Search

Adelaide Ann Hebert UTHealth McGovern Medical School, Houston, TX, USACorrespondence: Adelaide Ann Hebert, Email Adelaide.a.hebert@uth.tmc.eduPurpose: Atopic and contact dermatitis have been attributed to skin barrier abnormalities, immune system dysfunction and inflammation leading to pruritus. As these factors may involve oxidative stress, emollient devices containing antioxidants furfuryl palmitate and tocopherol may help reduce itching and inflammation. In this study, a post-marketing questionnaire was carried out of 40 users of a novel emollient device containing furfuryl palmitate and tocopherol (Relizema™ cream), who purchased it from a pharmacy or health-care professional to ascertain the emollient device’s action on itching, flushing and moisturizing.Patients and Methods: The post-marketing questionnaire, administered by trained pharmacy and health-care staff, collected data on age; diagnosis; number of times per day and for how many days the emollient device was applied; whether the product helped alleviate itching and flushing, and in what time frame if so; and how their skin felt after using the emollient.Results: Most patients had atopic dermatitis (n = 25) or irritant contact dermatitis (n = 10); most were aged ≥ 19 years (n = 20) or between 3 and 12 years (n = 12). Most used the emollient device twice a day (n = 26) or more (n = 11) with 27 using it for ≤ 30 days. Patients predominantly reported that the emollient device “significantly improved” itching (n = 34) and flushing (n = 31) with a response being noted within 1 day (n = 17) or 1 week (n = 22). All users felt the product “protected and moisturized” their skin, the product texture was “pleasant” to “excellent” and the “non-fragrance” smell was “acceptable” to “excellent”.Conclusion: Use of a novel emollient device containing ingredients aimed at managing atopic or contact dermatitis, including furfuryl palmitate and tocopherol, led to rapid improvements in itching and flushing. The emollient device was acceptable to the users.Keywords: post-marketing surveillance, pediatric, adult, skin barrier repair, steroid-free

Omar Pacha, Adelaide A HebertDepartment of Dermatology, University of Texas Health Science Center, Houston, TX, USAAbstract: Advances in current understanding of the pathophysiology of atopic dermatitis have led to improved targeting of the structural deficiencies in atopic skin. Ceramide deficiency appears to be one of the major alterations in atopic dermatitis and the replenishment of this epidermal component through topically applied ceramide based emollients appears to be safe, well tolerated, and effective. Recently a ceramide hyaluronic acid foam has become commercially available and increasing evidence supports its safety and efficacy in patients who suffer from atopic dermatitis.Keywords: atopic dermatitis, ceramide, Hylatopic, eczema, non-steroidal, dermatology

BackgroundOnce-daily topical oxymetazoline cream 1·0% significantly reduced persistent facial erythema of rosacea in trials requiring live, static patient assessments.ObjectivesTo evaluate critically the methodology of clinical trials that require live, static patient assessments by determining whether assessment of erythema is different when reference to the baseline photograph is allowed.MethodsIn two identically designed, randomized, phase III trials, adults with persistent facial erythema of rosacea applied oxymetazoline or vehicle once daily. This phase IV study evaluated standardized digital facial photographs from the phase III trials to record ≥ 1-grade Clinician Erythema Assessment (CEA) improvement at 1, 3, 6, 9 and 12 h postdose.ResultsAmong 835 patients (oxymetazoline n = 415, vehicle n = 420), significantly greater proportions of patients treated with oxymetazoline vs. vehicle achieved ≥ 1-grade CEA improvement. For the comparison between phase IV study results and the original phase III analysis, when reference to baseline photographs was allowed while evaluating post-treatment photographs, the results for oxymetazoline were similar to results of the phase III trials (up to 85.7%), but a significantly lower proportion of vehicle recipients achieved ≥ 1-grade CEA improvement (up to 29.7% [phase 4] vs. 52.3% [phase 3]; P

This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6-7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long-term control is needed before progress can be made towards recommending a core outcome measure.

Background/objectives: Efficacy and safety of roflumilast cream 0.15% were demonstrated in patients aged ≥ 6 years with atopic dermatitis (AD) in two Phase 3 trials. This Phase 3 parallel-group, double-blind trial (INTEGUMENT-PED; NCT04845620) compared the efficacy and safety of roflumilast cream 0.05% and a vehicle in patients aged 2-5 years with AD., Methods: Patients aged 2-5 years with mild-to-moderate AD were treated with once-daily roflumilast cream 0.05% or vehicle for 4 weeks. The primary efficacy endpoint was Validated Investigator Global Assessment for AD (vIGA-AD) Success (0 [Clear] or 1 [Almost Clear] plus ≥ 2-grade improvement from baseline) at Week 4. Other endpoints included ≥ 75% improvement in Eczema Area and Severity Index (EASI-75) and Worst Itch-Numeric Rating Score (WI-NRS) Success (≥ 4-point improvement in patients with baseline ≥ 4). Safety and tolerability were also assessed., Results: Among 437 and 215 patients treated with roflumilast and vehicle, respectively, significantly greater proportions of the roflumilast group achieved Week-4 vIGA-AD Success (25.4% vs. 10.7%; p < 0.0001), EASI-75 (39.4% vs. 20.6%; p < 0.0001), and WI-NRS Success (35.3% vs. 18.0%; nominal p = 0.0002). Improvement in pruritus was observed within 24 h after the first application (nominal p = 0.0014). Treatment-emergent adverse event (TEAE) rates were low in both groups, and 98.9% were mild or moderate. At all timepoints, stinging/burning that caused definite discomfort was reported by ≤ 0.7% of caregivers of patients in the roflumilast group., Conclusions: In this Phase 3 trial, once-daily roflumilast cream 0.05% improved AD signs/symptoms in patients aged 2-5 years, with early pruritus improvement, low AE rates, and local tolerability comparable with vehicle., Trial Registration: ClinicalTrials.gov: NCT04845620., (© 2024 The Author(s). Pediatric Dermatology published by Wiley Periodicals LLC.)

Cutaneous lupus erythematosus (CLE) is a complex autoimmune disease often characterized by a multitude of skin findings. CLE is generally classified into three main categories: acute CLE, subacute CLE and chronic CLE. The current therapeutic guidelines for CLE include counselling patients on general measures and medication regimens. Treatment options include optimized photoprotection, avoidance of environmental triggers, corticosteroids, topical and systemic immunomodulators, and antimalarials. To date, no biologic medications (i.e. monoclonal antibodies, mAbs) are approved for CLE. The first mAb for the treatment of both systemic lupus erythematosus (SLE) and active lupus nephritis was belimumab, and was approved for these diseases in 2011 and 2020, respectively. Belimumab is a specific inhibitor of B-lymphocyte stimulator. Anifrolumab, a type I interferon receptor antagonist, was approved in 2021 for SLE. Other mAbs with different targets, including a novel biologic that inhibits blood dendritic cell antigen 2, are currently under investigation for CLE. This review will describe the general treatment landscape for CLE. Selected studies related to these various mAbs will be discussed, as well as their safety profiles and efficacies demonstrated in clinical trials. Biologic medications can potentially augment the number of treatment options for patients living with CLE., Competing Interests: Conflicts of interest: AAH has the following conflicts of interest: research grants paid to the medical school from GSK and Biogen; and honoraria for data safety monitoring boards and consulting from Ortho Dermatologics and Sanofi-Regeneron. AJJ, CM and NK have no conflicts of interest to disclose., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Safety and efficacy of roflumilast cream 0.15% for atopic dermatitis (AD) were demonstrated in two 4-week phase 3 trials. Objective: Evaluate long-term safety, tolerability, and efficacy of roflumilast cream 0.15% in AD. Methods: In this open-label extension (OLE) trial (INTEGUMENT-OLE; NCT04804605), patients aged ≥6 years who completed one of the 4-week phase 3 trials applied roflumilast for up to 52 weeks. After 4 weeks of once-daily application, patients who achieved Validated Investigator Global Assessment for AD (vIGA-AD) of clear (0) switched to twice-weekly (BIW) application to normal-appearing flare-prone areas (proactive treatment). Results: Among 657 patients treated, 36.7% reported adverse events, including 4.7% that were treatment related. Application site pain and stinging/burning that caused definite discomfort at any visit were reported for 0.5% and 0.4%-2.1% of patients, respectively. Patients who achieved vIGA-AD 0 and switched to proactive BIW application maintained vIGA-AD 0/1 (almost clear) for a median of 281 days (Kaplan-Meier estimate). Conclusion: Roflumilast cream 0.15% was well tolerated for up to 56 weeks. BIW application to normal-appearing flare-prone sites maintained improvement in AD signs and symptoms, showing that proactive treatment represents an alternative to the current standard practice of reactive treatment.

Introduction: Tapinarof is a topical aryl hydrocarbon receptor (AhR) agonist in development for the treatment of atopic dermatitis (AD). In two phase 3 trials (ADORING 1 and 2), tapinarof cream 1% once daily (QD) demonstrated significant efficacy and was well tolerated in patients down to age 2 years with AD. Here, we evaluate patient-reported outcomes (PROs), including family impact, with tapinarof in ADORING 1 and 2., Methods: In ADORING 1 and 2, 813 patients were randomized to tapinarof or vehicle QD for 8 weeks. PROs were assessed using the Dermatology Life Quality Index (DLQI), Children's Dermatology Life Quality Index (CDLQI), Infants' Dermatitis Quality of Life Index (IDQOL), Dermatitis Family Impact Questionnaire (DFI), and Patient Oriented Eczema Measure (POEM)., Results: Mean baseline DLQI, CDLQI, IDQOL, and DFI scores indicated that the impact on families and patients' quality of life (QoL) of AD was moderate to very large. Mean POEM scores indicated moderate to severe AD symptoms at baseline. Tapinarof improved QoL versus vehicle across all endpoints at week 8: DLQI, - 6.2 vs - 3.5 (P = 0.0031) and - 5.5 vs - 3.5 (P = 0.0028); DFI, - 5.6 vs - 2.9 (P < 0.0001) and - 5.6 vs - 3.8 (P = 0.0037), in ADORING 1 and 2, respectively. Similar improvements in CDLQI and IDQOL were reported with tapinarof versus vehicle. Tapinarof also significantly improved CDLQI, DFI, and POEM sleep subdomain scores versus vehicle. POEM scores also improved with tapinarof versus vehicle: ≥ 12 years, - 9.4 vs - 5.3 and - 10.6 vs - 3.6 (both P < 0.0001); < 12 years, - 11.4 vs - 5.7 (P < 0.0001), and - 10.8 vs - 7.3 (P = 0.0005)., Conclusions: Tapinarof significantly improved QoL across PROs, including sleep and family impact, regardless of age, from week 1 (the earliest evaluation) through week 8. Tapinarof is a once-daily, non-steroidal cream that rapidly improves AD symptoms, sleep, and QoL in patients down to age 2 years with AD., Trial Registration: Clinical Trials.gov identifier: NCT05014568; NCT05032859., Competing Interests: Declarations. Conflict of Interest: Eric L. Simpson reports grants and fees for participation as a consultant and principal investigator from Eli Lilly, LEO Pharma, Pfizer, and Regeneron; grants for participation as a principal investigator from Galderma and Merck & Co.; and fees for consultant services from AbbVie, Boehringer Ingelheim, Dermavant Sciences, Inc., Incyte, Forte Bio, Pierre Fabre Dermo, and Sanofi Genzyme. Adelaide A. Hebert has received research support paid to the medical school from AbbVie, Arcutis, Dermavant Sciences, Inc., and Pfizer; has received honoraria from Arcutis, Dermavant Sciences, Inc., Galderma, Incyte, LEO Pharma, Novan, Ortho Dermatologics, Sun Pharma, and Verrica; and has received honoraria as part of Data Safety Monitoring Boards for Alphyn, GSK, Ortho Dermatologics, and Sanofi Regeneron. John Browning has served as an investigator for AbbVie, Acelyrin, Amgen, Arcutis, Dermavant Sciences, Inc., Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, UCB Pharma, and Vyne; and as a speaker for Krystal, Pfizer, and Regeneron. Rocco T. Serrao has served as a consultant and/or has received payment for the development of educational presentations, and/or has received grants from Abbott, AbbVie, Arcutis, Bristol Myers Squibb, Dermavant Sciences, Inc., Eli Lilly, Incyte, Janssen, Pfizer, Regeneron, and Sanofi-Genzyme. Howard Sofen has served as scientific adviser and/or clinical study investigator for AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant Sciences, Inc., Eli Lilly, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi-Genzyme, Sun Pharma, and UCB Biopharma. Philip M. Brown, Stephen C. Piscitelli, and Anna M. Tallman are employees of Dermavant Sciences, an Organon Company, Jersey City, NJ, USA. David S. Rubenstein is a former employee of Dermavant Sciences, Inc. Ethical Approval: Trials were conducted according to Good Clinical Practice and the Declaration of Helsinki. Approval was obtained from all local ethics committees or institutional review boards. All patients (or parents/legal guardians) provided written informed consent., (© 2025. The Author(s).)

Objective: To test the limited efficacy of women-focused educational materials within supervised cardiac rehabilitation (CR) for the first time when compared to standard co-educational CR., Methods: A multi-site, prospective, pilot study with blinded outcome assessment was conducted at two Canadian CR programs. At intake, participants selected women-only CR with women-focused education (12 weeks) or a standard co-educational program (16 weeks). Both were comprehensive programs, with one education session/week. Outcomes were disease-related knowledge, functional capacity, quality of life, and heart-health behaviours., Results: Of 114 women approached, 62 (54.4 %) consented. Forty elected the women-only CR program. Pre-CR medication adherence was high. Participants attended approximately 60 % of sessions; 55 (88.7 %) were retained at follow-up. Significant improvements in knowledge, quality of life, and functional capacity were observed in both groups (all p < .05). With adjustment for pre-CR scores, participants in women-only CR exhibited significantly greater improvements in knowledge (p < .05) and adherence to the Mediterranean diet (p = .04) post-program compared to control participants., Conclusion: Results support of the utility of this women-focused education in the CR setting., Practice Implications: Integrating women-focused education in CR can enhance health outcomes and address specific needs of female patients., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Lebrikizumab, a high-affinity monoclonal antibody targeting IL-13, previously demonstrated clinical efficacy in three randomized, double-blind, placebo-controlled Phase 3 trials that included adults and adolescents with moderate-to-severe atopic dermatitis (AD): ADvocate1, ADvocate2, and ADhere., Aim: This subset analysis evaluated 16-week physician- and patient-reported outcomes of lebrikizumab in the adolescent patients enrolled in these three trials., Methods: Eligible adolescents (≥12 to <18 years weighing ≥40kg) were randomized 2:1 to subcutaneous lebrikizumab (500 mg loading doses at baseline and Week 2 followed by 250 mg every 2 weeks) or placebo as monotherapy in ADvocate1&2, and in combination with topical corticosteroids (TCS) in the ADhere study. Week 16 analyses included clinical efficacy outcomes (IGA (0,1) with ≥2-point improvement, EASI 75, EASI 90), patient-reported Pruritus NRS ≥4-point improvement and Sleep-Loss Scale ≥2-point improvement., Results: Pooled ADvocate1&2 16-week results in lebrikizumab ( N  = 67) vs placebo ( N  = 35) were: IGA (0,1) 46.6% vs 14.3% ( p  < 0.01), EASI 75 62.0% vs 17.3% ( p  < 0.001), EASI 90 40.7% vs 11.5% ( p  < 0.01), Pruritus NRS 48.9% vs 13.1% ( p  < 0.01), and Sleep-Loss Scale 26.9% vs 6.9% ( p  = 0.137). Corresponding results for ADhere, (lebrikizumab + TCS, N  = 32; placebo + TCS, N  = 14), were consistent., Conclusions: Lebrikizumab treatment demonstrated efficacy in improving the signs and symptoms of AD in adolescent patients, consistent with the ADvocate and ADhere overall population results.

Background: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose triple-combination approved for acne (indicated in patients 12 years and older). As topical acne treatment in pediatric patients may be complicated by tolerability and/or a perceived lack of efficacy, post hoc analyses were used to investigate efficacy/safety of CAB in children and adolescents., Methods: Data were pooled from 2 phase 3, double-blind, 12-week studies (NCT04214639; NCT04214652). Participants aged 9 years and older with moderate-to-severe acne were randomized (2:1) to once-daily CAB or vehicle gel. Endpoints included treatment success (at least 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin) and least-squares mean percent change from baseline in inflammatory/noninflammatory lesions. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated. Post hoc analyses were conducted in adolescents aged 12 to 17 years (CAB, n=123; vehicle, n=50) with descriptive data shown for children aged 10 to 11 (CAB, n=3; vehicle, n=2)., Results: At week 12, 51.5% of CAB-treated adolescents achieved treatment success vs 24.9% with vehicle (P&lt;0.01). CAB also provided inflammatory/noninflammatory lesion reductions of 78.3%/73.7% vs 50.5%/42.9% with vehicle (P&lt;0.001, both). Most TEAEs were of mild-to-moderate severity, and &lt;2.5% of participants discontinued due to adverse events. Only the 3 children treated with CAB achieved treatment success, with lesion reductions ranging from 76% to 100%. One CAB-treated child experienced TEAEs and none discontinued., Conclusions: In 2 pooled phase 3 studies, once-daily CAB gel was well tolerated and efficacious in pediatric participants with acne, with over half achieving treatment success at week 12. J Drugs Dermatol. 2024;23(12):1049-1057. doi:10.36849/JDD.8643.

Importance: Safe, effective, and well-tolerated topical treatment options available for long-term use in patients with atopic dermatitis (AD) are limited and associated with low adherence rates., Objective: To evaluate efficacy and safety of once-daily roflumilast cream, 0.15%, vs vehicle cream in patients with AD., Design, Setting, and Participants: Two phase 3, randomized, double-blind, vehicle-controlled trials (Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis 1 and 2 [INTEGUMENT-1 and INTEGUMENT-2]), included patients from sites in the US, Canada, and Poland. Participants were 6 years or older with mild to moderate AD based on Validated Global Assessment for Atopic Dermatitis (assessed on a 5-point scale ranging from 0 [clear] to 4 [severe])., Intervention: Patients were randomized 2:1 to receive roflumilast cream, 0.15%, or vehicle cream once daily for 4 weeks., Main Outcomes and Measures: The primary efficacy end point was Validated Investigator Global Assessment for Atopic Dermatitis success at week 4, defined as a score of 0 or 1 plus at least a 2-grade improvement from baseline. Secondary end points included Eczema Area and Severity Index and Worst Itch Numeric Rating Scale. Safety and local tolerability were also evaluated., Results: Among 1337 patients (654 patients in INTEGUMENT-1 and 683 patients in INTEGUMENT-2), the mean (SD) age was 27.7 (19.2) years, and 761 participants (56.9%) were female. The mean body surface area involved was 13.6% (SD = 11.6%; range, 3.0% to 88.0%). Significantly more patients treated with roflumilast than vehicle achieved the primary end point (INTEGUMENT-1: 32.0% vs 15.2%, respectively; P < .001; INTEGUMENT-2: 28.9% vs 12.0%, respectively; P < .001). At week 4, statistically significant differences favoring roflumilast also occurred for the achievement of at least 75% reduction in the Eczema Area and Severity Index (INTEGUMENT-1: 43.2% vs 22.0%, respectively; P < .001; INTEGUMENT-2: 42.0% vs 19.7%, respectively; P < .001). Roflumilast was well tolerated with low rates of treatment-emergent adverse events. At each time point, investigators noted no signs of irritation at the application site in 885 patients who were treated with roflumilast (≥95%), and 885 patients who were treated with roflumilast (90%) reported no or mild sensation at the application site., Conclusions and Relevance: In 2 phase 3 trials enrolling adults and children, once-daily roflumilast cream, 0.15%, improved AD relative to vehicle cream, based on multiple efficacy end points, with favorable safety and tolerability., Trial Registration: ClinicalTrials.gov Identifiers: NCT04773587, NCT04773600.

A Cardiac College for Women curriculum was developed to address the dearth of women-focused cardiac rehabilitation (CR) education. This study investigated: (1) patient utilization of the education; (2) acceptability and applicability of the education; as well as (3) patient and CR providers' experiences implementing it. This was a multi-site, mixed-methods study. After baseline assessments at an academic CR program in two Canadian provinces, the 12 weekly 30 min structured in-person group education sessions were led by staff in the relevant discipline, with supporting online videos and written materials. Women reported their engagement with the education in weekly diaries, and completed a survey post-program. Semi-structured virtual interviews were held with willing participants and staff delivering the intervention. Transcripts were analyzed concurrently by two researchers independently via NVIVO using text condensation, followed by consensus reconciliation and multi-source validation. Forty patients participated in the women-focused education program, with 28 completing weekly diaries and 36 post-intervention surveys. Participants attended 80% of sessions (67%-89%). They spent an average of 30 min/week engaging additionally with the online education, with 83% rating the weekly content applicable (73%-100%). Overall acceptability was rated 4.3 ± 1.7/5. Twelve patients and 5 staff participated in interviews. Four themes were identified: contextual considerations, staffing and implementation issues, valued aspects, and suggestions for improvement. In conclusion, Cardiac College for Women was established as highly acceptable and applicable to patients, supporting their self-management. The women-specific CR education materials were also established as readily implementable by CR staff., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The handling editor LB declared a past collaboration with the authors SG, GM., (© 2024 Carson, Grace, Bomtempo, Hebert, Ross, Oh and Ghisi.)

The skin microbiome is essential for skin barrier function because it inhibits pathogen colonization, and decreased microbiome diversity correlates with increased Staphylococcus aureus (S. aureus) burden and atopic dermatitis (AD) severity. Managing S. aureuss-driven AD in clinical practice remains problematic due to complications such as AD exacerbation, impetigo, abscesses, and invasive infections. This project used a modified Delphi process comprising face-to-face discussions followed by a blinded vote to define 5 final consensus statements. A panel of 6 pediatric dermatologists developed a consensus on S. aureus-driven AD exacerbation, challenges in current treatments for AD with secondary bacterial infections, and new developments to improve patient care and outcomes. The panel's 5 consensus statements provide recommendations for dermatologists, pediatricians, and healthcare providers treating patients with secondary infected AD. These recommendations underscore the importance of recognizing and managing S. aureus skin infection in AD clinical practice and promoting antibiotic stewardship to mitigate resistance. The panel defined a significant unmet need for a single topical AD therapy effective against all symptoms, including pruritus, S. aureus-driven AD exacerbation, infection, and inflammation, across AD severity levels. J Drugs Dermatol. 2024;23(10):825-832. doi:10.36849/JDD.8240.

Background: Tapinarof cream 1% once daily (QD), a topical aryl hydrocarbon receptor agonist, downregulates pro-inflammatory Th2 cytokines, upregulates skin-barrier components, and reduces oxidative stress., Objective: To assess tapinarof efficacy and safety in adults and children down to 2 years of age with atopic dermatitis (AD)., Methods: Eight hundred and thirteen patients were randomized to tapinarof or vehicle QD in two 8-week phase 3 trials., Results: The primary efficacy endpoint, Validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 and ≥2-grade improvement from baseline at Week 8, was met with statistical significance in both trials: 45.4% versus 13.9% and 46.4% versus 18.0% (tapinarof vs vehicle; both P < .0001). Significantly superior Eczema Area and Severity Index 75 (EASI75) responses were also observed with tapinarof versus vehicle at Week 8: 55.8% versus 22.9% and 59.1% versus 21.2% (both P < .0001). Rapid improvements in patient-reported pruritus were also significant with tapinarof versus vehicle. Common adverse events (≥5%) of folliculitis, headache, and nasopharyngitis were mostly mild or moderate, with lower discontinuations due to adverse events in the tapinarof groups than with vehicle., Limitations: Long-term efficacy was not assessed., Conclusion: Tapinarof demonstrated highly significant efficacy and favorable safety and tolerability in a diverse population of patients with AD down to 2 years of age., Competing Interests: Conflicts of interest Dr Silverberg has received honoraria as a consultant and/or advisory board member for AbbVie, Alamar, Aldena, Amgen, AObiome, Arcutis, Arena, Asana, Aslan, BioMX, Biosion, Bodewell, Boehringer Ingelheim, Bristol Myers Squibb, Cara, Castle Biosciences, Celgene, Connect Biopharma, Corevitas, Dermavant Sciences, Inc, Dermira, Dermtech, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, LEO Pharma, Menlo, Novartis, Optum, Pfizer, RAPT, Recludix, Regeneron, Sanofi-Genzyme, Shaperon, TARGET-RWE, Union, and UpToDate; speaker for AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron, and Sanofi-Genzyme; and institution received grants from Galderma, Incyte, and Pfizer. Dr Eichenfield has served as a consultant, advisor, or investigator for AbbVie, Amgen, Apogee, Arcutis, Aslan, Bausch, Bristol Myers Squibb, Castle Biosciences, Dermavant Sciences, Inc, Eli Lilly, Forté, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi-Genzyme, and UCB Pharma. Dr Simpson reports grants and fees for participation as a consultant and principal investigator from Eli Lilly and Company, LEO Pharma, Pfizer, and Regeneron; grants for participation as a principal investigator from Galderma and Merck & Co; and fees for consultant services from AbbVie, Boehringer Ingelheim, Dermavant Sciences, Inc, Incyte, Forte Bio, Pierre Fabre Dermo, and Sanofi-Genzyme. Dr Gold has served as a consultant, and/or has received payment for the development of educational presentations, and/or has received grants from Amgen, Arcutis, Bristol Myers Squibb, Dermavant Sciences, Inc, Eli Lilly, LEO Pharma, Ortho Dermatologics, Pfizer, and UCB Biopharma. Dr Bissonnette has served as a consultant/investigator/advisory board member for AbbVie, Alumis, Almirall, Amgen, AnaptysBio, Arcutis, Aristea, Bausch Health, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Dermavant Sciences, Inc, Eli Lilly, Escalier, Janssen, Kyowa Kirin, LEO Pharma, Nimbus, Novartis, Pfizer, Regeneron, Sienna, and UCB Biopharma; and is an employee and shareholder of Innovaderm Research. Dr Papp has served as a consultant/speaker/scientific officer/has attended advisory boards for, or received grants or honoraria from AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Bausch Health/Valeant, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite Biopharma, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Evelo, Galapagos, Galderma, Genentech, Gilead, GlaxoSmithKline, Janssen, Kyowa Kirin, LEO Pharma, Medimmune, Meiji Seika Pharma, Merck (MSD), Merck-Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharma, Takeda, and UCB Biopharma. Dr Browning has served as an investigator for AbbVie, Acelyrin, Amgen, Arcutis, Dermavant, Inc, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, UCB Pharma, and Vyne; and as a speaker for Regeneron, Pfizer, and Krystal. Dr Kwong is a consultant, speaker, or principal investigator for AbbVie, Almirall, Amgen, Arcutis, Dermavant Sciences, Inc, Eli Lilly, Galderma, Incyte, L’Oréal, Novartis, Novum, Ortho, Pfizer, Regeneron/Sanofi, Sun, Verrica, and UCB Pharma. Dr Korman has served as an investigator and speaker for Abbott Labs, Genentech and Astellas; received grants and honoraria; served on the advisory board and was an investigator for Centocor; received grants and residency/fellowship program funding; and was investigator and speaker for Amgen, receiving grants and honoraria. Dr Brown, Dr Rubenstein, Dr Piscitelli, Dr Somerville, and Dr Tallman are employees of Dermavant Sciences, Inc, with stock options. Dr Hebert has received research support paid to the medical school from AbbVie, Arcutis, Dermavant Sciences, Inc, and Pfizer; and honoraria received from Alphyn, Apogee, Arcutis, Dermavant Sciences, Inc, Galderma, GSK, Incyte, LEO Pharma, Novan, Ortho Dermatologics, Pfizer, Sun Pharma, and Verrica; and from Sanofi Regeneron and Ortho Dermatologics as part of data safety monitoring boards. Dr Kircik has served as a consultant, speaker, investigator, or advisory board member for Abbott Laboratories, AbbVie, Ablynx, Aclaris, Acambis, Allergan, Inc, Almirall, Amgen, Inc, Anacor Pharmaceuticals, AnaptysBio, Arcutis Biotherapeutics, Arena Pharmaceuticals, Assos Pharmaceuticals, Astellas Pharma US, Inc, Asubio Pharmaceuticals, Bausch Health, Berlex Laboratories (Bayer HealthCare Pharmaceuticals), Biogen Idec, BioLife, Biopelle, Bristol Myers Squibb, Boehringer Ingelheim, Breckenridge Pharma, Cassiopea SpA, Centocor, Inc, Cellceutix, Cipher Pharmaceuticals, Coherus BioSciences, Colbar LifeScience, Combinatrix, Connetics Corporation, Coria Laboratories, Dermavant Sciences, Inc, Dermira, Dermik Laboratories, Dow Pharmaceutical Sciences, Inc, Dr Reddy's Laboratories, DUSA Pharmaceuticals, Embil Pharmaceutical Co Ltd, Eli Lilly, EOS, Exeltis, Ferndale Laboratories, Inc, Ferrer, Foamix Pharmaceuticals, Galderma, Genentech, Inc, GlaxoSmithKline, Glenmark Pharmaceuticals, Healthpoint, Ltd, Idera Pharmaceuticals, Incyte, Intendis, Innocutis, Innovail, ISDIN, Johnson & Johnson, Kyowa Kirin, Laboratory Skin Care Inc, LEO Pharma, L’Oréal, 3M, Maruho Co, Ltd, Medical International Technologies, Merck, Medicis Pharmaceutical Corp., Merz Pharma, NanoBio, Novartis AG, Noven Pharmaceuticals, Nucryst Pharmaceuticals Corp, Obagi, Onset Dermatologics, Ortho Neutrogena, Pediapharma, Pfizer, Promius Pharma, PuraCap, Pharmaderm, QLT, Inc, Quinnova Pharmaceuticals, Quatrix, Regeneron, Sanofi, Serono (Merck Serono International SA), SkinMedica, Inc, Stiefel Laboratories, Inc, Sun Pharma, Taro Pharmaceutical Industries, Toler Rx, Triax Pharmaceuticals, UCB Pharma, Valeant Pharmaceuticals Intl, Warner Chilcott, XenoPort, and ZAGE., (Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Clascoterone cream 1% is a topical androgen receptor inhibitor approved to treat acne vulgaris in patients =&gt;12 years of age. This report provides details of patients who developed laboratory signs of hypothalamic-pituitary-adrenal (HPA) axis suppression without clinical signs of adrenal suppression during the clascoterone development program., Methods: Two open-label, multicenter, Phase 2 trials evaluated HPA axis suppression in patients with moderate-to-severe acne vulgaris. Study 1 (NCT01831960) enrolled cohorts of adults =&gt;18 years of age and adolescents =&gt;12 to &lt;18 years of age. Study 2 (NCT02720627) enrolled adolescents 9 to &lt;12 years of age. Patients applied clascoterone twice daily at maximum-exposure dosages for 14 days. Adrenal suppression was evaluated via cosyntropin stimulation test (CST) at baseline and day 14. Patients with an abnormal CST result (serum cortisol level =&lt;18 &micro;g/dL) had a follow-up CST approximately 4 weeks later. Blood was collected for pharmacokinetic analysis. Other safety assessments included adverse events (AEs), physical examination/vital signs, and electrocardiography., Results: Overall, 5/69 clascoterone-treated patients had an abnormal CST result on day 14, including 1/20 adults, 2/22 patients aged =&gt;12 to &lt;18 years, and 2/27 patients aged 9 to &lt;12 years. All patients had normal cortisol levels at follow-up testing approximately 4 weeks later. No relationship was observed between abnormal CST results and clascoterone plasma concentrations or the amount of study drug applied. No clinically relevant AEs or clinically significant changes in safety measures were observed in patients with adrenal suppression., Conclusion: Clascoterone induced laboratory evidence of mild, reversible HPA axis suppression under maximum-use exposure. J Drugs Dermatol. 2024;23(6):433-437.&nbsp; &nbsp;&nbsp; doi:10.36849/JDD.7997.

Competing Interests: Conflicts of interest Dr Brandling-Bennett has served as principal investigator for Lilly. Dr Arkin has received consulting fees from AbbVie, Regeneron, and Verrica. Dr Hebert has received research grants (paid to UTHealth McGovern Medical School) from LEO Pharma, Mayne Pharma, UCB, GSK, Ortho Dermatolgics, Amgen, Arcutis, AbbVie, and Pfizer; has received honoraria from Pfizer, Arcutis, UCB, Verrica, LEO Pharma, Novan, Incyte, Janssen, Mayne Pharma, and Castle Creek Bioscience; and has served on drug safety monitoring boards for Ortho Dermatologics, GSK, and Sanofi Regeneron. Dr Cordoro has served as a member of a scientific steering committee for Celgene. Dr Curran has served as an advisory board member for Novartis, receiving honoraria. Dr Dalrymple has served as an advisory board member for Novartis. Dr Flohr is chief investigator of the UK National Institute for Health Research-funded TREAT (ISRCTN15837754, EudraCT 2,015-002,013-29) and SOFTER (Clinicaltrials.gov: NCT03270566) trials as well as the UK-Irish Atopic Eczema Systemic Therapy Register (A-STAR; ISRCTN11210918) and a principal investigator in the European Union (EU) Horizon 2020-funded BIOMAP Consortium (http://www.biomap-imi.eu/). He also leads the EU Trans-Foods Consortium. His department has received funding from Sanofi-Genzyme and Pfizer for host-microbiome research. Dr Gordon has received personal fees from AbbVie, Almirall, Amgen, BMS, Dermavant, Dermira, Lilly, Janssen, Kyowa Hakko Kirin, LEO Pharma, Novartis, Pfizer, Sun Pharma, and UCB and grants from BMS, Lilly, and UCB. Dr Irvine has received person fees from AbbVie, LEO Pharma, Lilly, Novartis, and Sanofi/Regeneron, and has received a grant from the UK National Institute for Health Research (research arm of the UK Department of Health) as co-principal investigator of a clinical trial comparing MTX with cyclosporine in children with severe atopic dermatitis. Dr Kirkorian has received honoraria from Verrica. Dr Lara-Corrales has served as an advisory board member for Ipsen, LEO Pharma, Lilly, Novartis, Pfizer, and Sanofi Genzyme; as a consultant for AbbVie, Avicanna, Janssen, Johnson & Johnson, Loreal, Pfizer, Pierre Fabre, Sanofi Genzyme, and Valeant; as a speaker for AbbVie, Amgen, Novartis, and Sanofi Genzyme; and has served as a site investigator for AbbVie, Clementia Pharmaceuticals, Janssen, Lilly, and, Mayne Pharma. Dr Jill Lindstrom has received consulting fees from AbbVie, AnaptysBio, Arena Pharmaceuticals, Aristea, Incyte, and Priovant. Dr Amy S. Paller has served as an investigator for AbbVie, Applied Pharma Research, Dermavant, Eli Lilly, Incyte, Janssen, Krystal, Regeneron, and UCB; Consultant for Aegerion Pharma, Azitra, BioCryst, Boehringer-Ingelheim, Bristol Myers Squibb, Castle Creek, Eli Lilly, Janssen, Krystal, LEO Pharma, Novartis, Regeneron, Sanofi/Genzyme, Seanergy, TWI Biotechnology, and UCB, and on the data safety monitoring board for AbbVie, Abeona, Catawba, Galderma, and InMed. Author Begolka has served as an advisory board member for Incyte and Pfizer, and has received a grant from Pfizer. Dr Tom has served as a site investigator for clinical trials for Janssen, Regeneron, Incyte, Pfizer, Dermira, Eli Lilly, and AbbVie, and has been on data safety committees for LEO Pharma. Dr Voorhees has received research grants from AbbVie, Celgene, and Lilly; has served as an advisory board member for BMS, Boehringer Ingelheim, Celgene, Novartis, and UCB; and had received consulting fees from Amgen. Dr Vleugels has received consulting fees from AbbVie, Pfizer, and Priovant. Dr Lee has received consulting fees from AbbVie and Krystal Biotech; served as an investigator for AbbVie, Amryt, Arcutis, BMS, Castle Creek Biosciences, Celgene, Galderma, Incyte, Janssen, Kiniksa, Lilly, Mayne Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Target Pharma, Trevi Therapeutics, and UCB; and has served as an advisory board member for Lilly, Novartis, Pfizer, and Regeneron. Dr Davies has received a fellow stipend from Pediatric Dermatology Research Alliance (PeDRA). Dr Siegfried has received consulting fees from AbbVie, Boehringer Ingelheim, Incyte, LEO Pharma, Novan, Novartis, Pierre Fabre, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Verrica; has received honoraria from Regeneron, Sanofi Genzyme, and Verrica; has served on data safety monitoring boards for LEO Pharma, Novan, Pfizer, and UCB; participated in contracted research for AI Therapeutics; served as principal investigator for Janssen, and her institution has received fees related to clinical trials from Janssen, Lilly, Pierre Fabre, Regeneron, and Verrica and in support of a 2020-2021 pediatric dermatology fellowship from Pfizer. Dr Chiu, Dr Callen, Dr Castello-Soccio, Dr Co, Author Hanna, Dr Kim, and Dr Reyes have no conflicts of interest to declare.

Background: The topical phosphodiesterase 4 inhibitor roflumilast has been studied in several dermatologic conditions., Objective: Roflumilast foam 0.3% is being investigated as a topical treatment for seborrheic dermatitis (SD)., Methods: In this phase 3, double-blinded trial, patients with SD were randomly assigned (2:1 ratio) to once-daily roflumilast foam 0.3% or vehicle foam for 8 weeks. The primary efficacy outcome was Investigator Global Assessment (IGA) Success at week 8, defined as IGA of 0 (Clear) or 1 (Almost Clear) plus ≥2-point improvement from baseline. Safety was also assessed., Results: 79.5% of roflumilast-treated and 58.0% of vehicle-treated patients met the primary endpoint (P < .001); statistically significant differences in IGA Success also favored roflumilast at week 2 (roflumilast: 43.0%; vehicle: 25.7%; P < .001) and week 4 (roflumilast: 73.1%; vehicle: 47.1%; P < .001). Roflumilast was well-tolerated with a low rate of treatment-emergent adverse events., Limitations: Study limitations include the 8-week treatment period for this chronic condition., Conclusions: Once-daily roflumilast foam was superior to vehicle in leading to IGA of Clear or Almost Clear plus ≥2-point improvement from baseline at 8 weeks in patients with SD. Longer trials are needed to determine durability and safety of roflumilast foam in SD., Competing Interests: Conflicts of interest Dr Blauvelt has served as a speaker (received honoraria) for AbbVie, Eli Lilly and Company, Pfizer, and UCB, served as a scientific adviser (received honoraria) for AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly and Company, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo, Lipidio, Microbion, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Paragon, Pfizer, Q32 Bio, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB Pharma, Union, Ventyx, Vibliome, and Xencor, and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Concert, Dermavant, Eli Lilly and Company, Evelo, Evommune, Galderma, Incyte, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB Pharma, and Ventyx. Dr Draelos received a research grant from Arcutis Biotherapeutics, Inc to contribute to the data presented in the paper. Dr Gold is an investigator, advisor and/or speaker for Arcutis, Abbvie, BMS, Lilly, Galderma, AnaptysBio, Amgen, Dermira, Dr Reddy, Ortho Dermatologics, Pfizer, Dermavant, Novartis, Sanofi, Regeneron, Leo, Cutera, UCB. Dr Alonso-Llamazares is an investigator for Arcutis Biotherapeutics, Inc; speaker for Celgene (Amgen), Dermira, Inc (Eli Lilly), Eli Lilly, Ortho Dermatologics, and UCB Pharma; and serves on advisory boards for LEO Pharma. Dr Bhatia is an advisor, consultant, and investigator for Arcutis Biotherapeutics, Inc and received grants/research funding and honoraria. Dr DuBois is an investigator for and receives grants/research funding from AbbVie, AiViva BioPharma, Inc, Allergan, Inc, Almirall, AnaptysBio, Arcutis Biotherapeutics, Inc, Bausch Health, Bellus Medical, Biofrontera, Inc, Brickell Biotech, Inc, Bristol-Myers Squibb, Caliway Biopharmaceuticals Co., Ltd, Cara Therapeutics, Croma-Pharma GmbH, Dermata Therapeutics, DermBiont, Inc, Dr Reddy's Laboratories, Endo Pharmaceuticals, Inc, Evommune, Inc, Galderma USA, Hexima Ltd., Incyte Corporation, LEO Laboratories Ltd (LEO Pharma), Merck, NFlection Therapeutics, Inc, Palvella Therapeutics, RAPT Therapeutics, and Therapeutics, Inc; is an advisory board member and receives honoraria from RAPT Therapeutics; and is an independent contractor for and receives other financial benefit from Vial Health Technology, Inc. Dr Forman is an investigator for Arcutis Biotherapeutics, Inc and received grants/research funding and honoraria. Dr Gooderham received investigator fees, speaker fees and/or honoraria from AbbVie, Akros, Amgen, AnaptysBio, Arcutis Biotherapeutics, Inc, Aristea Therapeutics, Aslan Pharmaceuticals, Bausch, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Dermavant Sciences, Inc, Dermira, Inc, Eli Lilly, Galderma Laboratories, L.P., GSK, plc, Incyte Corporation, Janssen Pharmaceuticals, Kyowa Kirin International, plc, MedImmune, Meiji Seika Pharma, Merck, MoonLake Immunotherapeutics, Nimbus Therapeutics, Novartis, Pfizer, Regeneron Pharmaceuticals, Roche, Sun Pharma, and UCB Pharma. Dr Green received investigator fees, speaker fees and/or consulting fees from Amgen, AbbVie, Arcutis, BMS, Dermavant, Eli Lilly, Nimbus, OrthoDerm, SunPharma, and UCB. Dr Guenthner is an investigator, consultant, speaker, and/or member of the scientific advisory board for AbbVie, Arcutis, Asana, Dermavant, Edesa Biotech, Foamix, Galderma, Genentech, Incyte, Janssen, Leo, Lilly, Menlo, Novartis, Ortho Derm, Pfizer, Regeneron/Sanofi, and UCB. Dr Hebert has received research grants from Arcutis, Pfizer, Leo, Galderma, Brickell, Lilly, Ortho Dermatologics, and Mayne; has received honoraria from Arcutis, Pfizer, Galderma, Lilly, Ortho Dermatologics, Bristol-Myers Squibb, Janssen, Mayne, Leo, Incyte, Almirall, Verrica, and Vyne; and serves on data safety monitoring boards for Regeneron, Sanofi, GSK, and Bausch. Dr Lain is an investigator for Arcutis Biotherapeutics, Inc and received grants/research funding and honoraria. Dr Moore received research funds or honoraria from AbbVie, Arcutis, Dermavant, Janssen, Lilly, and Nimbus. Dr Papp received investigator fees, speaker fees, clinical research grants, and/or honoraria from AbbVie, Akros, Amgen, Anacor Pharmaceuticals, Inc, Arcutis Biotherapeutics, Inc, Astellas Pharma US, Avillion LLP, Bausch Health/Valeant Pharmaceuticals International, Inc, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite BioPharma, Celgene, Celltrion Healthcare, Coherus Biosciences, Inc, Dermavant Sciences, Inc, Dermira, Inc, Dice Pharmaceuticals, Dow Pharma, Eli Lilly, Evelo Biosciences, Forbion, Galapagos, Galderma Laboratories, L.P., Genentech, Gilead, GSK, plc, Incyte Corporation, Janssen Pharmaceuticals, Kyowa Hakko Kirin, LEO Pharma, Medimmune, LLC, Meiji Seika Pharma, Merck (MSD), Merck-Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research Inc, Regeneron Pharmaceuticals, Reistone Biopharma, Roche, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, UCB Pharma, vTv Therapeutics, and Xencor. David M. Pariser is an investigator for and receives grants/research funding and/or honoraria from Almirall, Amgen, AOBiome, LLC, Asana BioSciences, LLC, Bickel Biotechnology, Celgene Corporation, Dermira, Inc, Eli Lilly and Company, LEO Pharma, US, Menlo Therapeutics, Novartis Pharmaceuticals Corp., Novo Nordisk A/S, Ortho Dermatologics, Pfizer Inc, and Regeneron Pharmaceuticals; is a consultant and/or serves on an advisory board for and receives honoraria from Bickel Biotechnology, Biofrontera AG, Dermira, Inc, Novartis Pharmaceuticals Corp., Pfizer Inc, Regeneron Pharmaceuticals, and Sanofi; and is on the Data Safety Monitoring Board and receives honoraria from Bristol-Myers Squibb. Dr Zirwas Received consulting fees, investigator fees, speaker fees, clinical research grants or sponsored research, and/or honoraria from AbbVie, All Free Clear/Sun, Anaptys Bio, Arcutis, Asana, AsepticMD, Avillion, Bausch Health, Cara, Concert, Dermavant, Edessa Biotech, EPI Health, Fit Bit, Galderma, Genentech/Novartis, Incyte, Janssen, L'Oreal, Leo, Level-Ex, Lilly, LUUM, Oculus, Peloton, Pfizer, Regeneron/Sanofi, Sol-Gel, Trevi, UCB, and Vyne. Author Kato, Dr Snyder, Author Krupa, Dr Burnett, Dr Berk, and Dr Chu are employees of Arcutis Biotherapeutics, Inc., (Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Thymic Stromal Lymphopoietin (TSLP) is an important cytokine that invokes early immune responses. TSLP, an IL-7-like cytokine encoded by the TSLP gene, activates JAK1 and JAK2 signaling pathways, stimulating dendritic cells to induce inflammatory Th2 cells. This cytokine is associated with pruritus in various cutaneous disorders, particularly atopic dermatitis. Varying levels of the cytokine TSLP have been demonstrated in studies of different cutaneous disorders. Pharmacological treatment targeting TSLP has been explored recently, particularly in the realm of atopic dermatitis.This review explores the relation of TSLP to cutaneous diseases, highlighting its potential as a biomarker for monitoring disease progression in discoid lupus erythematosus (DLE). The pharmacological therapy involving TSLP is discussed, along with the potential role of TSLP promotion in the treatment of alopecia areata. This overview examines the background, structure, and functions of TSLP, with a focus on its association with cutaneous disorders and a special focus on the impact of the atopic march., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: A once-daily, three-pronged approach using an antibiotic, antibacterial, and retinoid may provide faster acne improvement versus monotherapy or dual-combination products. This post hoc analysis compared threshold acne lesion reductions with clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel&mdash;the first FDA-approved triple-combination topical acne product&mdash;to its dyads and vehicle., Methods: Phase 2 (N=741; NCT03170388) and phase 3 (N=183; N=180; NCT04214639; NCT04214652), double-blind, 12-week studies randomized participants aged &ge;9 years with moderate-to-severe acne to once-daily CAB or vehicle gel; the phase 2 study included three additional dyad gel arms. The pooled percentage of participants achieving &ge;33%, &ge;50%, and &ge;75% reduction in inflammatory and noninflammatory acne lesions was evaluated., Results: As early as week 4 in the phase 2 study, &ge;33% reduction in inflammatory lesions occurred in a significantly greater percentage of CAB gel-treated participants (82.7%) than with the 3 dyads and vehicle (61.1-69.8%; P&lt;0.05, all). These early reductions were sustained throughout the study, with significantly (P&lt;0.05) more CAB-treated participants achieving &ge;50% reduction in inflammatory lesions versus dyads and vehicle from weeks 4-12. By week 12, CAB led to substantial reductions of &ge;75% in significantly more participants than dyads and vehicle (65.8% vs 49.9-51.2% and 21.6%; P&lt;0.05, all). Similar trends were observed for noninflammatory lesions in the phase 2 study and for inflammatory and noninflammatory lesions in the phase 3 studies., Conclusions: Lesion count reductions were significantly greater with CAB versus its dyads and vehicle gel as early as week 4, with substantial reductions observed after 12 weeks of treatment. This faster-acting and sustained efficacy of CAB gel&mdash;coupled with its optimized formulation, once-daily dosing, and tolerability&mdash;may positively impact treatment adherence. J Drugs Dermatol. 2024;23(3):&nbsp; &nbsp; &nbsp;doi:10.36849/JDD.7907.

Background: Despite their differential risk factor burden, context and often different forms of heart disease, cardiac rehabilitation (CR) programs generally do not provide women with needed secondary prevention information specific to them., Objective: to co-design evidence-informed, theory-based comprehensive women-focused education, building from Health e-University's Cardiac College for CR., Methods: A multi-disciplinary, multi-stakeholder steering committee (N = 18) oversaw the four-phase development of the women-focused curriculum. Phase 1 involved a literature review on women's CR information needs and preferences, phase 2 a CR program needs assessment, phase 3 content development (including determining content and mode, assigning experts to create the content, plain language review and translation), and phase 4 will comprise evaluation and implementation. In phase 2, a focus group was conducted with Canadian CR providers; it was analyzed using Braun and Clarke's iterative approach., Results: Nineteen providers participated in the focus group, with four themes emerging: current status of education, challenges to delivering women-focused education, delivery modes and topical resources. Results were consistent with those from our related global survey, supporting saturation of themes. Co-designed educational materials included 19 videos. These were organized across 5 webpages in English and French, specific to tests and treatments, exercise, diet, psychosocial well-being, and self-management. Twelve corresponding session slide decks with notes for clinicians were created, to support program delivery in CR flexibly., Conclusion: While further evaluation is underway, these open-access CR education resources will be disseminated for implementation, to support women in reducing their risk of cardiovascular sequelae., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Concise patient-reported outcome (PRO) instruments addressing the consequences of facial acne vulgaris (AV) on patients&rsquo; functioning and activities of daily living (ADL) are needed., Methods: A 12-week, single-arm, prospective cohort study was conducted in patients &ge;9 years old with moderate/severe non-nodular facial AV prescribed sarecycline as part of usual care. The primary endpoint included AV-specific patient- and caregiver-reported outcomes assessed with the expert panel questionnaire (EPQ, developed by 10 experts using a Delphi method) in patients (&gt;12 years) and caregivers (for patients 9-11 years). Additional assessments included parental/caregiver perspectives on children&rsquo;s AV., Results: A total of 253 patients completed the study. Following 12-weeks of treatment, there were significant (P &le;.0001) changes from baseline in the proportion of patients responding that they never or rarely: felt angry (31.6%), worried about AV worsening (28.9%), had thoughts about AV (20.9%), had a certain level of worries about AV (38.7%), altered their social media/selfie activity (23.7%), had an impact on real-life plans due to AV (22.9%), made efforts to hide AV (21.3%), felt picked-on/judged due to AV (15.0%), were concerned about their ability to reach future goals due to AV (13.8%), or had sleep impacted due to AV (18.2%). No significant change from baseline was observed for parent/caregiver&rsquo;s understanding of the child&rsquo;s AV concerns, from both patient and parent/caregiver perspectives., Conclusions: Over 12 weeks of AV management with oral sarecycline, patients reported significant reductions in AV-related effects on emotional/social functioning and ADL as measured by the EPQ, a simple PRO with potential for use in clinical practice. J Drugs Dermatol. 2024;23:1(Suppl 1):s4-11.

Atopic dermatitis (AD) is a chronic relapsing&ndash;remitting disease with a multifactorial etiology involving epidermal barrier and immunologic dysfunction. Topical therapies form the mainstay of AD treatment, but options are limited by adverse effects and restrictions on application site, duration, and extent of use. Tapinarof (VTAMA; Dermavant Sciences, Inc.) is a first-in-class, non-steroidal, topical aryl hydrocarbon receptor (AhR) agonist approved for the treatment of plaque psoriasis. AhR is a ligand-dependent transcription factor with wide-ranging roles, including regulation of homeostasis and immune response in skin cells. AhR expression and signaling are altered in many inflammatory skin diseases, and clinical trials with tapinarof have validated AhR as a therapeutic target capable of delivering significant efficacy. Tapinarof cream 1% once daily demonstrated efficacy versus vehicle in adults and adolescents with AD and is being investigated in the ADORING trials for the treatment of AD in adults and children down to 2 years of age. J Drugs Dermatol. 2024;23(2):23-28.&nbsp; doi:10.36849/JDD.8026.

Competing Interests: Conflicts of interest Dr Hebert has received research grants paid to the McGovern School of Medicine from AbbVie, Arcutis, Novan, and Pfizer; has received honoraria from Pfizer, Arcutis, Incyte, Novan, Ortho Dermatologics, Amyrt, Galderma, Almirall; and is a member of Data Safety Monitoring Boards for GSK, Ortho Dermatologics, and Sanofi Regeneron. Dr McLeod is an employee of RTI Health Solutions, which received funding from Novan, Inc. for data analysis. Dr Siegfried has received research support paid to the Saint Louis University School of Medicine from Regeneron and Amgen; honoraria from AbbVie, Alphyn, ASLAN Pharmaceuticals, Boehringer Ingelheim, Cara Therapeutics, Incyte, Leo, NobelPharma, Novan, Novartis, Pfizer, Pierre Fabre, Regeneron, Sanofi Genzyme, UCB, and Verrica; and is a salaried member of Data Safety Monitoring Boards for Leo, Novan, Pfizer, UCB, and Esperare. Dr Silverberg has received honoraria from Sanofi/Regeneron, Novan, Verrica, Pfizer, and Incyte. Drs. Cartwright and Maeda-Chubachi and Ms. Enloe are employees of and stockholders in Novan, Inc. Substantive editing was provided by Dana L. Randall, MS, PharmD, Intuitive Graphite, Inc. and funded by Novan, Inc.

Background: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged 12 years or older based on results from two identical pivotal Phase 3 trials. Integrated efficacy of clascoterone in patients aged 12 years&nbsp;or older&nbsp;with acne vulgaris from the pivotal trials (NCT02608450 and NCT02608476) and long-term extension (LTE) study (NCT02682264) is reported., Methods: In the pivotal trials, patients with moderate-to-severe acne vulgaris were randomized 1:1 to twice-daily application of clascoterone cream 1% or vehicle for 12 weeks; they could then enter the LTE study, where all patients applied clascoterone to the face and, if desired, trunk for up to 9 additional months. Efficacy was assessed from treatment success based on Investigator's Global Assessment scores (IGA 0/1) in patients aged 12 years or older in the intention-to-treat population; lesion counts were assessed through week 12. Missing data were handled using multiple imputation in the pivotal studies and were not imputed in the LTE study., Results: Of 1421 patients enrolled, 1143 (clascoterone, 576; vehicle, 567) completed week 12; 600 entered and 343 completed the LTE study. The treatment success rate and most lesion count reductions following clascoterone vs placebo treatment reached statistical significance at week 12; the overall treatment success rate increased to 30.2% for facial acne after 12 months and 31.7% for truncal acne after 9 months of treatment., Conclusions: The efficacy of clascoterone cream 1% for the treatment of acne vulgaris continued to increase over time for up to 12 months in patients aged 12 years or older with acne vulgaris. &nbsp; J Drugs Dermatol. 2024;23(1):1278-1283.&nbsp; &nbsp;&nbsp; doi:10.36849/JDD.7719.

Background/objectives: This subgroup analysis of the ALLEGRO phase 2b/3 trial (NCT03732807) evaluated the efficacy and safety of ritlecitinib, an oral, selective dual JAK3/TEC family kinase inhibitor, for the treatment of alopecia areata (AA) in patients aged 12-17 years., Methods: In ALLEGRO-2b/3, patients aged ≥12 years with AA and ≥50% scalp hair loss received once-daily ritlecitinib 50 or 30 mg (±4-week 200-mg loading dose) or 10 mg or placebo for 24 weeks. In a subsequent 24-week extension period, ritlecitinib groups continued their doses, and patients initially assigned to placebo switched to 200/50 or 50 mg daily. Clinician- and patient-reported hair regrowth outcomes and safety were assessed., Results: In total, 105 adolescents were randomized. At Week 24, 17%-28% of adolescents achieved a Severity of Alopecia Tool (SALT) score ≤20 (≤20% scalp without hair) in the ritlecitinib 30 mg and higher treatment groups versus 0% for placebo. At Week 48, 25%-50% of patients had a SALT score ≤20 across ritlecitinib treatment groups (30 mg and higher). Adolescents reporting that their AA "moderately" or "greatly" improved were 45%-61% in the ritlecitinib groups (30 mg and higher) (vs. 10%-22% for placebo) at Week 24 and 44%-80% at Week 48. The most common adverse events in adolescents were headache, acne, and nasopharyngitis. No deaths, major adverse cardiovascular events, malignancies, pulmonary embolisms, opportunistic infections, or herpes zoster infections were reported., Conclusion: Ritlecitinib treatment demonstrated clinician-reported efficacy, patient-reported improvement, and an acceptable safety profile through Week 48 in adolescents with AA with ≥50% scalp hair loss., (© 2023 Pfizer Inc. Pediatric Dermatology published by Wiley Periodicals LLC.)

Background: Eczema (also called atopic dermatitis) is a chronic, relapsing skin disease characterized by erythema, scaling, and pruritus., Methods: Study 1. A double-blind, uncontrolled study in patients with mild-moderate eczema, &ge;2 flares in prior 2 months, and baseline Scoring Atopic Dermatitis (SCORAD) score &le;15. Participants applied Eczema Flare-Up Relief Cream (EFRC) (N=65) BID for 56 days. Efficacy was assessed by SCORAD, patient-oriented SCORAD, skin sensitivity, Dermatology Life Quality Index (DLQI), and digital photography. Standard safety assessments were performed., Study 2: A 21-day open study of EFRC (N=50) to evaluate tolerability as well as its effect on eczema.&nbsp; Results: Study 1. EFRC significantly reduced overall SCORAD scores from baseline to day 56 (11.6 to 4.9, or a 57% reduction). The patient-oriented SCORAD was reduced from 18.6 to 6.8 from baseline to day 56. At day 56, itch and pain improved in 70.4% of children and 62% of adults. DLQI scores were decreased by 75% in adults and 61% in children by day 56. Global skin sensitivity, assessed by the Sensiscale 10-item questionnaire, was 13.1 at baseline and 3.6 at day 56, an improvement of 72%., Study 2: EFRC improved eczema-prone skin after 7 and 21 days.&nbsp; Conclusions: Study 1 showed that EFRC had good efficacy with significant reductions in overall SCORAD scores and subscores for the extent and intensity of eczema and subjective symptoms. Skin sensitivity also improved along with quality of life. Studies 2-3 also had significantly positive results and good tolerability. J Drugs Dermatol. 2023;22:10(Suppl 2):s5-9.

Methotrexate (MTX) is a readily accessible drug, first used in 1948 and employed for a wide variety of indications since then. However, despite widespread off-label use, FDA labeling does not include approved indications for the use of MTX for many inflammatory skin diseases in pediatric patients, including morphea, psoriasis, atopic dermatitis, and alopecia areata, among others. Without published treatment guidelines, some clinicians may be hesitant to use MTX off-label, or uncomfortable prescribing MTX in this population. To address this unmet need, an expert consensus committee was convened to develop evidence- and consensus-based guidelines for use of MTX to treat pediatric inflammatory skin disease. Clinicians with experience and expertise in clinical research, drug development, and treating inflammatory skin disease in pediatric patients with MTX were recruited. Five committees were created based on major topic areas: (1) indications and contraindications, (2) dosing, (3) interactions with immunizations and medications, (4) adverse effects (potential for and management of), and (5) monitoring needs. Pertinent questions were generated and addressed by the relevant committee. The entire group participated in a modified Delphi process to establish agreement on recommendations for each question. The committee developed 46 evidence- and consensus-based recommendations, each with >70% agreement among members, across all five topics. These are presented in tables and text, along with a discussion of supporting literature, and level of evidence. These evidence- and consensus-based recommendations will support safe and effective use of MTX for the underserved population of pediatric patients who may benefit from this valuable, time-honored medication., (© 2023 The Authors. Pediatric Dermatology published by Wiley Periodicals LLC.)

Background: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged &ge; 12 years based on results from two 12-week Phase 3 studies in patients with moderate-to-severe acne. Safety and efficacy of clascoterone in patients aged &ge; 12 years from an open-label, long-term extension study are presented.&nbsp; Methods: Enrolled patients applied clascoterone cream 1% twice daily to the entire face and, if desired by the patient and/or investigator, truncal acne, for up to 9 months. Patients achieving Investigator&rsquo;s Global Assessment score of 0 or 1 (IGA 0/1) could stop treatment and resume if/when acne worsened. Safety was assessed from treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs [telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus]) in all treated patients. Efficacy was assessed from IGA at each visit among those completing the study per-protocol (PP); face and trunk were evaluated individually.&nbsp; Results: Of 600 patients aged &ge; 12 years (original randomization: 311 clascoterone, 289 vehicle), 343 completed the extension study (177 clascoterone, 166 vehicle). There were 187 TEAEs in 108/598 clascoterone-treated patients (18.1%), including 56/311 (18.0%) and 52/287 (18.1%) patients originally randomized to clascoterone and vehicle, respectively; the most common LSRs (previous clascoterone/vehicle) were erythema (face, 8.0%/7.7%) and scaling/dryness (face, 10.0%/7.3%). The percentage of PP patients with facial and truncal IGA 0/1 increased to 48.9% (156/319) and 52.4% (65/124), respectively, at study end., Conclusions: Clascoterone cream 1% maintained a favorable safety and efficacy profile for up to 12 months in patients aged &ge; 12 years.&nbsp;Eichenfield LF, Hebert AA, Stein Gold L, et al. Long-term safety and efficacy of twice-daily topical clascoterone cream 1% in patients &ge; 12 years of age with acne vulgaris. J Drugs Dermatol. 2023;22(8):810-816. doi:10.36849/JDD.7592.

Molluscum contagiosum (MC) is a viral infection that affects primarily pediatric patients, sexually active young adults, and immunocompromised people of all ages. MC occurs all over the world, making up about one percent of skin disorders and appears to be increasing in prevalence. This cutaneous infection is often associated with atopic dermatitis and is typically self-limiting, although spontaneous resolution can take months to years. Many treatments exist, but only one-a drug-device product using topical cantharidin- is approved by the United States (US) Food and Drug Administration (FDA) for treatment of MC. For many years, there was a lack of an established or FDA-approved first-line treatment for MC, which might have contributed to the common "benign neglect" attitude of physicians regarding treatment of MC. Unfortunately, this noninterventional approach can increase risk of spreading infection and result in longer duration of infection, physical discomfort, and psychosocial issues due to persistence of the MC lesions. This article reviews available epidemiology data and explores treatment options and therapeutic gaps in MC management., Competing Interests: FINANCIAL DISCLOSURES: Dr. Hebert has received research grants (paid to UTHealth McGovern Medical School) from Verrica, Pfizer, Arcutis, GSK, Ortho Dermatologics, and Galderma, and has received honoraria from Verrica, Pfizer, Galderma, Arcutis, Vine, Almirall, Bristol Myres Squibb, Leo, Vyne, Aslan DSMB: Ortho Dermatologics, GSK, and Sanofi Regeneron. Dr. Del Rosso is a consultant/advisor and investigator for Verrica Pharmaceutical., (Copyright © 2023. Matrix Medical Communications. All rights reserved.)

Despite its high global prevalence, molluscum contagiosum (MC) is not well understood outside of dermatology. Due to the potential self-limiting nature of MC, a common clinical approach in management is to wait for the papules to resolve spontaneously over several weeks to months, without medical intervention. However, this "watch and wait" approach increases risk of spreading the virus to others, extending the duration of the infection, and emergence of several psychosocial issues (e.g., anxiety, embarrassment, isolation). Molluscum contagiosum can be particularly challenging to treat in immunocompromised patients (e.g., human immunodeficiency virus [HIV], organ transplant recipients). This article reviews diagnostic characteristics and treatment options for MC, as well as associated risk factors and comorbidities. Treatment of immunocompromised individuals, in whom the risks of diffuse MC with persistence and spread are relatively high, is emphasized. The authors highlight the importance of actively treating the MC papules, as opposed to letting the virus "run its course" with no active intervention, with the goals of reducing the risk of spreading infection to others, shortening the duration of infection, and decreasing adverse psychosocial sequelae commonly associated with MC., Competing Interests: FINANCIAL DISCLOSURES: Dr. Hebert has received research grants (paid to UTHealth McGovern Medical School) from Verrica, Pfizer, Arcutis, GSK, Ortho Dermatologics, and Galderma, and has received honoraria from Verrica, Pfizer, Galderma, Arcutis, Vine, Almirall, Bristol Myres Squibb, Leo, Vyne, Aslan DSMB: Ortho Dermatologics, GSK, and Sanofi Regeneron. Dr. Del Rosso is a consultant/advisor and investigator for Verrica Pharmaceutical., (Copyright © 2023. Matrix Medical Communications. All rights reserved.)

Cosmetic dermatology is a key subspecialty of academic dermatology. As such, academic centers are expected to demonstrate excellence in the teaching of cosmetic dermatology skills to trainees, the clinical delivery of cosmetic dermatology services to patients, and the performance of clinical research that advances knowledge and uncovers new therapies in cosmetic dermatology. The Association of Academic Cosmetic Dermatology (AACD), a newly formed medical professional society, includes as its principal aims the support of all of these areas. AACD is comprised of group of board-certified dermatologists who teach cosmetic and laser dermatology at US dermatology residency programs. An expert panel constituted by the AACD recently convened a workshop to review gaps pertaining to academic cosmetic dermatology. This panel considered needs and potential corrective initiatives in three domains: resident education, patient experience, and clinical research. The work of the panel was used to develop a roadmap, which was adopted by consensus, and which will serve to guide the AACD moving forward., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Pediatric psoriasis (PsO) and its associated comorbidities carry physical and psychosocial burdens in children and adolescents, which can negatively impact quality of life. However, features distinguishing pediatric PsO from eczema and other common inflammatory skin diseases may not be obvious to primary care providers, which may contribute to underrecognition and misdiagnosis. Accurate diagnosis of pediatric PsO is critical for managing the physical and psychological burdens associated with this disease. This review aims to support pediatricians with enough information to confidently diagnose pediatric PsO, assess associated physical and mental health comorbidities, and recommend first-line treatment options for children with mild to moderate PsO. To accomplish this, we provide information that distinguishes the appearance and symptoms of pediatric PsO from other common pediatric skin conditions. In addition, comorbidities and some of the mental health challenges associated with pediatric PsO are reviewed to help pediatricians provide appropriate care for patients in their clinical practice. Hebert AA, Browning J, Kwong PC, et al. Diagnosis and management of pediatric psoriasis: an overview for pediatricians. J Drugs Dermatol. 2023;22(8):742-752. doi:10.36849/JDD.7531.

Cosmetic and laser procedures are increasingly popular among patients and are skills in which dermatologists are regarded as well trained. Most dermatology residents intend to incorporate cosmetic procedures into their practice and prefer to learn such procedures during residency through direct patient care. However, there are notable challenges in optimizing how residents are trained in cosmetic and laser dermatology. To address these barriers and elevate the practice of cosmetic dermatology in academic medicine, the Association of Academic Cosmetic Dermatology (AACD) was founded in 2021 as the lead professional society for dermatologists who direct the education of resident trainees in cosmetic and laser dermatology. The AACD, a group of board-certified dermatologists who teach cosmetic and laser dermatology to residents, aims to improve cosmetic dermatology education through collaboration, research, and advocacy., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Pediatric acne is a common, complex, multifactorial inflammatory skin disease with various expressions in childhood that can be categorized by age, severity, and pubertal status., Methods: The Faces of Pediatric Acne Project (FoPAP) aims to improve patient outcomes. The FoPAP group developed an algorithm that follows a consensus paper and a clinical case series on pediatric acne by applying the selected literature and drawing from the clinical knowledge and experience of each group member., Results: The algorithm addresses neonatal, infantile, mid-childhood, preadolescent, and adolescent acne and starts with education on acne, general measures for prevention, treatment, maintenance, and ongoing skin care. Evaluation of pediatric acne requires a directed medical history and physical examination. For mid-childhood acne patients, a workup is warranted, and endocrine-associated abnormalities necessitate referral to a pediatric dermatologist. The second section of the algorithm identifies the type of pediatric acne, followed by the third section on acne treatment using a prescription or nonprescription treatment and skincare options. After successfully controlling the disease, maintenance treatment with topical agents and skincare using gentle cleansers and moisturizers containing lipids such as ceramides is important., Conclusions: The pediatric acne algorithm offers a comprehensive approach to treating and maintaining pediatric acne. In addition, it may support healthcare providers to bring more attention to pediatric acne patients and improve outcomes. Schachner LA, Andriessen A, Latanya Benjamin L, et al. The many faces of pediatric acne: a practical algorithm for treatment, maintenance therapy, and skincare recommendations for pediatric acne patients. J Drugs Dermatol. 2023;22(6):539-545. doi:10.36849/JDD.7440&nbsp.

Many indications in dermatology can be effectively managed with topical antibiotics, including acne vulgaris, wound infections, secondarily infected dermatitis, and impetigo. Dermatologists must be familiar with the wide spectrum of topical antibiotics available, including indications, mechanisms of action, adverse events, and spectra of activity. Dermatologists must also keep antibiotic resistance in mind when utilizing these medications. Due to the widespread use of topical antibiotics and their importance in dermatology, a literature review was performed using a systematic search of PubMed and Google Scholar with the terms topical antibiotics, skin infections, dermatology, antimicrobials, and inflammatory dermatoses to identify English-language articles published between 1965-2022 from any country. Relevant publications were manually reviewed for additional content. The following literature review will summarize the common topical antibiotics used in dermatology.

Malaria, Zika virus, West Nile virus, Dengue fever, and Lyme disease are common causes of morbidity and mortality around the world. While arthropod bites may cause local inflammation and discomfort, a greater concern is the potential to develop deadly systemic infection. The use of insect repellents (IRs) to prevent systemic infections constitutes a fundamental public health effort. Cost effectiveness, availability, and high efficacy against arthropod vectors are key characteristics of an ideal IR. Currently, numerous IRs are available on the market, with N,N-diethyl-3-methylbenzamide (DEET) being the most widely used. DEET has an excellent safety profile and remarkable protection against mosquitoes and various other arthropods. Other Environmental Protection Agency-registered IR ingredients (eg, permethrin, picaridin, IR3535, oil of lemon eucalyptus, oil of citronella, catnip oil, and 2-undecanone) are alternative IRs of great interest because some of these ingredients have efficacies comparable to that of DEET. These alternative IRs possess low toxicity and favorable customer experiences in use (eg, cosmetically pleasant, naturally occurring). This review summarizes the currently available Environmental Protection Agency-registered IRs, including their origins, mechanisms of action, side effect profiles, and available formulations. This review will enable the clinician to select the best IR option to meet a patient's needs and provide the greatest protection from arthropod bites and their sequelae., (Copyright © 2018 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Evidence suggests that wearing permethrin-treated military uniforms is not associated with current adverse health conditions. However, exposure through this route results in permethrin biomarker concentrations considerably higher than those in the U.S., Population: The U.S. Army is exploring different methods of uniform treatment that reduce exposure while maintaining effective protection from insect vector-borne diseases., Objective: To compare permethrin exposure when wearing two types of permethrin-treated military uniforms., Methods: Eight male soldiers participated in a 32-day crossover design study to compare permethrin exposure when wearing the current Army uniform (CurrU) and a uniform with a new applied fabric treatment (NewU). Each soldier wore the uniforms for designated 8 h/day time periods over 3 consecutive days separated by a 'wash-out' week of no exposure. Permethrin exposure was assessed from the urinary concentrations of 3-phenoxybenzoic acid (3-PBA) and of the sum of cis- and trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane-1-carboxylic acid (∑DCCA). Estimated dose was determined based on ∑DCCA concentrations., Results: Permethrin exposure biomarkers were 21% (3-PBA, p = 0.025) and 35% (∑DCCA, p < 0.001) lower when wearing the NewU compared to the CurrU; the dose was 33% lower (p = 0.05)., Significance: Findings suggest the new treatment reduces human permethrin exposure biomarkers resulting from wearing-treated military uniforms., (© 2022. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Sensitive skin exposed to external insults (i.e., allergens, chemicals, and radiation) becomes erythematosus, and with repeated aggravations may become chronically dry. This is often observed in atopic dermatitis and allergic contact dermatitis, two skin conditions that display key pathogenic components: barrier dysfunction, skewed inflammatory immune response, and pruritus. Recent studies have evidenced that oxidative stress is a possible fourth component of the pathogenesis of sensitive skin. In patients with persistent disease, new agents and combination therapies that target oxidative stress along with other hallmarks of dry and sensitive skin have depicted positive effects on clinical outcomes in infants with dry and sensitive skin. In this paper, we reviewed clinical registration studies of products that have been observed to reduce skin dryness with cosmetically acceptable effects. Overall, similar approaches may be explored to improve the management of dry skin across all age groups for better consistency in achieving treatment goals. ( SKINmed . 2022;20:414-419).

Importance: Once-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis., Objective: To evaluate the efficacy of roflumilast cream, 0.3%, applied once daily for 8 weeks in 2 trials of patients with plaque psoriasis., Design, Setting, and Participants: Two phase 3, randomized, double-blind, controlled, multicenter trials (DERMIS-1 [trial 1; n = 439] and DERMIS-2 [trial 2; n = 442]) were conducted at 40 centers (trial 1) and 39 centers (trial 2) in the US and Canada between December 9, 2019, and November 16, 2020, and between December 9, 2019, and November 23, 2020, respectively. Patients aged 2 years or older with plaque psoriasis involving 2% to 20% of body surface area were enrolled. The dates of final follow-up were November 20, 2020, and November 23, 2020, for trial 1 and trial 2, respectively., Interventions: Patients were randomized 2:1 to receive roflumilast cream, 0.3% (trial 1: n = 286; trial 2: n = 290), or vehicle cream (trial 1: n = 153; trial 2: n = 152) once daily for 8 weeks., Main Outcomes and Measures: The primary efficacy end point was Investigator Global Assessment (IGA) success (clear or almost clear status plus ≥2-grade improvement from baseline [score range, 0-4]) at week 8, analyzed using a Cochran-Mantel-Haenszel test stratified by site, baseline IGA score, and intertriginous involvement. There were 9 secondary outcomes, including intertriginous IGA success, 75% reduction in Psoriasis Area and Severity Index (PASI) score, and Worst Itch Numeric Rating Scale score of 4 or higher at baseline achieving 4-point reduction (WI-NRS success) at week 8 (scale: 0 [no itch] to 10 [worst imaginable itch]; minimum clinically important difference, 4 points)., Results: Among 881 participants (mean age, 47.5 years; 320 [36.3%] female), mean IGA scores in trial 1 were 2.9 [SD, 0.52] for roflumilast and 2.9 [SD, 0.45] for vehicle and in trial 2 were 2.9 [SD, 0.48] for roflumilast and 2.9 [SD, 0.47]) for vehicle. Statistically significantly greater percentages of roflumilast-treated patients than vehicle-treated patients had IGA success at week 8 (trial 1: 42.4% vs 6.1%; difference, 39.6% [95% CI, 32.3%-46.9%]; trial 2: 37.5% vs 6.9%; difference, 28.9% [95% CI, 20.8%-36.9%]; P < .001 for both). Of 9 secondary end points, statistically significant differences favoring roflumilast vs vehicle were observed for 8 in trial 1 and 9 in trial 2, including intertriginous IGA success (71.2% vs 13.8%; difference, 66.5% [95% CI, 47.1%-85.8%] and 68.1% vs 18.5%; difference, 51.6% [95% CI, 29.3%-73.8%]; P < .001 for both), 75% reduction in PASI score (41.6% vs 7.6%; difference, 36.1% [95% CI, 28.5%-43.8%] and 39.0% vs 5.3%; difference, 32.4% [95% CI, 24.9%-39.8%]; P < .001 for both), WI-NRS success (67.5% vs 26.8%; difference, 42.6% [95% CI, 31.3%-53.8%] and 69.4% vs 35.6%; difference, 30.2% [95% CI, 18.2%-42.2%]; P < .001 for both). The incidence of treatment-emergent adverse events was 25.2% with roflumilast vs 23.5% with vehicle in trial 1 and 25.9% with roflumilast vs 18.4% with vehicle in trial 2. The incidence of serious adverse events was 0.7% with roflumilast vs 0.7% with vehicle in trial 1 and 0% with roflumilast vs 0.7% with vehicle in trial 2., Conclusions and Relevance: Among patients with chronic plaque psoriasis, treatment with roflumilast cream, 0.3%, compared with vehicle cream resulted in better clinical status at 8 weeks. Further research is needed to assess efficacy compared with other active treatments and to assess longer-term efficacy and safety., Trial Registration: ClinicalTrials.gov Identifiers: NCT04211363, NCT04211389.