Zoryve foam (topical roflumilast foam) / Arcutis, Huadong Medicine, Sato Pharma - LARVOL DELTA

The Safety and Efficacy of Roflumilast Foam in HS (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Beth Israel Deaconess Medical Center

New P2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

Arcutis Canada Announces Health Canada Approval of ZORYVE Foam 0.3%, the First Steroid-Free Topical Foam for Scalp and Body Psoriasis, for Adults and Adolescents Ages 12 and Older (Canada Newswire) - "The Health Canada approval was supported by data from the pivotal Phase 3 ARRECTOR trial (ARandomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis) and a Phase 2 study, which together evaluated the efficacy and safety of roflumilast foam in individuals aged 12 years and older with scalp and body psoriasis."

Canada approval • Psoriasis

Roflumilast Foam 0.3% in Patients With Psoriasis of the Scalp and Body: Improvements in Patient-Reported Outcomes and Quality of Life (ISPOR-EU 2025) - P3 | "Treatment with roflumilast foam 0.3% improved patient-reported outcomes and quality of life in patients with psoriasis of the scalp and body."

Clinical • HEOR • Patient reported outcomes • Dermatology • Immunology • Psoriasis

Improvements in Scalp Outcomes With Roflumilast Foam 0.3% for Psoriasis of the Scalp and Body From the Phase 3 ARRECTOR Trial (ISPOR-EU 2025) - P3 | "Roflumilast foam 0.3% significantly reduced scalp symptom severity and ESI, compared with vehicle, including complete clearance of plaques on the scalp in many patients. The favorable safety profile and topical formulation make roflumilast foam 0.3% a compelling non-systemic alternative for patients with moderate-to-severe psoriasis involving the scalp and body, who may otherwise receive systemic therapy."

P3 data • Dermatology • Immunology • Psoriasis

Arcutis Announces Publication of Positive Long-Term Safety and Efficacy Data of ZORYVE (roflumilast) Foam 0.3% in Individuals with Seborrheic Dermatitis in American Journal of Clinical Dermatology (Arcutis Press Release) - "Once patients' disease had cleared (IGA=0) they were able to stop treatment and restart with any sign of disease returning....The primary endpoint was safety. Treatment-Emergent Adverse Events (TEAEs) were reported for 130 (32.5%) participants. The most common TEAE (≥2%) was COVID-19, which was reported for 15 (3.8%) participants, followed by headache in 13 (3.3%) participants. Serious Adverse Events (SAEs) were reported for 7 (1.8%) individuals, none of which were considered treatment related...On the assessment of IGA of Clear or Almost Clear (0 or 1), 56.4% (219/388) attained this level of efficacy at Week 4, 76% (260/342) at Week 24, and 80.4% (37/46) at Week 52....Based on investigator-rated local tolerability assessments, ≥96% of study participants had no evidence of local irritation."

P2 data • Seborrheic Dermatitis

Long-Term Safety and Efficacy of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis: A Phase II, Open-Label Trial of up to 52 Weeks. (PubMed, Am J Clin Dermatol) - P2 | "Roflumilast foam 0.3% was well tolerated and improved and/or maintained improvements in signs and symptoms of SD for up to 52 weeks."

Journal • P2 data • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

Clinical and Regulatory Developments (GlobeNewswire) - "The Company has begun enrolling patients in Phase 2 proof-of-concept studies with ZORYVE foam 0.3% for the treatment of patients with vitiligo, as well as patients with hidradenitis suppurativa, the first trials in the Company's effort to investigate further indication expansion opportunities for ZORYVE; The Company is preparing to initiate a Phase 1 study of ARQ-234, a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 receptor being developed as a potential biologic treatment in atopic dermatitis."

Enrollment status • New P1 trial • Atopic Dermatitis • Hidradenitis Suppurativa • Vitiligo

Commercial Highlights (GlobeNewswire) - "ZORYVE net product sales for the third quarter of 2025 were $99.2 million, reflecting 22% sequential growth over the second quarter of 2025 and 122% year-over-year growth. Sequential growth was driven by increasing demand across products, the launch of ZORYVE foam 0.3% in plaque psoriasis of the scalp and body, and improved gross-to-net (GTN) pricing; Following FDA approval in early October, the Company will launch ZORYVE cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5 by the end of October."

Launch US • Sales • Atopic Dermatitis • Psoriasis

Efficacy and Tolerability of Roflumilast Cream 0.3% and Foam 0.3% in Patients With Plaque Psoriasis Involving the Face and/or Genitals: Outcomes From the Phase 3 DERMIS-1/2 and ARRECTOR Trials (EADV 2025) - "Overall, treatment-related AEs from DERMIS-1/2 were reported for 4.0% and 3.6% of patients in the roflumilast cream and vehicle groups, respectively, and for 5.7% and 2.0% of patients in the roflumilast foam and vehicle groups from ARRECTOR. Both roflumilast cream 0.3% and foam 0.3% were well tolerated and improved psoriasis across several efficacy assessments after 8 weeks. Observed improvements in disease were consistent between the formulations in the overall populations and in patient subpopulations who had psoriasis with baseline facial and/or genital involvement."

Clinical • P3 data • Dermatology • Immunology • Psoriasis

Roflumilast foam 0.3% for the treatment of seborrheic dermatitis in patients with diverse skin types: subgroup analyses of the phase 3 STRATUM trial (EADV 2025) - P3 | "Roflumilast foam 0.3% reduced SD signs and symptoms across multiple efficacy assessments at 8 weeks, with similar improvements across race, ethnicity, and FST subgroups. In addition, hypopigmentation and hyperpigmentation improved during the study. These results suggest that roflumilast foam 0.3% monotherapy is an effective treatment option for SD across diverse patient populations."

Clinical • P3 data • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

Current Understanding of Seborrheic Dermatitis: Treatment Options. (PubMed, J Cutan Med Surg) - "The recent development of new treatments, such as the topical phosphodiesterase-4 inhibitor (roflumilast 0.3% foam), shows promise in providing effective, noncorticosteroid options for seborrheic dermatitis management. This review provides an overview of current, as well as emerging therapeutic options, and discusses the importance of personalized treatment strategies in managing seborrheic dermatitis. This is the third in a series of 3 reviews, each addressing different aspects of seborrheic dermatitis, including its epidemiology, diagnosis, and treatment considerations."

Journal • Dermatitis • Dermatology • Immunology • Inflammation • Seborrheic Dermatitis

Efficacy and Tolerability of Roflumilast Cream 0.3% and Foam 0.3% in Patients with Plaque Psoriasis Involving the Face and/or Genitals: Outcomes from the Phase 3 DERMIS-1/2 and ARRECTOR Trials (GlobeNewswire) - "Additionally, data from the Phase 3 DERMIS-1/2 and ARRECTOR trials demonstrated that, at Week 8, ZORYVE cream 0.3% and ZORYVE foam 0.3% were both well tolerated and improved signs and symptoms of plaque psoriasis in individuals with facial and/or genital involvement. Improvements in subgroups with facial and/or genital involvement were comparable with those in the overall population and consistent between the cream and foam formulations."

P3 data • Psoriasis

ZORYVE Foam 0.3% for the Treatment of Seborrheic Dermatitis in Patients with Diverse Skin Types: Subgroup Analyses of the Phase 3 STRATUM Trial (GlobeNewswire) - "Significant improvement in signs and symptoms of seborrheic dermatitis with ZORYVE foam 0.3%, as measured by Investigator Global Assessment (IGA) Success at Week 8 compared with vehicle, was reported for the overall population (79.5% vs 58.0%; primary endpoint), with similar responses across subgroups by race (White: 80.3% vs 57.2%; Black/African American: 71.5% vs 59.4%; other races: 82.0% vs 62.5%), ethnicity (Hispanic/Latino: 77.5% vs 70.8%; non-Hispanic/Latino: 80.0% vs 55.1%), and FST (I–III: 80.7% vs 55.1%; IV–VI: 76.3% vs 66.4%)....A higher proportion of participants in the ZORYVE foam 0.3% treatment group experienced no erythema (redness) and no scaling at Week 8 compared with vehicle in the overall patient population (key secondary endpoint) and among subpopulations."

P3 data • Seborrheic Dermatitis

A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Tulane University

New P2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV) (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Derm Texas, PLLC | Not yet recruiting ➔ Recruiting | Phase classification: PN/A ➔ P2 | N=35 ➔ 20 | Trial completion date: Aug 2027 ➔ Jun 2026 | Trial primary completion date: Aug 2027 ➔ May 2026

Enrollment change • Enrollment open • Phase classification • Trial completion date • Trial primary completion date • Dermatology • Immunology • Pediatrics • Vitiligo

An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV) (clinicaltrials.gov) - P=N/A | N=35 | Not yet recruiting | Sponsor: Derm Texas, PLLC

New trial • Dermatology • Immunology • Pediatrics • Vitiligo

Roflumilast Foam 0.3% Effective for Scalp, Body Psoriasis in Phase 3 Trial (HCPLive) - P3 | N=432 | ARRECTOR (NCT05028582) | Sponsor: Arcutis Biotherapeutics, Inc. | "A phase 3 study presented at the SDPA Annual Summer Dermatology Conference in Washington, DC, from June 25 to June 29th...The analysis showed patients well-tolerated roflumilast foam 0.3%, which was consistent with safety outcomes reported in previous trials of roflumilast cream 0.3% in patients with psoriasis. Treatment-related adverse events (TEAEs) were mild or moderate in the roflumilast (96%) and vehicle (92%) arms, with 5.7% and 2% considered related to the study treatment, respectively....At week 8, significantly more patients on roflumilast achieved S-IGA success, B-IGA success, SI-NRS/WI-NRS 0/1, PSSI-75/100, and improvement in PROs, compared with the control arm (P < .0001). Furthermore, investigators observed improvements in patient-reported Scalpdex and PSD component scores with roflumilast as early as week 2 and continued through week 8."

P3 data • Psoriasis

Roflumilast Foam 0.3% Demonstrates Favorable Pigmentation Profile in Seborrheic Dermatitis (DermatologyTimes) - P3 | N=457 | STRATUM (NCT04973228) | Sponsor: Arcutis Biotherapeutics, Inc. | "Presented at the 2025 Society of Dermatology Physician Associates (SDPA) Annual Summer Dermatology Conference, a poster highlighted results from the pivotal phase 3 STRATUM trial....At week 8, significantly more patients treated with roflumilast achieved Investigator's Global Assessment success compared to vehicle. Superior outcomes for roflumilast were also seen as early as week 2 and continued through week 4. Furthermore, roflumilast foam 0.3% was well tolerated. Any reported treatment-emergent adverse events (TEAEs) occurred in 23.0% of roflumilast-treated patients vs 21.6% in the vehicle group. Treatment-related TEAEs were infrequent (2.6% vs 3.3%). Only 1 serious adverse event was reported in the roflumilast treatment group (keratoacanthoma), which was deemed unrelated. Discontinuations due to AEs were rare: 0.7% (roflumilast) and 2.0% (vehicle)."

P3 data • Seborrheic Dermatitis

Safety and pigmentation changes from a phase 3 trial of roflumilast foam 0.3% in patients with seborrheic dermatitis (STRATUM) (CDA 2025) - P3 | "Safety (including pigmentation results) and local tolerability profiles were favorable across treatment groups following vehicle and roflumilast foam 0.3% application for 8 weeks in patients with SD."

Clinical • P3 data • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

Need for Speed: Topical Roflumilast for Rapid Control of Seborrheic Dermatitis Flares. (PubMed, J Drugs Dermatol) - "Topical roflumilast 0.3% foam is the most recent treatment for seborrheic dermatitis approved by the US Food and Drug Administration (FDA); however, its speed of action in controlling flares has not been fully explored...2025;24(6):634-635. doi:10.36849/JDD.8619."

Journal • Review • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

Efficacy and safety of once-daily roflumilast foam 0.3% for psoriasis of the scalp and body involving knees/elbows: Subgroup results from the phase 3 arrector trial (SID 2025) - P3 | "Safety in patients with knee/elbow involvement was consistent with the overall population. Once-daily ROF provided significant improvement across multiple efficacy measures in patients with psoriasis of the scalp and body involving knees/elbows."

Clinical • P3 data • Dermatitis • Dermatology • Immunology • Psoriasis • Seborrheic Dermatitis

Arcutis’ ZORYVE (roflumilast) Topical Foam 0.3% Approved by U.S. FDA for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older (GlobeNewswire) - "Arcutis Biotherapeutics...announced the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) topical foam 0.3% for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. ZORYVE foam is a once-daily, steroid-free topical and is now widely available as a treatment for plaque psoriasis....The approval is supported by positive results from Arcutis’ Phase 2 and pivotal Phase 3 trials in plaque psoriasis. The 'A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis' (ARRECTOR) and the Phase 2 (Trial 204) were multicenter, randomized, double-blind, vehicle-controlled studies evaluating the safety and efficacy of ZORYVE foam 0.3% in plaque psoriasis."

FDA approval • Psoriasis

Arcutis Announces Publication of Positive Data from ARRECTOR Trial Evaluating ZORYVE (roflumilast) Foam 0.3% in Individuals with Psoriasis in Journal of American Medical Association Dermatology (GlobeNewswire) - P3 | N=432 | ARRECTOR (NCT05028582) | Sponsor: Arcutis Biotherapeutics, Inc. | "ZORYVE foam provided a clinically meaningful improvement in scalp itch. 65.3% of individuals treated with ZORYVE achieved a clinically significant reduction in itch compared to 30.3% of individuals treated with vehicle at Week 8 (P<0.0001) as measured by a ≥ 4-point change from baseline in Scalp Itch-Numeric Rating Scale (SI-NRS). Significant improvement was seen in the ZORYVE treatment group as early as Week 2. The data also demonstrated improvement in body itch as measured by the Worst Itch-Numeric Rating Scale (WI-NRS) at Week 8, with 63.1% of those treated with ZORYVE foam 0.3% achieving a ≥ 4-point reduction in WI-NRS compared to 30.1% of those treated with vehicle (P<0.0001)."

P3 data • Psoriasis

Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial. (PubMed, JAMA Dermatol) - P3 | "These results demonstrate the potential of roflumilast foam, 0.3%, as monotherapy for patients with psoriasis of the scalp and body. ClinicalTrials.gov Identifier: NCT05028582."

Clinical • Journal • P3 data • Dermatology • Immunology • Pruritus • Psoriasis

Roflumilast for the Treatment of Seborrheic Dermatitis: A Review. (PubMed, Skin Therapy Lett) - "Recent clinical trials have validated the efficacy of non-steroidal roflumilast 0.3% foam for the treatment of SD. In this review, we analyze the safety and efficacy profile of roflumilast 0.3% foam."

Journal • Review • Dermatitis • Dermatology • Immunology • Inflammation • Seborrheic Dermatitis