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

Roflumilast Cream for Residual Disease in Patients With Atopic Dermatitis on Dupilumab: A Retrospective Chart Review Study. (PubMed, Dermatol Ther (Heidelb)) - "In this retrospective case series, adjunctive roflumilast cream was associated with physician-documented clinical improvement in most dupilumab-treated patients with residual AD."

Journal • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

INTEGUMENT-INFANT: Once-Daily Roflumilast Cream 0.05% in Infants Aged 3 to <24 Months With Atopic Dermatitis (EADV 2026) - No abstract available

Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Allergic Contact Dermatitis to Parabens Associated With Topical Roflumilast Cream: A Case Series of 2 Patients. (PubMed, Dermatitis) - No abstract available

Journal • Contact Dermatitis • Dermatitis • Dermatology • Immunology

PrZORYVE Cream 0.05% Receives Health Canada Approval for Children Aged 2 to 5 Years with Mild to Moderate Atopic Dermatitis (PRNewswire) - "The Health Canada approval of ZORYVE cream 0.05% was supported by data from Arcutis' pivotal Phase 3 INTEGUMENT-PED trial (INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis), a Phase 1 pharmacokinetic study, and the long-term extension study, INTEGUMENT-OLE."

Canada approval • Atopic Dermatitis • Immunology

Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream. (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: Integrative Skin Science and Research | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2026 ➔ Jul 2026

Enrollment open • Trial initiation date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Pushing the Boundaries of Topical Therapy in Patients with Atopic Dermatitis: A Review of Baseline Disease Severity and Burden in Clinical Trials. (PubMed, Dermatol Ther (Heidelb)) - "Many patients with AD treated in clinical trials of topical therapies report high levels of disease burden, overlapping with some patients eligible for systemic therapies. These results suggest that advanced topical therapies may be effective in patients with more extensive AD."

Clinical • Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • 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

Arcutis Biotherapeutics, Inc…announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05% to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months. (The Manila Times) - "The FDA has set a PDUFA target action date of February 23, 2027....The sNDA is supported by positive results from the Phase 2 open-label INTEGUMENT-INFANT study, as well as a Phase 1 open-label pharmacokinetic (PK) study, both of which evaluated once-daily ZORYVE cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis."

FDA filing • PDUFA • Atopic Dermatitis

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

Vitiligo Successfully Treated With Roflumilast Cream 0.3. (PubMed, J Drugs Dermatol) - "This case suggests that roflumilast cream 0.3% may have a positive therapeutic effect for patients with vitiligo who are unresponsive to other conventional therapies. &nbsp."

Journal • Dermatology • Immunology • Vitiligo

HDM3014-301: Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study (clinicaltrials.gov) - P3 | N=190 | Completed | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Oct 2025 | Trial primary completion date: Jun 2025 ➔ Oct 2025

Trial completion • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

Assessing the Adverse Events of Roflumilast and Tapinarof Use in Pediatric and Young Adult Patients with Atopic Dermatitis: A Systematic Review. (PubMed, Clin Drug Investig) - "Some limitations include the lack of direct comparative studies, limited data in pediatric and young adult populations, and heterogeneity of reported adverse events. Despite this, roflumilast and tapinarof demonstrate distinct adverse event profiles. Roflumilast was associated with an increased risk of treatment-related and nondermatologic adverse events, while tapinarof was associated with dermatologic adverse events. These findings highlight the importance of individualized treatment selection and careful monitoring of adverse events  when incorporating these therapies into the management of atopic dermatitis."

Adverse events • Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pediatrics

Arcutis Biotherapeutics…announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the indication for ZORYVE (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children down to age 2 (GlobeNewswire) - "The approval of the expanded indication is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study (ARQ-151-216) evaluating ZORYVE cream 0.3% in children ages 2 to 5 years with plaque psoriasis. This open-label study assessed pharmacokinetics, safety, tolerability, and exploratory efficacy in children with plaque psoriasis involving at least 2% body surface area."

FDA approval • Psoriasis

Improvement in Atopic Dermatitis With Once-Daily and Proactive Twice-Weekly Roflumilast Cream 0.15% or 0.05% in Patients Aged ≥2 Years: 52-Week Phase 3 INTEGUMENT-OLE Trial (CDA 2026) - P3 | "Roflumilast cream was well tolerated and provided long-term decreases in AD signs/symptoms for patients aged ≥2 years, supporting the use of roflumilast cream for long-term AD control, including proactive BIW application, without topical corticosteroids. Takeaway Message: Once-daily and proactive treatment with twice-daily roflumilast cream 0.15% and 0.05% were well tolerated and decreased signs and symptoms of AD and maintained improvements through up to 56 weeks of treatment in patients aged ≥2 years. These results support roflumilast as an alternative to commonly used topical therapies that are not recommended for long-term continuous use for patients with AD."

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Long-term treatment of atopic dermatitis with roflumilast cream 0.15% in patients aged 6 years or older (INTEGUMENT-OLE clinical study): a plain language summary. (PubMed, J Dermatolog Treat) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Polymorphic eruption of pregnancy successfully treated with dupilumab in the postpartum period: A case report. (PubMed, SAGE Open Med Case Rep) - "Prednisone was contraindicated given her gestational diabetes and gestational hypertension. Dupilumab was administered with betamethasone valerate ointment followed by transition to roflumilast cream. At 6-week follow-up, the skin was cleared of the rash. This case highlights a new potential utility for dupilumab in polymorphic eruption of pregnancy and may represent an alternative to oral steroids in severe or refractory disease."

Journal • Cardiovascular • Dermatology • Diabetes • Gestational Diabetes • Hypertension • Immunology • Metabolic Disorders • Pruritus

Improvement in Atopic Dermatitis Signs and Symptoms With Once-Daily and Proactive Twice-Weekly Roflumilast Cream 0.15% or 0.05%: 52-Week Phase 3 INTEGUMENT-OLE Trial Outcomes in Patients Aged ≥2 Years (EAACI 2026) - P3 | "Proactive BIW application maintained 'disease control' for >200 days. Roflumilast cream was well tolerated and is an appropriate alternative to topical corticosteroids and calcineurin inhibitors for AD treatment."

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Immunology

Atopic dermatitis Yardstick: a new era of topical and systemic treatments. (PubMed, Ann Allergy Asthma Immunol) - "These include roflumilast cream, tapinarof cream, lebrikizumab and nemolizumab. In the current AD Yardstick article, we aim to provide evidence-based information on these new treatments, as well as updated information on previously reviewed therapy. A new feature of the AD Yardstick article is the addition of patient vignettes, which provide practical guide and clinical pearls for clinicians."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

The Treatment of Perioral (Periorificial) Dermatitis With Topical Roflumilast 0.3% Cream: An Illustrative Case Study With Rapid Onset and Prolonged Remission. (PubMed, J Clin Aesthet Dermatol) - "Roflumilast cream, 0.3%, was approved in 2022 for the treatment of chronic plaque psoriasis, including intertriginous areas. Here, we present the case of a 30-year-old female patient who presented with periorificial dermatitis, which cleared in 5 days with once daily roflumilast cream, 0.3%, without adverse events, tolerability concerns, or recurrence 11 months after treatment initiation."

Journal • Dermatitis • Dermatology • Immunology • Psoriasis

Case Series: Successful Management of Refractory Plaque Psoriasis With Combined Laser Therapy and Topical Roflumilast in 2 Patients. (PubMed, J Clin Aesthet Dermatol) - "When pruritus returned and worsened, both subjects trialed roflumilast cream 0.3% as combination therapy alongside the ongoing laser treatments. The addition of roflumilast cream greatly improved each of their symptoms, ultimately leading to resolution of pruritus and significant improvement of plaque size and texture."

Journal • Dermatology • Immunology • Pruritus • 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

COMPARING 1.5% RUXOLITINIB CREAM AND OTHER THERAPIES FOR PEDIATRIC PATIENTS WITH ATOPIC DERMATITIS: A SYSTEMATIC LITERATURE REVIEW AND NETWORK META-ANALYSIS (ISPOR 2026) - "For each outcome, all treatments for which outcome data were reported, apart from dupilumab + TCS, could be connected in a network to 1.5% ruxolitinib cream through a common comparator (vehicle). Results of NMAs indicate 1.5% ruxolitinib cream offers similar or better disease control than that of available topical therapies for pediatric AD based on IGA-TS, EASI-75, and Itch NRS4 and similar safety in terms of TEAEs."

Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics

Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream. (clinicaltrials.gov) - P4 | N=40 | Not yet recruiting | Sponsor: Integrative Skin Science and Research

New P4 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Guidelines of care for the management of atopic dermatitis in pediatric patients. (PubMed, J Am Acad Dermatol) - "We make strong recommendations for the use of moisturizers, topical calcineurin inhibitors, topical corticosteroids, crisaborole ointment, roflumilast cream, ruxolitinib cream, tapinarof cream, dupilumab, tralokinumab, lebrikizumab, nemolizumab with concomitant topical therapy, upadacitinib, abrocitinib, and baricitinib in the treatment of pediatric AD. We make conditional recommendations in favor of bathing, bleach baths, wet dressings, phototherapy, methotrexate, mycophenolate mofetil, azathioprine, and cyclosporine. We conditionally recommend against the use of topical antimicrobials, PUVA phototherapy, and strongly recommend against systemic corticosteroids."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pediatrics

Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE (roflumilast) Cream 0.05% to Expand Indication for Treatment of Atopic Dermatitis to Infants Down to 3 Months (Arcutis Press Release) - "The sNDA is supported by positive results from a Phase 1 open-label pharmacokinetic (PK) trial and a Phase 2 open-label trial (INTEGUMENT-INFANT), both of which evaluated once-daily ZORYVE cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis."

FDA filing • Atopic Dermatitis