BACKGROUND: Although a variety of ablative, topical, and systemic therapies are used for molluscum contagiosum (MC), none has been well studied or approved by the US Food and Drug Administration. OBJECTIVES: To compare the efficacy and tolerability of topical SB206 (berdazimer sodium gel coadministered with hydrogel) with vehicle. METHODS: A 12-week, phase 2, multicenter, randomized, double-blind, vehicle-controlled clinical trial of topical SB206. RESULTS: A total of 256 patients (mean age, approximately 7 years) participated. Of patients who completed 12 weeks of treatment (n = 217), all MC lesions cleared in 20.0% of patients who received vehicle compared with 13.2%, 41.0%, and 35.1% of patients treated with twice daily SB206 4%, 8%, and 12%, respectively, and 41.9% of patients treated with once daily SB206 12%. Application-site erythema occurred in 10.6% of patients treated with SB206. Application-site reactions were the most common adverse events leading to treatment discontinuation, affecting 2 patients (approximately 4%) in each of the SB206 4%, 8%, and 12% twice daily groups and 0 patients in the vehicle or SB206 12% once daily groups. LIMITATIONS: A larger study is needed to confirm the efficacy of SB206 12% once daily and provide additional safety assessments. CONCLUSION: Of the doses studied, SB206 12% applied once daily provided the best balance between MC lesion clearance and tolerability for evaluation in a larger study.
RCT Entities:
BACKGROUND: Although a variety of ablative, topical, and systemic therapies are used for molluscum contagiosum (MC), none has been well studied or approved by the US Food and Drug Administration. OBJECTIVES: To compare the efficacy and tolerability of topical SB206 (berdazimer sodium gel coadministered with hydrogel) with vehicle. METHODS: A 12-week, phase 2, multicenter, randomized, double-blind, vehicle-controlled clinical trial of topical SB206. RESULTS: A total of 256 patients (mean age, approximately 7 years) participated. Of patients who completed 12 weeks of treatment (n = 217), all MC lesions cleared in 20.0% of patients who received vehicle compared with 13.2%, 41.0%, and 35.1% of patients treated with twice daily SB206 4%, 8%, and 12%, respectively, and 41.9% of patients treated with once daily SB206 12%. Application-site erythema occurred in 10.6% of patients treated with SB206. Application-site reactions were the most common adverse events leading to treatment discontinuation, affecting 2 patients (approximately 4%) in each of the SB206 4%, 8%, and 12% twice daily groups and 0 patients in the vehicle or SB206 12% once daily groups. LIMITATIONS: A larger study is needed to confirm the efficacy of SB206 12% once daily and provide additional safety assessments. CONCLUSION: Of the doses studied, SB206 12% applied once daily provided the best balance between MC lesion clearance and tolerability for evaluation in a larger study.
Authors: Francesco Lacarrubba; Giuseppe Micali; Andrea Calogero Trecarichi; Enrica Quattrocchi; Giuseppe Monfrecola; Anna Elisa Verzì Journal: Dermatol Ther (Heidelb) Date: 2022-10-14