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To investigate the clinical efficacy and safety of topical difamilast in mild-to-moderate atopic dermatitis (AD). Only randomized controlled trials (RCTs) that compared topical difamilast with vehicle treatment for patients with AD were included. PubMed, Web of Science, Ovid Medline, Cochrane Library, ClinicalTrials.gov and JapicCTI were searched to 10 April 2022. Five studies enrolling a total of 1009 patients with mild-to-moderate AD were identified. Compared with the topical vehicle, topical difamilast was associated with a significantly higher success rate according to the Investigator’s Global Assessment score at week 4 (relative risk, 2.82; 95% confidence interval [CI]: 2.11–3.77). Compared with the vehicle, difamilast was associated with a significant decrease in day 28 eczema area and severity index scores (mean difference [MD], −4.10; 95% CI: −5.32 to −2.87), verbal rating scale scores (MD, −0.51; 95% CI: −0.71 to −0.32), visual analog scale scores (MD, −12.15; 95% CI: −19.70 to −4.61), patient-oriented eczema measure values (MD, −3.99; 95% CI: −4.91 to −3.07), and total affected body surface area (MD, −6.48; 95% CI: −8.09 to −4.87). No difference in treatment-related adverse events was identified. This meta-analysis suggests that topical difamilast is an effective and safe treatment for mild-to-moderate AD.

expert review of clinical pharmacology

Clinical efficacy and safety of topical difamilast in the treatment of patients with atopic dermatitis: a systematic review and meta-analysis of randomized controlled trials