Acne vulgaris is an inflammatory skin condition affecting adolescents and adults of both sexes. Clascoterone cream 1% is indicated for the topical treatment of acne vulgaris in patients ≥12 years of age based on the results of two Phase 3 trials (NCT02608450 and NCT02608476). This post hoc analysis evaluated the efficacy and safety of clascoterone cream 1% in patient subgroups defined by age (adolescent vs adult) and sex (male vs female). Patients ≥12 years of age with mild-to-moderate acne applied clascoterone cream 1% or vehicle twice daily for 12 weeks. Efficacy was assessed from Investigator’s Global Assessment (IGA) treatment success and inflammatory, noninflammatory, and total lesion counts, and safety from frequency and severity of adverse events. Treatment with clascoterone cream 1% vs vehicle resulted in significantly greater IGA treatment success rates for all subgroups: at week 12, 47/287 (16.4%) vs 12/306 (3.9%) adolescent, 77/330 (23.3%) vs 29/309 (9.4%) adult, 32/226 (14.2%) vs 13/252 (5.2%) male, and 92/391 (23.5%) vs 28/363 (7.7%) female patients achieved IGA treatment success. Patients treated with clascoterone cream 1% vs vehicle in all subgroups also experienced significantly greater lesion count reductions. From baseline to week 12, clascoterone cream 1% treatment resulted in significantly larger reductions in lesion counts in adult vs adolescent patients; there were no statistically significant differences between male and female patients. Adverse events were similar across subgroups. These results further support the efficacy and tolerability of clascoterone cream 1% across the spectrum of patients ≥12 years of age with acne vulgaris.  .
BACKGROUND:Advanced topical nonsteroidal therapies are expanding options for atopic dermatitis (AD) by providing targeted anti-inflammatory control without many limitations of long-term topical corticosteroids. As these agents become more available, practical guidance is needed on their use as first-line therapy, proactive maintenance, combination regimens, safety, and long-term management. OBJECTIVE:To develop expert consensus statements defining the clinical role of advanced topical nonsteroidal therapies in AD. METHODS:A seven-dermatologist expert panel used a structured Delphi process informed by a literature review. Statements were drafted, iteratively refined, and voted on across multiple rounds. Evidence quality and strength of recommendations were assessed using the Strength of Recommendation Taxonomy (SORT). Consensus was predefined as ≥75% agreement. RESULTS:The panel reached unanimous consensus on seven statements regarding advanced topical nonsteroidal therapies, including topical ruxolitinib, tapinarof, roflumilast, crisaborole, tacrolimus, pimecrolimus, and delgocitinib. These therapies were considered effective in reducing AD signs and symptoms, including pruritus, and appropriate as first-line agents for many patients. Their use was associated with longer disease control, fewer relapses, and reduced cumulative topical corticosteroid exposure. The panel agreed that these therapies improve patient-reported outcomes, including quality of life and sleep, and can be safely incorporated into combination regimens with other topical or systemic treatments. They demonstrated favorable safety and tolerability profiles without the need for baseline or ongoing laboratory monitoring. Compared with topical corticosteroids, nonsteroidal therapies were preferred for long-term management to avoid steroid-associated adverse effects, with simplified dosing and suitability for sensitive and high-impact sites supporting adherence. CONCLUSION:Advanced topical nonsteroidal therapies represent an important evolution in AD management and are appropriate first-line options across disease severities, supporting sustained disease control and improved quality of life.
Dermatologists are regarded as experts in cosmetic and laser procedures. However, current Accreditation Council for Graduate Medical Education (ACGME) requirements emphasize observational exposure for dermatology residents rather than hands-on training in these procedures. As discussions continue regarding whether observational procedural learning should transition to hands-on training requirements, contemporary data describing existing training models, barriers to hand-on training, and the feasibility of providing such learning opportunities are needed. The aim of this study was to better understand current hands-on training models and assess faculty perceptions regarding the feasibility of implementing hands-on cosmetic and laser procedural minimums, as well as barriers to such training. An electronic survey was distributed to members of the Association of Academic Cosmetic Dermatology. Forty-five faculty representing 40 institutions completed the survey (30.4
Dermatologists play a central role in the diagnosis and medical management of vascular anomalies. Currently, vascular anomalies are categorized into vascular tumors and vascular malformations. The latest designations for the numerous types of vascular lesions are delineated in the International Society for the Study of Vascular Anomalies website (www.issva.org). The arenas for the therapy for hemangiomas, the most common vascular tumor, have been studied extensively and have been recognized as standard of care by the Society for Pediatric Dermatology, the American Academy of Dermatology and the American Academy of Pediatrics. Options for hemangioma treatment include systemic beta-blockers such as propranolol, atenolol, and nadolol, and the topical beta-blocker timolol. Vascular malformations and overgrowth syndromes encompass a separate set of treatment regimens. Recent pharmacological and technological advances in the medical management of vascular anomalies have decreased the need for surgery in many patients while also leading to improved outcomes and quality of life. This review will guide the dermatologist through the current medical treatment landscape for vascular malformations.
BACKGROUND:Acne pathophysiology and presentation may differ by patient age or sex. In clinical trials, clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel demonstrated efficacy and a positive safety profile in participants with moderate-to-severe acne. This post hoc analysis evaluated CAB efficacy/safety by age and sex. METHODS:In one phase 2 and two phase 3 double-blind, randomized, 12-week trials, participants aged ≥9 years with moderate to severe acne applied once-daily CAB or vehicle. Efficacy endpoints included Evaluator's Global Severity Score ≥2-grade reduction from baseline and clear/almost clear (treatment success) and least squares mean changes from baseline in inflammatory/noninflammatory lesions. Treatment-emergent adverse events (TEAEs) were assessed. Pooled data were analyzed by subgroups: younger (9-24 years; n=274) and older females (≥25 years; n=121); younger (n=241) and older males (n=21). RESULTS:At week 12, in all subgroups, treatment success was greater with CAB (42.3%-54.1%) than with vehicle (15.0%-22.5%), and lesion reductions were ≥70% with CAB versus 44.5%–55.2% with vehicle. For all efficacy endpoints, CAB was superior to vehicle for younger participants and older females (P≤0.05, all). CAB TEAE rates were consistent with the overall population. CONCLUSIONS:In 3 clinical trials, CAB, the only fixed-dose, triple-combination topical for acne, demonstrated ≥70% lesion reductions, with good tolerability regardless of participants' sex or age.  .
BACKGROUND:Molluscum contagiosum (MC), caused by the molluscum contagiosum virus, is a common viral skin infection in children. MC may persist for months to years and can substantially impair the quality of life for affected children and their families through discomfort, pruritus, cosmetic concerns, social stigma, and household transmission. Newer US Food and Drug Administration (FDA)-approved therapies have demonstrated patient-acceptable clearance rates, providing clinicians with additional options to treat pediatric MC. The paper summarized literature on MC in childhood and provided evidence-based guidance to help clinicians manage pediatric MC. METHODS:A panel of dermatologists developed a consensus paper to address the challenges of treating pediatric MC. The modified Delphi process comprised a two-pronged literature review, development of evidence-supported statements, physician review and modification, and a face-to-face panel meeting to discuss the systematic literature search results and draw on clinical experience and opinion to create six consensus statements, followed by voting. RESULTS:Consensus was achieved for 6 statements. Self-limiting, prolonged infection is common, particularly in children with impaired skin barrier conditions and immune deficiencies. Families may seek treatment to reduce patient discomfort from inflammatory symptoms, limit transmission, and reduce disease burden. Physicians should focus on patient and family quality of life through education and shared decision-making. Berdazimer gel 10.3% and cantharidin 0.7% are FDA-approved therapies that achieve meaningful lesion clearance (>50%) within 6 weeks to 3 months. CONCLUSIONS:The use of FDA-approved therapies with clinically meaningful clearance rates, combined with supportive management, provides an opportunity to improve outcomes and quality of life for children with MC.  .
Atopic dermatitis (AD) has the highest incidence in 3-6-month-olds. Common topical prescription treatments (eg, corticosteroids, calcineurin inhibitors, and a phosphodiesterase 4 inhibitor [PDE4i; crisaborole]) have limited efficacy, adverse event (AE) concerns, and/or use restrictions. Roflumilast (ROF) cream is a highly potent PDE4i formulated without potentially irritating ingredients. Efficacy and safety of ROF cream 0.15% and 0.05% for the treatment of mild-to-moderate AD in ≥6-year-olds and 2-5-year-olds, respectively, have been demonstrated in phase 3 clinical trials. The phase 2, open-label, INTEGUMENT-INFANT/ NCT06998056 study is evaluating ROF cream 0.05% in infants aged 3 months to <2 years with AD (mild/moderate [2/3] Validated Investigator Global Assessment for AD [vIGA-AD]; ≥ 3% body surface area affected). Caregivers will apply ROF once daily for 4 weeks. Safety assessments include treatment-emergent adverse events and application-site tolerability. Efficacy assessments include vIGA-AD, Scalp-IGA, Eczema Area and Severity Index, Body Surface Area-Scalp and -Total, Worst Scratch/Itch-Numeric Rating Scale, Dynamic Pruritus Scale, and quality-of-life and family impact measures. Approximately 100 patients will be enrolled in the United States, Canada, and the Dominican Republic begining in June 2025. Outcomes from INTEGUMENT-INFANT will provide important data on the potential use of ROF cream 0.05% in infants aged 3 months to <2 years with mild to-moderate AD.
BACKGROUND:INTEGUMENT-PED/NCT04845620, a 4-week, phase 3 trial, demonstrated efficacy and safety of roflumilast cream 0.05% in children aged 2-5 years with mild-to-moderate atopic dermatitis (AD). A phase 3 open-label extension trial (INTEGUMENT-OLE [NCT04804605]) investigated long-term outcomes continuing roflumilast cream for ≤ 56 weeks. METHODS:Caregivers of eligible patients from INTEGUMENT-PED applied roflumilast cream 0.05% once-daily in INTEGUMENT-OLE. Patients achieving Validated Investigator Global Assessment for AD (vIGA-AD) clear (0) at/after week 4 of INTEGUMENT-OLE switched to twice-weekly (BIW) application. Evaluation of safety (adverse events [AEs] and application-site tolerability) was the primary objective. Efficacy endpoints assessed from INTEGUMENT-PED baseline included vIGA-AD success (clear/almost clear [0/1] plus ≥ 2-point improvement), vIGA-AD 0/1, ≥ 75% improvement in Eczema Area and Severity Index, and Worst Itch-Numeric Rating Scale success (≥ 4-point improvement in patients with baseline score ≥ 4). Duration of vIGA-AD 0/1 and sign/symptom control ("disease control") with BIW application was determined. RESULTS:Among 562 patients, 14 (2.5%) had treatment-related AEs reported. Roflumilast was well tolerated; application-site pain AEs were reported for four (0.7%) patients. At treatment-week 56, AD signs/symptoms continued to improve (63.1% of patients achieved vIGA-AD 0/1). Of 170 (30.2%) patients who switched to BIW application, the median Kaplan-Meier duration of "disease control" was 238 days. CONCLUSIONS:Roflumilast cream 0.05% demonstrated a favorable long-term safety profile and durable efficacy for up to 56 weeks of treatment in children aged 2-5 years with AD, and "disease control" was maintained with BIW application. These results are consistent with previous studies, including patients aged ≥ 6 years from INTEGUMENT-OLE. TRIAL REGISTRATION:Clinicaltrials.gov identifier: NCT04845620.
Icotrokinra, a first-in-class targeted oral peptide, precisely blocks the interleukin (IL)-23 receptor and inhibits IL-23 pathway signaling. In phase 3 studies (ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1 and 2), icotrokinra provided superior skin clearance versus placebo and deucravacitinib in adults and adolescents with moderate-to-severe psoriasis and psoriasis affecting high-impact sites. This analysis evaluates icotrokinra safety through 1 year using pooled data from these four studies. Icotrokinra-randomized participants received 200-mg pills once daily, and placebo-randomized participants crossed over to icotrokinra at week 16; participants randomized to deucravacitinib 6 mg (ICONIC-ADVANCE 1 and 2 only) switched to icotrokinra at week 24. Pooled safety data are summarized for the placebo-controlled period (week 0–16, all studies), active-controlled period (week 0–24, ICONIC-ADVANCE 1 and 2), and through week 52 (all studies). During the placebo-controlled period across all studies, 568 participants received placebo and 1296 received icotrokinra. From week 0 to 24 in the ICONIC-ADVANCE studies, 632 participants received icotrokinra and 634 received deucravacitinib. Through week 52, 2400 icotrokinra-treated participants contributed 1840 participant-years [PY] of follow-up. Through week 16, in the icotrokinra and placebo groups, respectively, exposure-adjusted incidence rates/100 PY of adverse events (AEs; 232 and 269), serious AEs (5.2 and 6.6), infections (91 and 104), and AEs leading to discontinuation (6.6 and 10.0) were comparable between groups. Through week 24, in the ICONIC-ADVANCE studies, rates/100 PY with icotrokinra versus deucravacitinib were as follows: AEs, 204 vs 265; serious AEs, 6.4 vs 7.2; infections, 81 vs 119; AEs leading to discontinuation, 5.7 vs 6.8. Through week 52, event rates/100 PY in icotrokinra-treated participants were as follows: AEs, 167; serious AEs, 4.6; infections, 76; AEs leading to discontinuation, 3.0. In this analysis of 2400 icotrokinra-treated participants with psoriasis followed through 1 year, icotrokinra demonstrated favorable safety; event rates through week 16 were similar to placebo and remained consistent through week 52. NCT06095115, NCT06095102, NCT06143878, NCT06220604. Infographic available for this article.
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.
Roflumilast (ROF) cream demonstrated efficacy and safety in patients (pts) aged ≥6 years and 2-5 years with mild-to-moderate AD in the phase 3 INTEGUMENT-1/2 and INTEGUMENT-PED trials, respectively. Pts completing 1 of these studies could enroll in the phase 3 open-label extension (OLE) study (INTEGUMENT-OLE/NCT04804605). In the OLE, pts received ROF cream 0.15% (≥6 years) or 0.05% (2-5 years) once daily for up to 52 weeks. Pts achieving Validated Investigator Global Assessment for AD (vIGA-AD) of clear (0) at/after OLE week 4 transitioned to twice weekly (BIW) application (BIW was maintained as long as vIGA-AD 0/1 and adequate sign/symptom control were maintained). Efficacy endpoints were assessed from parent-study baseline. ROF improved signs/symptoms in pts from INTEGU-MENT-1/2 and -PED for vIGA-AD 0/1 (55.7% [117/210]; 63.1% [234/371]) and Worst Itch-Numeric Rating Scale 0/1 (47.1% [49/104]; 40.7% [116/285]) and decreased mean body surface area affected from baseline (14.8% to 3.7%; 22.3% to 4.9%), respectively. In INTEGUMENT-1/2 and -PED, 19.8% (130/658) and 30.2% (170/562) of pts used ROF BIW; median Kaplan-Meier durations of disease control were 281 days and 238 days, respectively. Overall, treatment-related AEs were reported by 3.7% of pts and application-site pain by <1%. In pts aged ≥2 years, ROF cream improved AD signs/symptoms long term, including with proactive BIW application, suggesting ROF is an appropriate alternative to traditional topical AD therapies.
BACKGROUND:Chronic hand eczema (CHE) is a common, heterogeneous inflammatory skin disease associated with substantial symptom burden, impaired hand function, reduced quality of life, and work-related disability. Despite its clinical impact, evidence-based guidance for long-term, steroid-sparing topical management has been limited. OBJECTIVE:To develop expert consensus statements on the role of advanced topical nonsteroidal therapies in CHE management. METHODS:A panel of seven dermatologists with expertise in CHE conducted a structured literature review, prioritizing CHE-specific trials when available. Evidence was evaluated using the Strength of Recommendation Taxonomy (SORT). Draft statements were refined through a Delphi consensus process, with consensus predefined as ≥75% agreement. RESULTS:The panel reached consensus on six statements addressing advanced topical nonsteroidal therapies in CHE. These agents were recognized as important steroid-sparing options appropriate for long-term use. Delgocitinib cream is currently the only topical therapy with CHE-specific regulatory approval and is considered an appropriate first-line advanced topical treatment. Clinical trial data show that advanced topical nonsteroidal therapies provide rapid and sustained improvements in erythema, scaling, fissuring, pruritus, and pain. Delgocitinib demonstrated sustained improvements in patient-reported outcomes and superior health-related quality-of-life benefits compared with oral alitretinoin in severe CHE. Treatment has also been associated with improved work productivity and daily functioning. These therapies have favorable safety profiles, with adverse events largely limited to local reactions, minimal systemic exposure, and no requirement for routine laboratory monitoring. Other topical nonsteroidal agents may have a role in selected patients, although CHE-specific data remain limited. CONCLUSION:This consensus provides practical guidance supporting individualized, steroid-sparing CHE management while identifying areas for future research.  .
INTRODUCTION:Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by pruritus, eczematous lesions, and a relapsing course. The pathophysiology of atopic dermatitis involves an interplay of skin barrier dysfunction, immune dysregulation, genetic predisposition, environmental triggers, and alterations in the skin microbiome. Pediatric AD is frequently associated with allergic comorbidities and imposes a substantial psychosocial burden on affected children and their families. This manuscript will describe recent innovations in topical, steroid-sparing therapies for pediatric AD, highlighting emerging agents such as roflumilast, ruxolitinib, and tapinarof, as well as investigational therapies. AREAS COVERED:PubMed and Clinicaltrials.gov were used to identify the latest advancements in topical therapies available for pediatric AD treatment, as of November 2025. First-line therapies include topical corticosteroids, topical calcineurin inhibitors, and the phosphodiesterase-4 inhibitor crisaborole, all of which have demonstrated efficacy but are limited by safety considerations, tolerability, and acceptability for long-term use. In recent years, novel topical agents with distinct mechanisms of action have expanded the therapeutic landscape, representing important steroid-sparing alternatives for children with AD. EXPERT OPINION:Emerging topical therapies for pediatric AD demonstrate substantial promise in addressing longstanding unmet needs, but long-term safety and practice-based effectiveness data remain critical for optimizing care.
Background: Sofpironium gel 12.45%, a first-in-class, topical anticholinergic (Ach) FDA approved for primary axillary hyperhidrosis (PAH) in persons ≥9 years, was retrometabolically designed to optimize efficacy and minimize Ach side effects. In vitro study results support the mechanism by which sofpironium likely exerts its early and clinically meaningful axilla sweat reduction and M3 receptor selectivity. Methods: Sofpironium vs. glycopyrrolate concentrations required to inhibit human muscarinic receptors were examined in vitro. IC50 values for 50% inhibition were determined by non-linear least squares regression analysis; Ki values represented binding affinity. Cardigan I (301) and II (302), randomized, double-blinded, vehicle-controlled phase 3 trials, included subjects ≥9 years with PAH ≥6 months. Treatment: 1 pump, sofpironium or vehicle, to each axilla once-daily at bedtime, x42 days (end of treatment, EOT). Co-primary efficacy: proportion achieving ≥2-point improvement in the Hyperhidrosis Disease Severity-Axillary (HDSM-Ax-7) and Gravimetric Sweat Production (GSP) change from baseline-EOT. Secondary: proportion achieving ≥1-point improvement in baseline-EOT HDSM-Ax-7. Exploratory: proportion achieving either ≥1 or ≥2 point improvement in HDSM-Ax-7 from baseline to each visit; subjects achieving ≥70% reduction in GSP from baseline to each visit. Statistics: multiple imputation, ANCOVA. Safety: Treatment emergent adverse events (TEAEs) and local tolerability. Results: In vitro, 10 nM of sofpironium inhibited ≥50% of M3 receptors;100 nM for M1/M2/M4/M5 receptors. Glycopyrrolate targeted multiple muscarinic receptors, achieving >50% inhibition of M1-–M5 receptors with 1 nM. Hence, glycopyrrolate was more potent but 10X less M3 receptor selective than sofpironium. Enrollment: 301,302 vehicle:sofpironium,177,171=348: 173,180=353. More sofpironium(s) subjects achieved HDSM-Ax-7 ≥1- and ≥2-point improvements vs. vehicle(v), beginning at day 8 through day 43/EOT. ≥1-point EOT, 301:v=111/166 (66.9%), s=127/157 (80.9%), P=.0053; 302:v=124/159 (78.0%), s=143/162 (88.3%), P=.0165; and at each visit, (P≤.05). ≥2-point EOT, 301:v=54/166 (32.5%), s=84/157 (53.5%), P=.0004; 302:v=75/159 (47.2%), 108/162 (66.7%). A higher proportion of sofpironium subjects achieved statistically significant GSP changes from baseline-EOT. More sofpironium subjects achieved ≥70% GSP reduction from baseline-EOT, 301:v=51/165 (30.9%), s=76/157 (48.4%), P=.0010; 302:v= 56/157 (35.7%), s=84/160 (52.5%), P=.0065; and at each visit. More TEAEs occurred in sofpironium subjects, mostly mild-moderate and transient. TEAEs to EOT, n/N (%), 301:v=20/176 (11.4%), s= 58/173 (33.5%); 302:v=20/171 (11.7%); s=80/180 (44.4%). Ach-TEAEs, predominantly mild-moderate and transient, to EOT, n/N (%), 301:v=0/176 (0%), s=30/173 (17.3%); mild: s=18/173 (10.4%). 302:v=3/171 (1.8%), s=42/180 (23.3%); mild: v=3/171 (1.8%),s=21/180 (11.7%). The most frequently observed Ach-TEAEs were eye disorders, 301:v=0, 0%; s=22/173, (12.7%), mild, 12, (6.9%). Total mydriasis,13, (7.5%); blurred vision, 9, (5.2%); dry eye,1,(0.6%), all mostly mild. 302:v=1/171, (0.6%) (mild), s=34/180, (18.9%), mild,17, (9.4%). Total blurred vision, v=1/171, (0.6%), s=21/180, (11.7%) and dry eye, s=6/180, (3.3%), were mostly mild, whereas mydriasis, s=9/180, (5.0%), was mostly moderate. Other Ach-TEAES: 301: dry mouth, 20, (11.6%), mostly mild; urinary retention, 2, (1.2%), moderate. 302: dry mouth, v=2/171, (1.2%); s=31/180, (17.2%), mostly mild; urinary retention, s=6/180, (3.3%), 3 mild, 3 moderate. Local tolerability baseline-EOT: minimal-mild erythema, burning, itching and stinging occurred more frequently in sofpironium subjects. Conclusions: In vitro, sofpironium exhibits M3 receptor selectivity; early/clinically meaningful improvement and predominantly mild-moderate and transient TEAEs were observed in two phase 3 clinical trials.