Roflumilast Foam Shows Long-Term Safety in Seborrheic Dermatitis

Seborrheic dermatitis (SD), a chronic and relapsing inflammatory condition of multifactorial origin, continues to present challenges in achieving durable long-term disease control. Topical antifungals, corticosteroids, and keratolytic agents are mainstays of therapy, yet limitations related to tolerability, adherence, and chronic use persist.¹

Roflumilast foam 0.3% is a topical phosphodiesterase type 4 (PDE4) inhibitor formulated for use across hair-bearing and intertriginous areas. The US FDA approved roflumilast foam for the treatment of seborrheic dermatitis in patients aged 9 years and older in December 2023, and subsequently for scalp and body plaque psoriasis in patients aged 12 years and older in 2025.^2-3

Study Design

The recently published phase 2 OLE study enrolled 400 participants aged ≥12 years with moderate to severe SD. Participants either rolled over from a prior double-blind phase 2 trial or were treatment-naïve. All participants applied roflumilast foam 0.3% once daily to all affected areas. Treatment could be paused upon disease clearance (Investigator Global Assessment [IGA] = 0) and restarted upon relapse. Of the total cohort, 338 individuals completed 24 weeks, and 62 continued through 52 weeks.⁴

The study’s primary endpoint was safety, with secondary endpoints assessing local tolerability, investigator- and patient-reported outcomes, and sustained efficacy over time.

Safety and Tolerability

Treatment-emergent adverse events (TEAEs) were reported in 130 participants (32.5%). The most common TEAE was COVID-19 (3.8%), followed by headache (3.3%). Seven participants (1.8%) experienced serious adverse events, none of which were treatment-related. Five participants (1.3%) discontinued due to adverse events.

Local tolerability was favorable: ≥96% of participants exhibited no local irritation per investigator assessment, and ≤1.1% reported stinging at the application site. Among those with baseline pigmentary changes, most demonstrated full resolution by study completion.

Efficacy Outcomes

Researchers found roflumilast foam demonstrated durable efficacy over the study duration. At week 4, 56.4% of evaluable participants achieved IGA of Clear or Almost Clear (0 or 1), increasing to 76% at week 24 and 80.4% at week 52. Among participants completing 52 weeks, 52.2% achieved complete clearance (IGA = 0).

Sustained reductions in erythema and scaling were also observed throughout treatment. Pruritus, a hallmark symptom of SD, improved substantially: among participants with baseline Worst Itch Numeric Rating Scale ≥4, 71.3% achieved a ≥4-point reduction by week 24, and 58.1% maintained this improvement through week 52.

Clinical Implications

The long-term safety data support the chronic use of topical roflumilast foam 0.3% in seborrheic dermatitis, a disease that often requires continuous or intermittent management. The observed tolerability profile is notable given the frequent involvement of sensitive and hair-bearing areas, where steroid-sparing alternatives are often desired.

“In my practice, I often see individuals with SD struggling with persistent itching, redness, and scaling in visible areas like the scalp, face, and chest. For many, this chronic condition is not only uncomfortable but also affects their self-esteem and quality of life,” said Andrew Alexis, MD, MPH, New York-based dermatologist and lead author of the paper, in a news release. “While topical antifungals, topical corticosteroids, and medicated shampoos are often used, these treatment routines can be complex and often fall short of desired patient outcomes. [roflumilast] foam represents a meaningful advancement for individuals living with this burdensome disease.”

From a mechanistic perspective, roflumilast inhibits PDE4, leading to reduced production of pro-inflammatory mediators such as TNF-α and IL-17, and restoration of epidermal immune balance. The drug represents the first topical agent with a novel mechanism of action approved for seborrheic dermatitis in over 2 decades.

Conclusion

The phase 2 OLE data reinforce that roflumilast foam 0.3% offers sustained efficacy and a favorable long-term safety profile for up to 52 weeks in patients with moderate to severe seborrheic dermatitis. The results support its role as a steroid-sparing, once-daily therapeutic option suitable for long-term disease control.

For clinicians managing seborrheic dermatitis, these findings provide evidence-based reassurance regarding chronic use of a PDE4 inhibitor topical formulation, addressing an unmet need for effective, well-tolerated, and patient-friendly treatment options.

References

1. LeFevre NM, Braudis K, Feigenbaum LS. Seborrheic Dermatitis: Diagnosis and Treatment. Am Fam Physician. 2025;112(2):166-173.

2. Zirwas MJ, Draelos ZD, DuBois J, et al. Efficacy of roflumilast foam, 0.3%, in patients With seborrheic dermatitis: A double-blind, vehicle-controlled phase 2a randomized clinical trial. JAMA Dermatol. 2023;159(6):613-620. doi:10.1001/jamadermatol.2023.0846

3. Gooderham MJ, Alonso-Llamazares J, Bagel J, et al. Roflumilast foam, 0.3%, for psoriasis of the scalp and body: The ARRECTOR phase 3 randomized clinical trial. JAMA Dermatol. 2025;161(7):698-706. doi:10.1001/jamadermatol.2025.1136

4. Arcutis announces publication of positive long-term safety and efficacy data of ZORYVE® (roflumilast) foam 0.3% in individuals with seborrheic dermatitis in American Journal of Clinical Dermatology. News release. Arcutis Biotherapeutics. Published November 4, 2025. Accessed November 5, 2025. https://investors.arcutis.com/news-releases/news-release-details/arcutis-announces-publication-positive-long-term-safety-and