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

An Open-label, Single Center Study Evaluating the Safety and Efficacy of Roflumilast Foam 0.3% in Subjects With Cutaneous Adverse Events Due to Checkpoint Inhibitors (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Massachusetts General Hospital | Initiation date: Aug 2026 ➔ Nov 2026

Adverse events • Checkpoint inhibition • Trial initiation date • Dermatitis • Dermatology • Immunology • Oncology

Symptom Relief and Disease Stabilization with Roflumilast Foam in LPP Spectrum Disorders: A Case Series (EADV 2026) - No abstract available

Clinical • Hidradenitis Suppurativa

ARQ-MA-000260: Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Harrison Dermatology

New P2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

The Safety and Efficacy of Roflumilast Foam in HS (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Beth Israel Deaconess Medical Center | Trial completion date: Dec 2028 ➔ May 2029 | Initiation date: Apr 2026 ➔ Sep 2026 | Trial primary completion date: Mar 2028 ➔ Aug 2028

Trial completion date • Trial initiation date • Trial primary completion date • Dermatology • Hidradenitis Suppurativa • Immunology

Efficacy and Safety of Roflumilast Foam 0.3% in Trial Participants With Seborrheic Dermatitis (clinicaltrials.gov) - P3 | N=309 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P3 trial • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

JAAD Game Changers: "Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: A randomized, double-blinded, vehicle-controlled, phase 3 trial". (PubMed, J Am Acad Dermatol) - No abstract available

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

Roflumilast foam versus vehicle foam for seborrheic dermatitis (STRATUM clinical study): a plain language summary. (PubMed, J Dermatolog Treat) - No abstract available

Journal • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

An Open-label, Single Center Study Evaluating the Safety and Efficacy of Roflumilast Foam 0.3% in Subjects With Cutaneous Adverse Events Due to Checkpoint Inhibitors (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Massachusetts General Hospital

Adverse events • Checkpoint inhibition • New P2 trial • Dermatitis • Dermatology • Immunology • Oncology

Treatment of Seborrheic Dermatitis and Post-Inflammatory Hypopigmentation With Roflumilast Foam in Skin of Color Patients. (PubMed, J Drugs Dermatol) - No abstract available

Journal • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% in Pediatric Participants With Scalp and Body Psoriasis (clinicaltrials.gov) - P1 | N=22 | Completed | Sponsor: Arcutis Biotherapeutics, Inc. | Recruiting ➔ Completed | N=16 ➔ 22 | Trial completion date: Feb 2027 ➔ Apr 2026 | Trial primary completion date: Dec 2026 ➔ Apr 2026

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Dermatology • Immunology • Pediatrics • Psoriasis

Once-daily roflumilast cream or foam 0.3% for psoriasis: Subgroup analysis by skin type (DERMIS-1/2 and ARRECTOR) (SID 2026) - "Trends were similar for ≥75% improvement in Psoriasis Area and Severity Index. ROF cream and foam were both well tolerated and improved psoriasis signs/symptoms across diverse skin types over 8 weeks."

Dermatology • Immunology • Plaque Psoriasis • Psoriasis

Roflumilast foam 0.3% in patients with seborrheic dermatitis and prior inadequate response, intolerance, and/or contraindications to topical antifungals and/or topical corticosteroids (SID 2026) - "Among 140 and 189 pts with prior inadequate response, intolerance, or contraindications to topical AFs (pTAF) and/or topical CS (pTCS), respectively, higher proportions in the ROF versus VEH groups achieved IGA success (pTAF: 80.5% vs 27.6%; pTCS: 78.8% vs 48.3%; both P<0.001), WI-NRS success (66.3% vs 34.9%, P=0.005; 58.4% vs 37.6%), erythema 0 (62.2% vs 13.6%; 57.1 vs 20.0%; both P<0.0001), and scaling 0 (53.4% vs 16.4%; 55.2% vs 30.4%; both P<0.02) at week 8. ROF improved signs and symptoms of SebDerm in pts with pTAF or pTCS, and had a similar safety profile, as the overall population."

Clinical • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

Roflumilast Foam 0.3% in Patients With Seborrheic Dermatitis: Subgroup Analysis of Patients With Involvement of the Face and/or Scalp in the STRATUM Trial (AAD 2026) - P3 | "Treatment-related adverse events were reported for 2.6% and 3.3% of patients in the roflumilast and vehicle groups, respectively; 1 (0.3%) serious adverse event (keratoacanthoma, not at application site, unrelated) was reported (roflumilast). Roflumilast foam 0.3% was well tolerated and improved SD signs/symptoms, including in patients with facial and/or scalp involvement."

Clinical • Dermatitis • Dermatology • Immunology • Seborrheic Dermatitis

Key Results from Additional Studies Supporting the ZORYVE Portfolio Presented in Posters:…Phase 3 DERMIS-1/2 and ARRECTOR trials (GlobeNewswire) - "Further analysis from the previously published Phase 3 DERMIS-1/2 and ARRECTOR trials (e-poster) found that ZORYVE cream 0.3% and foam 0.3% improved psoriasis severity, reducing Psoriasis Area and Severity Index (PASI) total and component scores more than vehicle cream or vehicle foam. Mean improvements in psoriasis were reported with ZORYVE cream and foam across body regions: head and neck, trunk, and upper and lower extremities."

P3 data • Psoriasis

Key Results from Additional Studies Supporting the ZORYVE Portfolio Presented in Posters:…STRATUM Phase 3 trial (GlobeNewswire) - "Findings from a STRATUM Phase 3 trial subgroup analysis (e-poster) show that ZORYVE foam 0.3% was well tolerated and improved signs and symptoms of seborrheic dermatitis through 8 weeks of treatment in individuals with seborrheic dermatitis including those with face and/or scalp involvement. The analysis supports ZORYVE foam 0.3% as a suitable potential treatment of anatomical areas where topical steroid use is limited by safety considerations, such as the face."

P3 data • Seborrheic Dermatitis

Arcutis to Present New Clinical Data in a Late-Breaking Podium Presentation and Scientific Posters at the 2026 American Academy of Dermatology Annual Meeting (Arcutis Press Release) - "In an AAD late-breaking podium presentation, the Company will share new efficacy, safety, and tolerability results from its INTEGUMENT-INFANT Phase 2 trial...In addition, a five-minute poster presentation will highlight long-term caregiver-reported outcomes from its INTEGUMENT-OLE Phase 3 trial of ZORYVE cream 0.05% in children aged 2 to 5 years with mild to moderate atopic dermatitis. Additional results will be presented in two e-posters from a STRATUM Phase 3 trial subgroup analysis in individuals with seborrheic dermatitis with face and scalp involvement, and Psoriasis Area and Severity Index (PASI) outcomes from the Phase 3 DERMIS-1/2 and ARRECTOR trials in individuals with plaque psoriasis."

Clinical data • Atopic Dermatitis • Psoriasis • Seborrheic Dermatitis

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

Enrollment open • Dermatology • Hidradenitis Suppurativa • Immunology

Arcutis Biotherapeutics, Inc. Announces Termination of Promotion Agreement with Kowa (GlobeNewswire) - "The agreement covered sales and promotion of ZORYVE (roflumilast) by Kowa to primary care physicians and pediatricians in the United States. Following the termination, Arcutis plans to assume responsibility for sales and promotion of ZORYVE in the pediatric and primary care settings. The Company is finalizing its plans for promotion to these clinicians and will provide further updates during the Q4 earnings call on February 25, 2026....Under the terms of the Termination Agreement, Kowa will cease all sales and promotions of ZORYVE and Arcutis will not be required to make any further payments."

Commercial • Atopic Dermatitis • Psoriasis • Seborrheic Dermatitis

Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% in Pediatric Participants With Scalp and Body Psoriasis (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Arcutis Biotherapeutics, Inc.

New P1 trial • Dermatology • Immunology • Pediatrics • Psoriasis

Expand the ZORYVE franchise into additional indications through strategic life cycle management beginning with proof-of-concept studies in vitiligo and hidradenitis suppurativa. (The Manila Times) - "Expect to report decision on program advancement for investigational ZORYVE foam 0.3% for the treatment of vitiligo in the fourth quarter of 2026; Expect to report decision on program advancement for investigational ZORYVE foam 0.3% for the treatment of hidradenitis suppurativa in the first quarter of 2027."

Clinical • Hidradenitis Suppurativa • Vitiligo

Grow our core ZORYVE business as we establish ZORYVE as the foundational therapy for adults and children who need long-term therapeutic solutions for managing their plaque psoriasis, seborrheic dermatitis, and atopic dermatitis. (The Manila Times) - "Sustainable momentum of ZORYVE franchise with 2026 net product sales expected in the $455-$470 million range; Targeted ~20% expansion of dermatology sales force to optimize prescriber targeting and call frequency, deepening adoption of ZORYVE."

Sales projection • Atopic Dermatitis • Psoriasis • Seborrheic Dermatitis

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

Enrollment open • Dermatology • Hidradenitis Suppurativa • Immunology

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