Roflumilast Foam 0.3% Demonstrates Favorable Pigmentation Profile in Seborrheic Dermatitis

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Presented at the 2025 Society of Dermatology Physician Associates (SDPA) Annual Summer Dermatology Conference, a poster¹ highlighted results from the pivotal phase 3 STRATUM trial (NCT04973228)² examining the safety, pigmentation outcomes, and efficacy of roflumilast foam 0.3% (Zoryve; Arcutis Biotherapeutics, Inc) in patients with seborrheic dermatitis.

Led by Andrew Alexis, MD, MPH, and a team of clinical investigators, the trial built on earlier findings supporting the therapy's 2023 approval from the FDA³ by assessing not just clinical clearance but also the impact of treatment on pigmentary changes, particularly in patients with skin of color. Prior safety data from a long-term phase 2 trial suggested that pigmentation abnormalities often resolved over time with treatment, prompting further investigation in the STRATUM trial.

The STRATUM trial enrolled 457 patients aged 9 years and older with at least moderate seborrheic dermatitis affecting the scalp and/or non-scalp areas. Participants were randomized in a 2:1 ratio to receive either roflumilast foam 0.3% (n=304) or vehicle foam (n=153), applied once daily for 8 weeks.

At week 8, significantly more patients treated with roflumilast achieved Investigator's Global Assessment success compared to vehicle. Superior outcomes for roflumilast were also seen as early as week 2 and continued through week 4.

Furthermore, roflumilast foam 0.3% was well tolerated. Any reported treatment-emergent adverse events (TEAEs) occurred in 23.0% of roflumilast-treated patients vs 21.6% in the vehicle group. Treatment-related TEAEs were infrequent (2.6% vs 3.3%). Only 1 serious adverse event was reported in the roflumilast treatment group (keratoacanthoma), which was deemed unrelated. Discontinuations due to AEs were rare: 0.7% (roflumilast) and 2.0% (vehicle).

Commonly-reported AEs included COVID-19 (3.6% in roflumilast group vs 3.3% in vehicle), nausea 1.6% in roflumilast group vs 0% in vehicle), and UTI or nasopharyngitis, each of which occurred in >1% of patients.

Although dyspigmentation was uncommon overall, the study paid particular attention to this endpoint due to its clinical relevance.

Hypopigmentation at baseline was observed in 4.2% (19/457) of patients. It was more common in non-white patients (9.9%) compared to white patients (2.5%). Of 17 evaluable patients with baseline hypopigmentation, 64.7% achieved full resolution by week 8.

Hyperpigmentation was present at baseline in 3.5% (16/457) of patients. Again, it was observably more common in non-white patients (9.9%) versus white patients (1.7%). Of 13 evaluable patients, 46.2% had full resolution at week 8.

At the end of the 8-week treatment period, 98.3% of patients with hypopigmentation showed either no change or improvement, and 99.5% of patients with hyperpigmentation showed no change or improvement.

Only 7 new pigmentary events occurred during the trial, including 1 new case of hypopigmentation (white patient) and 6 cases of hyperpigmentation (4 white, 2 Black or African American).

These findings complement prior long-term safety data supporting roflumilast foam 0.3% as a reliable treatment option for seborrheic dermatitis, with the potential to improve both visible symptoms and related pigmentary concerns over time.

References

1. Alexis AF, Blauvelt A, Forman SB, et al. Safety and pigmentation changes from a phase 3 trial of roflumilast foam 0.3% in patients with seborrheic dermatitis (STRATUM). Poster presented at: Society of Dermatology Physician Associates (SDPA) 2025 Annual Summer Dermatology Conference; June 26-29, 2025; Washington, DC.
2. Trial of PDE4 inhibition with roflumilast (ARQ-154) foam 0.3% for the management of seborrheic dermatitis (STRATUM). ClinicalTrials.gov. Updated March 12, 2024. Accessed June 29, 2025. https://clinicaltrials.gov/study/NCT04973228
3. FDA approves Arcutis’ ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals aged 9 years and older. News release. Arcutis Biotherapeutics. December 15, 2023. Accessed June 29, 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/

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