Roflumilast Foam 0.3% in Seborrheic Dermatitis: Clinical Trials and Long-Term Outcomes

In Roflumilast Foam 0.3% in Seborrheic Dermatitis: Clinical Trials and Long-Term Outcomes, our panel delves into the following critical questions:

Roflumilast foam 0.3% was recently approved for treatment of SD by the FDA in adolescents and adults. Please describe the design and patient populations in the phase 2 open-label extension and the phase 3 trials.

What are your impressions of the long term efficacy as measured by Investigator Global Assessment (IGA), in patients receiving roflumilast foam 0.3% in both the phase 2-OLE and the phase 3 trials?

Based on the Phase 3 and long-term extension data for roflumilast foam 0.3% (Alexis 2025; Blauvelt 2024), what are your perceptions of its tolerability and safety profile, and how does this align with what you are seeing in your own clinical practice?

Led by Dr. Bunick, Dr. Ungar discusses roflumilast foam 0.3%, which was recently FDA-approved for adolescents and adults with seborrheic dermatitis, following evaluation in both a phase 2 open-label extension (OLE) and the phase 3 STRATUM trial. The phase 2 OLE enrolled patients who had completed earlier studies, allowing assessment of long-term efficacy and safety over 52 weeks in a real-world-like population with moderate-to-severe SD. The phase 3 STRATUM trial included a broader patient population and compared roflumilast foam to vehicle, evaluating short-term efficacy and tolerability in controlled conditions. In the phase 2 OLE, Investigator Global Assessment (IGA) scores showed that 76.0% of patients achieved “clear or almost clear” at week 24, increasing to 80.4% at week 52, demonstrating sustained long-term efficacy. In the phase 3 STRATUM trial, IGA success was observed in 43.0% of patients at week 2 and 73.1% at week 4, compared with 25.7% and 47.1% in the vehicle group, respectively, highlighting rapid improvement. Both trials reported a favorable tolerability and safety profile, with adverse events generally mild and consistent with expectations for topical therapy. These findings align with clinical experience, where roflumilast foam is well-tolerated for both short-term flares and long-term management. Overall, the data support roflumilast foam as an effective, durable, and safe non-steroidal option for patients with SD.

Throughout the conversation, the experts provide a comprehensive reflection on the field and the factors that may shape how clinicians approach care moving forward.

Our next episode, Emerging Non-Steroidal Therapies and Long-Term Management of Seborrheic Dermatitis, expert dermatologists further explore promising non-steroidal therapies under investigation, including crisaborole and ruxolitinib, and their potential to improve inflammation control and disease outcomes in seborrheic dermatitis. It also examines how adverse-event profiles of topical steroids, antifungals, and non-steroidal agents influence treatment persistence and informs strategies for long-term management, particularly in patients with recurrent or difficult-to-control disease.