Researchers of a phase 2a clinical trial conducted across 24 sites in the United States and Canada focused on the evaluation of roflumilast foam, 0.3%, as a potential treatment for seborrheic dermatitis, involving adult patients (aged ≥18 years) with a clinical diagnosis of seborrheic dermatitis for a duration of three months or longer. Participants had an Investigator Global Assessment score of 3 or greater, indicating at least a moderate severity, and the affected area was 20% or less of their body surface, including the scalp, face, trunk, and/or intertriginous areas.
Analysis of the data showed that the nonsteroidal roflumilast foam, 0.3%, administered once daily, demonstrated efficacy in treating erythema (redness), scaling, and itch associated with seborrheic dermatitis. Furthermore, the treatment showed favorable local tolerability, suggesting that it is well-tolerated by the patients. These findings suggest that roflumilast foam, 0.3%, has the potential to address the existing need for an effective and cosmetically acceptable treatment for seborrheic dermatitis.
Reference: 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 [published online ahead of print, 2023 May 3]. JAMA Dermatol. 2023;e230846. doi:10.1001/jamadermatol.2023.0846
Link: https://jamanetwork.com/journals/jamadermatology/fullarticle/2804569?resultClick=1