Arcutis To Present Multiple New ZORYVE® (roflumilast) Data Analyses at European Academy of Dermatology and Venereology Congress
- New analysis of ZORYVE foam 0.3% demonstrates reduction in signs and symptoms of seborrheic dermatitis in individuals with diverse skin types
- New data show improved quality of life and decreased impact on families for investigational ZORYVE cream 0.05% in children aged 2–5 years with atopic dermatitis
- Data demonstrate both ZORYVE cream 0.3% and ZORYVE foam 0.3% improved signs and symptoms of plaque psoriasis in individuals with facial and/or genital involvement
WESTLAKE VILLAGE, Calif. and PARIS, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on immuno-dermatology, today announced that new data on ZORYVE (roflumilast) efficacy across three common skin conditions—seborrheic dermatitis, atopic dermatitis, and psoriasis—will be presented at the 34th Annual European Academy of Dermatology and Venereology (EADV) Congress, which is taking place September 17–20, 2025, in Paris.
ZORYVE Foam 0.3% for the Treatment of Seborrheic Dermatitis in Patients with Diverse Skin Types: Subgroup Analyses of the Phase 3 STRATUM Trial (Oral Presentation)
Friday, September 19 | 14:15–15:45 CEST
Presenter: Raj Chovatiya, MD, PhD, MSCI, associate professor at the Rosalind Franklin University Chicago Medical School, founder and director of the Center for Medical Dermatology and Immunology Research
A new subgroup analysis from the STRATUM study further highlights the efficacy of ZORYVE foam 0.3% in individuals with diverse skin types, across ethnicity, race, and Fitzpatrick skin type (FST).
The data demonstrated:
- 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%).
- ZORYVE foam 0.3% improved itch, as measured by Worst Itch-Numeric Rating Scale (WI-NRS) Success at Week 8 compared with vehicle, in the overall patient population and across the subgroups by race (White: 60.1% vs 41.5%; Black/African American: 59.7% vs 48.9%; other races: 83.0% vs 23.1%), ethnicity (Hispanic/Latino: 50.8% vs 45.0%; non-Hispanic/Latino: 66.3% vs 39.5%), and FST (I–III: 60.2% vs 39.5%; IV–VI: 69.5% vs 43.5%).
- 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.
- The safety and tolerability of ZORYVE foam 0.3% were previously confirmed in the STRATUM Phase 3 study. Among all participants in the ZORYVE foam 0.3% and vehicle treatment groups with hypopigmentation (n=17) and hyperpigmentation (n=13) at baseline, improvement was seen across all subgroups: 57.1% of White participants and 87.5% of Black/African American participants achieved partial or full resolution of hypopigmentation, and 75% of White participants and 60% of Black/African American participants achieved partial or full resolution of hyperpigmentation.
"It is critical to understand how a treatment will perform across diverse skin types to ensure it is safe and effective and does not further exacerbate signs or symptoms that are commonly associated with seborrheic dermatitis," said Raj Chovatiya, MD, PhD, MSCI. "These new analyses from the STRATUM Phase 3 data confirm that ZORYVE foam 0.3% is a highly effective and well-tolerated treatment option for seborrheic dermatitis across diverse populations. Additionally, these results are consistent with previous long-term ZORYVE seborrheic dermatitis trials where hypopigmentation and hyperpigmentation improved over time."
Caregiver-Reported Outcomes from the Phase 3 INTEGUMENT-PED Trial of Children Aged 2–5 Years with Atopic Dermatitis and Treated with Roflumilast Cream 0.05%
L. Eichenfield, et al.
Poster 3255
An additional presentation highlights patient-reported outcomes (PROs), as reported by caregivers, from the INTEGUMENT-PED Phase 3 trial in children aged 2–5 years with atopic dermatitis. Data demonstrate that children who received a once-daily application of investigational ZORYVE cream 0.05% had greater improvements versus vehicle across various PROs assessing signs, symptoms, and severity of atopic dermatitis, as well as improved quality of life (QoL) and decreased negative impact on the family after 4 weeks. Improvements were observed in SCORing Atopic Dermatitis (SCORAD) total and component scores (i.e., itch, sleep loss, and dryness intensity) and in disease severity and impact questions (as measured by Patient-Oriented Eczema Measure, or POEM). Additionally, ZORYVE cream 0.05% was well tolerated, with no or minimal irritation at the application site, including after the first application. Outcomes were consistent with those reported for children aged ≥6 years with atopic dermatitis who participated in the 4-week INTEGUMENT-1 and -2 trials.
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
M. Gooderham, et al.
Poster 2754
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.
Recommendations for Approach to Genital Psoriasis Physical Exam, Diagnosis, and Treatment Across Age Groups: A Progress Report from the Genital Psoriasis Wellness Consortium Consensus Panel
M. Payette, et al.
Poster P2402
Lastly, as a follow-up to the Genital Psoriasis Wellness Consortium's earlier work, which previously established expert consensus to support comprehensive genital psoriasis care, a poster outlining recommended approaches for exams, diagnosis, and treatment across age groups—ranging from pediatric and adolescent to adult and geriatric—will be presented at the conference. By integrating best practices in communication, treatment selection, and individualized care, these recommendations aim to improve diagnosis, optimize treatment, and enhance adherence across the lifespan.
"The data being presented at EADV 2025 underscore the versatility, tolerability, and impact of ZORYVE across multiple chronic, immune-mediated skin conditions and diverse age groups and skin types," said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis Biotherapeutics. "At Arcutis, we remain committed to advancing innovative therapies that meaningfully improve the lives of people living with inflammatory skin diseases, and we are proud to share these important results with the dermatology community at this year's EADV Congress."
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 is a next-generation, highly potent, and selective topical phosphodiesterase-4 (PDE4) inhibitor. PDE4, an established target in dermatology, is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators.
ZORYVE (roflumilast) cream 0.3% is approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. ZORYVE (roflumilast) cream 0.15% is approved by the FDA for the topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older. In 2024, ZORYVE cream 0.15% was awarded Glamour's Beauty and Wellness Award for "Eczema Product." ZORYVE (roflumilast) topical foam 0.3% is uniquely formulated for use anywhere on the body, including hair-bearing areas, and is indicated for treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older, as well as seborrheic dermatitis in patients 9 years of age and older. Recently, both ZORYVE cream 0.3% and ZORYVE foam 0.3% were awarded the National Psoriasis Foundation's Seal of Recognition—the first FDA-approved product to receive the honor. Additionally, ZORYVE was awarded by Allure with a prestigious "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.
INDICATIONS
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.
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 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.
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 (≥1%) for ZORYVE foam 0.3% for plaque psoriasis include headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).
The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include 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 (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam.
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.
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 real-world use of ZORYVE and the potential for ZORYVE cream or foam to advance the standard of care in atopic dermatitis, seborrheic 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, 2025, 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
[email protected]
Investors
Brian Schoelkopf, Head of Investor Relations
[email protected]
