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BackgroundTreatment for both facial and truncal acne has not sufficiently been studied.ObjectivesTo evaluate the long-term safety and efficacy of trifarotene in both facial and truncal acne.MethodsIn a multicentre, open-label, 52-week study, patients with moderate facial and truncal acne received trifarotene 50 μg/g cream (trifarotene). Assessments included local tolerability, safety, investigator and physician's global assessments (IGA, PGA) and quality of life (QOL). A validated QOL questionnaire was completed by the patient at Baseline, Week 12, 26 and 52/ET.ResultsOf 453 patients enrolled, 342 (75.5%) completed the study. Trifarotene-related treatment-emergent adverse events (TEAEs) were reported in 12.6% of patients, and none was serious. Most related TEAEs were cutaneous and occurred during the first 3 months. Signs and symptoms of local tolerability were mostly mild or moderate and severe signs, and symptoms were reported for 2.2% to 7.1% of patients for the face and 2.5% to 5.4% for the trunk. Local irritation increased during the first week of treatment on the face and up to Weeks 2 to 4 on the trunk with both decreasing thereafter. At Week 12, IGA and PGA success rates were 26.6% and 38.6%, respectively. Success rates increased to 65.1% and 66.9%, respectively at Week 52. Overall success (both IGA and PGA success in the same patient) was 57.9% at Week 52. At Week 52 visit, 92/171 (53.8%) patients who had completed their assessments had scores from 0 to 1 (i.e. no effect of acne on their QOL) vs. 47/208 (22.6%) patients at Baseline visit.ConclusionIn this 52-week study, trifarotene was safe, well tolerated and effective in moderate facial and truncal acne.

Skin aging has long been considered a purely cosmetic problem. However, as life expectancy increases, skin aging is taking on a functional dimension that goes beyond cosmetics and appearance. Preventive or therapeutic strategies are needed to target cellular senescence, a key process underlying the alterations in skin function and appearance that occur with aging, as well as to address the age‐related skin changes associated with 'dermatoporosis' and chronic skin insufficiency/fragility syndrome. Thus, given the need for effective anti‐aging products that improve both the appearance and function of the skin, it is essential to distinguish active ingredients that have been proven to be effective, among the large number of available over‐the‐counter cosmeceuticals. This brief review focuses on a core group of topical actives, describing their clinical effects on senescence and aging, and their molecular mechanisms of action. These actives include hyaluronic acid, which has hydrating and viscoelastic properties and has been shown to reduce skin atrophy; retinaldehyde, which activates retinoid receptors and increases cutaneous elasticity; vitamins C and E, which provide stable oxidative protection; and niacinamide, which reduces inflammation and mitigates the effects of senescence. [ABSTRACT FROM AUTHOR]

This article discusses the issues of skin aging and photoaging, which not only affect the appearance of the skin but also its function and susceptibility to disease, as well as mental health and well-being. The article highlights the advances in aging and photoaging research, which have led to the development of more sophisticated anti-aging treatments that target cellular processes to improve skin function and appearance. The article also emphasizes the importance of evidence-based approaches and individualized treatments to ensure patient safety and meet patient needs. The article summarizes the highlights from meetings on anti-aging treatments and provides reviews on topics such as cellular senescence, topical active ingredients, multilevel anti-aging strategies, and the impact of the COVID-19 pandemic on anti-aging trends. The overall message is that interventions targeting cellular aging and senescence, along with preventative measures and holistic approaches, can improve skin health and well-being. [Extracted from the article]

Zoe Diana Draelos Dermatology Consulting Services, PLLC, High Point, NC, USACorrespondence: Zoe Diana Draelos, Dermatology Consulting Services, PLLC, 2444 North Main Street, High Point, NC, 27262, USA, Tel +1-336-841-2040, Fax +1 336-841-2044, Email zdraelos@northstate.netIntroduction: This study examined the efficacy and tolerability of a once-daily regimen of a 3% salicylic acid treatment gel containing turmeric and a low concentration of salicylic acid plus shea butter exfoliating moisturizer when used as monotherapy or in as an adjunct to other Rx psoriasis medications.Patients and Methods: This single-site 12-week study enrolled 20 subjects > 18 years of age with mild-to-moderate psoriasis involving < 10% body surface area. Assessments were performed at baseline and Weeks 4, 8, and 12 using a 5-point scale (0 = none to 4 = severe). The investigator-assessed efficacy (changes from baseline for erythema, desquamation, induration, and overall global assessment [IGA]) and tolerability (irritation and edema). Study subjects assessed efficacy parameters of redness, scaling, and overall skin problems along with tolerability parameters of stinging, burning, itching, and irritation. Subjects applied the turmeric and salicylic acid treatment gel along with a moisturizer once daily to all affected areas.Results: Half (50%) of the subjects were using concomitant Rx psoriasis treatments, while the other 50% received the study psoriasis treatment regimen as monotherapy. Investigator assessments of erythema, desquamation, induration, and IGA scores showed significant reductions from baseline (P ≤ 0.021) at Weeks 4, 8, and 12. At Week 12, these reductions reached 48%, 46%, 51%, and 48%, for these parameters, respectively. The investigator observed no irritation or edema at any time point. Subject assessments of redness, scaling, and overall improvement demonstrated significant reductions in 8 of 9 assessments (P ≤ 0.037). The subjects reported mild irritation at Weeks 4, 8, and 12. No treatment compliance issues or adverse events related to study product occurred during the study.Conclusion: A once-daily over-the-counter (OTC) turmeric/salicylic acid gel followed by a shea butter/salicylic acid exfoliating moisturizer demonstrated excellent tolerability and efficacy in plaque-type psoriasis after 12 weeks of once-daily use.Keywords: psoriasis, salicylic acid, shea butter, turmeric, curcumin

Abstract Objective To develop the content for two new patient reported outcome (PRO) measures to: a) assess the severity of symptoms; and b) the impact of facial skin oiliness on emotional wellbeing using qualitative data from face to face, and internet focus groups in Germany and the US. Methods Using input from initial treatment satisfaction focus groups (n = 42), a review of relevant literature and expert clinicians (n = 3), a discussion guide was developed to guide qualitative inquiry using Internet focus groups (IFGs). IFGs were conducted with German (n = 26) and US (n = 28) sufferers of oily skin. Questionnaire items were generated using coded transcript data from the focus groups. Cognitive debriefing was conducted online with 42 participants and face to face with an additional five participants to assess the comprehension of the items. Results There were equal numbers of male and female participants; mean age was 35.4 (SD 9.3) years. On average, participants had had oily skin for 15.2 years, and 74% (n = 40) reported having mild-moderate acne. Participants reported using visual, tactile and sensory (feel without touching their face) methods to evaluate the severity of facial oiliness. Oily facial skin had both an emotional and social impact, and was associated with feelings of unattractiveness, self-consciousness, embarrassment, irritation and frustration. Items were generated for a measure of oily skin severity (Oily Skin Self-Assessment Scale) and a measure of the impact of oily skin on emotional well-being (Oily Skin Impact Scale). Cognitive debriefing resulted in minor changes to the draft items and confirmed their face and content validity. Conclusion The research provides insight into the experience of having oily skin and illustrates significant difficulties associated with the condition. Item content was developed for early versions of two PRO measures of the symptoms and emotional impact of oily facial skin. The psychometric validation of these measures reported elsewhere.

Acne vulgaris is the most common skin condition in the US, affecting up to 50 million Americans. The American Academy of Dermatology (AAD) guidelines on acne treatment were developed to provide recommendations for the diagnosis, grading, and treatment of acne in adolescents and adults to support clinicians in their therapeutic decision-making process. The most recent acne guidelines were published in 2016, and the approach to care and the therapeutic landscape of acne have evolved since that time. The Acne Management Consensus Roundtable was convened in 2022 to discuss unmet needs in the management of acne. The main focus of the meeting was the role of androgens in acne pathology; the evaluation of clascoterone, the first topical anti-androgen that specifically addresses sebum production in acne; and the identification of the place of clascoterone in therapy. Clascoterone was approved by the US Food and Drug Administration for the treatment of acne in patients 12 years and older in 2020. This report aims to highlight important limitations of the 2016 AAD treatment guidelines and to familiarize practitioners with clascoterone and its indication, efficacy and safety profile, and potential use across diverse patient populations. With its new mechanism of action, clascoterone may be able to fulfill important unmet needs in acne treatment. Baldwin H, Farberg AS, Frey C, et al. Unmet needs in the management of acne vulgaris: a consensus statement. J Drugs Dermatol. 2023;22(6):582-587. doi:10.36849/JDD.7587.

Objective: Topical therapies remain the mainstay in treating patients with acne and rosacea. However, emerging real-world evidence demonstrates that desired treatment outcomes might not be achieved if patient satisfaction and adherence are low. Poor tolerability of active drug(s) and vehicle components and/or the drug delivery system could negatively influence adherence. Additionally, adherence might be lower with complex treatment regimens involving the application of multiple topical formulations. Optimizing vehicle tolerability and simplifying regimens that use fixed-dose combinations may improve treatment outcomes, better patient satisfaction, and reduce overall treatment costs. This qualitative review discusses several innovative drug delivery technologies and formulations aimed at improving patient satisfaction and adherence., Methods: The authors conducted a search of current and emerging topical drug delivery technologies used in clinical studies, reviewed primary literature on the chemical characteristics of topical dosage forms, and compared the impacts on treatment outcomes for acne and rosacea., Results: This article provides insight into innovative vehicles and drug delivery systems that have emerged allowing for fixed-dose combinations of incompatible active drugs and improving the tolerability of historically irritative active ingredients., Limitations: Further research is needed to fully highlight the impact of patient satisfaction and modern topical formulations on adherence and treatment outcomes., Conclusion: Drug microencapsulation is a delivery technology that has enabled development of a topical fixed-dose combination of benzoyl peroxide and tretinoin preventing the oxidation of tretinoin by benzoyl peroxide and improving the tolerability of the active ingredients., Competing Interests: DISCLOSURES: Dr. Stein Gold is an investigator, advisor, and/or speaker for Galderma, Sol Gel, Ortho Dermatologics, Sun Pharma, and Almirall. Dr. Draelos is a researcher and consultant for Galderma. Dr. Desai has served as a consultant for Galderma, and several other industry organizations in a role of a clinical investigator and/or consultant. The remaining authors have no relevant conflicts of interest to disclose related to the content of this article., (Copyright © 2023. Matrix Medical Communications. All rights reserved.)

Background: Patients with atopic dermatitis (AD) need safe and effective topical treatments., Objective: To assess safety and efficacy of roflumilast cream in patients with mild to moderate AD., Methods: In this phase 2, proof of concept trial, patients (N=136) aged &ge;12 years with AD were randomized to once-daily roflumilast cream 0.15%, roflumilast cream 0.05%, or vehicle cream for 4 weeks. Absolute change from baseline in Eczema Area and Severity Index (EASI) score at week 4 (primary endpoint), percentage change and responder rates, Validated Investigator Global Assessment-AD (vIGA-AD), and safety were assessed., Results: At week 4, mean absolute changes in EASI were &minus;6.4 (P=0.097 vs vehicle), &minus;6.0 (P=0.356), and &minus;4.8 with roflumilast 0.15%, roflumilast 0.05%, and vehicle, respectively. Significant improvements were observed for percentage change from baseline in EASI, patients reaching 75% improvement in EASI, and patients achieving vIGA-AD score of &ldquo;clear&rdquo; or &ldquo;almost clear.&rdquo; Treatment-related adverse events (AEs) occurred in 2 (2.2%) patients receiving roflumilast (mild rash and moderate application site pain). Only 1 (1.1%) patient receiving roflumilast discontinued study/drug due to an AE., Limitations: Small number of patients., Conclusions: Results support additional larger clinical trials of roflumilast cream to assess its potential as a once-daily, nonsteroidal topical AD treatment., Clinicaltrials: gov identifier NCT03916081 J Drugs Dermatol. 2023;22(2):139-147. doi:10.36849/JDD.7295.

Acne vulgaris of the trunk carries with it a major psychosocial impact and an unmet need for adequate management. Approximately 50% of patients with facial acne also exhibit involvement of the back, chest, and/or upper arms. The trunk poses a therapeutic challenge given its occlusion by clothing, the tendency for mechanical rubbing, a sebum physiology that differs from the face, as well as the fact that there is a large surface area for topical therapies to cover. Furthermore, truncal acne is underreported for a variety of reasons such as cultural barriers, sentiments of embarrassment, and prioritization of facial acne. To date, few medications have been studied specifically for truncal acne. In this article, an updated review of truncal acne and available therapies is provided. The most recent evidence for tazarotene, a third-generation retinoid previously approved for psoriasis and facial acne vulgaris over two decades ago, is also reviewed and compared to trifarotene, a fourth-generation retinoid that is the only approved tropical retinoid for both facial and truncal acne. J Drugs Dermatol. 2022;21:12(Suppl):s5-14.

Background: Atopic dermatitis (AD) is a prevalent inflammatory, pruritic skin disease. The Janus kinase (JAK) pathway is a treatment target., Objectives: To assess the efficacy, safety and pharmacokinetics of topical cream brepocitinib, a small-molecule tyrosine kinase 2 (TYK2)/JAK1 inhibitor, in participants with mild-to-moderate AD., Methods: In this phase IIb, double-blind, dose-ranging study, participants were randomized to receive one of eight treatments for 6 weeks: brepocitinib 0·1% once daily (QD), 0·3% QD or twice daily (BID), 1·0% QD or BID, 3·0% QD, or vehicle QD or BID. The primary endpoint was the percentage change from baseline in the Eczema Area and Severity Index (EASI) total score at week 6. Adverse events (AEs) were monitored., Results: Overall, 292 participants were enrolled and randomized. The brepocitinib 1% QD and 1% BID groups achieved statistically significantly greater (with multiplicity-adjusted P < 0·05 due to Hochberg's step-up method) percentage reductions from baseline in EASI total score at week 6 [least squares mean (90% confidence interval, CI): QD: -70·1 (-82·1 to -58·0); BID: -75·0 (-83·8 to -66·2)] compared with respective vehicle [QD: -44·4 (-57·3 to -31·6); BID: -47·6 (-57·5 to -37·7)]. There was not a dose-dependent trend in AE frequency, and there were no serious AEs or deaths., Conclusions: Topical brepocitinib is effective and well tolerated in participants with mild-to-moderate AD. What is already known about this topic? Janus kinase (JAK) inhibitors are in development for treatment of atopic dermatitis (AD). The tyrosine kinase 2 and JAK 1 inhibition by brepocitinib may bring a new profile for topical JAK inhibitors for treatment of mild-to-moderate AD. What does this study add? Topical brepocitinib can provide rapid, effective symptom reduction, and could offer a novel alternative to current topical treatments for mild-to-moderate AD., (© 2022 Pfizer Inc and The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)

Background: While topical retinoids are a mainstay of acne treatment, acne can manifest differently in various skin types. The objective of these post hoc analyses from two pooled phase 3 studies was to examine efficacy and safety of tazarotene 0.045% and quality of life improvements in self-identified Caucasian adults with moderate-to-severe acne., Methods: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants aged &ge;9 years with moderate-to-severe acne were randomized (1:1) to tazarotene 0.045% lotion or vehicle lotion (N=1,614); a subset of adults (&ge;18 years) who self-reported Caucasian (White) race (n=645) were examined. Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment (endpoint) success (&ge;2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 0 [clear] or 1 [almost clear]). Quality of life, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability were also assessed., Results: At week 12, tazarotene lotion significantly reduced lesion counts by ~60% (least-squares mean percent changes from baseline, tazarotene vs vehicle: inflammatory, -61.2% vs -51.1%; noninflammatory, -59.7% vs -49.3%; P&lt;0.001, both). Significantly more participants achieved treatment success with tazarotene lotion versus vehicle (P&lt;0.001). Numerical improvements in quality-of-life domains were observed from baseline to week 12. Most TEAEs were unrelated to treatment, and rates of moderate-to-severe erythema decreased from baseline to week 12 with tazarotene treatment., Conclusions: Tazarotene 0.045% lotion was efficacious and well tolerated over 12 weeks and led to quality-of-life improvements in Caucasian adults with moderate-to-severe acne. These results, along with those from patients with skin of color, demonstrate that once daily tazarotene 0.045% lotion is an effective and well-tolerated treatment option regardless of race or skin color.J Drugs Dermatol. 2022;21(10):1061-1069. doi:10.36849/JDD.6834.

Background: Topical retinoids like tretinoin are a mainstay of acne treatment but associated cutaneous irritation and drying may lead to poor adherence. As vehicle optimization can improve patient preference and adherence, tretinoin 0.05% lotion (Altreno&reg;) was formulated using polymeric emulsion technology for uniform delivery of micronized tretinoin and moisturizing/hydrating excipients. This study compared tolerability and participant preference of a branded tretinoin 0.05% lotion versus generic cream., Methods: In this single-center, double-blind, split-face study, 25 adult females with acne were randomized to apply lotion and cream to opposite cheeks once daily for 2 weeks. Investigator-assessed skin irritation and appearance, as well as participant ratings of the products and skin sensations, were evaluated immediately after first use and after 2 weeks., Results: At week 2, there was significantly greater erythema, scaling, and dryness (122%&ndash;144%; P&lt;0.01 each) and decreased skin softness, smoothness, radiance, and brightness (~40% difference; P&lt;0.01 each) on the cream-treated versus lotion-treated side of the face. More participants agreed that the lotion was gentle, comfortable/soothing, spreadable, absorbent, not sticky, and left minimal residue versus cream (range: 72%&ndash;92% vs 8%&ndash;36%). Agreement scores on skin sensations (eg, soft, not dry, less dull) were similarly higher for lotion versus cream. Overall, ~70% of participants preferred to take home the lotion over the cream., Conclusions: After 2 weeks of once-daily use, tretinoin 0.05% lotion was associated with less irritation and superior skin appearance/ sensation versus generic 0.05% cream, with most participants preferring the lotion over cream. These results demonstrate the importance of a well-designed vehicle formulation on tolerability and patient preference. J Drugs Dermatol. 2022;21(8): 875-880. doi:10.36849/JDD.6945.

Objective: We evaluated the efficacy and safety of trifarotene plus oral doxycycline in acne., Methods: This was a randomized (2:1 ratio) 12-week, double-blind study of once-daily trifarotene cream 50µg/g plus enteric-coated doxycycline 120mg (T+D) versus trifarotene vehicle and doxycycline placebo (V+P). Patients were aged 12 years or older with severe facial acne (≥20 inflammatory lesions, 30 to 120 non-inflammatory lesions, and ≤4 nodules). Efficacy outcomes included change from baseline in lesion counts and success (score of 0/1 with ≥2 grade improvement) on investigator global assessment (IGA). Safety was assessed by adverse events and local tolerability., Results: The study enrolled 133 subjects in the T+D group and 69 subjects in the V+P group. The population was balanced, with an approximately even ratio of adolescent (12-17 years) and adult (≥18 years) subjects. The absolute change in lesion counts from baseline were: -69.1 T+D versus -48.1 V+P for total lesions, -29.4 T+D versus -19.5 V+P for inflammatory lesions, and -39.5 T+D versus -28.2 for non-inflammatory lesions ( P <0.0001 for all). Success was achieved by 31.7 percent of subjects in the T+D group versus 15.8 percent in the V+P group ( P =0.0107). The safety and tolerability profiles were comparable between the T+D and V+P arms., Conclusion: T+D was demonstrated to be safe and efficacious as a treatment option for patients with severe acne., Competing Interests: DISCLOSURES: James Del Rosso has acted as a research investigator, consultant and/or speaker for Almirall, Bausch Health (Ortho Dermatology), BiopharmX, Cassiopea, EPI Health, Galderma, JEM Health, La Roche Posay, LEO Pharma, Mayne Pharma, Sol-Gel, Sonoma, Sun Pharma, and Vyne Therapeutics (Foamix); Sandra Marchese Johnson has been advisor or speaker for Nielsen, Amgen, Allergan, Regeneron, Sanofi Genzyme, and Candela, and an investigator for Arcutis, Aurigene, Amgen, Regeneron, Galderma, Nielsen, Dermavant, Lilly, Therapeutics, GSK, Aclaris, Foamix, Novartis, Abbvie, Gage, Cassiopea, National Psoriasis Foundation, University of Pennsylvania; Todd Schlesinger has received equipment/research funding from AbbVie/Allergan, Acrutis, Almirall, Anterios, AOBiome, Astellas Pharma US, Athenex, Biofrontera, Biorasi, Boehringer Ingelheim, Brickell Biotech, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Celgene, Centocor Ortho Biotech (Now Janssen Biotech), ChemoCentryx, Coherus Biosciences, Concert Pharmaceuticals, Corrona, Cutanea Life Sciences, Dermavant, Dermira, DT Pharmacy & DT Collagen, Lilly, EPI Health, Galderma, Janssen Pharmaceuticals, Kiniksa, Leo, Merz, Nestle Skin Health, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sisaf and Trevi, and has acted as in consulting, speaking or advisory capacity for AbbVie, Allergan, Almirall, Amgen, Bioderma, Biofrontera AG, BioPharmx, Bristol Myers Squibb, Castle Biosciences, Celgene, CMS Aesthetics DCME, DUSA/Sun Pharma, Lilly, EPI Health, Foundation for Research and Education in Dermatology (FRED), Galderma, Greenway Therapeutix, Kintor, MED Learning Group, Merz, MJH Associates, Nextphase Therapeutics, Novartis, Ortho Dermatologics, Pharmatecture, Pierre Fabre, Plasmed, Prolacta Bioscience, Regeneron, Remedly, Inc, Sanofi Genzyme, SkinCeuticals/L’Oreal, SUN Pharma, UCB and Verrica; Lawrence Green has served as consultant, investigator or speaker for Almirall, Cassiopea, Galderma, Ortho-Derm, Sol-Gel, SunPharma, and Vyne; Nestor Sanchez has acted as consultant for Galderma; Edward Lain has performed research, consulted, and/or was a member of a speaker bureau for Galderma, Bausch Health, Valeant, Ortho Dermatologics, Novartis, Dr Reddy's, Sol Gel, Vyne, Almirall, Actavis, Cassiopea, and Dermira; Zoe Draelos received a grant from Galderma to function as a research site for the acne project; Jean Phillipe York and Rajeev Chavda are employees of Galderma., (Copyright © 2022. Matrix Medical Communications. All rights reserved.)