Scholarly Activity

INTRODUCTION: A cell harvesting device for preparing non-cultured autologous skin cell suspension (ASCS) at the point-of-care is FDA-approved for repigmentation of stable depigmented vitiligo lesions in patients 18 years and older. The pivotal RSVP trial showed ≥80% repigmentation at Week-24 in 36% of lesions treated with laser ablation, ASCS, and narrowband ultraviolet B phototherapy compared to 0% with phototherapy alone (p = 0.012). The objective of this analysis was to evaluate the potential economic impact of laser ablation plus ASCS with phototherapy versus phototherapy alone for repigmentation of stable vitiligo lesions from a US payer perspective.

METHODS: A 5-year decision-tree model was developed reflecting clinical pathways of adults with stable vitiligo lesions who had an inadequate response to prior topicals and phototherapy. Patients entering the model were treated with ASCS plus phototherapy or phototherapy alone and assessed for treatment response at Weeks-24 and 52 based on the RSVP trial's effectiveness endpoints. Durable response for Year-2 onwards was proxied by melanocyte-keratinocyte transplantation data. Model outcomes included per-patient total and incremental healthcare costs, treatment costs and total costs, cost per-patient per-month (PPPM), and cost per-patient per-year (PPPY). One-way sensitivity analyses assessed model result robustness.

RESULTS: The cumulative total per-patient cost for ASCS plus phototherapy increased from $28,177 to $92,779 between Year-1 and Year-5. Phototherapy alone increased from $21,146 to $101,518 over the same period. Compared to phototherapy alone, ASCS plus phototherapy incurred $7,030 more total per-patient cumulative costs in Year-1 and $8,738 less by Year-5 (-$146 PMPM; -$1,748 PPPY). Breakeven occurred between Years 2-3. Results were most sensitive to changes in ASCS response at Weeks-24 and 52 and healthcare costs.

CONCLUSION: Among adults with stable vitiligo with prior inadequate response to topicals or phototherapy, ASCS treatment may lead to lower all-cause direct medical costs over 5 years compared to phototherapy alone.

Psoriasis, a chronic inflammatory skin condition, can have a significant impact on patients' quality of life. Adoption of novel and emerging treatments has significantly improved psoriasis care in clinical practice, but challenges remain. The 'Bridging the Gaps in Challenging Psoriasis' meeting was held in October 2024 to discuss relevant evidence, knowledge gaps, and best practices pertaining to challenging presentations of psoriasis. This report captures important insights and practice impacting guidance gathered from the panel discussion on five topics. The meeting commenced with an in-depth discussion on managing psoriasis in high-impact areas (e.g., scalp, intertriginous regions, nails, and the palms and soles) followed by a discussion on the importance of identifying and addressing common comorbidities associated with psoriasis. The panel explored key considerations and unique challenges when treating psoriasis in patients with darker skin tones ('skin of color') and highlighted the need for tailored therapeutic approaches. A comprehensive dialogue ensued on strategies for managing primary and secondary treatment failures. The session concluded with a concise discussion on the future of psoriasis treatments and pharmacologic therapies currently being developed to manage psoriasis. While discussing various challenging psoriasis scenarios, the dermatology experts emphasized the need to approach psoriasis as a systemic disease and advocated for comprehensive management that addresses both the skin and the broader health of the patient.

INTRODUCTION: A low-dose modified formulation of minocycline hydrochloride, DFD-29, is under evaluation for treating papulopustular rosacea (PPR).

OBJECTIVE: To determine the efficacy and safety of DFD-29, 40 mg, compared with doxycycline, 40 mg, and placebo for treating PPR.

DESIGN, SETTING, AND PARTICIPANTS: This study included data from 2 double-blind, placebo-controlled, phase 3 randomized clinical trials (MVOR-1 and MVOR-2) conducted between March 2022 and May 2023 at 61 centers in the US and Germany. Healthy adults 18 years and older with moderate to severe PPR were included.

INTERVENTIONS: Participants were randomized 3:3:2 to oral DFD-29 (minocycline hydrochloride capsules), 40 mg; doxycycline, 40 mg; or placebo once daily for 16 weeks.

MAIN OUTCOMES AND MEASURES: The coprimary efficacy outcomes were (1) proportion of participants with Investigator's Global Assessment (IGA) treatment success with DFD-29 vs placebo and (2) total inflammatory lesion count reductions with DFD-29 vs placebo. Secondary outcomes included comparisons between DFD-29 and doxycycline in coprimary outcomes and between DFD-29 and placebo in erythema reduction.

RESULTS: Of 653 participants enrolled, 323 were randomized in MVOR-1 (247 [76.5%] women; mean [SD] age, 47.2 [13.7] years) and 330 were randomized in MVOR-2 (249 [75.5%] women; mean [SD] age, 51.6 [14.0] years). DFD-29 demonstrated superior efficacy in IGA success rates compared with placebo (MVOR-1: treatment difference [TD], 32.9%; 95% CI, 19.6-46.2; P <  .001; MVOR-2: TD, 34.1%; 95% CI, 21.3-46.8; P <  .001) and compared with doxycycline (MVOR-1: TD, 18.0%; 95% CI, 5.0-31.1; P = .01; MVOR-2: TD, 28.3%; 95% CI, 17.4-39.3; P <  .001). DFD-29 also showed superior efficacy in least-squares mean reductions in total inflammatory lesions vs placebo (MVOR-1: TD, -9.2; 95% CI, -11.5 to -6.9; P <  .001; MVOR-2: TD, -6.8; 95% CI, -8.9 to -4.8; P <  .001) and doxycycline (MVOR-1: TD, -4.7; 95% CI, -6.7 to -2.8; P <  .001; MVOR-2: TD, -3.5; 95% CI, -5.4 to -1.6; P <  .001). Adverse events with DFD-29, doxycycline, and placebo were reported in 32 of 121 (26.4%), 25 of 116 (21.6%), and 27 of 76 (35.5%), respectively, in MVOR-1 and 51 of 122 (41.8%), 40 of 121 (33.1%), and 30 of 82 (36.6%), respectively, in MVOR-2. The most common adverse events with DFD-29, doxycycline, and placebo were nasopharyngitis, reported in 4 of 121 (3.3%), 2 of 116 (1.7%), and 3 of 76 (3.9%), respectively, in MVOR-1 and 13 of 122 (10.7%), 10 of 121 (8.3%), and 13 of 82 (15.9%), respectively, in MVOR-2, and COVID-19, reported in 4 of 121 (3.3%), 3 of 116 (2.6%), and 4 of 76 (5.3%) in MVOR-1 and 7 of 122 (5.7%), 8 of 121 (6.6%), and 5 of 82 (6.1%) in MVOR-2.

CONCLUSIONS AND RELEVANCE: In this study, DFD-29 was superior in efficacy to both doxycycline and placebo and demonstrated a favorable risk-benefit profile in the treatment of PPR.

TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT05296629 and NCT05343455.

BACKGROUND: Abrocitinib has a manageable long-term safety profile for patients with moderate-to-severe atopic dermatitis. Identifying populations at higher risk of adverse events will help optimize dose selection.

OBJECTIVE: To evaluate abrocitinib long-term safety by age.

METHODS: Data (cutoff: September 25, 2021) from JADE clinical trials were pooled in a consistent-dose cohort (patients who received the same abrocitinib dose throughout exposure) or a variable-dose cohort (patients who received abrocitinib 200 mg [12 wk], were randomly assigned later to receive abrocitinib 200 mg, 100 mg, or placebo [up to 40 wk], and assigned to receive abrocitinib 200 mg or 100 mg in the long-term study). Data were stratified post hoc by age at baseline (12 to < 18 y; 18 to < 40 y, 40 to < 65 y, and ≥65 y). Incidence rates of treatment-emergent adverse events (TEAEs) of special interest were assessed.

RESULTS: Analysis included 3,802 patients (exposure: 5,214 patient-years). The incidence rates for serious adverse events, TEAEs leading to study discontinuation, serious infections, herpes zoster, thrombocytopenia, lymphopenia, nonmelanoma skin cancer, malignancies (excluding nonmelanoma skin cancer), major cardiovascular events, and venous thromboembolism were numerically higher in patients aged 65 years or older than in younger patients. Overall, adolescents had the lowest rates for TEAEs of special interest.

CONCLUSIONS: Abrocitinib has a manageable long-term safety profile. TEAEs of special interest were lower in adolescents and higher in the 65-years-old or older age group. Risk of specific TEAEs was numerically higher in patients aged 65 years or older treated with abrocitinib 200 mg and underscores the importance of dose selection in older patients.

BACKGROUND: There is a lack of evidence-based consensus to assist clinicians in using photobiomodulation (PBM).

OBJECTIVE: To create a consensus on the safe and effective use of PBM.

METHODS: A systematic literature review of Embase and MEDLINE was conducted in June 2022 to identify publications reporting research on PBM. An international multidisciplinary panel was convened to draft recommendations informed by the systematic search; they were refined through 2 rounds of Delphi survey, 2 consensus meetings, and iterative review by all panelists until unanimous consensus was achieved.

RESULTS: A multidisciplinary panel of experts (n = 21) was assembled based on publication history. The key findings that informed the consensus developed by the expert panel were as follows: PBM is a safe treatment modality for adult patients and red light PBM does not induce DNA damage. PBM is an effective treatment option for peripheral neuropathy, androgenic alopecia, wound ulcers due to multiple etiologies, decubitus ulcers, pain attributed to diabetic foot ulcers, and acute radiation dermatitis.

CONCLUSION: The systematic literature search and structured Delphi consensus approach culminated in an evidence-based clinical practice guideline for safe and effective use of PBM in medical and aesthetic applications. Future research will further bolster our understanding of this evolving noninvasive technique.

BACKGROUND: There is ambiguity regarding the topical cosmetic ingredients preferred for common skin complaints.

OBJECTIVE: To determine which topical ingredients are frequently recommended by cosmetic dermatologists for fine lines and wrinkles, acne, redness, dark spots, large pores, dry skin, and oily skin.

METHODS: Literature review to develop long list of ingredients. Reduced by expert panel to most salient ingredients. Two rounds of Delphi consensus survey with second expert panel of clinicians and teachers. Comparative literature review to summarize published evidence supporting each consensus ingredient.

RESULTS: List of 318 ingredients reduced by a panel of 17 dermatologists to 83. Two Delphi rounds completed by 62 dermatologists at 43 centers. Consensus achieved for 23 ingredients, including the following: azelaic acid (acne, dark spots); benzoyl peroxide (acne, oily skin); glycolic acid (acne, dark spots); mineral sunscreen (fine lines and wrinkles, redness); niacinamide (redness, dark spots); retinoids (fine lines and wrinkles, acne, dark spots, large pores, oily skin); salicylic acid (acne, oily skin); vitamin C (fine lines and wrinkles, dark spots). Most consensus ingredients supported by level 1b or 2b evidence.

LIMITATIONS: Some ingredients based on expert opinion.

CONCLUSION: Consensus exists among expert cosmetic dermatologists regarding ingredients most useful for common dermatologic concerns.

Background/Objective: Evaluating the measurement properties (MPs) of Clinician-Reported Outcome Measures (ClinROMs) is crucial for selecting appropriate instruments for vitiligo assessment. This review critically appraises the existing evidence on the MPs of the ClinROMs used in vitiligo.

Methods: A systematic search was conducted in PubMed, Embase, and the Cochrane Library up to 20 February 2024, identifying validated ClinROMs in vitiligo. Studies were included if they provided original data on ClinROM development or analysis, excluding those solely validating other instruments. The assessment of ClinROM quality and risk of bias analysis followed COSMIN guidelines, and ClinROMs with the highest number of sufficiently rated MPs supported by a moderate/high Quality of Evidence (QoE) were identified per construct category (extent/repigmentation and evolution/activity).

Results: This review included 22 studies evaluating 12 ClinROMs. For extent/repigmentation, the Vitiligo Area and Severity Index (VASI), Vitiligo Extent Score (VES), and VESplus each had four MPs rated sufficient with a moderate/high QoE. For evolution, the Vitiligo Disease Improvement Score (VDIS) and Vitiligo Disease Activity Score (VDAS) similarly had four MPs rated sufficient with a moderate/high QoE. For activity evaluated based on a single time point, the Vitiligo Signs of Activity Score (VSAS), the only validated ClinROM for visible signs of disease activity, had three MPs rated sufficient with a moderate/high QoE.

Conclusions: Six ClinROMs demonstrated the highest quality ratings across two key constructs. However, none underwent a complete evaluation of all their MPs, highlighting the need for further validation and refinement.

Objectives: To quantify treatment priorities and unmet need among adults and adolescents with vitiligo in the United States (US). Methods: An adaptive self-explicated preference-elicitation survey was administered to adults (age ≥18 years) and adolescents (age 12-17 years) with non-segmental vitiligo. The preference-elicitation included 26 attributes related to treatment efficacy, safety, and mode of administration. Relative importance (RI) of each attribute was estimated using latent class analysis (LCA). Satisfaction with the 10 most important attributes for each patient was elicited using rating scales. RI and satisfaction were combined to estimate unmet need using a modified outcome-driven innovation approach which defines unmet need as high RI combined with low satisfaction. Results: The sample comprised adults (N=321) and adolescents (N-201) who received vitiligo care from 83 sites across the US. They had a mean (SD) age of 26 (9.1) and 14 (1.6) years, respectively. More than 50% of participants self-identified as non-White; 50% were female. Fitzpatrick skin types were 23.9% Type I-II (pale white, fair), 43.6% III-IV (darker white, light brown), and 32.4% V-VI (brown, black). LCA identified three preference segments: Efficacy (N=182,34.9%), most important attributes were amount of repigmentation on the entire body (RI=5.16) and reducing the emotional burden of vitiligo (RI=5.00); Mode of Administration (MOA) (N=159,30.5%), most important attributes were having an oral (RI=4.80), systemic (RI=5.03) treatment; Safety (N=181,34.7%), most important attributes were avoiding cardiovascular events (RI=4.53), cancer (RI=4.38), or shingles (RI=4.42). Among the full sample, the greatest areas of unmet need were reducing the emotional burden of vitiligo and having access to an oral systemic (rather than topical) treatment. Conclusions: Treatment preferences among people with vitiligo are heterogeneous. In addition to repigmentation, reducing the emotional burden of vitiligo is a key treatment goal for patients. An effective oral systemic treatment could help address unmet need in this patient population.

Background: Acne-induced post-inflammatory hyperpigmentation (PIH) is a common, long-lasting sequela of acne with a significant psychosocial impact. To assess its impact on sufferers, interviews were conducted in a phase IV study of trifarotene treatment of acne and PIH. Methods: Cross-sectional blinded qualitative interviews as a sub-study of a 6-month phase IV randomized controlled study of patients (n=123) with acne and moderate-to-marked PIH treated with trifarotene or vehicle. Semi-structured interviews conducted by trained interviewers with patients (n=30, 18-34 y). Results: Patients had a mean age of 24.8 years, 73.3% had Fitzpatrick skin types IV-VI, and 40% (12/30) were treated with trifarotene. More than half (60%) rated their PIH severity at ≥7 at study entry, and 57% said PIH disturbed their daily life at a level of 7 (0=no disturbance to 10=worst disturbance). Improvement in PIH was reported by 100% of the trifarotene group vs 83% in the vehicle group and those in the trifarotene group had a greater reduction in self-reported PIH severity (-5.5 vs -3.5 vehicle). Patients reported lack of treatment success with prior treatments but noticeable improvements in uniformity of skin color during this study: “my skin got brighter, lighter, the dark spots have faded,” and “at first it was very, very noticeable … it just faded.” Other patients reported increased self-confidence and reduced reliance on makeup and lengthy cover-up daily routines. AEs were more common with vehicle vs trifarotene (30.2% vs 16.7%). Conclusions: Patients described noticeable and meaningful changes in the appearance of PIH and daily life impacts.

Background: Trifarotene belongs to a new generation of topical retinoids for acne. Data indicate multiple mechanisms through which trifarotene may interrupt acne pathogenesis and improve acne-related scarring and pigmentation. Acne sequelae impact patients’ lives and frequently outlast the causative acne lesion. Thus, treatment addressing both acne lesions and sequelae is likely to improve long-term outcomes. Methods: Two vehicle-controlled, 24-week phase 4 studies evaluated trifarotene treatment (with appropriate skin care regimen) and 1) atrophic acne scarring and 2) acne-related hyperpigmentation. The scarring study (Study 1) utilized a split-face design (N = 121) while the pigmentation study (Study 2) randomized patients 1:1 to active or vehicle arms (N = 123). Results: In study 1, trifarotene treatment resulted in significant improvement in scar counts, with differences from vehicle apparent as early as week 2 (W2) and progressively improving through W24. There was also a significant difference between trifarotene and vehicle in scar global assessment (SGA) success from W12 through W24. Study 2 enrolled a diverse population of patients with a range of skin tones. In study 2, trifarotene treatment accelerated pigment reduction at week 12 vs vehicle. Active and vehicle were similar at week 24. Although not a defined study endpoint, reduction in macular erythema was also observed. Trifarotene was well tolerated in both studies, with tolerability scores higher than vehicle but mild in severity. Conclusions: Management of atrophic acne scarring and hyperpigmentation is an important consideration in acne therapy. Trifarotene achieved rapid improvements in these acne sequelae along with efficacious acne control.

Background: Acne is highly visible andone of the most common skin diseases. Healthcare professionals should have a reliable first-line approach that is efficacious and suited for a broad range of patient skin types, ages, and demographics. Methods: Including the Phase 3 program, trifarotene has been studied in thousands of acne subjects in clinical trials. Most recently two vehicle-controlled, 24-week phase 4 studies evaluated trifarotene treatment of acne and 1) atrophic acne scarring (4-1) and 2) acne-related hyperpigmentation (4-2). The scarring study 4-1) utilized a split-face design (N = 121) while the pigmentation study (Phase4-2) randomized subjects 1:1 to active or vehicle arms (N = 123). Results: The studies were international, with men and women in the studies ranging from 9 to 58 years of age. The phase 3 studies were majority White, but included substantial diversity, including 74 Black/African-American and 195 Latino subjects treated with trifarotene. In 4-2 <50% of subjects were White. Additionally, 30.6% of subjects in 4-1 and 61.7% of subjects in 4-2 had type IV-VI skin. Approximately 35% of subjects in 4-1 and 2 identified as Hispanic/Latino. In Study 2, 18.2% of subjects in the trifarotene group were Asian. In all studies, trifarotene was significantly superior to vehicle in improving acne. In 4-1, trifarotene rapidly improved atrophic acne scars and in 4-2 trifarotene reduced hyperpigmentation. In all studies, trifarotene had a positive risk/benefit ratio. Conclusions: Across a broad range of subject types, trifarotene had good efficacy for improving acne, atrophic scars, and hyperpigmentation, and safety.

Background: Atopic dermatitis (AD), a highly pruritic inflammatory skin disease, typically begins in childhood and affects up to 23% of children globally. Ruxolitinib cream was effective and well tolerated in adults/adolescents (TRuE-AD1/TRuE-AD2 [NCT03745638/NCT03745651]) and children 2–<12 years old (y/o; TRuE-AD3 [NCT04921969]). Here, efficacy by baseline clinical characteristics in children 2–<12 y/o enrolled in TRuE-AD3 is reported. Methods: Patients 2–<12 y/o with AD for ≥3 months, Investigator’s Global Assessment (IGA) score of 2/3, and 3%–20% affected body surface area (BSA) were randomized (2:2:1) to apply twice-daily ruxolitinib cream (0.75%/1.5%) or vehicle for 8 weeks. Results: Patients 2–<12 y/o (N=330) had a median (range) age of 6 (2–11) years; AD duration, 4.8 (0.3–11.3) years; mean (SD) affected BSA was 10.5% (5.40%). At Week 8, 49/134 (36.6%) children applying 0.75% ruxolitinib cream and 74/131 (56.5%) applying 1.5% ruxolitinib cream vs 7/65 (10.8%) applying vehicle achieved IGA treatment success (IGA-TS; score 0/1 with ≥2-grade improvement from baseline); 69/134 (51.5%) and 88/131 (67.2%) vs 10/65 (15.4%) achieved ≥75% improvement in Eczema Area and Severity Index (EASI75), respectively. IGA-TS was observed regardless of baseline AD severity measure. For IGA-TS: IGA score of 2 and 3, 32.3%/48.4% vs 0% and 37.9%/59.0% vs 14.3%, respectively; EASI score ≤7 and >7, 41.7%/58.8% vs 17.2% and 30.6%/55.0% vs 5.6%. Ruxolitinib cream was well tolerated; no serious treatment-emergent adverse events were reported. Conclusions: Ruxolitinib cream is a well-tolerated and effective treatment for AD in children 2–<12 y/o, independent of baseline clinical characteristics.

Introduction: High frequency ultrasound (HFU) has been shown to be useful for Hidradenitis Suppurativa (HS) evaluation along with physical examination.1 Sonographic features of HS include dermal thickening, widening of hair follicles, anechoic or hypoechoic fluid deposits and fistulous tracts.2,3 Pre-surgical margin mapping with HFU, prior to CO2 laser surgery – an effective treatment for HS, may reduce recurrence rates; however, there is little existing literature on margin mapping methodology.4 Methods: This work describes methodology for HFU margin mapping of HS lesions prior to CO2 laser surgery. Results: Unlike traditional US imaging, skin imaging requires utilization of transducers with high frequency (15 MHz and above). A 1-2 mm gel bed is required for better visualization of changes in superficial features.5 For margin mapping, dermal thickening was found to be the most relevant HFU feature of HS. Skin marker was used to mark the border at the transition point between normal and thickened dermis every 1-2 cm around the HS lesion to demarcate the area of excision. Isolated lesions within 2-3 cm on the surrounding skin were evaluated for the presence of any sinus tracts connecting them to the main lesion as that would impact the area to be excised. Conclusion: Change in dermal thickening was the most pertinent HFU feature of HS when performing preoperative margin mapping. Future studies are needed to evaluate if preoperative margin mapping of HS lesions with HFU correlates with lower recurrence rates.

Introduction: Hidradenitis suppurativa (HS), a chronic, systemic inflammatory skin disease characterized by deep, painful, and difficult-to-treat lesions, often requires rescue interventions alongside conventional treatment.[1] Here, we investigate the impact of bimekizumab (BKZ), a monoclonal IgG1 antibody that inhibits interleukin (IL)-17F and IL-17A, on the need for concomitant rescue interventions in patients with moderate to severe HS. Methods: We report pooled, post hoc analysis from the initial treatment period (Weeks 0–16) of the BE HEARD I&II trials.[2,3] Adult patients with moderate to severe HS were randomized to BKZ (320mg every 2 weeks [Q2W] or Q4W) or placebo (PBO). The incidence of concomitant rescue interventions for HS, including medical (antibiotics, analgesics) and procedural (incision/drainage, intralesional triamcinolone injection), and time to first procedural intervention, are reported. Results: Overall, 1,014 patients were randomized to BKZ (n=868) or PBO (n=146) across BE HEARD I&II. In BKZ-treated and PBO-treated patients, 4.1% (n=36) and 8.9% (n=13) received ≥1 rescue analgesic; 4.0% (n=35) and 5.5% (n=8), received ≥1 rescue systemic antibiotic. Incidence of ≥1 incision/drainage intervention was 2.1% (n=18) in BKZ-treated and 3.4% (n=5) in PBO-treated patients; 1.6% BKZ-treated (n=14) and 3.4% PBO-treated (n=5) received ≥1 intralesional triamcinolone injection. Time to first procedural intervention was 65.3±36.2 (mean days±standard deviation) in BKZ-treated and 30.4±17.0 in PBO-treated patients. Conclusions: Over 16 weeks, the incidence of concomitant interventions for HS was low in BKZ-treated patients; low levels of rescue analgesic use in BKZ-treated patients may indicate reduced pain burden. Time to first procedure was numerically longer for BKZ- versus PBO-treated patients.

Roflumilast is a nonsteroidal, highly potent phosphodiesterase 4 inhibitor developed as once-daily cream and foam formulations being studied in patients for long-term treatment of atopic dermatitis and seborrheic dermatitis (SD). Roflumilast cream 0.3% is approved as a once-daily, nonsteroidal cream for patients with chronic plaque psoriasis, including sensitive areas such as intertriginous, face, and genital areas. Efficacy and safety of once-daily roflumilast foam 0.3% in patients ≥9 years old with at least moderate SD from this phase 3 randomized controlled trial (NCT04973228) were reported previously. Roflumilast foam 0.3% (n=304) demonstrated statistically significant improvements in efficacy compared with vehicle (n=153) with low rates of adverse events, which were similar between treatment groups. Here we report the patient-reported outcomes: Worst Itch Numeric Rating Scale (WI-NRS), Scalpdex, and Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI), and local tolerability. Among patients with baseline WI-NRS score ≥2, more roflumilast-treated than vehicle-treated achieved WI-NRS score 0/1 at Week 8 (70.7% vs. 52.9%; P=0.0085), with improvements in itch compared to vehicle as early as 48 hours after first treatment (mean percent change from baseline [CfB]: -27.87% vs. -13.11%; nominal P=0.0024). Roflumilast-treated patients reported greater improvements in least squares (LS) mean CfB DLQI score (-3.8 vs. -2.7; nominal P<0.001), while those with scalp involvement, had greater improvements in LS mean CfB Scalpdex score (-23.21 vs. -15.42; nominal P<0.001) at Week 8. Local tolerability and safety were favorable. Treatment with once-daily roflumilast foam 0.3% reduced pruritus and improved quality of life with favorable tolerability. Sponsored by Arcutis Biotherapeutics, Inc.

Tapinarof cream 1% once daily (QD) demonstrated significant efficacy versus vehicle and was well-tolerated in adults and children down to 2 years of age with moderate to severe atopic dermatitis (AD) in two pivotal phase 3 trials (ADORING 1 and 2). Here, we present baseline characteristics and outcomes from the prespecified interim analysis of ADORING 3, the long-term extension trial assessing safety and efficacy of up to 48-weeks’ open-label tapinarof. 728 patients enrolled in ADORING 3, representing a large, diverse AD population comprising a high proportion (91%) of eligible patients from the pivotal ADORING trials, 28 patients from a 4-week maximal usage pharmacokinetic trial, and an additional 76 tapinarof-naive patients aged 2-17 years with various disease severities (mild; or moderate or worse with body surface area [BSA] ≥40%), who were ineligible for preceding trials. The majority of patients in ADORING 3 were pediatric; 26.6% were aged 2-6 years; 27.1% 7-11 years; 29.3% 12-17 years; and 17.0% were adults. Overall, 46.6% were male, 52.6% White, 11.1% Asian, 30.1% Black/African American, and 4.4% other race categories. Patients with AD present different phenotypes and treatment responses. A high proportion of primarily pediatric patients elected to rollover from previous trials, and the diverse population enrolled in ADORING 3 is representative across the broad spectrum of disease severity, BSA affected (up to 95%), and demographics. No new safety signals were reported with long-term treatment in this interim analysis. The full analysis in 2024 will report further safety and efficacy data with tapinarof cream 1% QD.

Introduction: New topical treatments were recently FDA approved for patients with plaque psoriasis. This study was designed to assess the effect of education on knowledge, competence, and confidence regarding new topical psoriasis treatments. Methods: Dermatologists (n= 76) participated in an online CME activity that featured video with synchronized slides. A repeated-pair design with pre/post-assessment including 3 multiple choice questions that assessed knowledge or competence and one confidence assessment question assess effectiveness, with each participant serving as his/her own control. A McNemar’s test was conducted to assess question level statistical significance (P <.05). The activity launched 3/10/23 and data were collected approximately 60 days post-launch. Data are presented as %improved (%pre/%post) correct responses. Results are presented by learning theme. New Topical Psoriasis Treatments: • 11% improved (58%/54%; P = NS) change in knowledge regarding calcipotriene/ betamethasone data • 34% increase in confidence in identifying patients who would benefit from new topical psoriasis treatments Psoriasis in Sensitive Areas: • 18% (49%/63%) increase in knowledge about the suitability of roflumilast in difficult to treat areas Psoriasis in Patients with Skin of Color: • 18% improved (53%/67%) competence in counseling patients with diverse skin tones on pigmentary changes associated with healing psoriasis. Discussion: Online CME resulted in improved knowledge, competence, and confidence among dermatologists regarding new topical psoriasis treatments. Baseline and post-education results suggest that there are remaining gaps regarding new topical treatments, managing psoriasis in difficult areas, and in treating psoriasis in patients with diverse skin tones.