Roflumilast in seborrheic dermatitis: Review

Seborrheic dermatitis (SD) is a chronic skin condition that can significantly impact patients’ quality of life. While topical antifungals and corticosteroids are often used, they frequently provide only a partial response or may lead to side effects with long-term use. The objective of our study was to evaluate the efficacy and safety of topical phosphodiesterase-4 inhibitor (0.3% roflumilast foam [ROF]) in the treatment of SD. We conducted a comprehensive literature search in PubMed, Embase, Scopus, and Cochrane databases until May 2024. Our inclusion criteria were randomized, non-randomized, and open-label trials that compared ROF with a control; patients with SD treated with ROF; and reported relevant outcomes. We excluded studies with overlapping populations. The risk of bias was assessed using Cochrane’s guidelines. R programming was used to evaluate the risk ratio using a random-effects model and assess heterogeneity. Our analysis included three studies comprising a total of 1083 patients. The pooled results at week 4 showed that 53.64% (95% CI, 30.25%–77.03%; p = 0.88; I 2 = 98%) of patients in the ROF group achieved Investigator Global Assessment success, and 53.91% (95% CI, 47.40%–60.43%; p = 0.55; I 2 = 72%) achieved Worst Itch Numeric Rating Scale success. Furthermore, a subgroup analysis of randomized controlled trials (RCTs) was performed, which reduced the heterogeneity and demonstrated the significant efficacy of ROF in the treatment of SD. The key limitations of our study were the short follow-up period and the high degree of heterogeneity in our pooled analysis. We concluded that ROF shows promise for the treatment of SD, but further RCTs with extended follow-up periods are needed to fully evaluate its efficacy. This review was prospectively registered on PROSPERO (ID-CRD42024546079) and was conducted without any funding support.