STRATUM Trial: Roflumilast Foam Works Across Skin Types, With Raj Chovatiya, MD, PhD

Use of roflumilast foam 0.3% (Zoryve) was associated with significant improvements in seborrheic dermatitis symptoms, itch relief, and pigmentation across diverse patient populations, regardless of race, ethnicity, or skin type, according to a new analysis of the pivotal STRATUM trial.

Presented at the European Association of Dermatology and Venereology (EADV) 2025 Congress, the results offer clinicians insight into the potential effects of roflumilast foam 0.3% among this heterogeneous patient population.

“What's been a really fun journey over the past few years has really been understanding and exploring seborrheic dermatitis, one of the more common chronic inflammatory skin diseases we see, but not something that necessarily gets the same spotlight as atopic dermatitis or psoriasis,” Raj Chovatiya, MD, PhD, dermatologist and clinical associate professor at Rosalind Franklin University Chicago Medical School, founder and director of the Center for Medical Dermatology and Immunology Research in Chicago, in an interview with HCPLive. "And really the approval of roflumilast foam has really, [and] I don't use this word often, been a game changer for that disease state, given that we just haven't really had much in the way of targeted treatment for this particular disease.”

Approved by the US Food and Drug Administration in July 2023 for seborrheic dermatitis, roflumilast foam 0.3%, a highly potent phosphodiesterase-4 inhibitor from Arcutis Biotherapeutics, was evaluated in the phase 3 STRATUM trial which compared its efficacy and safety with vehicle foam in patients aged 9 years or older with moderate-to-severe seborrheic dermatitis. Eligible patients had stable disease for at least 4 weeks, Investigator Global Assessment (IGA) scores ≥3, and moderate-to-severe erythema and scaling at baseline.

The primary endpoint was IGA success, which is defined as achieving clear/almost clear (0/1) with at least a 2-point improvement, at week 8. Secondary endpoints included improvements in itch (Worst Itch-Numeric Rating Scale [WI-NRS]), scaling, erythema, pigmentation changes, and safety. Outcomes were assessed across subgroups by race, ethnicity, and Fitzpatrick skin type (FST).

A total of 457 patients participated, including 356 who self-identified as White, 51 as Black/African American, 97 as Hispanic/Latino, and 50 as other races. Stratification by FST resulted in cohorts of 330 patients with type I–III and 127 with type IV–VI.

By week 8, significantly greater proportions of patients treated with roflumilast foam versus vehicle achieved IGA success overall (79.5% vs 58.0%) and across subgroups, with response rates consistent among White (80.3% vs 57.2%), Black/African American (71.5% vs 59.4%), and other racial groups (82.0% vs 62.5%). Similar trends were observed across ethnicity and FST groups, with patients of darker skin types (IV–VI) achieving comparable outcomes (76.3% vs 66.4%).

For WI-NRS success, 62.8% of roflumilast-treated patients achieved ≥4-point itch reduction compared with 40.6% in the vehicle group. Again, efficacy was consistent across racial, ethnic, and FST subgroups, with notable improvements among patients with skin of color (69.5% vs 43.5% for FST IV–VI). Similar improvements were observed in scaling and erythema resolution.

Investigators pointed out pigmentary changes improved during treatment. Among patients with hypopigmentation at baseline, 57.1% of White patients and 80.0% of non-White patients experienced partial or complete improvement by week 8. For hyperpigmentation, rates were 75.0% and 55.6%, respectively, by week 8.

Roflumilast foam 0.3% was well tolerated, with most treatment-emergent adverse events classified as mild or moderate. Overall, treatment-related adverse events observed in 2.6% of patients in the roflumilast group compared with 3.3% in the vehicle group.

Relevant disclosures for Chovatiya include AbbVie, Amgen, AnaptysBio, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, CLn Skin Care, Dermavant, Eli Lilly, EMD Serono, FIDE, Formation Bio, Galderma, Genentech, GSK, Incyte, LEO Pharma, L'Oréal, Nektar Therapeutics, Novartis, Opsidio, Pfizer, RAPT, Regeneron, Sanofi, Sitryx, Takeda, TRex Bio, and UCB.

References:

1. Chovatiya R. Roflumilast foam 0.3% for the treatment of seborrheic dermatitis in patients with diverse skin types: subgroup analyses of the phase 3 STRATUM trial. Presented at the European Association of Dermatology and Venereology (EADV) 2025 Congress. Paris, France. September 17-20, 2025.

2. Arcutis Biotherapeutics. FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older. Arcutis Biotherapeutics. Published December 15, 2023. Accessed September 18, 2025. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-topical-foam-0-3-for-the-treatment-of-seborrheic-dermatitis-in-individuals-aged-9-years-and-older/