given the chronic nature of AD.
Conclusion: Results demonstrate the safety and efficacy of HCB 0.1% lotion in the treatment of mild to moderate AD in children 3 months to 18 years of age.
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.
Holly R. Mason MD PhD, Jil K. Swanson PA-C, Jonhan Ho MD, Timothy J. Patton DO| |
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.
Jacob Levitt, MD, Terry Feldman, MD; Ildiko Riss, MD and On-Tai Leung, MD| |
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.
The Treatment of Inflammatory Facial Dermatoses With Topical Corticosteroids:Focus on Clocortolone Pivalate 0.1% Cream
Methods: Clocortolone pivalate 0.01% cream was applied to affected facial skin in subjects presenting with seborrheic dermatitis, contact dermatitis, atopic dermatitis, or psoriasis. Application was completed three times daily for 21 days. Assessments of erythema, edema, transudation, lichenification, scaling, pruritus and/or pain were completed at baseline and Days 4, 7, 14, and 21. Overall therapeutic response was assessed at all follow-up visits. Forty-nine subjects were entered, ranging in age from 1 month to 88 years of age. Thirty-eight subjects completed the studies, with 11 subjects lost to follow-up after the first visit. Individuals between the ages of 13 and 19 years were pre-emptively excluded to avoid potential application of a corticosteroid to acne-affected or acne-prone skin.
Results: Treatment with clocortolone pivalate 0.1% cream resulted in decreases in erythema, edema, transudation, lichenification, scaling, and pruritus/pain in 76% of treated study subjects. The overall therapeutic response in approximately two-thirds of the subjects (68%) was rated as good to excellent. There were 7 adverse events noted over the course of the study that were judged to be related to treatment, all of which were cutaneous and localized to the site of application (acneiform eruptions, burning, and folliculitis).
Conclusion: Clocortolone pivalate 0.1% cream was effective in relieving the signs and symptoms of corticosteroid-responsive inflammatory dermatoses involving facial skin, including seborrheic dermatitis, contact dermatitis, atopic dermatitis, and psoriasis. Overall, the safety profile was favorable and devoid of any treatment-related serious adverse events.
J Drugs Dermatol. 2012;11(10):1194-1198.
Kendra Gail Bergstrom 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.
Brian Berman MD PhD,a,b Charles Ellis MD,c and Craig Elmets MDd,*| |
J Drugs Dermatol. 2016;15(2):224-228.
Magdalene A. Dohil MD| |
J Drugs Dermatol. 2013;12(suppl 9):s128-s132.
Neal Bhatia MD| |
J Drugs Dermatol. 2013;12(7):796-798.
Dede Liu MD,a Peter Chow BS,b Sarah Strawn MD,a Anand Rajpara MD,a Ting Wang MD,a and Daniel Aires MD JDa| |
Danah M. Holman, Amer N. Kalaaji MD| |
Aditya K. Gupta MD PhD FRCP (C), Melody Chow HBSc| |
Brian Berman MD PhD, James Q. Del Rosso DO, Jacquelyn Levin DO, Paul C. Contard MD PhD| |
Fortunately, Promius Pharma, one of the leaders in this field, has now brought to market a generic formulation of clocortolone pivalate 0.1% that is exactly the same as their original branded product. This has been shown to be effective and well tolerated in the management of several corticosteroid-responsive dermatoses, and is a welcome addition to the treatment armamentarium.
Fiona P. Blanco MD, Richard K. Scher MD FACP| |
Effects of a Novel Formulation ofFluocinonide 0.1% Cream on Skin BarrierFunction in Atopic Dermatitis
Matthew T. Woods MD, Peter A. Brown BS, Shahana F. Baig-Lewis MPH, Eric L. Simpson MD MCR| |
Design: The authors performed an open-label, investigator-blinded, side-by-side, controlled trial examining skin barrier function before and after a two-week course of a class I, super-potent topical steroid.
Setting: Outpatient university-based dermatology clinic in Portland, OR.
Subjects: Twenty-five subjects aged 12 or older with a diagnosis of moderate, severe, or very severe AD were recruited for this study. Intervention: Fluocinonide 0.1% cream, a novel formulation of a class I super-potent topical steroid was applied to all affected areas, except a control site, once daily for two weeks or until clear. The control target site was treated with the vehicle once daily. Main Outcome Measure(s): The study’s primary outcome was change in skin barrier function as measured by basal transepidermal water loss (TEWL) in acute lesional skin from baseline as measured at two weeks.
Results: TEWL readings significantly decreased (reflecting improved barrier function) in both the active and control target sites. The active target site decreased 14.35±16 mg/cm2 per hour; 95 percent confidence interval, P<0.001. The control target site decreased 8.75±11.80 mg/cm2 per hour in 25 subjects; 95 percent confidence interval, P<0.001. Skin electrical capacitance also improved significantly, reflecting improved stratum corneum hydration with therapy. Pruritus, clinical severity, and quality of life scores all showed significant improvement by the end of the study.
Conclusion: The authors have shown that short-term treatment with a novel formulation of 0.1% fluocinonide led to significantly improved barrier function as measured by basal TEWL in subjects with active moderate to severe AD. These data suggest short-term treatment with AD with a super-potent corticosteroid improves skin barrier function.
J Drugs Dermatol. 2011;10(2):171-176.
Lawrence F. Eichenfield MD, Melissa L. Bogen ELS| |
Efficacy and Safety of a New Once-Daily Topical Ketoconazole 2% Gel in the Treatment of Seborrheic Dermatitis: A Phase III Trial
Boni Elewski MD, Mark R. Ling MD PhD, Tania J. Phillips MD| |
Scott JM Lim DO, W Elliot Love MSIV| |
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
Samreen Z. Choudhry MD,a Neal Bhatia MD,b Roger Ceilley MD,c Firas Hougeir MD,d
Robert Lieberman MD,e Iltefat Hamzavi MD,a and Henry W. Lim MDa
J Drugs Dermatol. 2014;13(2):148-153.
Craig G. Burkhart, MPH,MD and Heidi R. Burhart, BA| |
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.
J Drugs Dermatol. 2012;11(8):979-987.
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.
Steven L. Harlan MD FAAD| |
Objective: To assess patient reported outcomes in patients receiving compounded topical (hydrocortisone 0.75% and precipitated sulfur 0.5%) lotion for up to 15 years for common dermatological conditions of the face.
Methods: In a retrospective study, 300 patients were randomly sampled from the dermatology clinic who had used, or were continuing to use, a lotion based, pharmacy-compounded topical preparation for the face. The topical compound was used in therapies for seborrheic dermatitis and combination with prescription topical therapy for patients with acne and rosacea with tolerability problems.
Results: None of the 300 patients experienced steroid acne, rebound phenomenon, or perioral dermatitis associated with use of hydrocortisone 0.75% and precipitated sulfur 0.5% on the face.
Conclusion: There was no evidence found that perioral dermatitis, steroid acne, or rebound phenomenon occurs when sulfur is compounded with topical hydrocortisone 0.75%.
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.
Vicky Kwan Wong, BA; Christine Della Croce, MA; Sara Schonfeld; Anthony M. Mastrangelo, PhD and Mark Lebwohl, MD| |
Alopecia Areata Treated With Efalizumab: A Case With Significant HairRe-Growth After Long-Term Therapy
Jeffrey R. Smith MPH, Russell S. Akin MD, Michael J. Wells MD| |
Whitney P. Bowe MD, Magdalene A. Dohil MD, Alan C. Logan ND, Andrew F. Alexis MD MPH| |
Hendrik Uyttendaele, Md, PhD; Joseph Obadiah, MD and Marc Grossman, MD| |
Adaeze Egesi BS, Grace Sun MS, Amor Khachemoune MD , Rashid M. Rashid MD PhD| |
Sowmya Nanjappa MD, Matthew Snyder PharmD, and John N. Greene MD FACP| |
Extravasation of medications can manifest as tenderness, pain, tissue necrosis, and thrombophlebitis and lead to infection and severe long-term complications. Risk factors for leakage of medications include mechanical and pharmacologic mechanisms such as cannulation technique, vasoconstriction, and cytotoxicity. Well-known vesicants like anthracyclines, vinca alkaloids, and vasopressors are usually administered with proper caution. Often overlooked are many antimicrobial agents, which typically act via differences in osmolality and pH. Vancomycin harms the vascular wall by the latter (pH 2.5-4.5). Although similar in appearance to vancomycin hypersensitivity reactions (eg, linear immunoglobulin A bullous dermatosis), we present a patient whose dermatitis and subsequent cellulitis likely originated due to extravasation of the drug from the peripheral intravenous catheter. The visible dermatitis mimicked bullous cellulitis from toxin-producing Staphylococcus aureus, Group A Streptococcus, and gram-negative rods or anaerobes in the setting of neutropenia. Our case illustrates the importance of getting an appropriate history and recognizing non-infectious causes of rashes that mimic chronic infections.
Natural supplements are currently experiencing a renaissance in dermatology. Although they have been used for centuries, many have been recently validated for various skin conditions by scientific studies. Natural supplements, such as mushroom extracts, are capable of accelerating the skin turnover rate and repairing dermal molecular components that provide structure and elasticity to the skin. Moreover, teas and feverfew have anti-inflammatory, anti-irritant, and antioxidant properties, and their applications include the treatment of sensitive skin, shaving-induced irritation or redness, and photoprotection. Dyschromia is one of the most common dermatological concerns in patients with darker skin, and blinded controlled studies have found that hyperpigmentation can be assuaged by the skin lightening effects of soy, niacinamide, n-acetylglucosamine, licorice extract, arbutin, vitamin c, kojic acid, emblica extract, lignin peroxidase, and glutathione. Blinded controlled studies have also demonstrated that atopic dermatitis can be mitigated by oatmeal, feverfew, chamomile, aloe vera, licorice, and dexpanthenol.
Peter A. Lio MD| |
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.
Joseph F. Fowler Jr. MD, Heather Woolery-Lloyd MD, Heidi Waldorf MD, Ritu Saini MD| |
A Novel Foam Formulation of Ketoconazole 2% for the Treatment of Seborrheic Dermatitis on Multiple Body Regions
Boni E. Elewski MD, William Abramovits MD, Steven Kempers MD, Joel Schlessinger MD, Theodore Rosen MD, Aditya K. Gupta MD PhD, Sabra Abraham MS, Richard Rowell| |
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.
Regine J. Mathieu BS,a Nikoo Cheraghi MD,b and Marian A. Russo MDb| |
Leon Kircik MD| |
Joshua Zeichner MDa and Sophie Seite PhDb| |
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Tolerance to Calcitriol and Tacalcitol in Three Patients with Allergic Contact Dermatitis to Calcipotriol
Foti Caterina MD, Carnimeo Luigi MD, Bonamonte Domenico MD, Conserva Anna MD, Casulli Claudia MD, Angelini Gianni MD| |
Rodrigo Roldán-Marín MD, Fernando de-la-BarredaBecerril MD| |
Amy K. Schecter, BS; Michelle D. Lewis, MD; Leslie Robinson-Bostom, MD and Teddy D. Pan, MD| |
Joseph Bikowski MD FAAD| |
Noah Scheinfeld, MD| |
First generation antihistamines such as hydroxizine are effetive but cause sedation. The initial second generation antihistamines, terfanadine and astemizole, were effective non-sedating medications but had drug interactions that caused cardiac problem and have been pulled from the market in the United States. Later second generation antihistamines, such as loratidine and cetirizine, have been found to be effective in the treatment of allergic rhinitis, and the latter to be effective in the treatment of chronic idiopathic urticaria. More recently, third generation antihistamines have been developed from existing agents (e.g. desloratadine is the active metabolite of loratidine, levocetirizine is the racemically active component of cetirizine, and fexofenadine is a derivative of terfanadine) to increase effectiveness and decrease side effects. Desloratadine has been released in the United States and Europe, while levocetirizine is currently only available in Europe. This article will review over 50 clinical studies and reviews regarding desloratadine and levocetirizine with an overview of their possible dermatological use.
Elnaz F. Firoz BA, Bahar F. Firoz MD MPH, James F. Williams PA-C, Jeffrey S. Henning DO| |
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.
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.
A Natural Cream-to-Powder Formulation Developed for the Prevention of Diaper Dermatitis in Diaper-Wearing Infants and Children: Barrier Property and In-Use Tolerance Studies
Hemali B. Gunt PhD,a Stanley B. Levy MD,b Celeste A. Lutrario BSa| |
Johnathan J. Ledet MD and Lee H. Grafton MD| |
Mark Abdelmalek MD, Shruti Mahindrakar BS, Elizabeth Wiser MD| |
Patricia T Ting BSc, Shane Silver MD FRCPC| |
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.
Efficacy of a Hand Regimen in Skin Barrier Protection in Individuals With Occupational Irritant Contact Dermatitis
Laura Jordan DO MS| |
A Multicenter, Open-Label Study to Assess the Safety and Efficacy of Ciclopirox Topical Suspension 0.77% in the Treatment of Diaper Dermatitis Due to Candida Albicans
Elizabeth Gallup MD JD MBA, The Ciclopirox TS Investigators, Todd Plott MD| |
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.
Dermal Microflora Restoration With Ammonia-Oxidizing Bacteria Nitrosomonas Eutropha in the Treatment of Keratosis Pilaris: A Randomized Clinical Trial
Nicole Y. Lee MD MPH,a Omer Ibrahim MD,b Shilpi Khetarpal MD,c Mariya Gaber,d Spiros Jamas ScD,d Ioannis Gryllos PhD,d and Jeffrey S. Dover MD FRCPCe| |
J Drugs Dermatol. 2018;17(3):285-288.
Adam J. Friedman MD FAAD,a Erika C. von Grote PhD,b Matthew H. Meckfessel PhDb| |
J Drugs Dermatol. 2016;15(5):633-639.
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.
Lauren Craig MD and Michael Cosulich MD| |
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.
Gretchen E. Korver MD PhD, Ronald Harris MD MBA, Marta J. Petersen MD| |
Topical Tacrolimus 0.1% Improves Symptoms of Hand Dermatitis in Patients Treated With a Prednisone Taper
Jennifer Krejci-Manwaring MD, Martha Ann McCarty MS PA-C, Fabian Camacho MS MA, Janeen Manuel PhD,Jennifer Hartle MPH, Alan Fleischer Jr MD, Steven R. Feldman MD PhD| |
Objective: To evaluate symptoms of hand dermatitis in subjects treated with a prednisone taper combined with topical tacrolimus 0.1% ointment versus vehicle.
Methods: Thirty-two subjects with moderate to severe hand dermatitis were enrolled in a randomized double-blind controlled trial. Subjects received a 3-week taper of prednisone and was randomized 2:1 to apply topical tacrolimus or its vehicle twice daily for 12 weeks. Disease severity was evaluated at baseline and at 5 follow-up visits (weeks 1-14). Any occurrence of relapse was recorded by patients.
Results: Twenty-two of the 32 subjects (69%) had relapse of their disease. The mean time to recurrence for tacrolimus versus vehicle was 48 versus 39 days, respectively (P=.78). A greater improvement of induration (P=.003) and scaling (P=.003) for patients with tacrolimus compared to vehicle was detected, as well as subjective improvement (%) from week 1 to week 12 (P=.04) compared to vehicle. Improvement in erythema (P<.0001), fissuring (P=.0003), pruritus (P=.06), and investigator’s global assessment (P<.0001) with tacrolimus was not found to exceed improvement with vehicle.
Limitations: Small sample size provides limited power to detect differences in response.
Conclusions: Topical tacrolimus improves induration and scaling, and there is a trend suggesting it prolongs the time to recurrence.
An Open-label Study of the Safety and Efficacy of Sertaconazole Nitrate in the Treatment of Seborrheic Dermatitis
Boni E. Elewski MD and Wendy C. Cantrell CRNP| |
Design: Single-center, open-label study.
Setting: One academic medical center.
Participants: Twenty adult male and female subjects aged 22 to 85 years (average, 56 years) with mild-to-severe seborrheic dermatitis of the face.
Measurements: The primary efficacy evaluation was the proportion of subjects with a score of 0 or 1 at the end of treatment (week 4) on the Investigator's Static Global Assessment scale. Secondary end points included percent change from baseline to week 4 in sum individual scores of erythema, scaling, induration, and pruritus at a preselected target lesion. Other end points included change in scores on Subject's Global Assessment scale and the Dermatology Life Quality Index.
Results: Success on the primary end point was achieved by 10 of 17 evaluable subjects (58.8%). Improvements in Investigator's Static Global Assessment score from baseline were statistically significant at each week. Significant improvements were also demonstrated in erythema, scaling, induration, and pruritus at week 4 compared to baseline. Improvement in Subject's Global Assessment scores compared to baseline were significant only at week 1 (P=0.031). Change in total mean SD Dermatology Life Quality Index scores from baseline to week 4 was 0.34 (± 0.62, P=0.039).
Conclusion: The results of this preliminary study support the efficacy and safety of sertaconazole nitrate cream, 2%, for the treatment of seborrheic dermatitis.
J Drugs Dermatol. 2011;10(8):898-902.
A Randomized Controlled Clinical Trial Assessing the Effect of Betamethasone Valerate 0.12% Foam on the Short-Term Treatment of Stasis Dermatitis
Stefan C. Weiss MD MHSc, Josephine Nguyen MD, Susan Chon MD, Alexa B. Kimball MD MPH| |
Objective: To investigate the efficacy of twice-daily application of the topical steroid betamethasone valerate 0.12% foam for the treatment of stasis dermatitis.
Design: 42-day randomized, double-blinded, vehicle-controlled, pilot study.
Settings: Outpatient dermatology clinic at a university-affiliated clinic.
Subjects: 19 subjects, mean age of 73, with mild to moderate bilateral stasis dermatitis.
Intervention: Twice-daily application of betamethasone valerate 0.12% foam versus vehicle foam to bilateral randomly assigned lower legs for 28 days with follow-up to day 42.
Main Outcome Measures: The primary clinical endpoints were the mean change in erythema, scale, swelling, petechiae, post-inflammatory hyperpigmentation, and self-reported pruritus, assessed on a 5-point Likert scale (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe). Secondary endpoints were changes in health related quality of life (HRQL) using the EuroQol-5D (EQ-5D) utility score and visual analog scale (VAS) and the Dermatology Life Quality Index (DLQI).
Results: Although there was no overall difference between the foam and vehicle-treated leg at days 14 and 28, the steroid-treated leg, but not the vehicle-treated leg, showed statistical improvement over baseline. Improvement in the steroid-treated leg was statistically better than vehicle at days 14 and 28 in terms of erythema (P < .05) and petechiae (P < .05). Improvement in VAS was notable at days 14 (7.1%), 28 (9.7%), and 42 (9.6%) (P < .001). Similarly, there was a statistically significant improvement in the DLQI compared to baseline on visit days 14 (188.9%) and 28 (126.1%) (P < .001).
Conclusions: This study suggests that betamethasone valerate 0.12% foam is an effective and well-tolerated short-term treatment of stasis dermatitis, but that higher potency steroids may be needed to achieve better efficacy. Furthermore, these results are the first to suggest that the application of effective topical anti-inflammatory therapy can lead to improvement in HRQL.
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.
Long-term Safety of Ketoconazole Foam, 2% in the Treatment of Seborrheic Dermatitis: Results of a Phase IV, Open-Label Study
Zoe D. Draelos MD a, Steven R. Feldman MD PhD b, Victoria Butners BSc c, and Alessandra B. Alió Saenz MD c| |
Objective: To assess the long-term safety of ketoconazole foam, 2%, twice daily, as required.
Methods: A 12-month, open-label, multicenter study. Subjects were evaluated at baseline and at weeks 4, 8, 16, 26, 39, and 52 (or early termination [ET]) for adverse events (AEs), serious AEs (SAEs), target lesion erythema, scaling, and pruritus, as well as Investigator's Static Global Assessment (ISGA) scores. Physical examinations were performed at baseline and at week 52/ET, and laboratory evaluations at baseline and at weeks 8, 26, and 52. A poststudy product-preference questionnaire was completed.
Results: Of 500 subjects enrolled, 498 were included in the safety population, and 363 completed the study. Overall, 57% of subjects reported ≥1 AE. Treatment-related AEs occurred in 14% of subjects, including application-site irritation (8%), application-site pain (4%), application-site pruritus (1%), and increased alanine aminotransferase (1%). Seven subjects were withdrawn because of treatment-related AEs. No SAEs (21 in 17 subjects) were considered to be related to study drug. Mean target lesion erythema, scaling, and pruritus scores improved by 2 units from baseline at all study visits; mean ISGA score improved by 1 unit at week 4 and by 2 units at subsequent visits. The foam vehicle was preferred by 67% of subjects.
Limitations: Evaluation of severity was limited to target lesion; no objective measure of adherence.
Conclusion: The long-term safety profile of ketoconazole foam, 2%, in subjects with seborrheic dermatitis was favorable and efficacy was maintained. This trial was registered at clinicaltrials.gov (NCT00703846).
J Drugs Dermatol. 2013;12(1):e1-e6.
Evaluation of the Performance of a Nature-Based Sensitive Skin Regimen in Subjects With Clinically Diagnosed Sensitive Skin
Zoe Diana Draelos MD,a Stanley B. Levy MD,b Celeste Lutrario,c Hemali Gunt PhDc| |
The Multifunctionality of 10% Sodium Sulfacetamide, 5% Sulfur Emollient Foamin the Treatment of Inflammatory Facial Dermatoses
Zoe Diana Draelos MD| |
Visible Light Photopatch Testing of Common Photocontactant in Female Filipino Adults With and Without Melasma: A Cross-sectional Study
Vermen M. Verallo-Rodwell MD, Jeni M. Pua MD, Desiree Bautista MD| |
Comparison of Skin Concentrations Following Topical Versus Oral Corticosteroid Treatment: Reconsidering the Treatment of Common Inflammatory Dermatoses
Richard W. McClain BS, Brad A. Yentzer MD, Steven R. Feldman MD PhD| |
Purpose: To analyze the assumption that oral corticosteroid therapy should be more potent than topical therapy by comparing relative corticosteroid concentrations in the skin expected with topical versus systemic administration.
Methods: The estimated skin concentration of prednisone following oral dosing was calculated based on data showing 70–100% bioavailability and an even tissue distribution. Data on the concentration of corticosteroids found in skin after topical application were obtained from the literature. The relative potencies of corticosteroid molecules were then used to compare skin concentrations of corticosteroid following topical versus oral treatment.
Results: Data derived from the existing literature demonstrated that hydrocortisone 2.5% ointment, triamcinolone 0.1% ointment, and clobetasol 0.05% foam achieved effective skin concentrations greater than the effective concentration achieved by oral prednisone. Betamethasone 0.1% cream achieved effective concentrations in skin within the range created by oral prednisone.
Limitations: This analysis was limited by the paucity of data regarding cutaneous concentrations of corticosteroids after topical application, and by the differing experimental designs utilized in the available studies.
Conclusion: Most topical corticosteroids have the potential to achieve greater effective drug levels in the superficial layers of skin than those achieved with standard doses of oral prednisone. The apparently greater efficacy of oral corticosteroid therapy may be attributable, in part, to poor patient compliance with topical therapy. Systemic alterations in immune function following oral, but not topical, corticosteroid use may also play a role.
David S. Lee MD,a* Nicholas Gulati BA,b* Frank Martiniuk PhD,c William R. Levis MDd| |
J Drugs Dermatol. 2011;10(10):1192-1194.
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| |
Martha P. Arroyo, MD, PhD; Patricia Heller, MD and Miriam Keltz Pomeranz, MD| |
Drug reactions are an uncommon and unpredictable complication of medical therapy. Cutaneous drug reaction rates occur with a frequency of 1% to 8% and can be higher for certain classes of drugs1. They can range from mild morbilliform eruptions to more severe forms such as drug-hypersensitivity syndrome, toxic epidermal necrolysis or anaphylaxis. Acute generalized exanthematous pustulosis (AGEP) is a rare presentation of a drug reaction and can be difficult to distinguish from other pustular dermatoses. Herein we review a case of AGEP and include a discussion of salient clinical and histological features of AGEP.
Mark A. Strom BS,a Girish C. Mohan MD,b and Peter A. Lio MDa| |
Efficacy of Topical 4% Quassia amara Gel in Facial Seborrheic Dermatitis:A Randomized, Double-Blind, Comparative Study
Christian Diehl MDa and Alicia Ferrari MDb| |
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.
Photodistributed Erythema Multiforme: Palitaxel-related Photosensitive Conditions in Patients With Cancer
Philip R. Cohen MD| |
Yasuhiro Horiuchi MD, SangJae Bae MD, Ichiro Katayama MD| |
Roselyn E. Epps MD| |
Heat-Shock Proteins as Drugs: Potential Applications in Cancer, Infections, and Autoimmune and Atopic Diseases
Aton M. Holzer MD, Frank Martiniuk PhD, William R. Levis MD| |
Aditya K Gupta MD PhD FRCP(C), Karyn Nicol HBMSc| |
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.
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Rebecca Lu BA, Rajani Katta MD| |
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.
Julie M. Kaufmann; Elizabeth K. Hale, MD; Robin Ashinoff, MD and David E. Cohen, MD| |
James R. Schwartz PhD| |
J Drugs Dermatol. 2016;15(2):140-144.
Liza Brown DO and Stanley Skopit DO MSE FAOCD FAAD| |
CPT Sunghun Cho MC, USA, CPT Jennifer J. Breedlove MC, USA, Sean T. Gunning MD Grace Sun MD, Carina A. Wasko MD, Sylvia Hsu MD| |
F. Emily Bell, MD and Melissa P. Daniles, MCS| |
Lissy Hu BA,a Christina Alexander BA,b Nicole F. Velez MD,c F. Clarissa Yang MD,c
Alvaro Laga Canales MD MMSc,c,d Stephanie Liu MD,c and Ruth Ann Vleugels MD MPHc,
J Drugs Dermatol. 2015;14(6):628-630.
Ife J. Rodney MD, Oge C. Onwudiwe MD, Valerie D. Callender MD, and Rebat M. Halder MD| |
J Drugs Dermatol. 2013;12(4):420-427.
Catherine Warner BS, Young Kwak BA, Mary H.B. Glover MD, and Loretta S. Davis MD| |
J Drugs Dermatol. 2014;13(3):360-362.
Joanne E. Smucker BSa and Joslyn S. Kirby MDb| |
J Drugs Dermatol. 2014;13(3):356-358.
Sujatha Tadicherla MD, Kate Ross BS, Philip D. Shenefelt MD, Neil A. Fenske MD| |
Jennifer Rivard MD, Henry W. Lim MD| |
Pilot Evaluation of a Novel Topical Formulation Containing High Level, Cholesterol-Dominant, Physiological Lipids for Specific Targeting of Skin Barrier Deficits in Aging Skin
Hema Sundaram MD,a Ana Du BS,b Margarita Yatskayer MS,b Stephen Lynch PhD,b Yevgeniy Krol,c and Christian Oresajo PhDb| |
Christina Shwereb, Eve J Lowenstein MD PhD| |
Tracy M. Campbell MD, Rachel Neems BS, Julie Moore MD| |
An Open-Label Pilot Study of Naftifine 1% Gel in the Treatment of Seborrheic Dermatitis of the Scalp
Topical antifungal treatment is a mainstay of therapy for Seborrehic Dermatitis (SD). Although the amidazole and ciclopyridine antifungals have been extensively studied, few clinical efficacy data are available for topical allylamine therapy in SD. The objective of this open-label exploratory study was to evaluate the efficacy and safety of natifine HCl 1% gel applied twice daily for 4 weeks, as topical treatment of moderate SD of the scalp. Nine subjects (5 men, 4 women) with a mean age of 56 (33-81) years with SD of the scalp were enrolled and made 4 visits to the site. At Visit 1 (Week 0), subjects were screened, enrolled, baseline efficacy data were obtained, and treatment was initiated. Subjects returned at Week 2, Week 4 (end of treatment), and Week 6 for efficacy and safety assessments. Efficacy was evaluated by changes from baseline in investigator-rated scores on 0-5-grade scales: (1) SD Global Evaluation Scale (SDGES), (2) Erythema Severity Scale, (3) Scaling Severity Scale, (4) % Scalp Involvement Scale, and subject-rated scores on the (4) Itching Severity Scale, and (5) Global Improvement Scale, where 0=none and 5=most severe. Mean severity scores for the SDGES and % Scalp Involvement scales progressively declined (improved) 66% and 54% from respective baseline levels at Week 6. Mean erythema rating decreased 38% from baseline and scaling decreased 50% from baseline by Weeks 4 and 6. Itching improved in 5 of 9 (56%) subjects by the end of treatment. A total of 8 of 9 (89%) subjects rated their symptoms as improved from baseline at the end of treatment and Week 6. There were no treatment-related adverse events during the study. These results suggest that naftifine 1% gel applied twice daily for 4 weeks is effective and safe topical treatment for moderate SD of the scalp.
J Drugs Dermatol.2012;11(4):514-518.
Michael Lundin BS,a Simran Chawa BS,a Amit Sachdev MD,b Dhaval Bhanusali MD,c Kristina Seiffert-Sinha MD,d Animesh A. Sinha MD PhDd| |
J Drugs Dermatol. 2014;13(4):409-413.
Aanand N. Geria MD, Christina N. Lawson MD, Rebat M. Halder MD| |
J Drugs Dermatol. 2011;10(5):483-489.
Keyvan Nouri, MD and Halland Chen, MD| |
These potential side effects can be divided into intraoperative and postoperative complications. Intraoperative complications include bleeding, damage to vital organs, nerve injuries, allergic reactions to anesthetics, and electrocautery-associated complications. Postoperative complications include contact dermatitis, infection, chondritis, wound dehiscence, necrosis of the skin, suture spitting, suture tracking, excessive granulation tissue, non-healing wounds, pigment change, and scars/keloids. In this article, these surgical complications and their management will be covered.
Frank Martiniuk PhD, David S. Lee MD, Anthony Gaspari MD, Herman Yee MD PhD, Luis Chiriboga PhD, Maryann Huie PhD, Kam-Meng Tchou-Wong PhD, and William R. Levis MD| |
Alan Menter, MD| |
Topical corticosteroids, however, including low-potency fluocinolone acetonide, also exert an anti-metabolic effect, resulting in decreased epidermal turnover, and, thus, may produce a mild depigmenting effect. When used in combination with tretinoin and hydroquinone in the treatment of melasma, fluocinolone acetonide 0.01% suppresses biosynthetic and secretory functions of melanocytes, and thus melanin production, leading to early response in melasma, synergy among the three agents, and no significant side effects over an 8-week period.
Joy Makdisi BS,a Bijal Amin MD,b and Adam Friedman MDa,c| |
J Drugs Dermatol. 2013;12(9):1050-1051.
Lichenoid Dermatitis From Interferon alpha-2a in a Patient With Metastatic Renal Cell Carcinoma and Seronegative HCV
Amelia E. Bush MD,a Sharon R. Hymes MD,b and Sirunya Silapunt MDc| |
Cutaneous reactions to interferon, including a lichenoid drug reaction, are most commonly reported in patients undergoing treatment for hepatitis C virus (HCV) infection. There have been case reports of interferon-induced lichen planus in seronegative HCV patients with lymphoproliferative disorders and melanoma. We report the case of a 71-year-old man undergoing treatment with interferon for metastatic renal cell carcinoma (RCC) who developed an eruption 2 months after starting interferon. Clinical and histological findings from biopsies supported a diagnosis of interferon-induced lichen planus. To our knowledge, this is the first known case of a lichenoid drug eruption from interferon in a seronegative HCV patient with metastatic RCC.
J Drugs Dermatol. 2017;16(7):714-716.
Gina R. Chacon MD, David J. Wolfson MD, Carlos Palacio MD, Animesh A. Sinha MD PhD| |
Ritu Saini MD FAAD, Deborah S. Sarnoff MD FAAD FACP| |
Colin A. Ruff MD, Justin J. Vujevich MD, Leonard H. Goldberg MD FRCP| |
Yulia K. Khan, Amer N. Kalaaji MD, Bart L. Clarke MD| |
Cutaneous Lupus Erythematosus in a Patient Undergoing Intravitreal Bevacizumab Injections: Case Report and Review of the Literature
Nathan Cleaver DO,a James Ramirez MD,b and Stuart Gildenberg MDa| |
CASE PRESENTATION: We report a case of a 63 year-old Caucasian female who presented with subacute cutaneous lupus erythematosus six weeks after initiating two intravitreal injections of bevacizumab for central serous choroidopathy.
CONCLUSION: We report the first documented case of a cutaneous lupus erythematosus eruption following bevacizumab administration as a monotherapy.
J Drugs Dermatol. 2013;12(9):1052-1055.
Beneficial Effect of a Moisturizing Cream as Adjunctive Treatment to Oral Isotretinoin or Topical Tretinoin in the Management of Acne
Sabine Laquieze MD, Janusz Czernielewski MD, Marie-José Rueda MD| |
Background: Scalp hyperkeratosis and/or alopecia are common pediatric dermatologic findings. In Caucasian children, scalp hyperkeratosis
of childhood is most often associated with atopic and seborrheic dermatides. Recent data is lacking on the clinical meaning of scalp hyperkeratosis and alopecia in children of color.
Objective: To determine diagnosis associated with scalp hyperkeratosis and/or alopecia in a predominately Black and Hispanic pediatric patient population.
Methods: A retrospective chart review was conducted for all children (0-17 years of age) seen at our institution who had a scalp fungal culture for the evaluation of scalp hyperkeratosis and/or alopecia from January 2007 to September 2009. Fungal culture was performed using cotton swab technique, plating onto Sabouraud's and Mycosel media. Demographic features, fungal culture results, clinical symptoms, physical findings and final diagnosis were reviewed.
Results: 164 children were identified who were eligible for inclusion in the study, 75 of whom were Black and 56 Hispanic/Latino. Scalp hyperkeratosis was noted in 106 patients and alopecia was noted in 71 subjects. Tinea capitis was the final diagnosis in 50 out of 80 children who had hyperkeratosis without alopecia (60%), 16 of 43 children with alopecia alone (37.2%) and 23 of 28 children with both hyperkeratosis and alopecia (82.1%, P=0.0007). The odds ratio of tinea capitis in the presence of hyperkeratosis with alopecia was 7.49 with a 95 percent confidence limit of 2.19-25.70.
Conclusion: Scalp hyperkeratosis, especially when accompanied by alopecia, is usually associated with tinea capitis in Black and Hispanic children. Fungal culture and empirical anti-fungal therapy are warranted in children of color with scalp hyperkeratosis.
J Drugs Dermatol. 2011;10(5):511-516.
Sharona Yashar MD, Steven S. Wu MD, Scott W. Binder MD, Jonathan Cotliar MD| |
Zoe Diana Draelos MD| |
METHODS: Seven sites on the anterior leg of 30 subjects were dry shaven with 10 upward strokes. Subjects rated the stinging of petrolatum (negative control), isopropyl alcohol (positive control), Cetaphil Lotion, triamcinolone 0.1% cream, triamcinolone 0.2% spray, betamethasone foam, and clobetasol 0.05% spray, 1 minute after product application, using a scale of 0 (no symptoms) to 10 (intolerable stinging/burning). The investigator assessed erythema at the sites 30 minutes after application of the products using a scale of 0 (none) to 4 (severe).
RESULTS: Stinging rating score of each product was statistically significant from one another. Petrolatum produced the least stinging (0) and isopropyl alcohol the most (10). Stinging with triamcinolone spray, Cetaphil Lotion, and triamcinolone cream ranked in the lower half of the rating scale (all below 5). Betamethasone foam and clobetal spray ranked the highest at >7. When corrected for the erythema caused by shaving, triamcinolone spray and Cetaphil Lotion produced the least amount of erythema of all the products tested.
DISCUSSION: Rapid evaporation of the volatile vehicle of triamcinolone spray and the non-irriating nature of the medication left behind may contribute to its low erythema and stinging. This product may be an appropriate choice for patients with compromised skin but who require the advantages and conveniences of a spray vehicle.
J Drugs Dermatol. 2016;15(7):870-873.
Laura F. Sandoval DO,a Scott A. Davis MA,a and Steven R. Feldman MD PhDa,b,c| |
PURPOSE: The primary aim of this study is to determine how dermatologists classify particular topical corticosteroids according to potency, and which products they prefer in cases when allergenicity is a concern.
METHODS: The data were collected and analyzed from 105 US-based dermatologists surveyed at the 2011 Summer American Academy of Dermatology meeting.
RESULTS: The majority of dermatologists were in agreement on the potency ranking of many commonly prescribed topical corticosteroids. Two thirds of the surveyed dermatologists expressed concern about allergy to topical corticosteroids. In cases of a suspected allergy, desoximetasone was the leading product dermatologists would choose to prescribe.
LIMITATIONS: The survey was limited to attendees of an educational conference, possibly leading to an overestimation of dermatologist knowledge of topical steroids.
CONCLUSIONS: This study shows that dermatologists are generally knowledgeable about group classifications of corticosteroids in terms of potency and that they can appropriately select a topical product with low potential for allergy.
J Drugs Dermatol. 2013;12(7):786-789.
A Double-Blind, Placebo-Controlled Pilot Study to Estimate the Efficacy and Tolerability of a Nonsteroidal Cream for the Treatment of Cradle Cap (Seborrheic Dermatitis)
Elmer David MD,a Hanan Tanuos MD,a Timothy Sullivan MD,b Albert Yan MD,c and Leon H. Kircik MDd-f| |
J Drugs Dermatol. 2013;12(4):448-452.
Avnee Shah BS, Jenna ONeill MD, Steven R. Feldman MD PhD| |
Nazanin Saedi MDa and Anand K. Ganesan MDb| |
MATERIALS/METHODS: With approval from the institutional review board at the University of California, Irvine, an electronic survey was sent to practicing dermatologists that contained 18 questions regarding the approach to evaluating and treating hyperpigmentation under the eyes, in the axilla, and along the neck.
RESULTS: Fifty dermatologists completed the survey, and 46 (92%) reported treating patients with darker skin. The ethnic groups treated were Latino (97.8%), African American (97.8%), Middle Eastern (77.6%), and Asian (88.9%). Thirty-six reported treating patients with hyperpigmentation under the eyes, and 22 (61.1%) thought the hyperpigmentation was a result of idiopathic increase in melanin deposition. Forty-two responded to treating hyperpigmentation in the axilla, most of whom thought it was related to acanthosis nigricans (69.0%) or contact dermatitis (59.5%). Forty responded to treating hyperpigmentation on the neck, most of whom treated the condition with hydroquinone (66%). Treatments for these 3 areas were not found to be effective.
CONCLUSIONS: Hyperpigmentation under the eyes, under the arms, or on the neck is a significant problem in darker-skinned patients that is refractory to currently available treatments, highlighting the necessity of developing treatment approaches directed toward this population. Two cases of hyperpigmentation on the neck are presented, describing a new entity that primarily affects dark-skinned individuals.
J Drugs Dermatol. 2013;12(5):563-567.
Safety and Efficacy of a Fixed Combination Halobetasol and Tazarotene Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: A Pooled Analysis of Two Phase 3 Studies
Jeffrey L. Sugarman MD PhD,a Jonathan Weiss MD,b Emil A. Tanghetti MD,c Jerry Bagel MD,d Paul S. Yamauchi MD,e Linda Stein Gold MD,f Tina Lin, PharmD,g Gina Martin MOT,h Radhakrishnan Pillai PhD,h Robert Israel MDi| |
Maj. J. Scott Henning DO and Bahar F. Firoz MD MPH| |
Methods: A cross-sectional study was performed for all dermatology visits presenting to the Combat Dermatology Clinic, Ibn Sina, Iraq, between January 15, 2008 and July 15, 2008.
Results: In the six-month period reviewed, 2,696 total patients were evaluated. The most prevalent diagnoses included eczematous dermatitis [17%, n=462] and benign neoplasms [14%, n=375]. Eight percent (n=205) of the total visits were for skin cancer. This included: basal cell carcinoma, squamous cell carcinoma both in-situ and invasive, mycosis fungoides and melanoma. Actinic keratosis comprised 5% of the total visits (n=129). Bacterial infections comprised 6% (n=158) of the total visits and 31 of these cases were community acquired methicillin resistant Staphylococcus aureus (MRSA).
Limitations: Cross-sectional study with referral bias.
Conclusion: This is the largest publication of the prevalence of skin disease in an exclusively dermatologic clinic in a combat setting. For the first time the presence of skin cancer is noted in a combat setting. The prevalence of MRSA is noted and was exclusively seen in U.S. soldiers. There was a statistically significant rise in the prevalence of eczematous dermatitides when compared with previous conflicts. Dermatologists can have a significant and strategic impact on deployed military medicine.
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.
Efficacy and Tolerability of a Skin Brightening/Anti-Aging Cosmeceutical Containing Retinol 0.5%, Niacinamide, Hexylresorcinol, and Resveratrol
Patricia Farris MD,a Joshua Zeichner MD,b and Diane Berson MDc| |
The use of this skin brightening/anti-aging cosmeceutical was found to provide statistically significant improvements in all efficacy endpoints by study end. Fine lines, radiance, and smoothness were significantly improved as early as week 2 (P<.001). By week 4, hyperpigmentation, overall skin clarity, evenness of skin tone, and wrinkles showed statistically significant improvement compared to baseline. Mild retinoid dermatitis including flaking and redness occurred early in the study as reflected by tolerability scores. By week 10, subjects reported no stinging, itching, dryness, or tingling.
The results of this open-label clinical study suggest that a topical cream containing retinol 0.5% in combination with niacinamide, resveratrol, and hexylresorcinol is efficacious and tolerable for skin brightening/anti-aging when used with a complementary skin care regimen including SPF 30 sun protection.
J Drugs Dermatol. 2016;15(7):863-868.
Wendy E. Roberts MD| |
J Drugs Dermatol. 2014;13(4):472-482.
Pivotal Trial of the Efficacy and Safety of Oxymetazoline Cream 1.0% for the Treatment of Persistent Facial Erythema Associated With Rosacea: Findings from the First REVEAL Trial
Leon H. Kircik MD,a Janet DuBois MD,b Zoe Diana Draelos MD,c Philip Werschler MD FAAD FAACS,d Kimberly Grande MD,e Fran E. Cook-Bolden MD,f Emily Weng ScD MBA,g David R. Berk MD,g and Gurpreet Ahluwalia PhDg| |
J Drugs Dermatol. 2018;17(1):97-105.
A Double-Blind, Randomized, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Naftifine 2% Cream in Tinea cruris
Objective: To evaluate their therapeutic regimen of 8% and 10% topical precipitated sulfur in petrolatum ointment for single day, three successive nights or three successive days in management of scabies.
Patients and Methods: This single-blinded, comparative study was conducted in the Department of Dermatology-Baghdad Teaching Hospital from April 2008 through October 2009. A total of 97 patients with scabies were enrolled in this study. The diagnosis was established on clinical basis. The patients treated with 8% and 10% topical sulfur in petrolatum ointment were divided randomly into three groups: Group A: 33 patients treated for single day (24 hours); Group B: 32 patients treated for three successive nights (from 6 p.m. to 8 p.m. to 6 a.m. to 8 a.m. and bathing every day); and Group C: 32 patients treated for three successive days (bathing every 24 hours). The patients were seen regularly every two weeks for the duration of four weeks.
Results: Study included 58 (59.8%) males and 39 (40.2%) females, with a male to female ratio 1.4:1. The age range of males at presentation from 3 to 64 (26.74±15.98) years, while the females age ranged at presentation from 3 to 60 (24.05±14.53) years of age. At the end of the study, the response to treatment was: Group A, response in 14 (42.4%) patients and no response in 19 (57.6%); Group B, response in 29 (90.6%) patients and no response in 3 (9.4%); and Group C, response in 31 (96.9%) patients and no response in 1 (3.1%). There is significant statistical difference among the response of 3 groups with (P=0.00000011), but no statistically significant difference between the response of Group C and Group B, (P=0.6055). Mild burning sensation and irritating (sulfur) dermatitis were the only side effects of 8% and 10% sulfur. Pruritic rash occurred in Group C mainly, in 11 (34.4%) patients, 8 (25%) in Group B and 4 (12.1%) in Group A, with no significance (P=0.1058). Recurrence or relapse occurred in Group A mainly, with 4 (12.1%) patients, and in Group B, 1 patient, (3.1%), with no recurrence in group C, with significance (P=0.0060).
Conclusion: Three successive days and three successive nights of 8% and 10% sulfur ointment were effective regimens with no statistical difference in favor of three successive days, while single-day application was much less effective but with fewer side effects.
J Drugs Dermatol. 2012;11(3):357-364.
Evidence-Based Skincare: The Importance of Offering Moisturization, Relief, and Protection in Common Skin Disorders
Leon H. Kircik MD| |
Lawrence F. Eichenfield MD| |
Firas George Hougeir MD| |
Resident Spotlight. Orlando Dermatology Aesthetic & Clinical Conference (ODAC): Fourth Annual ARTE Poster Competition
Mara Therese P. Evangelista MD, Renita Ahluwalia MD, and Charlotte M. Clark MD| |
April W. Armstrong MD MPH, C.T. Harskamp BA, S. Cheeney MS, and C.W. Schupp PhD| |
Leon H. Kircik MD| |
Adjunctive Trichloroacetic Acid Therapy Enhances Response to Squaric Acid Response to Verruca Vulgaris
J Drugs Dermatol. 2012;11(10):1228-1230.
Leon H. Kircik MD| |
RESIDENT ROUNDS: PART I
Program Spotlight: Department of Dermatology,Oregon Health & Science University
Jonathan I. Silverberg MD PhD MPH and Nanette B. Silverberg MD| |
Background: Vitiligo vulgaris is a chronic autoimmune depigmenting disorder affecting individuals of all skin colors. Lesions are commonly noted in the periorificial face and over the upper and lower extremities in areas of friction. Although there have been many published reports of successful therapies for vitiligo, few have assessed differential response based on skin color.
Objective: To determine if topical tacrolimus is more effective at treating vitiligo in individuals of color.
Methods: An IRB-approved chart review of patients with a diagnosis of vitiligo was conducted including patients seen between May 2001 and April 2006. Patients with vitiligo were treated with tacrolimus 0.03% for children ages 2-15 years of age and tacrolimus 0.1% ointment for individuals 16 years of age or older, applied twice-daily to all hypopigmented or depigmented lesions. A review of clinical features, Fitzpatrick skin type and response to topical tacrolimus were recorded.
Results: Topical tacrolimus was effective in all Fitzpatrick skin types, with superior efficacy on body lesions in individuals of Fitzpatrick types 3-4 (Fisher exact test, P=0.03). Further, individuals with Fitzpatrick type 3-4 skin had shorter interval to >75 percent improvement of lesions on the body (Kaplan-Meier Log-rank, P=0.03) and head and neck (P=0.016).
Conclusion: Topical tacrolimus is an effective treatment for vitiligo irrespective of skin tone, with greatest benefit in Fitzpatrick type 3-4 skin. Repigmentation of lesions on the head and neck is superior to repigmentation of the body and extremities in all racial subgroups.
J Drugs Dermatol. 2011;10(5):507-510.
Whitney P. Bowe MD| |
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.
Prescilia Isedeh MD and Henry W. Lim MD| |
A pinpoint papular variant of PMLE has been reported in individuals with skin phototype IV-VI,4 characterized by the development of pinpoint papules, 1 to 2 mm, on sun-exposed areas after ultraviolet radiation.5 PMLE has a predilection for the arms, forearms, hands, head and neck region, usually with sparing of the face.2,4 We report two cases of American-American males who presented with the pinpoint papular variant of PMLE involving the face.
J Drugs Dermatol. 2013;12(11):1285-1286.
Kristin Totoraitis BS,a Joel L. Cohen MD,b and Adam Friedman MDc| |
Surgical procedures are an important piece of a dermatologist’s daily practice. Therefore, the optimization of post-surgical wound healing is an area of utmost importance and interest. Although low risk, one notable barrier to proper wound healing is surgical site infection.
In an attempt to mitigate this risk and improve surgical outcomes, multiple topical products continue to be used both pre- and postprocedure. Traditionally, this includes both topical antibiotics and antiseptics. However, these products are not without consequence.
The overuse of topical antibiotics as prophylaxis for infection has contributed to increased bacterial resistance, and in fact is no longer recommended by the American Academy of Dermatology in clean post surgical wounds. Topical antiseptics, including chlorhexidine and povidone-iodine, can have a cytotoxic effect on keratinocytes and may actually impede wound healing as a result. In addition, chlorhexidine in particular can produce both otologic and ocular toxic effects when used on the face. Emerging products, such as hypochlorous acid, may be a potential alternative to the more commonly used agents, as it has effective antimicrobial actions and minimal adverse effects. Therefore, the purpose of this review is to highlight several topical products used to optimize post-surgical wound healing and discuss both their efficacy and safety.
J Drugs Dermatol. 2017;16(3):209-212.
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.
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.
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.
Resident Rounds. Part III: Case Report: Temporary Traumatic Discoloration from Handling Moss-Covered Firewood
Kristine B. Zitelli MDa and Brian B. Adams MD MPHa,b| |
James Q. Del Rosso DO| |
Lindsey A. Brodell MD and Milan Anadkat MD| |
Lisa H. Lam PharmDa and Jeffrey L. Sugarman MD PhDb| |
OBJECTIVE: The objective of this study was to investigate the real world effects of chronic TCS use and its effects on adrenal suppression in a chronic disease such as psoriasis.
MATERIALS: This retrospective study utilized data from screening visits of a psoriasis clinical trial in which subjects had been on chronic TCS.
RESULTS: In this study, subjects with moderate to severe psoriasis affecting 16-20% of total body surface area (BSA) and using high-potency TCS at screening had a lower post-cosyntropin cortisol level (18.83 mcg/dL) compared to those with moderate psoriasis involving 10-15% of total BSA and using lower potency TCS at screening (23.22 mcg/dL; P=0.03). Both subject groups had lower post-cosyntropin cortisol levels compared to normal, healthy adults (P<0.001 for both).
CONCLUSION: This suggests that real world chronic use of high potency TCS over a larger BSA may result in silent adrenal suppression.
J Drugs Dermatol. 2016;15(8):945-948.
Taurine Chloramine Inhibits NO and TNF-α Production in Zymosan Plus Interferon-γ Activated RAW 264.7 Cells
Bo Sook Kim,a In Soo Cho,b Seung Yong Park,c Georgia Schuller-Levis,d William Levis,e Eunkyue Parkd| |
Taurine is present abundantly in various tissues, especially in leukocytes embattled to foreign invaders such as microorganisms or oxidants. Taurine-chloramine (Tau-Cl) is produced from taurine at the site of inflammation via the myeoloperoxidase-halide pathway in leukocytes induced by oxidants and/or infectious materials. Previously, our data demonstrated that Tau-Cl inhibited nitric oxide (NO) production and TNF-α secretion induced by lipopolysaccharide (LPS), a Toll-like receptor 4 (TLR-4) ligand or lipoarabinomannan (LAM), a TLR-2 ligand plus interferon-γ (IFN-γ) in peritoneal macrophages or RAW 264.7 cells. Zymosan, a β-glucan of yeast cell wall, is a ligand for TLR-2 and dectin-1 and stimulates macrophages to produce proinflammatory mediators such as NO and TNF-α. Based on our previous data, we examined the effect of zymosan and IFN-γ induced production of NO and TNF-α in the absence or presence of Tau-Cl or taurine using RAW 264.7 cells. Production of NO and secretion of TNF-α is increased when zymosan is combined with IFN-γ. Tau-Cl inhibited production of NO and secretion of TNF-α in zymosan plus IFN-γ activated RAW 264.7 cells in a dose-dependent manner (99% vs. 48% using 0.8mM Tau-Cl). Taurine was without effect. Nitric oxide synthase protein (iNOS), induced by zymosan plus IFN-γ, was inhibited by Tau-Cl (0.8mM) as measured using western blot analysis. NOS mRNA was inhibited by Tau-Cl at four, eight and 16 hours post activation, but not at 24 hours. TNF-α mRNA was inhibited at four hours and eight hours, but not at 16 and 24 hours. These data suggest that expression of both iNOS and TNF-α mRNAs are inhibited by treatment with Tau-Cl within four and eight hours, but not at later time points. Transient suppression of activation of RAW 264.7 cells induced by zymosan may play a critical physiological role for taurine in protecting against tissue injury from initial overt inflammation. This study indicates that tropical treatment of taurine may ameliorate inflammatory dermatoses caused by an environmental yeast or abnormal immune function.
J Drugs Dermatol. 2011;10(6):659-665.
Deborah S. Sarnoff MD FAAD FACP| |
Robert A. Swerlick MD aand Caren F. Campbell MD b| |
J Drugs Dermatol. 2013;12(1):99-102.
Topical Pimecrolimus 1% Reverses Long-term Suberythemal Ultraviolet B—induced Epidermal Langerhans Cell Reduction and Morphologic Changes in Mice
Methods:Thirty female mice were randomly divided into two groups, including four subgroups: (1A) control, (1B) pimecrolimus 1% only, (2A) 25 mJ/cm2 UVB only, (2B) UVB plus pimecrolimus. After being treated for 60 days, the dorsal skin was collected and given immunohistochemical staining of active caspase 3, and immunofluorescence staining for cluster of differentiation 1a (CD1a).
Results:Our results show that, compared with the control subgroup, the CD1a+ LC number in the epidermal sheet of the UVB-only subgroup decreased substantially from 578.6 per mm2 to 227 per mm2 (P<.001). Compared with the UVB-only subgroup, the UVB plus pimecrolimus subgroup significantly restored the LC number from 227 per mm2 to 475.7 per mm2 (P<.001). Compared with other subgroups, the LC morphology of the UVB-only subgroup became rounder, and the LC dendrites became shorter. There were no significant active caspase 3-positive cells in the epidermis in any of the four subgroups.
Conclusion:Our results show that topical pimecrolimus 1% reverses long-term UVB-induced epidermal LC reduction and morphologic changes in mice, where the exact mechanism is likely not related to apoptosis.
J Drugs Dermatol. 2012;11(9):e25-e27.
Staci Brandt PA-C MBA MSa and Peter Lio MDb| |
J Drugs Dermatol. 2014;13(3):264-266.
Kehinde Ogunmakin MD, Bryan Carroll MD, and Daneeque Woolfolk MD| |
Topical Cyclosporine Versus Emulsion Vehicle for the Treatment of Brittle Nails: A Randomized Controlled Pilot Study
Julian Mackay-Wiggan MD MS,a Jackleen Marji MD PhD,a John G. Walt MBA,b Angela Campbell,a Carol
Coppola,a Bibhas Chakraborty PhD,c David A. Hollander MD MBA,b and Scott M. Whitcup MDb
OBJECTIVE: To assess the efficacy and safety of topical cyclosporine emulsion (CsAE) versus emulsion (vehicle) alone in the treatment of brittle nail syndrome.
RESULTS: Twenty-four patients were randomized to topical CsAE emulsion or emulsion (vehicle) for 24 weeks. Four fingernails of each patient were included; the 2 most severe brittle nails and the second most normal nail were treated with the same medication. The fourth nail, the most normal nail, remained untreated and was used to assess nail growth. The prespecified primary endpoint was change from baseline in Physician Global Assessment (PGA) score (0 to 5 scale) at each follow-up visit. Safety evaluations were conducted at each visit.
RESULTS: In the intent-to-treat population (n=12 for each treatment arm), the PGA score for treated nails improved from baseline (CsAE, 0.7 to 1.4; emulsion, 0.7 to 1.5; P<0.05 for each), with no significant between-group differences. Untreated nails did not improve in overall appearance (0.0 to 0.3 grade; P>0.05). Statistically and clinically significant improvement from baseline was reported for nail length/appearance in both CsAE and vehicle groups.
LIMITATIONS: Sample size was relatively small. The difference in PGA between treated and untreated nails was not analyzed. Baseline disease severity may have been too mild, limiting detection of efficacy.
CONCLUSIONS: Both CsAE and emulsion vehicle applied topically appeared to improve signs and symptoms of brittle nail syndrome and were well tolerated. These findings warrant corroboration in a larger population and inclusion of comparison with an inactive control and a higher concentration of CsAE, the former which may help in distinguishing the efficacy of vehicle emulsion from CsAE.
J Drugs Dermatol. 2014;13(10):1232-1239.
Julia Schwartz MDa and Adam J. Friedman MDa,b| |
J Drugs Dermatol. 2012;11(8):1000-1002.
Salman M.S. Alsaad MDa and Maryann Mikhail MDb| |
Objective/Methods: To present dermatologists with a complete review of the literature with regard to anatomy, definition, etiology, and treatment of periocular hyperpigmentation.
Conclusions: Our understanding of the causes and treatment of periocular hyperpigmentation continues to advance. Nevertheless, we are in need of additional controlled clinical trials and novel therapeutic options. Individual patients will likely benefit most from a combination of approaches. Although more randomized clinical studies are necessary, Pfaffia paniculata/Ptychopetalum olacoides B.⁄Lilium candidum L. - associated compound cream seems to be a promising option, with 90% improvement. For patients with increased melanin deposition, quality-switched ruby laser therapy could offer a better treatment option. In the hands of experienced professionals, a surgical option might be suitable, either by autologous fat transplantation or hyaluronic acid filler.
J Drugs Dermatol. 2013;12(2):154-157.
Brian Keng Yeng Chia MRCP(UK) and Hong Liang Tey MRCP(UK)| |
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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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.
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.
Clinical Improvements in Very Dry Skin from a Natural Ingredient-Based Moisturizing Cream Compared With a Leading Colloidal Oatmeal Control
Hemali B. Gunt PhD,a Stanley B. Levy MD,b Celeste A. Lutrario BSa| |
Richard R. Winkelmann DO,a James Del Rosso DO FAOCD,b and Darrell S. Rigel MD MSc| |
J Drugs Dermatol. 2015;14(3):254-259.
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.
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.
Quality of Life and Satisfaction of Patients After Full-Face Injections of Abobotulinum Toxin Type A: A Randomized, Phase IV Clinical Trial
Doris Hexsel MD,a,b Cristiano Brum MD Ms,a,c Manoela D. Porto MD,a Mariana Soirefmann MD Ms,a,b
Carolina Siega BSc,a Juliana Schilling-Souza BPharm,a and Ticiana C. Rodrigues MD PhDa,d
OBJECTIVE: To assess the quality of life and satisfaction of patients treated with full-face injections of variable doses of abobotulinum toxin A (ABO).
METHODS: Ninety subjects were randomized into 3 different groups, receiving 120-165 U, 166-205 U and 206-250 U, respectively. WHOQOL- BREF and Satisfaction and Self-assessment Questionnaire (SSQ) were completed by subjects up to 6 months after treatment.
RESULTS: Most of the subjects were women (96.5%). For the physical domain in WHOQOL, a difference was observed between baseline and visit 2 (p = 0.036). There was no difference between groups for mean grades regarding amount of wrinkles, beauty, harmony and symmetry. However, there was a significant difference in the mean grades between visits. Patients' opinions also showed an improvement in their self-image up to four months after treatment, according to the self-grading.
CONCLUSION: The results presented in this study show improvements in patients' quality of life during the peak of action of BoNT-A treatment, regarding the physical aspect. In addition, patients reported good satisfaction after a full-face approach.
J Drugs Dermatol. 2013;12(12):1363-1367.
Steven R. Feldman MD PhD| |
J Drugs Dermatol. 2014;13(4):423-427.
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.
William Levis MD and Frank Martiniuk PhD| |
Yang Yu BS,a,b Jackson Champer MS,a David Beynet MD,a Jenny Kim MD PhD,a,c Adam J. Friedman MDd,e| |
J Drugs Dermatol. 2015;14(5):461-465.
Geoffrey F. S. Lim BS,a Catherine Y. Ding MD,b Katy Burris MDb| |
J Drugs Dermatol. 2014;13(6):755-757.
Joel Wolf BA and William R. Levis MD| |
Adjunctive Use of a Facial Moisturizer SPF 30 Containing Ceramide Precursor Improves Tolerability of Topical Tretinoin 0.05%: A Randomized, Investigator-Blinded, Split-Face Study
Methods:This was a randomized, investigator/evaluator-blinded, split-face comparison in subjects with healthy skin. Subjects applied tretinoin cream 0.05% once daily to the whole face and Cetaphil® Dermacontrol Moisturizer (CDM) once daily to one side of the face based on randomization. Tolerability, perference and skin hydration were evaluated at each week, and a cosmetic acceptability questionnaire regarding CDM was completed at the end of the study.
Results: The majority (about 83% to 86%) of subjects experienced skin irritations on both sides of their face, though predominantly mild for the CDM + tretinoin treated side. Tolerability preferences favored the CDM+tretinoin sides. Adjunctive use of CDM with a topical tretinoin cream improves tolerance of the treatment.
J Drugs Dermatol. 2012;11(9):1104-1107.
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 email@example.com
Generational Dermatology: Model for Prevention and Multi Decade Approach Toward the Evolving, Aging Patient
Wendy E. Roberts MD FAAD| |
J Drugs Dermatol. 2013;12(12):1396-1399.
Charlene Lam MD MPH, Jeffery J. Miller MD MBA, and Joslyn S. Kirby MD| |
Assessment of Efficacy and Irritation of Ingenol Mebutate Gel 0.015% Used With or Without Dimethicone Lotion for Treatment of Actinic Keratosis on the Face
Shelbi C. Jim On MD, Peter W. Hashim MD, John K. Nia MD, and Mark G. Lebwohl MD| |
Background: Ingenol mebutate gel 0.015% provides high clearance rates for actinic keratosis (AK) on the face and scalp but causes transient local skin responses (LSRs).
Objective: This study sought to determine whether the application of 1% dimethicone would decrease ingenol mebutate–associated LSRs and/or affect efficacy during the treatment of multiple AKs on the face.
Methods: Ingenol mebutate gel 0.015% was applied for 3 days to two 25 cm2 areas, each containing 3 to 8 AKs on the face of each subject, followed by application of 1% dimethicone lotion in an investigator-blinded manner to one randomly selected AK-containing area until LSRs were no longer present.
Results: In total, 20 subjects were enrolled and completed the study. Topical 1% dimethicone lotion applied during and after treatment of facial AK with ingenol mebutate gel 0.015% reduced mean total LSR scores at days 8 and 15 compared with ingenol mebutate gel only, although the difference was not statistically significant. Efficacy was equivalent between the two treatment arms.
Limitations: The study evaluated a relatively small number of subjects, all of whom were white.
Conclusions: The application of 1% dimethicone following ingenol mebutate gel 0.015% produced a trend toward lower severity of some LSRs, with no difference in efficacy.
J Drugs Dermatol. 2017;16(5):432-436.
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.
Del Rosso, J.Q.| |
Theresa N. Canavan MD and Boni E. Elewski MD| |
J Drugs Dermatol. 2015;14(suppl 10):s42-s47.
Postoperative Wound Care After Dermatologic Procedures: A Comparison of 2 Commonly Used Petrolatum-Based Ointments
Adisbeth Morales-Burgos MD,a,b Michael P. Loosemore MD, a,band Leonard H. Goldberg MDa-c| |
J Drugs Dermatol. 2013;12(2):163-164.
Efinaconazole 10% and Tavaborole 5% Penetrate Across Poly-ureaurethane 16%: Results of In Vitro Release Testing and Clinical Implications of Onychodystrophy in Onychomycosis
Chris G. Adigun MD,a Tracey C. Vlahovic DPM,b Michael B. McClellan MS,c Kailas D. Thakker PhD,c Ryan R. Klein PhD,c Tuan A. Elstrom BS,d and Daniel B. Ward Jr. MD FAADd| |
OBJECTIVE: The purpose of this work was to determine through in vitro release testing (IVRT) whether poly-ureaurethane 16% allows for penetration of efinaconazole 10% or tavaborole 5%. Results could spur subsequent clinical studies which would have implications for the addition of an antifungal based on fungal confirmation, after addresssing the underlying nail dystrophy primarily.
METHODS: A vertical diffusion cell system was used to evaluate the ability of efinaconazole 10% and tavaborole 5% to penetrate across poly-ureaurethane 16%. The diffusion cells had a 1.0 cm2 surface area and approximately 8 mL receptor volume. Poly-ureaurethane 16% was applied to a 0.45 μm nylon membrane and allowed to dry before use. Efinaconazole 10% or tavaborole 5% was then applied to the poly-ureaurethane 16% coated membrane, and samples were pulled from the receptor chamber at various times. Reverse phase chromatography was then used to assess the penetration of each active ingredient across the membrane.
RESULTS: The flux and permeability of efinaconazole or tavaborole across poly-ureaurethane 16% were determined from efinaconazole 10% or tavaborole 5%, respectively. The flux and permeability of efinaconazole were determined to be 503.9 +/- 31.9 μg/cm2/hr and 14.0 +/- 0.9 nm/sec. The flux and permeability of tavaborole were determined to be 755.5 +/- 290.4 μg/cm2/hr and 42.0 +/- 16.1 nm/sec.
CONCLUSION: In addition to the treatment of onychoschizia, onychorrhexis, and other signs of severe dessication of the nail plate, a barrier that regulates TOWL should be considered in the management onychomycosis to address barrier dysfunction and to promote stabilization of the damaged nail. Previously published flux values across the nail are reported to be 1.4 μg/cm2/day for efinaconazole and 204 μg/cm2/day for tavaborole. These values are substantially lower than the herein determined flux for both molecules across poly-ureaurethane 16%. A comparison of the data suggests that poly-ureaurethane 16%, if used prior to efinaconazole or tavaborole, would not limit the ability of either active ingredient to access the nail, and therefore, would be unlikely to reduce their antifungal effect. Onychodystrophy is inherent in, and often precedes onychomycosis, and consideration should be given for initiation of treatment in the same sequence: stabilizing and protecting the nail plate barrier primarily, and subsequently adding oral or topical antifungals after laboratory confirmation. Future clinical studies will be needed to determine combination efficacy for in vivo use.
J Drugs Dermatol. 2016;15(9):1116-1120.
Robert M. Hurwitz MD, Larry J. Buckel MD, Thomas J. Eads MD| |
Topical Minocycline Foam for the Treatment of Impetigo in Children: Results of a Randomized, Double-Blind, Phase 2 Study
Shlomo Chamny MD,a Dan Miron MD,b Nadia Lumelsky MD,c Hana Shalev MD,d Elana Gazal PhD,e Rita Keynan,e Avner Shemer MD,f and Dov Tamarkin PhDe| |
J Drugs Dermatol. 2016;15(10):1238-1243.
Kendra Gail Bergstrom MD FAAD| |
Objective: To demonstrate the pattern of cutaneous reactions related to PPI usage and to evaluate the risk of developing PPI drug eruptions among adult patients.
Methods: We reviewed the spontaneous reports of any adverse events associated with PPI use, as reported from January 2005 through May 2010 to the Adverse Drug Reaction Center at Siriraj Hospital in Thailand. Each control was sampled from 15 patients who had consecutive hospital numbers from each study case.
Results: The prevalence of cutaneous reactions to PPIs varied, ranging from three to 20 per 100,000 of the treated population. Sixty-four patients with a history of reaction to PPIs, and 65 controls were enrolled. Most cutaneous reactions were attributed to omeprazole (n=50; 78.1%), and the most frequently observed cutaneous reaction was maculopapular rash (43.8%). None of the patients experienced a cross-reaction between individual PPIs.
Conclusion: Cutaneous adverse reactions to PPIs range from minor drug rashes to a severe, life-threatening reaction. Individuals with a history of adverse drug reaction have an increased risk of cutaneous reaction to PPIs.
J Drugs Dermatol. 2012;11(10):e43-e47.
Effective Topical Combination Therapy for Treatment of Lichen Striatus in Children: A Case Series and Review
J Drugs Dermatol. 2012;11(7):872-875.
Adam Rees MD, Quyn Sherrod MD, Lorraine Young MD| |
J Drugs Dermatol. 2011;10(4):414-417.
Whitney P. Bowe MDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2014;13(suppl 7):s89-s94.
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| |
Increased Prevalence of Psychiatric Disorders and Health Care-Associated Costs Among Patients With Moderate-to-Severe Psoriasis
Methods: In a retrospective, matched case-control study, data for services from nearly 75 health care plans in the United States (U.S.) were collected from PharMetrics Patient Centric Database using International Classification of Diseases, Ninth Revision Clinical Modification codes, identifying a total of 39,855 adults with moderate-to-severe psoriasis (n=7,971) and without (controls; n=31,884). Patients with psoriasis had at least one psoriasis health care claim and received at least one medical/prescription treatment claim within two consecutive years. Psychiatric comorbidities and treatments among patients and controls were determined by claims. Annual inpatient, outpatient, emergency room, and prescription costs for those with and without psoriasis and those with and without psychiatric disorders were compared.
Results: Patients had significantly higher prevalence of anxiety (6.9% versus 4.4%), depression (9.2% versus 5.3%), bipolar disorder (1.1% versus 0.5%), or delirium (0.3% versus 0.1%; P<0.05) than controls (others P<0.0001). Significantly higher proportions of patients with psoriasis received antidepressants (6.1% versus 0.9%), anxiolytics (5.0% versus 0.8%), or antipsychotics (5.9% versus 0.9%) compared with controls (each P<0.0001). Total health care costs for patients with psoriasis (US $11, 369.47) were significantly higher than for controls ($3,427.60; P<0.001). Psoriasis patients with psychiatric disorders had significantly higher health care costs ($17,637.66) than those without psychiatric disorders ($10,362.80; P<0.001).
Conclusion: The prevalence of psychiatric disorders is higher in patients with moderate-to-severe psoriasis than in controls. Annual health care costs are higher in psoriasis patients with psychiatric disorders than in those without psychiatric disorders.
J Drugs Dermatol. 2011;10(8):843-850.
Mohamed Réda Khmamouche MD,a,b Adil Debbagh MD,a Tarik Mahfoud MD,b Rachid Aassab MD,a
Siham Lkhoyaali MD,a Mohamed Ichou MD,b and Hassan Errihani MDa
J Drugs Dermatol. 2014;13(8):983-984.
Melissa B. Hoffman MD,a Rachna A. Bhandari MD,b and Animesh A. Sinha MD PhDc| |
J Drugs Dermatol. 2016;15(7):821-829.
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.
Acquired Epidermodysplasia Verruciformis and Its Relationship to Immunosuppressive Therapy: Report of a Case and Review of the Literature
Channa G. Ovits MD, Bijal D. Amin MD, Caroline Halverstam MD| |
Fran E. Cook-Bolden MD| |
Emily C. Milam BA and Evan A. Rieder MD| |
J Drugs Dermatol. 2016;15(4):452-456.
The Effect of Hand-Foot Skin Reaction Associated With the Multikinase Inhibitors Sorafenib and Sunitinib on Health-Related Quality of Life
Methods: Twenty-three patients with HFSR related to SO or SU were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for clinical severity and for impact on HRQOL through completion of the patient self-administered Skindex-16 (SK-16). Clinical severity scores were compared to HRQOL assessments.
Results: Of the 23 patients with HFSR, clinical severity was grade 1 in 17.4%, grade 2 in 74%, and grade 3 in 8.6%. Median SK-16 scores were reported for symptoms (53.3), emotions (30.6), and functioning subscales (33.3). Median symptoms and emotions scores positively correlated with HFSR clinical severity grade.
Conclusions: These findings demonstrate that HFSR related to SO or SU negatively impacts HRQOL, with the symptoms domain being most significantly affected. In addition, CTCAE toxicity grading correlates with HRQOL.
J Drugs Dermatol. 2012;11(11)e61-e65.
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.
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.
Alan B. Fleischer Jr. MDa and Isabelle Raymond PhDb| |
J Drugs Dermatol. 2016;15(9):1111-1114.
Reduction of Facial Redness With Resveratrol Added to Topical Product Containing Green Tea Polyphenols and Caffeine
Georgina Ferzli MD MS, Mital Patel MD, Natasha Phrsai BS, and Neil Brody MD PhD| |
METHODS: Subjects (n=16) presenting with facial redness applied the resveratrol-enriched product twice daily to the entire face. Reduction in redness was evaluated by trained staff members and dermatology house staff officers. Evaluators compared clinical photographs and spectrally enhanced images taken before treatment and at 2-week intervals for up to 12 weeks.
RESULTS: 16 of 16 clinical images showed improvement and 13 of 16 spectrally enhanced images were improved. Reduction in facial redness continued to evolve over the duration of the study period but was generally detectable by 6 weeks of treatment. Adverse effects were not observed in any subject.
CONCLUSION: The skin product combination of resveratrol, green tea polyphenols, and caffeine safely reduces facial redness in most patients by 6 weeks of continuous treatment and may provide further improvement with additional treatment.
J Drugs Dermatol. 2013;12(7):770-774.
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.
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.
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.
Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Enhanced Lotion Formulation of Halobetasol Propionate, 0.05% Versus Its Vehicle in Adult Subjects With Plaque Psoriasis
David Pariser MD,a Michael Bukhalo MD,b Scott Guenthner MD,c Steven Kempers MD,d Stephen Shideler MD,e Linda Stein Gold MD,f Eduardo Tschen MD MBA,g Jim Berg,h Mary Beth Ferdon PhD,h and Syd Dromgoole PhDh| |
BACKGROUND: A novel lotion formulation of halobetasol propionate, 0.05% (HBP Lotion) with enhanced vehicle characteristics of a cream while preserving the ease of use and cosmetic elegance of a lotion has been developed to treat plaque psoriasis. OBJECTIVE: Determine the safety and effectiveness of HBP Lotion in patients with plaque psoriasis. METHODS: Two prospective, randomized, vehicle-controlled clinical studies were conducted in 443 adult subjects with moderate-severe plaque psoriasis. Subjects applied the test article to psoriatic plaques within the treatment area twice daily for 14 days. Efficacy data are based upon treatment “success” defined as those subjects that achieved scores of 0=clear or 1=almost clear with at least a two-grade improvement relative to baseline for an Investigator’s Global Assessment (IGA) and clinical signs (plaque elevation, erythema, scaling). Safety data are presented as adverse events and local skin reactions. RESULTS: After two weeks of treatment with HBP Lotion, 44.5% of the HBP Lotion treated subjects in each study achieved (a) treatment “success” (ie, an IGA score of 0=clear or 1=almost clear and >2 grade improvement compared to baseline) and (b) a notable reduction in plaque elevation, erythema, scaling, and pruritus. In contrast, only 6.3% and 7.1% of VEH subjects in Studies 1 and 2, respectively, achieved treatment success and the reduction of disease related signs was materially lower. Statistically, at day 15 in both Phase 3 studies, treatment success with HBP Lotion was superior to VEH (P less than 0.001). From a safety perspective the outcomes were in general unremarkable with similar findings in the HBP Lotion and VEH treatment groups. CONCLUSIONS: The results demonstrate the safety and effectiveness of HBP Lotion in the treatment of plaque psoriasis. Furthermore, this novel HBP lotion formulation is also distinguished by its moisturization qualities and ease of use.
J Drugs Dermatol. 2017;16(3):234-240.
Adam B. Blechman MD,a Christine E. Cabell MD,b Christine H. Weinberger MD,c Anna Duckworth MD,d Justin J. Leitenberger MD,e Fiona O. Zwald MD,f and Mark A. Russell MDg| |
The Food and Drug Administration approved Ruxolitinib in 2011 for the treatment of primary myelofibrosis. Five-year safety data showed a higher incidence of skin cancer in patients treated with Ruxolitinib compared to best available therapy for myelofibrosis. This report presents a series of five patients with history of myelofibrosis treated with Ruxolitinib who subsequently developed numerous skin cancers with aggressive biological behavior. Each patient in this report was treated by a Mohs surgeon affiliated with an academic institution. All patients had a history of myelofibrosis and were exposed to Ruxolitinib. Some patients were exposed to other immunomodulatory medications such as Hydroxyurea and Rituximab. The total number of skin cancers and skin cancers with particularly aggressive behavior were noted. All five patients in this series developed numerous skin cancers with aggressive biological behavior during or after therapy with Ruxolitinib. Also, one patient developed lentigo maligna melanoma and another developed metastatic undifferentiated pleomorphic sarcoma. The repeat observation of skin cancers with aggressive features during JAK inhibitor treatment suggests that these medications may promote cutaneous malignant transformation in at risk patients. Further surveillance and testing of JAK kinases regarding the risk of skin cancers is indicated.
J Drugs Dermatol. 2017;16(5):508-511.
A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Assess the Efficacy and Safety of Clindamycin 1.2% and Tretinoin 0.025% Combination Gel for the Treatment of Acne Rosacea Over 12 Weeks
Background: Papulopustular acne rosacea is a chronic inflammatory condition which can be difficult to treat. Many patients are unwilling to use systemic medications, and single topical agents alone may not address all the symptoms of rosacea. A combination topical clindamycin phosphate 1.2% and tretinoin 0.025% gel is efficacious for acne vulgaris, and may be helpful for rosacea, since acne vulgaris and rosacea shares many similar clinical and histologic features.
Objective: To assess the preliminary efficacy and safety of a combination gel consisting of clindamycin phosphate 1.2% and tretinoin 0.025% on papulopustular rosacea after 12 weeks of usage.
Methods: Randomized, double-blind, placebo controlled two site study of 79 participants with moderate to severe papulopustular acne rosacea using both physician and subjects' validated assessment tools. Primary endpoint consisted of statistically significant reduction in absolute papule or pustule count after 12 weeks of usage.
Results: There was no significant difference in papule/pustule count between placebo and treated groups after 12 weeks (P=0.10). However, there was nearly significant improvement in physicians' assessments of the telangiectasia component of rosacea (P=0.06) and erythematotelangiectatic rosacea subtype (P=0.05) in treated versus placebo group after 12 weeks. The only significant adverse event different was facial scaling, which was significantly increased in treated group (P=0.01), but this did not result in discontinuation of study drug.
Conclusions: A combination gel of clindamycin phosphate 1.2% and tretinoin 0.025% may improve the telangiectatic component of rosacea and appears to better treat the erythemotelangiectatic subtype of rosacea rather than papulopustular subtype. Our preliminary study suggests that future studies with much larger sample size might confirm our findings. Clinical Trials: NCT00823901.
J Drugs Dermatol. 2012;11(3):333-339.
Isoconazole Nitrate vs Isoconazole Nitrate and Diflucortolone Valerate in the Treatment of Tinea Inguinalis: Results of a Multicenter Retrospective Study
Patients and Methods: Treatment duration was three weeks. The efficacy of the treatment was based on the assessment of several signs and symptoms, which were collected on a 4-point scale. All patients were examined clinically before the beginning of the treatment, one week later, two weeks later, and at the end of the treatment. Mycological examinations were performed before the beginning of the treatment and at the end of the study.
Results: Treatment results with the combination of isoconazole nitrate and diflucortolone valerate were superior regarding erythema and pruritus. Both erythema and pruritus resolved in a larger percentage of patients and more quickly. Both regimens were well tolerated. Mycological cure rates were similar in both groups of patients.
Conclusions: Combination therapy with isoconazole nitrate and diflucortolone valerate is an effective and well-tolerated regimen in adult patients with tinea inguinalis.
J Drugs Dermatol. 2012;11(11)e70-e73.
J Drugs Dermatol. 2012;11(8):907-910.
Mycobacterium Fortuitum Infection Following Adalimumab Treatment for Psoriasis and Subsequent Complication-Free Treatment With Alternate TNF-α Blockers
Michael B. Chang BS, Jennifer C. Sri MD, Marcia Driscoll MD, Anthony A. Gaspari MD| |
J Drugs Dermatol. 2011;10(8):927-929.
Successful Treatment of a Lichenoid-Like Granulomatous Reaction to Purple Tattoo Pigment With Intralesional Kenalog
Stephanie Feldstein MDa and Jared Jagdeo MD MSb,c,d| |
J Drugs Dermatol. 2015;14(6):638-640.
Fixed drug eruptions often have a characteristic appearance, which, when correlated with the clinical history, can be easily identified. However, multifocal fixed drug eruptions, especially the non-pigmenting variety, can present a diagnostic challenge, especially in the absence of a complete medication history. We present such a case, in which the patient was taking two over-the-counter medications, both of which contain uncommon causes of multifocal fixed drug eruptions.
J Drugs Dermatol. 2012;11(2):244-246.
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.
Bryce L. Desmond DO, R. Scott Thomas DO, and Stephanie S. Howerter DO| |
Zuxu Yao PhD,a Ronald Moy MD,b Talisha Allen BS,a and Burkhard Jansen MDa| |
J Drugs Dermatol. 2017;16(10):979-986.
Ross Brothers MD, Rawn E. Bosley MD, and Steven Daveluy MD| |
J Drugs Dermatol. 2014;13(8):960-966.
Lauren C. Strazzulla BA, Lorena Avila MD, Kristen Lo Sicco MD, Jerry Shapiro MD| |
Lichen planopilaris (LPP) is a variant of lichen planus that affects the scalp causing scarring hair loss. Patients also frequently experience symptoms of scalp itch, pain, and burning. To date, there are no long-term remittive nor curative therapies available. Low-dose naltrexone has anti-inflammatory properties and has recently been described in the context of treating autoimmune conditions. This retrospective medical record review describes four LPP patients treated with low-dose (3 milligrams per day) naltrexone. This medication provided benefit in these four patients including reduction in symptoms of pruritus, clinical evidence of inflammation of the scalp, and disease progression. All patients tolerated naltrexone without adverse effects. This is the first case series demonstrating the beneficial effects of low-dose naltrexone for patients with LPP. This medication was well-tolerated by the patients and is cost-effective.
J Drugs Dermatol. 2017;16(11):1140-1142.
Stratum Corneum Abnormalities and Disease-Affected Skin: Strategies for Successful Outcomes in Inflammatory Acne
Laura Jordan DO MS and Hilary E. Baldwin MD b| |
J Drugs Dermatol. 2016;15(10):1170-1173.
The Static Physician’s Global Assessment of Genitalia: A Clinical Outcome Measure for the Severity of Genital Psoriasis
Joseph F. Merola MD MMSc,a Alison Potts Bleakman PhD,b Alice B. Gottlieb MD PhD,c Alan Menter MD,d April N. Naegeli PhD,b Robert Bissonnette MD MS FAAD FRCPC,e Lyn Guenther MD FRCPC,f John Sullivan MBBS MS,g Kim Meeuwis MD PhD,h Kyoungah See PhD,b and Kristina Callis Duffin MD MSi| |
Introduction: Genital psoriasis is a common but frequently overlooked manifestation of psoriasis with a considerable impact on patients’ quality of life. Currently no validated clinical trial outcome measures exist to assess genital psoriasis severity that meet regulatory agency requirements.
Methods: This study describes the development of the static Physician’s Global Assessment of Genitalia (sPGA-G) scale, a clinical outcome measure for the assessment of genital psoriasis severity that accounts for the erythematous clinical presentation of genital psoriasis. The reliability of the sPGA-G was evaluated using scores collected from clinician assessments of photographs of genital psoriasis cases. Scores were collected from 10 academic and clinical experts in genital psoriasis and 95 clinician assessors who participated in either in-person (n=28) or online (n=67) sPGA-G training modules.
Results: The sPGA-G had a high inter-rater reliability (IRR, measured by Kendall’s W) for expert raters (W=0.856, P less than 0.0001), in-person assessors (W=0.822, P less than 0.0001), and online assessors (W=0.678, P less than 0.0001). IRR was also high for all clinical assessors combined, (W=0.714, P less than 0.0001).
Discussion: This study demonstrates that the sPGA-G is an intuitive and reliable clinical outcome measure that specifically measures the severity of genital psoriasis.
J Drugs Dermatol. 2017;16(8):793-799.
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Jason Chouake and Adam Friedman| |
News, Views, & Reviews
The Role of RNA Interference in Dermatology: Current Perspectives and Future Directions
Econazole Nitrate Foam 1% for the Treatment of Tinea Pedis: Results from Two Double-Blind, Vehicle-Controlled, Phase 3 Clinical Trials
Boni E. Elewski MDa and Tracey C. Vlahovic DPMb| |
OBJECTIVE: To evaluate econazole nitrate foam 1% versus foam vehicle for treatment of interdigital tinea pedis.
METHODS: Two randomized, double-blind, parallel-group, vehicle-controlled, multicenter studies enrolled males and females ≥12 years old with a clinical diagnosis of interdigital tinea pedis and baseline fungal culture positive for a dermatophyte. Subjects applied econazole nitrate foam 1% (n=246) or foam vehicle (n=249) once daily for 4 weeks. The primary endpoint was proportion of subjects achieving a complete cure (negative KOH, negative fungal culture, complete resolution of all signs and symptoms) at 2 weeks post-treatment (Day 43). Secondary endpoints included mycologic cure (negative KOH and negative culture) and effective treatment (mycologic cure + no or mild erythema and/or scaling and all other signs and symptoms absent).
RESULTS: The complete cure rate at Day 43 was 24.3% for econazole nitrate foam 1% vs 3.6% for foam vehicle. In addition, higher rates of mycologic cure (67.6% vs 16.9%) and effective treatment (48.6% vs 10.8%) were observed with econazole nitrate foam 1% versus the foam vehicle. There were few adverse events and only nasopharyngitis and headache were experienced by >1% of subjects. No serious adverse events were reported for econazole nitrate foam 1%.
CONCLUSIONS: Econazole nitrate foam 1% exhibited superiority over foam vehicle for the primary and secondary endpoints with a high mycologic cure rate for all pathogens evaluated. Econazole nitrate foam 1% was safe and well tolerated with a safety profile comparable with the foam vehicle. Econazole nitrate foam 1% presents a novel alternative for the management of tinea pedis.
J Drugs Dermatol. 2014;13(7):803-808.
Lawrence Transfer Factor: Transference of Specific Immune Memory by Dialyzable Leukocyte Extract from a CD8+ T Cell Line
Jason F. Wang BA,a Andrew J. Park BA,b Tina Rendini RN,c William R. Levis MD| |
Lawrence transfer factor (TF) is defined as dialyzable leukocyte extract (DLE) that can transfer antigen-specific cell-mediated immunity from a person testing positive for the antigen in a delayed type hypersensitivity skin test manner to a person negative for the same antigen.
A recent article by Myles et al1 has identified a DLE isolated from an established CD8+ T cell line capable of transferring antigen-specific immunity. The DLE contains a portion of the beta chain of the T cell receptor and additional nucleotide and protein factors that are being subjected to further modern biochemical analysis.
After months of study that included interviews of TF physician-scientists, we conclude that an antigen-specific TF exists for most, if not all, antigens. By working from a CD8+ T cell line with modern biochemical technology, it should be possible to identify and patent products capable of treating infectious diseases, antigen-responsive cancers, and autoimmune disorders.
J Drugs Dermatol. 2017;16(12):1198-1206.
Joshua A. Zeichner MD| |
J Drugs Dermatol. 2016;15(1 Suppl 1):s11-s16.
Macrene Alexiades MD PhD| |
OBJECTIVE: To clinically study the cosmetic effects of a novel jasmonate complex LR2412-Cx in the treatment of visible skin aging.
METHODS: LR2412-Cx was evaluated in a 15-subject open-label prospective clinical trial for the treatment of fine wrinkle appearance, texture, and pores. Subjects were evaluated by an investigator at baseline, day 1, day 3, and week 6 with the Alexiades comprehensive grading scale of skin aging, and introducing a novel pore-grading scale and subject quality of life assessments.
RESULTS: The mean (SEM) at baseline and at week 6 following twice-daily application were: for the appearance of wrinkles 2.91 (0.12) and 2.70 (0.10); for texture 2.91 (0.10) and 2.55 (0.10); and for pores 3.29 (0.08) and 2.46 (0.09), respectively. The differences in all 3 categories at all follow-up intervals were statistically significant (P<.005). The percentage improvement in investigator-assessed grades relative to baseline at day 1, day 3, and week 6 were: 2.3%, 4.9%, and 7.4% for the appearance of wrinkles, 5.7%, 9.4%, and 12.4% for texture, and 14.2%, 21.6% and 25.2% for pores, respectively. No significant untoward effects were reported.
CONCLUSION: Visionnaire LR2412-Cx is a novel jasmonate-containing compound that is safe and effective for the cosmetic treatment of fine wrinkle appearance, texture, and pores of the facial skin.
J Drugs Dermatol. 2016;15(2):209-215.
J Drugs Dermatol. 2012;11(6):769-771.
Improvement of Actinic Keratoses Using Topical DNA Repair Enzymes: A Randomized Placebo-Controlled Trial
Marie Stoddard BS,a Jennifer Herrmann MD,b,c,d Lauren Moy MD,eand Ronald Moy MDb,c| |
J Drugs Dermatol. 2017;16(10):1030-1034.
Joshua W. Hagen MD PhDa and William R. Levis MDb| |
Jay M. Smith MD,a J. Erin Reid MD,b and Morgan L. Wilson MDa| |
Amanda Pickert MD| |
The Effect of an Anti-Inflammatory Botanical Cleanser/Night Mask Combination on Facial Redness Reduction
Zoe Diana Draelos MDa and Angela Donald ND MScb| |
Treatment of Inverse/Intertriginous Psoriasis: Updated Guidelines from the Medical Board of the National Psoriasis Foundation
Hasan Khosravi MD,a Michael P. Siegel PhD,b Abby S. Van Voorhees MD,c and Joseph F. Merola MD MMSca,d| |
Inverse or intertriginous psoriasis commonly involves skin fold areas including the axillae, perianal skin, intergluteal cleft, inframammary, genital/inguinal, abdominal, and retroauricular folds. After reviewing the literature for new treatments, a task force was convened to update a consensus on inverse psoriasis therapy. Short-term treatment continues to be low-potency topical steroids. In order to avoid steroid-induced adverse effects, long-term therapy includes topical immunomodulators, calcitriol, and calcipotriene. Second and third-line therapies include antimicrobials, emollients, and tar-based products. Inverse psoriasis resistant to topical therapy has been shown to respond to botulinum toxin injections, excimer laser therapy, and certain systemic agents (such as anti-TNF and anti-IL12/IL23 therapy). Based on promising results from case reports and prior clinical experience, these systemic agents should be strongly considered in inverse psoriasis resistant to topical therapy. However, they need further evidence-based evaluation. The use of randomized trials and objective severity indices may allow for more robust therapeutic data.
J Drugs Dermatol. 2017;16(8):760-766.
Carlos Galzote,a Mini Thomas PhD,b and Mukta Sachdev MDc| |
J Drugs Dermatol. 2016;15(10):1244-1248.
Joshua A. Zeichner MD| |
J Drugs Dermatol. 2015;14(suppl 10):s32-s34.
Patrick M. Zito DO PharmD,a,b Adrianna M. Gonzalez BS,a Joshua D. Fox MD,a Megan Cronin MD,a Nicholas Mackrides MD,a Robert S. Kirsner MD PhD,a and Anna J. Nichols MD PhDa| |
J Drugs Dermatol. 2012;11(5):622-625.
Robin Lewallen, MD| |
Jason Chouake and Adam Friedman| |
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.
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
Resident Rounds: Part I: Program Spotlight: The University of California, Irvine Department of Dermatology Residency Training Program
Nazanin Saedi MD, Amy Reinstadler MD, Sam Truong MD, Kristen Kelly MD| |
Resident Rounds is a new section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds will feature three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the University of California, Irvine Department of Dermatology Residency Training Program. The editor of Resident Rounds is Omar A. Ibrahimi, MD, PhD. Dr. Ibrahimi is a recent graduate of the Harvard Combined Program in Dermatology and currently a fellow in Mohs, Laser and Cosmetic Surgery at the University of California Davis. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at firstname.lastname@example.org
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.
Tracey C. Vlahovic DPM| |
J Drugs Dermatol. 2016;15(Suppl 2):s56-59.
Efficacy and Safety of Minoxidil 5% Foam in Combination With a Botanical Hair Solution in Men With Androgenic Alopecia
Terrence C. Keaney MD,a Hanh Pham MA,b Erika von Grote PhD,b and Matthew H. Meckfessel PhDc| |
J Drugs Dermatol. 2016;15(4):406-412.
The Efficacy and Safety of Topical Dapsone Gel, 5% for the Treatment of Acne Vulgaris in Adult Females With Skin of Color
Andrew F. Alexis MD MPH,a Cheryl Burgess MD,b Valerie D. Callender MD,c Jo L. Herzog MD,d Wendy E. Roberts MD,e Eric S. Schweiger MD,f Toni C. Stockton MD,g and Conor J. Gallagher PhDh| |
OBJECTIVE: Evaluate safety and efficacy of dapsone gel, 5% applied topically twice daily for 12 weeks in women with SOC.
METHODS: Females with SOC aged 18 years and older with facial acne participated in a multicenter, open-label, single-group, 12-week pilot study of twice-daily monotherapy with dapsone gel, 5%. The investigator-rated 5-point Global Acne Assessment Score (GAAS) was used to assess efficacy. The impact of acne on subjects was assessed using the validated Acne Symptom and Impact Scale (ASIS).
RESULTS: The study enrolled and treated 68 women with SOC and facial acne. GAAS decreased significantly from baseline to week 12 (mean, -1.2 [95% CI, -1.4, -1.0]; P<.001), a 39.0% improvement. Overall, 42.9% of subjects were responders based on a GAAS of 0 or 1 at week 12. Subjects also experienced significant reductions in mean total lesions (52% decrease), inflammatory lesions (65%), and comedo counts (41%; all P<.001). Dapsone gel, 5% monotherapy was associated with significant improvement in subject-assessed acne signs (P<.001) and impact on quality of life (QOL; P<.001), based on ASIS. Dapsone gel, 5% used twice daily was well tolerated, with no treatment-related adverse events. The local dermal tolerability scores tended to remain stable or decrease from baseline to week 12.
CONCLUSIONS: Monotherapy with dapsone gel, 5% administered twice daily was safe and effective for treatment of facial acne in women with SOC. Significant improvement in overall acne severity and both inflammatory lesions and comedones was observed. Further, study subjects reported considerable improvement in both acne signs and impact on QOL.
J Drugs Dermatol. 2016;15(2):197-204.
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.
Helena A. Jenkinson MD,a Alan E. Siroy MD MPH,b Adrienne Choksi MDc| |
J Drugs Dermatol. 2017;16(10):1050-1052.
Laura Winterfield MD MPH,a Ruth Ann Vleugels MD MPH,b and Kelly K. Park MD MSLa| |
Efficacy and Safety of Minoxidil 2% Solution in Combination With a Botanical Hair Solution in Women With Female Pattern Hair Loss/Androgenic Alopecia
Amy McMichael MD,a Hanh Pham MA,b Erika von Grote PhD,c and Matthew H. Meckfessel PhDc| |
J Drugs Dermatol. 2016;15(4):398-404.
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.
Apremilast and Narrowband Ultraviolet-B Combination Therapy for Treating Moderate-to-Severe Plaque Psoriasis
Jerry Bagel MD MS, Elise Nelson LPN, Brian R. Keegan MD PhD| |
J Drugs Dermatol. 2017;16(10):957-962.
Oregano Extract Ointment for Wound Healing: A Randomized, Double-Blind, Petrolatum-Controlled Study Evaluating Efficacy
Jennifer Ragi MD,a Amy Pappert MD,a Babar Rao MD,a Daphna Havkin-Frenkel PhD,b Sandy Milgraum MDa| |
Background: Wound healing is a dynamic and complex process affected by tissue hydration, the presence of bacteria, inflammation, and other variables. Oregano has potent antibacterial, antifungal, antioxidant, and anti-inflammatory properties. Studies of oregano ointment
on wound healing are lacking.
Objective: To determine the efficacy of 3% oregano extract ointment on wound healing.
Methods: An investigator initiated, randomized, double-blind, petrolatum-controlled study was performed to determine the effects of oregano ointment on wound healing. Forty patients who underwent surgical excision were enrolled and randomized. Cultures were obtained on day 12 and scars were evaluated using the Patient and Observer Scar Assessment tool on day 12, 45, and 90.
Results: The oregano ointment group had 19 percent of cultures test positive for Staphlococcus aureus compared to 41 percent in the petrolatum group. One patient in the oregano ointment group developed a cellulitis compared to three patients in the petrolatum group. The oregano group had a statistically significant improvement over petrolatum in scar color, pigmentation, and pliability.
Conclusion: Oregano extract ointment decreased bacterial contamination and subsequent infection on post-surgical wounds and had equivalent overall scar appearance compared to petrolatum.
J Drugs Dermatol. 2011;10(10):1168-1172.
Anh N. Tran MSa,b and John Y. Koo MDa| |
J Drugs Dermatol. 2014;13(9):1118-1122.
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.
Adam J. Luber BA, Shaheen H. Ensanyat BS, and Joshua A. Zeichner MD| |
J Drugs Dermatol. 2014;13(2):130-134.
Paraneoplastic Pityriasis Rubra Pilaris as the Presenting Manifestation of Metastatic Squamous Cell Carcinoma
Isabel M. Remedios MD,a J. Daniel Jensen MD,b Kathleen Beckum MD,b
Kristopher McKay MD,b and Rebecca Kissel MDb
J Drugs Dermatol. 2014;13(5):610-612.
Heather Kiraly Orkwis DO and Daniel M. Stewart DO| |
Penelope J. Kallis BS BA,a Alexandra Price MD,a Jacquelyn R. Dosal MD,a Anna J. Nichols MD PhD,a and Jonette Keri MD PhDa,b| |
Sheila M. Greenlaw MD,a Mariko Yasuda MD,a Karen Wiss MDa,b| |
Resident Rounds is a section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds includes three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the University of Massachusetts Medical School Dermatology Residency Program. The editor of Resident Rounds is Omar A. Ibrahimi, MD, PhD. He is currently the Director of Cutaneous Laser and Cosmetic Surgery and a Mohs surgeon at the University of Connecticut. Dr. Ibrahimi is also a Visiting Scientist at the Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at email@example.com
Justin Finch MD| |
Ashley R. Mason MD and Melinda R. Mohr MDa| |
Resident Rounds is a new section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds will feature three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the Eastern Virginia Medical School Dermatology Residency Program. The editor of Resident Rounds is Omar A. Ibrahimi, MD, PhD. Dr. Ibrahimi is a recent graduate of the Harvard Combined Program in Dermatology and currently a fellow in Mohs, Laser and Cosmetic Surgery at the University of California Davis. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at firstname.lastname@example.org
Resident Rounds: Part I - Program Spotlight: Department of Dermatology, University Hospitals Case Medical Center
Jeffrey F. Scott MD, Ashley Feneran DO, and Kevin D. Cooper MD| |
Ali Alikhan MD and Alison J. Bruce MBBS| |
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.
Leon Kircik MD,a,b,c Mark G. Lebwohl MD,c James Q. Del Rosso DO,d
Jerry Bagel MD,eLinda Stein Gold MD,f Jonathan S. Weiss MDg
In both Phase 3 studies, a statistically significantly greater percentage of subjects in the desoximetasone spray 0.25% compared to vehicle group achieved both Clinical Success and Treatment Success at Day 28. These results, which were the primary efficacy variables, demonstrated superior efficacy in the active study group for both overall improvement of plaque psoriasis (by PGA) and in the individual psoriasis lesion (by TLSS) designated at baseline as the most severely involved plaque (target lesion). Assessment of secondary efficacy variables in both Phase 3 studies showed that subjects receiving desoximetasone Spray 0.25% twice daily exhibited statistically significantly mean changes from Baseline to Day 28 in PGA, TLSS, and % BSA affected when compared to subjects receiving vehicle spray twice daily.
Tolerability and safety were assessed at all study visits. No statistically significant differences were observed between study arms and no major safety signals related to AEs were noted. No stinging and burning were reported with the spray formulation. This Class I topical corticosteroid has shown to be safe and efficacious in moderate to severe plaque psoriasis.
J Drugs Dermatol. 2013;12(12):1404-1410.
Comparison of the Efficacy of Long-Pulsed Nd:YAG Laser Intervention for Treatment of Onychomycosis of Toenails or Fingernails
Yan Li MD, Sisi Yu MS, Jing Xu MS, Ruina Zhang MS, and Junying Zhao BS| |
METHODS: One hundred and twelve affected fingernails or toenails in 37 patients with onychomycosis were randomized into Group 1 (22 patients with 50 affected fingernails) and Group 2 (15 patients with 62 affected toenails). These patients were further classified into three subgroups (Grade II, III, and IV) according to Scoring Clinical Index of Onychomycosis. All the affected nails were treated with long-pulse Nd:YAG 1064 nm laser intervention, once weekly, for continuous weeks, and were followed up for 24 weeks.
RESULTS: The response rates at weeks 8, 16, and 24 were 0, 0 and 52%, respectively, for Group 1, and 10, 32 and 71% for Group 2. The inter-group difference in efficacy was statistically significant (P<0.05). Even in the same subgroup, the response rate of Group 2 was higher than that of Group 1.
CONCLUSIONS: The efficacy of long-pulsed Nd:YAG 1064 nm laser intervention against affected toenails is superior to that against fingernails. It is also effective for treatment of onychomycosis with different severity.
J Drugs Dermatol. 2014;13(10):1258-1263.
Efficacy and Safety of Toreforant, a Selective Histamine H4 Receptor Antagonist, for the Treatment of Moderate-to-Severe Plaque Psoriasis: Results from a Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Ellen Frankel MD,a Michael Song MD,b Shu Li PhD,b Jingzhi Jiang MS,b Robin L. Thurmond PhD,c Bruce Randazzo MD PhDc,d| |
Wendy C. Cantrell DNP CRNP and Boni E. Elewksi MD| |
METHODS: Ketoconazole 2% foam was evaluated in a single-center, open-label, one-arm pilot study which enrolled eleven subjects to gain 10 evaluable subjects aged 21 years and older with a clinical diagnosis of tinea versicolor and positive KOH using calcofluor. The subjects came for 4 scheduled visits (baseline, week 1, week 2, and week 4) and were instructed to apply ketoconazole 2% foam to all affected areas twice daily for 2 weeks. At each visit, mycological and clinical assessment of a target area was done, along with static global assessment and body surface area estimation of the disease in each subject. Patient questionnaires were given at baseline and at week 2 to rate pruritus and satisfaction with the foam.
RESULTS: At the week 2 visit, following the treatment period, three out of ten evaluable subjects had negative skin samples prepared with KOH/calcifluor. Of these three, one subject later showed recurrence of fungal elements consistent with tinea versicolor at the week 4 follow-up visit. The other negative subjects remained negative and four additional subjects tested negative at week 4. Three subjects with positive samples at week 4 had only yeast forms without hyphae present. Investigator ratings of the target area were averaged for each clinical feature and demonstrated improvement in scale, hyper- or hypopigmentation, erythema, and induration throughout the study. Average pruritus score increased slightly 1 week after the baseline visit, but then improved steadily over the remaining visits. The investigator’s static global assessment rating showed improvement from mild to moderate disease at baseline to minimal or no disease at week 4 in 7 subjects. The remaining subjects showed neither improvement nor progression of the disease throughout the study. One out of the eleven subjects enrolled did not complete the study. One subject noted mild skin burning sensation after application of medicine. Post-treatment patient questionnaires indicated overall satisfaction with the foam vehicle.
LIMITATIONS: This was a single-arm, open-label, noncomparative trial.
Conclusion: Ketoconazole 2% foam improved overall clinical assessment and microscopic evidence of pityriasis versicolor in all subjects with favorable patient feedback regarding the novel foam vehicle.
J Drugs Dermatol. 2014;13(7):855-859.
Claudia Hossain BS,a Dennis A. Porto MD,b Iltefat Hamzavi MD,b and Henry W. Lim MDb| |
J Drugs Dermatol. 2016;15(4):384-387.
Reason Wilken MD,a Derek Ho BS,b Tatyana Petukhova MD,a and Jared Jagdeo MD MSa,c,d| |
J Drugs Dermatol. 2015;14(3):303-304.
This is a case report of a 69-year-old female with Parkinson's disease who developed an asymptomatic eruption on her legs bilaterally. Clinical and histologic examination was consistent with livedo reticularis, which was temporally associated with initiation of rasagiline. The pathogenesis of livedo reticularis is discussed along with the possible mechanisms for both rasagiline and amantidine causing drug-induced livedo reticularis in patients.
J Drugs Dermatol.2012;11(6):764-765.
A Short Educational Intervention Measurably Benefits Keloid-Prone Individuals' Knowledge of Prevention and Treatment
Sarah Y. Lee BA,a Judy H. Borovicka MD,a Jaimee S. Holbrook MD,a Mary J. Kwasny ScD,b Dennis P. West PhD,a and Roopal V. Kundu MDa| |
OBJECTIVE: We sought to evaluate the use of the Internet as a health information resource within a keloid patient population and the effects of an educational intervention on patient knowledge about keloids.
METHODS: A consecutive convenience sample of subjects completed a questionnaire on keloid-related Internet use and on personal and family history of keloids. Participants listened to a short educational intervention on keloid-related topics followed by assessment of relevant knowledge at baseline, immediately postintervention, and 3 months after the intervention.
RESULTS: Among 40 participants, 55% reported having used the Internet to obtain keloid-related information. Subjects who had used the Internet to obtain keloid-related information had baseline knowledge similar to those who had not. When subjects were assessed immediately and 3 months postintervention, the intervention improved knowledge that not all raised scars are keloids, that keloids are not cancerous, and that certain areas of the body are more prone to keloid formation. The proportion of subjects who reported being less likely to obtain piercings or tattoos because of the intervention was 80% and 75%, respectively.
LIMITATIONS: This study was performed at a single academic center.
CONCLUSION: The Internet is a commonly used information resource for keloid-prone individuals, but keloid-related knowledge was not greater among Internet keloid-related information seekers. A very short educational intervention benefits keloid-prone individuals by improving knowledge about keloid prevention and treatment and by discouraging them from obtaining piercings and tattoos.
J Drugs Dermatol. 2013;12(4):397-402.
A Randomized, Double-Blind, Vehicle-Controlled Efficacy and Safety Study of Naftifine 2% Cream in the Treatment of Tinea Pedis
Lawrence Charles Parish MD,a,b Jennifer L. Parish MD,a Hirak B. Routh MB BS,b Alan B. Fleischer Jr. MD,c Edward V. Avakian MA PhD,c Stefan Plaum MD,c Bhushan Hardas MD MBAc| |
Objective: Naftifine HCl 2% cream (NAFT-2) is a topical allylamine antifungal agent under development in the United States. This randomized,
double-blind, vehicle-controlled, phase 3 trial evaluated the efficacy and safety of two weeks of NAFT-2 treatment in subjects
with tinea pedis. Naftifine 1% cream (NAFT-1) treatment for four weeks and vehicle were also evaluated as a positive control.
Methods: 709 subjects were randomly assigned 2:1:2:1 to one of four treatment groups: (i) NAFT-2 (n= 235), (ii) two-week vehicle (n=118), (iii) NAFT-1 (n=237), or (iv) four-week vehicle (n=119). Efficacy was evaluated at baseline, week 2, week 4, and week 6 and consisted of mycology determination (KOH and dermatophyte culture) and scoring of clinical symptom severity (erythema, scaling, and pruritus). Efficacy was only analyzed in 425 subjects with positive baseline dermatophyte culture. Safety was evaluated by adverse events (AE) and laboratory values in 707 subjects.
Results: At week 6, NAFT-2 subjects achieved 18 percent complete cure rate, 67 percent mycological cure rate, 57 percent treatment effectiveness, 22 percent clinical cure rate, and 78 percent clinical success rate compared to respective vehicle rates of seven percent (one-sided, P<0.01), 21 percent (P<0.001), 20 percent (P<0.001), 11 percent (P=0.04) and 49 percent (P<0.001). Week 6 efficacy responses in NAFT-1-treated subjects were significantly higher than vehicle subjects and almost identical to NAFT-2 subjects. Mycological cure and clinical response rates in both NAFT-2 and NAFT-1 increased from week 2 to week 6. Treatment-related AEs occurred in five percent of NAFT-2 subjects, seven percent of vehicle subjects, four percent of NAFT-1 subjects and eight percent of vehicle subjects. The most common AEs for all groups were application site pruritus and skin irritation.
Conclusion: Topical NAFT-2 for two weeks is safe and provides significantly superior antifungal treatment than vehicle in tinea pedis subjects. NAFT-2 produces equivalent efficacy responses to four weeks of NAFT-1 treatment. The fungicidal activity of naftifine continues to increase for at least one month after treatment is completed. (Clinical Trials Identification Numbe=NCT00750139).
J Drugs Dermatol. 2011;10(11):1282-1288.
Program Spotlight - The University of Texas Southwestern Medical Center Dermatology Residency Program
Ponciano D. Cruz Jr. 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 University of Texas Southwestern Medical Center Dermatology Residency Program. The editor of Resident Rounds is Omar A. Ibrahimi, MD, PhD. He is currently the Director of Cutaneous Laser and Cosmetic Surgery and a Mohs surgeon at the University of Connecticut. Dr. Ibrahimi is also a Visiting Scientist at the Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at OIbrahimi@jddonline.com
Program Spotlight: The USF Department of Dermatology and Cutaneous Surgery Residency Training Program
Resident Rounds is a section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds includes three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the USF Department of Dermatology and Cutaneous Surgery Residency Training Program. The editor of Resident Rounds is Omar A. Ibrahimi MD PhD. He is currently the Director of Cutaneous Laser and Cosmetic Surgery and a Mohs surgeon at the University of Connecticut. Dr. Ibrahimi is also a Visiting Scientist at the Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at OIbrahimi@jddonline.com.
Alison M. Tisack MD, Richard H. Huggins MD, and Henry W. Lim MD| |
J Drugs Dermatol. 2013;12(7):819-820.
Lawrence F. Eichenfield MD and Sheila Fallon Friedlander MD| |
Fungal infection of the nails is an increasingly recognized disease in infants and children. However, it can be difficult to distinguish clinically from other nail dystrophies. In addition, many mistakenly believe that onychomycosis does not occur in childhood. Under-recognition of this infectious disorder therefore occurs. Although many consider “nail fungus” a trivial cosmetic concern, it can lead to discomfort, risk of secondary infection, and a more significant health threat in immunocompromised or diabetic individuals. It should always be considered in the differential diagnosis of nail plate disorders in children as it is one of the more common causes.
Here we review the latest data on prevalence of the disease, reasons for its relatively low incidence compared with adults, and important predisposing factors. It is important to confirm the clinical diagnosis of onychomycosis in children, and affected individuals should be examined for concomitant tinea pedis. As familial disease often occurs, it is important to check parents and siblings as well for onychomycosis and tinea pedis.
Treatment of onychomycosis is challenging, and recurrence appears to be more common in children than in adults. Prolonged systemic antifungal therapy is commonly required. However, pediatric practitioners and parents alike hesitate when asked to treat young children with a systemic drug that requires laboratory monitoring and can have systemic toxicities. Due to their thinner, faster-growing nails, children are theoretically more likely to respond to topical monotherapy than adults, and therefore good candidates for topical antifungal therapy.
The clinical data on the use of topical antifungals in pediatric onychomycosis is scarce. We review data that exist from case reports and small clinical trials. New topical antifungals are now available that afford better nail penetration and additional delivery routes to the site of infection. Pediatric trials are now on-going, and should clarify the usefulness of these agents in children.
J Drugs Dermatol. 2017;16(2):105-109.
Carlo Pincelli MD,a Peter H. Schafer PhD,b Lars E. French MD,c Matthias Augustin MD,d James G. Krueger MD PhDe| |
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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| |
J Drugs Dermatol. 2013;12(3):344-346.
Nikhil Chakravarty,a,b Caitlyn Kellogg,b Jason Alvarez,b,c Ozlem Equils MD FAAP,b,d,e Margie Morgan PhDe| |
Stuart Maddin MD,a John Quiring PhD,b and Lynne Bulgerc| |
METHODS: This phase 3, randomized, placebo-controlled trial investigated the noninferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsules dosed QD for 12 weeks, with a 40-week follow-up period. Clinical Cure (Investigator’s Global Assessment plus mycological examination) was the primary outcome measure and Clinical Improvement was a secondary endpoint. Safety and efficacy of itraconazole 200-mg tablets were also compared with placebo.
RESULTS: Significantly more patients in the intent-to-treat per-protocol populations on itraconazole (200-mg tablet or 2 100-mg capsules) achieved Complete Cure and Clinical Improvement compared with placebo. For both endpoints, itraconazole 200-mg tablet QD was noninferior to itraconazole 100-mg capsules and superior to placebo. All treatment groups demonstrated a similar safety profile with no new safety signals identified.
LIMITATIONS: Absolute patient blinding was not possible; the number of tablets versus capsules differed, and the appearance of the active drugs could not be masked. However, efficacy was based on objective assessments from blinded investigators.
CONCLUSIONS: Once-daily itraconazole 200-mg was well-tolerated, and may be an effective alternative to 2 itraconazole 100-mg capsules for the treatment of toenail onychomycosis. The convenience of a simpler dosing regimen may improve patient compliance (ClinicalTrials.gov number, NCT00356915).
J Drugs Dermatol. 2013;12(7):758-763.
Brandon L. Adler BA and Adam J. Friedman MD| |
Jeffrey F. Scott MD, Danyelle Dawes MD, and Kevin D. Cooper MD| |
Objective: To evaluate the efficacy and safety of treating vitiligo patients with anti-TNF-α agents.
Methods: A total of 6 patients were recruited. All patients had widespread non-segmental vitiligo. Biologics, including infliximab, etanercept, and adalimumab, were given according to treatment regimens used for psoriasis. Photographs were taken at the initial visit, every two months during the therapy and then six months after therapy completion.
Results: All patients completed the treatment; two patients were treated with infliximab, two with etanercept, and two with adalimumab. All of the biologics were well tolerated throughout the treatment period, and none of the patients reported any significant adverse events. Digital images were compared before, during and after treatment. Repigmentation of the vitiliginous areas was not observed in any of the patients. Vitiligo worsened in one patient who was treated with infliximab and developed a psoriasiform rash. However, the remaining patients did not develop any new depigmented patches during treatment or at the six-month follow-up; vitiligo was considered stable in these five patients.
Conclusions: Although the anti-TNF-α agents were well tolerated in all six vitiligo patients, efficacy was not observed. Further evaluation with larger studies may be required.
J Drugs Dermatol. 2012;11(4):534-539.
Randomized, Double-Blind, Split-Face Study Evaluating Fractional Ablative Erbium:YAG Laser-Mediated Trans-Epidermal Delivery of Cosmetic Actives and a Novel Acoustic Pressure Wave Ultrasound Technology for the Treatment of Skin Aging, Melasma, and Acne Scars
Macrene Alexiades MD PhDa,b| |
AIM: Evaluate the safety and efficacy of a novel acoustic pressure wave ultrasound device following fractional ablative Er:YAG 2940-nm laser (FELR) and topical agents for rhytids, melasma, and acne scars.
STUDY DESIGN: Randomized, blinded, parallel group split-face side-by-side, controlled study evaluating FELR and topical anti-aging and anti-pigment agents to entire face succeeded by ultrasound to randomized side. Fifteen subjects were enrolled to three treatment arms:rhytids, melasma, and acne scars. Two monthly treatments were administered with 1, 3, and 6 month follow-up. Efficacy was assessed by Comprehensive Grading Scale of Rhytids, Laxity, and Photoaging by Investigator and two blinded physician evaluators. Subject assessments, digital photographs, and reflectance spectroscopic analyses were obtained.
RESULTS: Rhytid severity was reduced from a mean of 3.25 to 2.60 on the 4-point grading scale. Spectrophotometric analysis demonstrated increases in lightness (L*) and reductions in redness (a*) and pigment (b*), with greater improvements on the ultrasound side as compared to FELR and topicals alone. Moderate erythema post-treatment resolved in 7 days and no serious adverse events were observed.
CONCLUSION: In this randomized, paired split-face clinical study, FELR-facilitated TED of topical anti-aging actives with ultrasound treatment is safe and effective with improvement in rhytids, melasma, and acne scars. Statistically significant greater improvement in pigment levels was observed on the ultrasound side as compared to FELR-TED and topical agents alone.
J Drugs Dermatol. 2015;14(11):1191-1198.
Update on the Management of Rosacea: A Status Report on the Current Role and New Horizons With Topical Azelaic Acid
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2014;13(suppl 12):s101-s107.
Non-Tuberculous Mycobacterial Infections Following Cosmetic Laser Procedures: A Case Report and Review of the Literature
Jacqueline Goulart Berliner MD,a Bishr Aldabagh MD,a Thaddeus Mully MD,b
Siegrid S. Yu MD,a Brian S. Schwartz MD,c Timothy G. Berger MDa
J Drugs Dermatol. 2015;14(1):80-83.
Drivers of Healthcare Costs Among the Costliest Patients With Psoriasis Over Three Years in a United States Health Plan
April W. Armstrong MD MPH,a Yang Zhao PhD,b Vivian Herrera PhD,b Yunfeng Li PhD,b Tim Bancroft PhD,e Michael Hull MS,c and Aylin Altan PhDd| |
OBJECTIVE: To compare patients with psoriasis by cost level over 3 years.
METHODS: Psoriasis patients in a large US health plan in 2011-2013 were identified. Four groups were created by healthcare costs excluding biologics: patients having top 10% of costs in all 3 years (Top), top 10% in 2 of 3 years (High), bottom 90% in 2 of 3 years (Medium), and bottom 90% in all 3 years (Bottom). Comorbidities, utilization, and costs between groups were compared.
RESULTS: The study included 18,653 patients: 514 (3%), 805 (4%), 2,443 (13%), and 14,891 (80%) patients in the Top, High, Medium, and Bottom groups, respectively. Significantly more patients in the Top vs Bottom group had diabetes (31.1% vs 9.4%), cardiovascular disease (26.5% vs 4.3%), psoriatic arthritis (25.7% vs 10.7%), depression (27.8% vs 6.9%), and anxiety (22.0% vs 7.9%) in 2011 (all P less than 0.05). Patients in the Top group had more unique 2011 prescriptions (17.7 vs 6.6; P less than 0.001) than the Bottom group, but similar biologic use (22.4% vs 21.6%). Patients in the Top, High, Medium, and Bottom groups had mean 2011 total costs of $68,913, $40,575, $24,292, and $8,815, and contributed to 14%, 13%, 23%, and 51% of the overall costs, respectively. Mean total costs increased 14-18% over time for all groups. Although mean 2011 total costs for patients in the Top group were 7.8 times of those in the Bottom group, psoriasis-related costs were less disparate ($8,716 vs $4,541). Compared with patients in the Bottom group, those in the Top group were more likely to have any 2011 hospitalization (36.8% vs 2.6%; psoriasis-related: 11.1% vs 0.7%) or emergency visit (50.8% vs 20.8%; psoriasis-related: 3.9% vs 1.0%).
CONCLUSION: The costliest patients with psoriasis had significantly higher prevalence of comorbidities, prescription fills, inpatient and emergency utilization, but not biologic medication use or biologic costs.
J Drugs Dermatol. 2017;16(7):651-658.
Rachel Seidel,b.c Nicolette Lavi,c and Lisa Chipps MD MSa,c| |
CASE: A woman in her second trimester presented with an intensely pruritic vesiculobullous rash diagnosed as PG. She was started on prednisone and gradually tapered to an appropriate maintenance dose until her uncomplicated delivery of a full-term healthy newborn.
CONCLUSION: Proper management of PG requires a suitable pharmacotherapy regimen, close observation, and collaboration with a multi-disciplinary treatment team. These steps are crucial to reduce maternal morbidity, lessen fetal risk, and adequately prepare for the possibility of unfavorable obstetric outcomes.
J Drugs Dermatol. 2015;14(8):904-907.
Bensal HP for Second Intention Healing Following Mohs Micrographic Surgery or Shave Skin Biopsy: An Open-label Pilot Study
Breanne Mordorski BA,a Adam J. Friedman MD,b and Leon H. Kircik MDc| |
J Drugs Dermatol. 2016;15(10):1197-1202.
Lichenoid Drug Reaction Following Influenza Vaccination in an HIV-Positive Patient: A Case Report and Literature Review
Emily W. de Golian MD,a Christina B. Brennan MD,b and Loretta S. Davis MDb| |
J Drugs Dermatol. 2014;13(7):873-875.
A Pilot, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of IncobotulinumtoxinA Injections in the Treatment of Rosacea
Steven H. Dayan MD,a,b,c Nazanin Ashourian PhD,a,b and Katherine Cho MPHa,b| |
BACKGROUND: Rosacea has a variable presentation. Whereas the pathophysiology may differ, erythema, and flushing are the most consistent findings in all patients.
OBJECTIVE: To evaluate the safety and efficacy of incobotulinumtoxinA in reducing the severity of rosacea symptoms.
METHODS: Nine subjects with erythematotelangiectactic or papulopustular rosacea were randomized in 2 groups. Subjects in Group 1 (n=4) received up to a total of 20 U of incobotulinumtoxinA in the affected area (across both cheeks). Subjects in Group 2 (n=5) were injected with equal volumes of a saline solution. Rosacea Clinical Scores and subject satisfaction were evaluated at baseline and at 1, 4, 12, and 16 weeks post-treatment. At week 16, both groups were injected with incobotulinumtoxinA. Follow-up visits were performed at 1 and 4 weeks post-retreatment.
RESULTS: Patients in Group 1 exhibited reduction in the primary features of rosacea within 4 weeks of treatment with incobotulinumtoxinA. Consistent with this observation, patients in Group 2 (who had received the placebo in the first arm without significant changes to their symptoms) exhibited reductions in all of the primary and some of the secondary features upon treatment with incobotulinumtoxinA.
CONCLUSIONS: IncobotulinumtoxinA may be a safe and effective agent to reduce the severity of rosacea symptoms and increase patient satisfaction.
J Drugs Dermatol. 2017;16(6):549-554.
J Drugs Dermatol. 2012;11(3):385-389.
Emil A. Tanghetti MD,1 J. Mark Jackson MD,2 Kevin Tate Belasco DO MS,3 Amanda Friedrichs MD,4 Firas Hougier MD,5 Sandra Marchese Johnson MD,6 Francisco A. Kerdel MD,7 Dimitry Palceski DO FAOCD,8 H. Chih-ho Hong MD FRCPC,9 Anna Hinek MD MSc FRCPC,10 Maria Jose Rueda Cadena MD11| |
J Drugs Dermatol. 2015;14(1):33-40.
Margo H. Lederhandler MD, Anthony Ho BA, Nooshin Brinster MD, Roger S. Ho MD, Tracey N. Liebman MD, Kristen Lo Sicco MD| |
Scoping Scalp Disorders: Practical Use of a Novel Dermatoscope to Diagnose Hair and Scalp Conditions
Nicole E. Rogers MD| |
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.
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.
Pilot Randomized-Control Trial to Assess the Effect Product Sampling has on Adherence Using Adapalene/Benzoyl Peroxide Gel in Acne Patients
Laura F. Sandoval DO,a Ashley Semble MS,a Cheryl J. Gustafson MD,a Karen E. Huang MS,a Michelle M. Levender MD,a and Steven R. Feldman MD PhDa,b,c| |
PURPOSE: To determine whether demonstrating to patients how to properly apply a topical acne medication through the use of a sample product will improve adherence.
METHODS: Subjects with mild to moderate acne were instructed to use adapalene/benzoyl peroxide gel once daily for six weeks. Subjects were randomized into sample or no sample group. Sample group received a demonstration on how to apply the medication using a product sample. The primary outcome was median adherence, recorded using electronic monitoring, and secondary outcomes were efficacy measures including the Acne Global Assessment (AGA) and lesion counts and the Perceived Medical Condition Self-Management Scale (PMCSMS).
RESULTS: Data from 17 patients was collected and analyzed. Median adherence rates were 50% in the sample group and 35% in the no sample group (p=0.67). The median percent improvement in non-inflammatory lesions were 46% for the sample group and 33% for the no-sample group (p=0.10).
LIMITATIONS: The small size of this pilot study limited the extent of subgroup analyses.
CONCLUSIONS: Objective electronic monitoring expanded our previous observations of poor adherence in the treatment of acne. There is a considerable potential effect size on adherence for the use of samples, supporting the need for future, well powered studies to assess the value of using samples in the treatment of acne and other dermatologic skin diseases.
J Drugs Dermatol. 2014;13(2):135-140.
A Comparative Study of the Safety and Efficacy of 75% Mulberry (Morus alba) Extract Oil Versus Placebo as a Topical Treatment for Melasma: A Randomized, Single-Blind, Placebo-Controlled Trial
Glen Alvin MD, Nino Catambay MD, Ailynne Vergara MD, Maria Jasmin Jamora MD| |
Background: Melasma is an aesthetically undesirable skin condition which remains difficult to treat. Mulberry is a whitening agent with antioxidant properties.
Objective: To evaluate the safety and efficacy of 75% mulberry extract oil as a treatment for melasma versus placebo.
Patients and Methods: 50 patients were recruited and randomly assigned into two groups, with 25 treated with 75% mulberry extract oil and the other 25 treated with placebo. All patients had a negative repeat open application test (ROAT) to both mulberry extract and placebo. Patients were followed up regularly at four-week intervals for a total of eight weeks. The severity of the melasma was assessed using the melasma area and severity score (MASI), Mexameter reading, melasma quality of life score (MelasQOL) and any adverse events noted.
Results: The mean MASI score significantly improved from 4.076 (±0.24) at baseline to 2.884 (±0.25) at week 8 for the 75% mulberry extract oil group while the placebo group showed an improvement of a lesser magnitude. Mexameter readings for the mulberry group showed a significant drop from 355.56 (±59.51) at baseline to 312.52 (±57.03) at week 8 compared to the placebo group, whose Mexameter readings deteriorated from 368.24 (±46.62) at baseline to 372.12 (±44.47) at week 8. The MelasQOL score also improved tremendously for the 75% mulberry extract oil group, falling from 58.84 (SD: ±3.18) at baseline to 44.16 (SD: ±4.29) at week 8, unlike the placebo group that showed a less dramatic improvement from 57.44 (SD: ±4.66) at baseline to 54.28 (SD: ±4.79) at week 8. With regards to the adverse events, only mild itching was reported in four patients from the 75% mulberry extract oil group while there were 12 cases of either itching or erythema reported from the placebo group.
J Drugs Dermatol. 2011;10(9):1025-1031.
Case Report of Multiple Keratoacanthomas and Squamous Cell Carcinomas in a Patient Receiving Pembrolizumab
Soham Chaudhari DO, a Argentina Leon MD,b Ethan Levin MD,b Isaac Neuhaus MD,b and Wilson Liao MDb| |
PD-1 is expressed on antigen-stimulated T cells and induces a downstream signaling pathway that works by negative feedback to inhibit T cell proliferation, cytokine release, and cytotoxicity. PD-1 antibodies increase tumor cell killing peripherally and have a role in advanced melanoma treatment. We describe a case of an 84 year old female with stage 4 metastatic melanoma in a trial of the PD-1 inhibitor pembrolizumab who developed multiple keratoacanthomas after several months of treatment. While keratoacanthomas have been reported in patients taking BRAF inhibitors, no such reports exist for those on pembrolizumab, making this the first case report to point out this association for further investigative studies.
J Drugs Dermatol. 2017;16(5):513-515.
A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Luliconazole Cream 1% Once Daily for 7 Days in Patients Aged ≥ 12 Years With Tinea Cruris
Terry M. Jones MD,a Michael T. Jarratt MD,b Ines Mendez-Moguel MD,c Nelly Paz MD,d Steven K. Grekin DO,e
Christina Cognata Smith PharmD MBA,f and Mandeep Kaur MD MSf
OBJECTIVE: This phase 3 study evaluated the safety and efficacy of topical luliconazole cream 1% in patients with tinea cruris.
METHODS: 483 patients were enrolled and 256 male and female patients aged ≥12 years with clinically evident tinea cruris and eligible for modified intent-to-treat analysis were randomized 2:1 to receive luliconazole cream 1% (n=165) or vehicle (n=91) once daily for 7 days. Efficacy was evaluated at baseline and at days 7, 14, 21, and 28 based on mycology (potassium hydroxide, fungal culture) and clinical signs (erythema, scaling, pruritus). The primary outcome was complete clearance at day 28 (21 days posttreatment). Safety evaluations included adverse events and laboratory assessments.
RESULTS: Complete clearance was obtained in 21.2% (35/165) of patients treated with luliconazole cream 1% compared with 4.4% (4/91) treated with vehicle (P<0.001). The safety profile of luliconazole cream 1% was similar to vehicle.
LIMITATIONS: The study was conducted under controlled conditions in a relatively small population.
CONCLUSION: Luliconazole cream 1% applied once daily for 7 days is more effective than vehicle and well tolerated in patients with tinea cruris.
J Drugs Dermatol. 2014;13(1):32-38.
Jennifer V. Nguyen MD| |
J Drugs Dermatol. 2014;13(suppl 1):s12-s16.
Linda F. Stein Gold MD,a Tracey Vlahovic DPM,b Amit Verma DrPH,c Babajide Olayinka MSc,c
Alan B. Fleischer Jr. MDc
OBJECTIVE: The objective of this analysis is to present data from two pooled randomized, vehicle-controlled studies that evaluated efficacy of once daily topical naftifine gel 2% and vehicle at end of treatment (week 2) and at 4 weeks post-treatment in subjects with moccasin tinea pedis.
METHODS: At visit 1, subjects were randomized to naftifine gel 2% or vehicle groups and subjects underwent baseline mycology culture, KOH, and symptom (erythema, scaling, and pruritus) severity grading. Naftifine gel 2% and vehicle treatment were applied once daily for 2 weeks and the subjects returned at weeks 2 and 6 for efficacy evaluation (mycology culture and grading of symptom severity). A total of 1174 subjects were enrolled with interdigital tinea pedis with or without moccasin infection. Of these subjects, 674 subjects had interdigital presentation while 500 subjects had moccasin infection in addition to the interdigital presentation. All 1174 subjects with interdigital presentation satisfied the inclusion criteria of a minimum of moderate erythema and scaling, and mild pruritus. Of the 500 subjects who had moccasin presentation, 380 satisfied the same inclusion criteria as mentioned above. Since data was analyzed as observed cases, between 337 and 349 subjects had data available for analysis of efficacy. Mycologic cure is defined as a negative dermatophyte culture and KOH, treatment effectiveness is defined as mycologic cure and symptom severity scores of 0 or 1, and complete cure is defined as mycologic cure and symptoms severity scores of 0.
RESULTS: At week 6, the cure rates in the naftifine arm vs. the vehicle were statistically higher (P<0.0001) for mycological cure rate (65.8% vs. 7.8%), treatment effectiveness (51.4% vs 4.4%), and complete cure rate (19.2% vs 0.9%).
CONCLUSION: Two weeks application of topical naftifine gel 2% is an effective monotherapy treatment for moccasin tinea pedis.
J Drugs Dermatol. 2015;14(10):1138-1144.
David Schairer BA, Laura Schairer BA, Adam Friedman MD| |
Efficacy and Safety of Once-Daily Dapsone Gel, 7.5% for Treatment of Adolescents and Adults With Acne Vulgaris: First of Two Identically Designed, Large, Multicenter, Randomized, Vehicle-controlled Trials
Linda F. Stein Gold MD,a Michael T. Jarratt MD,b Alicia D. Bucko DO,c Steven K. Grekin DO,d
Joshua M. Berlin MD,e Michael Bukhalo MD,f Jonathan S. Weiss MD,g David R. Berk MD,h
Joan–En Chang–Lin PhD,h Vince Lin PhD,h and Alexandre Kaoukhov MDh
OBJECTIVE: The objective of this study was to assess the efficacy and safety of a new, once-daily formulation of dapsone gel, 7.5%, with a 50% higher dapsone concentration, versus vehicle over 12 weeks in patients with acne.
METHODS: This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients with moderate acne aged 12 years and older with 20 to 50 inflammatory lesions and 30 to 100 noninflammatory lesions on the face, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized to receive topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions.
RESULTS: The intent-to-treat population comprised 2102 patients, 1044 in the dapsone gel, 7.5% group and 1058 in the vehicle group. At week 12, 29.9% of patients in the dapsone gel, 7.5% group and 21.2% in the vehicle group (P<.001) had GAAS success. Mean inflammatory lesions decreased by 55.5% and 49.0%, noninflammatory lesions decreased by 44.4% and 38.4%, and total lesions decreased by 48.7% and 42.4% in the dapsone gel, 7.5% and vehicle groups (all P<.001), respectively, at week 12. The incidence of adverse events was similar in the dapsone gel, 7.5% (19.1%) and vehicle (20.6%) groups. Most events in both groups were mild or moderate in severity. Most patients receiving dapsone gel, 7.5% and vehicle had a severity rating of “none” for stinging/burning, dryness, scaling, and erythema scales at all time points.
CONCLUSIONS: Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne.
J Drugs Dermatol. 2016;15(5):553-561.
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.
Uchenna R. Okereke MD,a Sara Colozza,b David E. Cohen MD MPHc| |
OBSERVATIONS: A 60 year-old female with stage IV lung cancer was treated with erlotinib (100 mg/d). The patient elected to discontinue erlotinib after four years secondary to adverse systemic reactions. However, five months later small, monomorphic, rough, folliculocentric papules with surrounding mild erythema characteristic of keratosis pilaris were noted on upper back and arms.
CONCLUSIONS AND RELEVANCE: This serves as the first documented case of new onset keratosis pilaris in a patient after discontinuation of erlotinib. We report the present case to show the possible association of keratosis pilaris with not only RAF inhibitors, but also the EGFR inhibitor erlotinib. Further investigation will determine whether this is a class effect with other systemic EGFR inhibitors.
J Drugs Dermatol. 2014;13(11):1410-1411.
Christine Rønneberg Mehren MD,a Anders Clemmensen MD,a Anne Boe-Hansen Dall MD,a
Peter Philipsen PhD,a and Robert Gniadecki MDa,b
AIM: To assess the relative contribution of the different symptom domains on HRQoL in psoriasis.
METHODS: 165 psoriasis patients (41.2 % with psoriasis arthritis (PsA)) were enrolled in a single-center cohort-study. For the assessment of HRQoL, patients completed EuroQoL (EQ-5D), the Short Form 36-item Health Survey (SF-36), the Health Assessment Questionaire (HAQ), and Dermatological Life Quality Index (DLQI) questionnaires. Multiple regression analysis was applied to determine the contribution of the measured parameters to the EuroQoL score (used as a reference measure for overall HRQoL).
RESULTS: Psoriasis arthritis (PsA) patients showed a higher impairment in all HRQoL measures than the patients without PsA. PASI, number of affected joints (PsA-score), DLQI and HAQ were significant predictors of HRQoL (R2=0.57). HAQ was the dominant contributor to HRQoL, both in patients with PsA and without PsA (partial eta 0.23 and 0.28, respectively.) Final model with improved R2 (0.61) was obtained by backward regression analysis, and included 6 parameters: PASI, PsA-score, and three questions from HAQ and one question from DLQI questionnaire.
CONCLUSION: Musculoskeletal symptoms are an essential component of HRQoL in psoriasis, even in patients without active PsA. A model consisting of PASI, PsA-score, and 4 questions derived from DLQI and HAQ seems to reflect total HRQoL impairment in psoriasis. This finding may further optimize drug therapy in psoriasis.
J Drugs Dermatol. 2014;13(3):246-250.
Short-Term and Low-Dose Oral FluconazoleTreatment Can Cause Stevens-JohnsonSyndrome in HIV-Negative Patients
Efi Pasmatzi MD, Alexandra Monastirli MD,Sophia Georgiou MD, George Sgouros MD, Dionysios Tsambaos MD PhD| |
J Drugs Dermatol. 2011;10(11):1328-1330.
Pearl E. Grimes MD| |
OBJECTIVE: To assess the efficacy and safety of bimatoprost 0.03% alone and in combination with a topical steroid (mometasone) compared with mometasone alone in patients with nonsegmental vitiligo on nonfacial areas in a proof-of-concept study.
METHODS: This randomized, double-blind, controlled study was conducted over a 20-week treatment period. Patients were randomized to 1 of 3 treatment groups: bimatoprost monotherapy (n=11), bimatoprost plus mometasone (n=10), and mometasone plus placebo (n=11). The primary outcome was global response at week 20, based on an investigator’s assessment of improvement score of at least 5 (at least 50%–75% improvement from baseline) on an 8-point scale (0=worse; 7=cleared). Other outcomes included global response at other visits, response by anatomic site, change from baseline lesion severity (overall and by site), and safety.
RESULTS: Because of a lack of response observed for the primary end point, a post hoc analysis with a less stringent definition of response (score of ≥4 [25%–50% improvement]) was conducted. In this analysis, 46% of the bimatoprost plus mometasone group responded overall compared with 18% in the bimatoprost monotherapy group, and no patients in the mometasone plus placebo group. Greater response rates were observed in both bimatoprost groups compared with the mometasone plus placebo group starting at week 12. There were no differences among groups in signs and symptoms of irritation.
CONCLUSIONS: Bimatoprost alone or with mometasone provided greater repigmentation than treatment with mometasone alone. Larger studies that also assess facial lesions are warranted.
J Drugs Dermatol. 2016;15(6):703-710.
Evaluation of a Prescription Strength 4% Hydroquinone/10% L-Ascorbic Acid Treatment System for Normal to Oily Skin
Suzanne Bruce MDa and JoAnne Watson DPMb| |
Methods: Patients with minimal or mild facial photodamage and hyperpigmentation, and normal to oily facial skin, used the treatment system for 12 weeks.
Results: Of 34 females enrolled, 30 completed. Median scores for the overall integrated assessment of photodamage, overall intensity of pigmentation, fine lines and wrinkles, tactile roughness, and laxity were significantly improved at week 12 compared with baseline. Furthermore, ≥90 percent of patients considered their skin was smoother, softer, more evenly toned, and more radiant, and 100 percent were satisfied with the overall appearance of their skin.
Conclusion: The treatment system can help to ameliorate early signs of photodamage in normal to oily skin.
J Drugs Dermatol. 2011;10(12):1455-1461.
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| |
Detection and Relevance of Naftifine Hydrochloride in the Stratum Corneum Up to Four Weeks Following the Last Application of Naftifine Cream and Gel, 2%
Stefan Plaum MD, Amit Verma DrPH MPH, Alan B. Fleischer Jr. MD,
Babajide Olayinka MSc, and Bhushan Hardas MD
OBJECTIVE: The objective is to use tape stripping methodology to assess the amount of drug available in the SC over a 28 day period following the last dose.
METHODS: This was an open-label, single-exposure study on subjects comparing the amount of drug that was absorbed into the SC following topical application for 2-weeks. Twelve subjects were dosed daily (6 with naftifine cream, 2% and 6 with naftifine gel, 2%). Subjects had twelve 8 cm2 test application sites demarcated on the upper back. Twenty-five individual sequential strips were obtained from each test site. Of these, 11 sites were dosed once daily with the drug (5.0μL/cm2) for days 1 to 14 and the final site served as the control. On days 15, 29, and 43, a site was stripped to collect the SC in order to process the amount of drug present.
RESULTS: Naftifine was present on all tape strip samples collected over the 28 day period following two weeks of application. Furthermore, the most relevant, deeper tape strip sets reflecting the SC, showed potentially clinically relevant presence of naftifine in the skin for 28-days post-treatment.
CONCLUSIONS: Naftifine was present in the tape strips on all sample collection days up to and including four weeks following the last drug application. These findings help explain the progressive improvement in clinical and mycological response rates during the treatment period and for up to four weeks post-treatment in the clinical trials using naftifine.
J Drugs Dermatol. 2013;12(9):1004-1008.
Efficacy and Safety of Naftifine HCl Gel 2% in the Treatment of Interdigital and Moccasin Type Tinea Pedis: Pooled Results from Two Multicenter, Randomized, Double-Blind, Vehicle-Controlled Trials
Linda F. Stein Gold MD,a Lawrence Charles Parish, MD,b,c Tracey Vlahovic DPM,d Leon Kircik MD,e Stefan
Plaum MD,f Alan B. Fleischer Jr MD,f Amit Verma DrPH,f Babajide Olayinka MSc,f
and Bhushan Hardas MDf on behalf of the NAFT-600 Study Group*
OBJECTIVE: To evaluate the efficacy and safety of two-weeks once daily application of naftifine gel 2% in the treatment of tinea pedis.
METHODS: At baseline, 1715 subjects were randomly assigned 2:1 to naftifine gel 2% (n=1144) and vehicle (n=571). Efficacy consisting of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity was evaluated at baseline and weeks 2, 4, and 6. Efficacy was analyzed in 1174 subjects (n=782, naftifine; n=392, vehicle) with a positive baseline dermatophyte culture and KOH for whom week 6 assessments were available. Safety was evaluated by adverse events (AE) and laboratory values in 1714 subjects (n=1143, naftifine; n=571, vehicle).
RESULTS: Subjects treated with naftifine gel 2% for interdigital-type tinea pedis demonstrated greater improvement from baseline for complete cure (P=0.001), mycological cure (P<0.0001), and treatment effectiveness (P<0.0001) as early as 2 weeks when compared to vehicle; however the highest response rates were seen 4-weeks post treatment (P<0.0001, for all endpoints). Statistically significant results for complete cure, mycological cure, and treatment effectiveness (P<0.0001, for all endpoints) were also seen at week 6 among subjects with moccasin-type tinea pedis. Treatment related adverse events were minimal.
CONCLUSIONS: Treatment with naftifine gel 2% applied once daily for two weeks is well-tolerated and is effective in treating both interdigital-type and moccasin-type tinea pedis. Continuous improvement is observed from the end of treatment to four-weeks after treatment cessation among key outcome measures (complete cure, mycological cure, and treatment effectiveness) as well as clinical signs and symptoms (erythema, scaling, and pruritus).
J Drugs Dermatol. 2013;12(8):911-918.
The Active Natural Anti-Oxidant Properties of Chamomile, Milk Thistle, and Halophilic Bacterial Components in Human Skin In Vitro
Andrew Mamalis BS,a, b Duc-Huy Nguyen,a Neil Brody MD PhD,c and Jared Jagdeo MD MSa,b,c| |
J Drugs Dermatol. 2013;12(7):780-784.
James Q. Del Rosso DO FAOCDa and Emil Tanghetti MDb| |
J Drugs Dermatol.2013;12(3 suppl 2):s53-s58.
Horatio F. Wildman MD and Richard D. Granstein MD| |
Efficacy, Safety, and Tolerability of 4% 5-Fluorouracil Cream in a Novel Patented Aqueous Cream Containing Peanut Oil Once Daily Compared With 5% 5-Fluorouracil Cream Twice Daily: Meeting the Challenge in the Treatment of Actinic Keratosis
Magdalene A. Dohil MD| |
J Drugs Dermatol. 2016;15(10):1218-1224.
Pivotal Trial of the Efficacy and Safety of Oxymetazoline Cream 1.0% for the Treatment of Persistent Facial Erythema Associated With Rosacea: Findings from the Second REVEAL Trial
Leslie Baumann MD,a David J. Goldberg MD,b Linda Stein Gold MD,c Emil A. Tanghetti MD,d Edward Lain MD,e Joely Kaufman MD,f Emily Weng ScD MBA,g David R. Berk MD,g and Gurpreet Ahluwalia PhDg| |
J Drugs Dermatol. 2018;17(3):290-298.
A Phase III, Multicenter, Parallel-Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam Versus Vehicle in Women With Female Pattern Hair Loss
Wilma Bergfeld MD,a Ken Washenik MD PhD,b,c Valerie Callender MD,d Paul Zhang PhD,e Carlos Quiza MD,e Uday Doshi PhD,e and Ulrike Blume-Peytavi MDf| |
OBJECTIVE: To compare the efficacy and safety of once-daily 5% MTF with vehicle foam for the treatment of FPHL.
MATERIALS AND METHODS: This was a Phase III, randomized, double-blind, vehicle-controlled, parallel-group, international multicenter trial (17 sites) in women aged at least 18 years with FPHL (grade D3 to D6 on the Savin Density Scale), treated once daily with 5% MTF or vehicle foam for 24 weeks. The co-primary efficacy endpoints were the change from baseline at week 24 in target area hair count (TAHC) and subject assessment of scalp coverage. Also evaluated were TAHC at week 12, expert panel review of hair regrowth at week 24, and change from baseline in total unit area density (TUAD, sum of hair diameters/cm2) at weeks 12 and 24.
RESULTS: A total of 404 women were enrolled. At 12 and 24 weeks, 5% MTF treatment resulted in regrowth of 10.9 hairs/cm2 and 9.1 hairs/cm2 more than vehicle foam, respectively (both P<.0001). Improved scalp coverage at week 24 was observed by both subject self-assessment (0.69-point improvement over vehicle foam; P<.0001) and expert panel review (0.36-point improvement over the vehicle foam; P<.0001). TUAD increased by 658 μm/cm2 and 644 μm/cm2 more with 5% MTF than with vehicle foam at weeks 12 and 24, respectively (both P<.0001). MTF was well tolerated. A low incidence of scalp irritation and facial hypertrichosis was observed, with no clinically significant differences between groups.
CONCLUSION: Five percent MTF once daily for 24 weeks was well tolerated and promoted hair regrowth in women with FPHL, resulting in improved scalp coverage and increased hair density compared with vehicle foam. ClinicalTrials.gov identifier: nCT01226459
J Drugs Dermatol. 2016;15(7):874-881.
Brian C. Schulte BSE, Wesley Wu MD, and Ted Rosen MD| |
J Drugs Dermatol. 2015;14(9):964-968.
Efficacy and Tolerability Assessment of a Topical Formulation Containing Copper Sulfate and Hypericum perforatum on Patients With Herpes Skin Lesions: A Comparative, Randomized Controlled Trial
Objectives: The study assessed the comparative efficacy and tolerability of a single use, topical formulation containing copper sulfate pentahydrate and Hypericum perforatum that is marketed as Dynamiclear™ to a topical 5% Acyclovir cream standard preparation and use.
Methods: A prospective, randomized, multi-centered, comparative, open-label clinical study was conducted. A total of 149 participants between 18 and 55 years of age with active HSV-1 and HSV-2 lesions were recruited for the 14-day clinical trial. Participants were randomized into two groups: A (n=61), those receiving the Dynamiclear formulation, and B (n=59), those receiving 5% Acyclovir. Efficacy parameters were assessed via physical examination at baseline (day 1), day 2, 3, 8, and 14. Laboratory safety tests were conducted at baseline and on day 14.
Results: Use of the Dynamiclear formulation was found to have no significant adverse effects and was well tolerated by participants. All hematological and biochemical markers were within normal range for the Dynamiclear group. Statistically, odds for being affected by burning and stinging sensation were 1.9 times greater in the Acyclovir group in comparison to the Dynamiclear group. Similarly, the odds of being affected by symptoms of acute pain, erythema and vesiculation were 1.8, 2.4, and 4.4 times higher in the Acyclovir group in comparison to the Dynamiclear group.
Conclusions: The Dynamiclear formulation was well tolerated, and efficacy was demonstrated in a number of measured parameters, which are helpful in the symptomatic management of HSV-1 and HSV-2 lesions in adult patients. Remarkably, the effects seen from this product came from a single application.
J Drugs Dermatol. 2012;11(2):209-215.
Taylor L. Braunberger MD,a Amanda F. Nahhas DO,a Linda M. Katz MD MPH,b Nakissa Sadrieh PhD,b and Henry W. Lim MDa| |
J Drugs Dermatol. 2018;17(4):387-391.
Zoon Balanitis Revisited: Report of Balanitis Circumscripta Plasmacellularis Resolving With Topical Mupirocin Ointment Monotherapy
Michael A. Lee MDa and Philip R. Cohen MDb| |
INTRODUCTION: Zoon balanitis is an idiopathic benign inflammatory condition of the glans penis and prepuce. A patient with biopsy confirmed diagnosis of Zoon balanitis who was successfully treated with topical mupirocin ointment monotherapy is described.
METHOD: A search using PubMed database was performed using the following terms: Zoon balanitis (cases, diagnosis, treatment of), balanitis circumscripta plasmacellularis, and mupirocin. Relevant papers and their reference citations were reviewed and evaluated.
RESULTS: The gold standard of treatment for Zoon balanitis has previously been circumcision. More recently, topical calcineurin inhibitors have been shown to be effective. Our patient had successful resolution of his Zoon balanitis after 3 months of mupirocin ointment monotherapy.
DISCUSSION: Zoon balanitis is a benign inflammatory dermatosis. Previous successful treatment modalities include circumcision, phototherapy, laser therapy, and topical calcineurin inhibitors. Topical mupirocin ointment twice daily resulted in resolution of Zoon balanitis in our patient. Additional evaluation of mupirocin ointment as a therapeutic agent should be considered as a potential first-line therapy in patients with Zoon balanitis.
J Drugs Dermatol. 2017;16(3):285-287.
Vic A. Narurkar MD,a Sabrina G. Fabi MD FAAD FAACS,b Vivian W. Bucay MD FAAD,c Ruth Tedaldi MD,d Jeanine B. Downie MD,e Joshua A. Zeichner MD,f Kimberly Butterwick MD,g Amy Taub MD,h Kuniko Kadoya PhD,i Elizabeth T. Makino BS MBA CCRA,i Rahul C. Mehta PhD,i and Virginia L. Vega PhDi| |
SkinMedica’s HA5 Rejuvenating Hydrator (SkinMedica Inc., an Allergan company, Irvine, CA) promotes restoration of endogenous epidermal HA homeostasis and provides instant smoothing and hydration of the skin. These dual benefits are accomplished through the combination of 2 breakthrough technologies: 1) a unique blend of actives powered by SkinMedica proprietary flower-derived stem cell extract that restores the endogenous production of HA; and 2) a proprietary mix of 5 HA forms that plump the skin, decreasing the appearance of fine lines/wrinkles.
Pre-clinical studies demonstrated that HA5 induces expression of key epidermal differentiation and barrier markers as well as epidermal HA synthases. A decrease expression of hyaluronidases was also observed upon HA5 application. Initial clinical studies showed that within 15 minutes of application, HA5 instantly improves the appearance of fine lines/wrinkles and skin hydration. Subjects that continue using HA5 (for 8 weeks) demonstrated significant improvements in fine lines/wrinkles, tactile roughness, and skin hydration. In summary, the blend of these 2 key technologies present in HA5 promotes restoration of endogenous epidermal HA while delivering instant smoothing effects.
J Drugs Dermatol. 2016;15(1 Suppl 2):s24-s37.
David Schairer BA and Adam Friedman MD| |
Alan R. Shalita MD,a Ronald Falcon MD,b Alan Olansky MD,c Patricia Iannotta MD,d Arash Akhavan MD,e Doris Day MD,f, Anthony Janiga MD,g Prashant Singri MD,h and John E. Kallal PhDi| |
Objective: To assess the usefulness of a novel dietary supplement in the overall management of patients with inflammatory acne vulgaris.
Methods: 235 patients with inflammatory acne vulgaris were enrolled by dermatologists in a multicenter, open-label, 8-week, prospective study evaluating the effects of adding NicAzel, 1 to 4 tablets daily, to their current acne treatment regimen.
Results: A statistically significant (P<.0001) number of patients demonstrated improvement over their previous acne treatment regimens after both 4 and 8 weeks of NicAzel (nicotinamide, azelaic acid, zinc, pyridoxine, copper, folic acid; Elorac Inc, Vernon Hills, IL) use. At week 8, 88% of the patients experienced a visible reduction in inflammatory lesions, and 81% of the patients rated their appearance as much or moderately better compared with baseline. Three-quarters (76%) of the patients thought NicAzel was at least as effective as previous treatment with oral antibiotics.
Conclusion: Patients with inflammatory acne showed significant improvement in acne severity and overall appearance when NicAzel was added to their existing treatment regimen.
J Drugs Dermatol. 2012;11(12):1428-1433.
News, Views, & Reviews
Manifestations and Treatment of Cutaneous Lupus Erythematosus (Part II of II)
David Schairer BA and Adam Friedman MD| |
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.
Shawn Shetty MD and A. Razzaque Ahmed MD DSc| |
J Drugs Dermatol. 2013;12(6):672-677.
J. Mark Jackson MDa and Michelle Pelle MDb| |
Many topical medications are available for the treatment of papulopustular rosacea. While treatments contain metronidazole, azelaic acid, or sodium sulfacetamide-sulfur as the active ingredient, the composition of the vehicle formulations varies widely. These vehicles come in gels, creams, lotions and foams; some ingredients are common to many vehicles, while some vehicles contain unique ingredients designed to optimize skin penetration and delivery of the active drug to its target. Vehicles can also influence tolerability, which is always a concern in patients with heightened skin sensitivity, and compliance, which is typically lower for topical treatments than oral treatments. Ideally, the vehicle of any rosacea treatment should enhance drug delivery, be nonirritating and be easy to use. Ingredients that help repair barrier function are also desirable. This review will focus on the key components of the vehicles from the most commonly used topical therapies for papulopustular rosacea and how vehicle formulations influence the delivery of active ingredient, skin barrier repair, tolerability and compliance.
J Drugs Dermatol. 2011;10(6):627-633.
Customized Single-agent Therapy Management of Severe Inflammatory Acne: A Randomized, Double-blind, Parallel-group, Controlled Study of a New Treatment - Adapalene 0.3%-Benzoyl Peroxide 2.5% Gel
Jonathan Weiss MD,a Linda Stein Gold MD,b Matthew Leoni MD,c Maria Jose Rueda MD,d Hong Liu Msc,c and Emil Tanghetti MDe| |
OBJECTIVES: To demonstrate superior efficacy of adapalene 0.3%-benzoyl peroxide 2.5% gel (0.3% A/BPO) vs. vehicle, and to assess efficacy of 0.3% A/BPO vs. 0.1% A/BPO in subjects with severe inflammatory acne (Investigator’s Global Assessment [IGA] of 4) in the context of a larger trial in a moderate and severe population.
METHODS: This was a multicenter, randomized, double-blind, parallel-group, 12-week study. Subjects were randomized to receive 0.3% A/BPO, 0.1% A/BPO (benchmark) or vehicle (comparator) once daily for 12 weeks. Co-primary efficacy endpoints were success rate at week 12 (percentage of subjects rated “clear” or “almost clear,” ≥3-grade IGA improvement), and change in inflammatory (IN) and noninflammatory (NIN) lesion counts from baseline to week 12. Secondary efficacy endpoints were percent changes in IN and NIN lesion counts. Safety endpoints were incidence of adverse events (AEs) and local tolerability signs/symptoms.
RESULTS: In the severe inflammatory acne population, a total of 252 subjects were randomized with 106, 112 and 34 subjects in the 0.3% A/BPO, 0.1% A/BPO and vehicle groups, respectively, reaching a high rate of study completion (88.5%). At week 12, both 0.3% A/BPO and 0.1% A/BPO were superior to vehicle in terms of lesion count reduction. However for success rate, only 0.3% A/BPO achieved significantly greater efficacy over vehicle with a treatment difference of 20.1% (31.9% vs. 11.8%; 95% Confidence Interval (CI): [6.0%, 34.2%], P=.029), whereas 0.1% A/BPO did not (treatment difference vs. vehicle of 8.8%; P=.443). This translates to an 11% difference between active treatments in favor of 0.3% A/BPO. Also, 0.3% A/BPO was safe and well tolerated.
CONCLUSIONS: Availability of this new treatment option should allow clinicians to better customize severe inflammatory acne management, and the high-strength product provides a step-up treatment when needed.
J Drugs Dermatol. 2015;14(12):1427-1435.
Andrew C. Krakowski MD,a Lawrence F. Eichenfield, MDb| |
Joshua A. Zeichner MD| |
J Drugs Dermatol. 2013;12(12):1418-1427.
Evelyn J. Cheung MD, Jaroslaw J. Jedrych MD, and Joseph C. English III MD| |
J Drugs Dermatol. 2015;14(10):1161-1162.
Neal D. Bhatia MDa and James Q. Del Rosso DO FAOCDb| |
The pathophysiology of papulopustular rosacea (PPR) is primarily characterized by inflammation associated with several factors such as abnormal innate immune response, neurovascular dysregulation, stratum corneum barrier dysfunction, and depletion of antioxidant reserve, with no definitive evidence supporting an underlying microbial etiology. Several molecular inflammatory pathways have now been identified that enable the development of therapeutic agents that target the signs and symptoms of disease by modifying specific pathophysiological mechanisms. Available evidence demonstrates that topical and oral agents commonly used to treat PPR appear to modify some of these pathophysiological mechanisms and may prove to be complimentary when used in combination potentially leading to better therapeutic outcomes.
During the past two decades, six clinical studies have been published on the benefits of combining oral and topical therapies for PPR. Four studies suggest that doxycycline, including anti-inflammatory dose doxycycline (doxycycline 40 mg modified-release capsule once daily) can be combined with topical metronidazole or azelaic acid in patients with PPR to achieve more rapid control of a flare. At present, subantimicrobial dosing of a tetracycline agent that also maintains anti-inflammatory activity has only been established with doxycycline. Although antibiotic doses of tetracycline agents (such as doxycycline, minocycline, and tetracycline) are known to be effective for PPR, the use of subantimicrobial dosing of doxycycline avoids the risk of antibiotic resistance.
J Drugs Dermatol. 2012;11(7):838-844.
J Drugs Dermatol. 2013;12(10):1177-1179.
Planimetric Post-hoc Analysis of Women With Onychomycosis from Tavaborole 5% Phase III Studies: Evidence of Greater Improvements in Patients With >50% Baseline Infection
David M. Pariser MD,a Martin E. Wendelken DPM RN,b Anthony M. Rycerz Jr. PhD,c Nicole Gellings Lowe PhD,c John Montgomery Yost MD MPH,d and Shari R. Lipner MD PhDe| |
Prospective, Randomized, Investigator-Blinded, Split-Face Evaluation of a Topical Crosslinked Hyaluronic Acid Serum for Post-Procedural Improvement of Skin Quality and Biomechanical Attributes
Hema Sundaram MD FAAD,a Angnieszka Cegielska MD,b Agnieszka Wojciechowska,b and Patrice Delobel PhDc| |
J Drugs Dermatol. 2018;17(4):442-450.
Benjamin H. Kaffenberger MD, Stephanie K. Fabbro MD, and Katya L. Harfmann MD| |
Complementary Antioxidant Function of Caffeine and Green Tea Polyphenols in Normal Human Skin Fibroblasts
Jared Jagdeo MD MS and Neil Brody MD PhD| |
The study of free radicals is particularly relevant in the context of human skin carcinogenesis and photoaging because of these oxidants´ ability to induce DNA mutations and produce lipid peroxidation byproducts, including 4-hydroxy-2-nonenal (HNE). Therefore, it is important to identify and evaluate agents with the ability to modulate intracellular free radicals and HNE. The purpose of this research is to investigate the ability of antioxidants green tea polyphenols (GTPs) and caffeine, alone and in combination, to modulate the hydrogen peroxide (H2O2)-induced upregulation of reactive oxygen species (ROS) free radicals and HNE in normal human skin fibroblast WS-1 cells in vitro. GTPs and caffeine were selected for evaluation because these compounds have demonstrated antioxidative properties in various skin models. Furthermore, GTPs and caffeine share a close natural botanical association as caffeine is present in green tea, as well. Hydrogen peroxide is a well-known generator of free radicals that is produced during endogenous and UV-induced oxidation processes in human skin and was used to upregulate ROS and HNE in normal human fibroblast WS-1 cells. Using a flow cytometry-based assay, the results demonstrate that at 0.001% concentration, green tea polyphenols alone, and in combination with 0.1 mM caffeine, inhibited the upregulation