Abstract
BACKGROUND: Molluscum contagiosum (MC) is a contagious viral skin infection. Berdazimer gel, 10.3% (SB206 12%) is approved in the United States as the first topical, at-home MC prescription medication. OBJECTIVE: To assess safety and tolerability of SB206 12% in Japanese patients with MC. METHODS: SKN15B01 (JRCT2031230123) was a phase 2, multicenter, single-group, open-label study in Japanese patients ≥2 years old with 3-70 baseline MC lesions. Patients with only periocular MC and/or immunosuppression were excluded. SB206 12% was applied once daily to lesions for 12 weeks. Safety endpoints included adverse events and local skin reactions. Exploratory efficacy endpoints included percentage of patients with complete lesion clearance and lesion count percent change from baseline. RESULTS: Twenty patients (12 males, 8 females) with mean (range) age of 5.2 (3-13) years and mean (range) baseline lesion counts of 22.5 (8-44). Complete clearance and percent change from baseline at week 12 were 60% and -89.2%, respectively. The most common treatment-related adverse events were application site-erythema (25%, n = 5), -pain (25%, n = 5), -pruritis (25%, n = 5), and -dermatitis (20%, n = 4), all mild/moderate in severity. LIMITATIONS: Single-group study; small sample size. CONCLUSION: Safety and efficacy of berdazimer gel, 10.3% in Japanese patients were favorable and consistent with previous studies.