JAMA Dermatol

Roflumilast foam improves scalp and body psoriasis symptoms

May 12, 2025

Roflumilast foam, 0.3%, is effective in improving signs and symptoms of psoriasis on the scalp and body, including pruritus, with low rates of adverse events. These findings suggest that roflumilast foam could be a valuable monotherapy for patients with psoriasis.

Study details: The phase 3 randomized ARRECTO trial (NCT05028582) was conducted at 49 sites in Canada and the U.S. and included 432 participants ≥12 years with plaque psoriasis affecting up to 25% of the scalp and body. Participants were randomized to receive either roflumilast foam, 0.3%, or vehicle foam daily for 8 weeks. The primary endpoints were Scalp-Investigator Global Assessment (S-IGA) and Body-IGA (B-IGA) success at week 8.

Results: At week 8, 66.4% of patients in the roflumilast group achieved S-IGA success compared with 27.8% in the vehicle group (P < .001). Additionally, 45.5% of the roflumilast group achieved B-IGA success vs. 20.1% in the vehicle group (P < .001). Significant improvements were observed as early as 24 hours after the first application. Both groups had low rates of adverse events, with roflumilast demonstrating a favorable tolerability profile.

Source:

Gooderham MJ, et al. (2025, May 7). JAMA Dermatol. Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial. https://pubmed.ncbi.nlm.nih.gov/40332898/