WESTLAKE VILLAGE, Calif., and DENVER, March 18, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will present new data from its clinical development program and marketed ZORYVE® (roflumilast) portfolio during the 2026 American Academy of Dermatology (AAD) Annual Meeting taking place March 27-31 in Denver.
In an AAD late-breaking podium presentation, the Company will share new efficacy, safety, and tolerability results from its INTEGUMENT-INFANT Phase 2 trial evaluating investigational once-daily ZORYVE cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis, building on recently announced topline data. 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.
“This year’s AAD presentations reflect the continued momentum of our clinical development program and the expanding body of evidence supporting the value of ZORYVE across atopic dermatitis, seborrheic dermatitis, and plaque psoriasis,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “We are particularly excited to share new results from the INTEGUMENT‑INFANT trial evaluating investigational ZORYVE cream 0.05% in infants with mild to moderate atopic dermatitis, with its inclusion as a late‑breaking session underscoring the need for additional therapeutic options for this underserved pediatric age group.”
Details of the presentations are as follows:
- Podium: INTEGUMENT-INFANT: Once-Daily Roflumilast Cream 0.05% in Infants Aged 3–<24 Months With Atopic Dermatitis
Abstract: #79891
Presenter: Lawrence F. Eichenfield, MD
Late-Breaking Session 1
Date: Saturday, March 28
Time: 10:12–10:24 a.m. MDT
Location: Bellco Theatre 3
- 5-minute Poster Presentation: Once-Daily and Proactive Twice-Weekly Roflumilast Cream 0.05% in Caregiver-Reported Outcomes: Long-Term Results for Patients Aged 2–5 Years With Mild to Moderate Atopic Dermatitis in the INTEGUMENT-OLE Trial
Presenter: Lawrence F. Eichenfield, MD
Date: Friday, March 27
Time: 4:25–4:30 p.m. MDT
Location: Lobby C, Poster Center 1
Poster Presentations
The following posters will be available electronically at the conference beginning Friday, March 27:
- E-Poster: 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
Lead Author: Laura Ferris, MD
- E-Poster: Roflumilast Cream 0.3% and Foam 0.3% in Psoriasis Area and Severity Index (PASI) Across Body Regions and Clinical Signs for Patients With Plaque Psoriasis
Lead Author: Melinda Gooderham, MD
About ZORYVE® (roflumilast)
ZORYVE is the number one prescribed branded topical therapy across three major inflammatory dermatoses combined—atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. ZORYVE cream is a topical formulation of roflumilast, an advanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor. Inhibiting PDE4, an intracellular enzyme that is an established target in dermatology, decreases the production of pro-inflammatory mediators. This decreases inflammation in the skin and balances the skin’s immune system.
Demonstrating both clinical impact and broad industry recognition, ZORYVE has been honored with multiple prestigious awards and recommendations. ZORYVE was awarded by Allure with the "2025 Best of Beauty Breakthrough Award," making it the first FDA-approved medication for atopic dermatitis, plaque psoriasis, and seborrheic dermatitis to win this prominent award. ZORYVE cream 0.3% and ZORYVE foam 0.3% were also awarded the National Psoriasis Foundation’s Seal of Recognition—the first FDA-approved prescription brand to receive the honor. Additionally, the American Academy of Dermatology (AAD) issued a strong recommendation for the use of ZORYVE cream 0.15% in adult patients with mild to moderate atopic dermatitis, according to updated guidelines released in June 2025. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Best Eczema Product.”
About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform, coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.
INDICATIONS
ZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.
ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.
ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.
ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.
ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.
IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.
The most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for pediatric patients with atopic dermatitis 2 to 5 years of age were upper respiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis (1.6%), conjunctivitis (1.4%), and headache (1.1%).
The most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for patients with atopic dermatitis 6 years of age or older were headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
The most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for plaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).
The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for plaque psoriasis were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).
The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for investigational ZORYVE cream 0.05% to achieve the desired clinical trial results and to advance the standard of care in atopic dermatitis in infants aged 3–<24 months, and long-term use in children aged 2-5 years old, and the use of ZORYVE in seberrheic dermatitis and plaque psoriasis. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2026, as well as any subsequent filings with the SEC. Any forward-looking statements that the Company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com
Investors
Brian Schoelkopf, Head of Investor Relations
ir@arcutis.com
