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

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

Roflumilast Foam 0.3% in Patients With Scalp and Body Psoriasis: Improvements in Patient-Reported Outcomes (AAD 2025) - P3 | "Treatment with roflumilast foam 0.3% improved patient-reported outcomes and quality of life in patients with scalp and body psoriasis. Sponsored by Arcutis Biotherapeutics, Inc."

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

Arcutis Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "ZORYVE cream: The Company aims to obtain Medicaid coverage in additional states, as well as some Medicare coverage, during 2025....The Company submitted an sNDA for ZORYVE cream 0.05% to the FDA for the treatment of atopic dermatitis in children ages 2 to 5 with an anticipated target action date in Q4 of 2025, if accepted as submitted....ZORYVE foam...which was accepted by the FDA in September with a PDUFA action date set for May 22, 2025....ARQ-255...the Company announced that it completed enrollment in a Phase 1b study evaluating ARQ-255 for the treatment of alopecia areata, with data expected in H1 2025....ARQ-234...being developed as a potential biologic treatment in atopic dermatitis....The Company has continued preclinical development efforts and is working towards submitting an Investigational New Drug application in 2025."

Enrollment closed • IND • P1 data • PDUFA • Reimbursement • Alopecia • Atopic Dermatitis • Psoriasis

Child and Adult Seborrheic Dermatitis: A Narrative Review of the Current Treatment Landscape. (PubMed, Dermatol Ther (Heidelb)) - "The treatment of SD requires an individualized approach, utilizing a range of topical, systemic, and procedural interventions. The advent of new treatments like roflumilast foam offers novel, well-tolerated, and safer options than what has been available in the past."

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

Real-World Use of Tapinarof Cream 1% Once Daily in Patients with Seborrheic Dermatitis: A Case Series. (PubMed, J Clin Aesthet Dermatol) - "Topical roflumilast foam was approved for the treatment of SD in 2023, but additional options are needed. The efficacy and potential remittive effect may be attributed to the unique mechanism of action and clinical profile of tapinarof cream. Tapinarof is a novel topical therapy that may be beneficial for patients with SD."

Journal • Real-world evidence • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis • Seborrheic Dermatitis

Arcutis Canada Announces Health Canada Approval of ZORYVE Foam to Treat Seborrheic Dermatitis in Individuals 9 Years of Age and Older (Canada Newswire) - "Arcutis Canada Inc...is pleased to announce that Health Canada has approved ZORYVE (roflumilast foam 0.3%), for the treatment of seborrheic dermatitis in patients 9 years of age and older. Health Canada's approval of this steroid-free, once-daily phosphodiesterase-4 (PDE4) inhibitor brings a novel approach to the management of seborrheic dermatitis, offering a new once-daily treatment option for this chronic skin condition....Health Canada approval of ZORYVE foam is based on Phase 2 and pivotal Phase 3 trial results."

Canada approval • Immunology • Seborrheic Dermatitis

Arcutis Announces Health Canada Approval of ZORYVE (Roflumilast) Foam 0.3% to Treat Seborrheic Dermatitis in Individuals 9 Years of Age and Older (GlobeNewswire) - "Arcutis Biotherapeutics, Inc...announced that its wholly-owned subsidiary Arcutis Canada, Inc. has received regulatory approval from Health Canada for ZORYVE (roflumilast) topical foam 0.3% for the treatment of seborrheic dermatitis in patients 9 years of age and older....The approval of ZORYVE foam 0.3% for seborrheic dermatitis in Canada was supported by positive results from a vehicle-controlled pivotal Phase 3 study (STRATUM), as well as a Phase 2 study, a long-term open-label extension study, and a Phase 1 pharmacokinetic study."

Canada approval • Dermatitis • Immunology • Seborrheic Dermatitis

Recalcitrant Folliculitis Decalvans Successfully Treated with Roflumilast 0.3% (EADV 2024) - "Roflumilast is more potent than apremilast and crisaborole, with roflumilast more closely mimicking the three key binding sites of cAMP to PDE4...The patient was subsequently treated with ketoconazole shampoo, clindamycin solution, clobetasol shampoo and multiple courses of week-long oral antibiotics with only temporary and partial relief...For ease of application, the patient will continue on roflumilast foam 0.3% once daily and start isotretinoin 10mg every third day... This case report of a 35-year-old male with folliculitis decalvans recalcitrant to topical antifungals, topical corticosteroids and oral antibiotics was successfully treated with roflumilast cream 0.3% resulting in a reduction of erythematous papules with improvement in tenderness and pruritus. These results suggest that roflumilast cream 0.3% may be a suitable treatment option for patients with folliculitis decalvans when other treatments offer limited support. Early, safe treatments are essential for..."

Alopecia • Cardiovascular • Dermatitis • Dermatology • Dermatopathology • Heart Failure • Inflammation • Pain • Pruritus • Psoriasis • Seborrheic Dermatitis

FDA Accepts Arcutis’ Supplemental New Drug Application for ZORYVE (roflumilast) Foam for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over (GlobeNewswire) - "Arcutis Biotherapeutics, Inc...announced the FDA has accepted its sNDA for ZORYVE (roflumilast) foam 0.3%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis. The FDA assigned the application a PDUFA target action date of May 22, 2025....The sNDA is supported by positive results from Arcutis’ pivotal ARRECTOR Phase 3 trial..."

FDA filing • PDUFA • Dermatology • Immunology • Psoriasis