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.
The study examined the effectiveness and safety of berdazimer gel, a topical antiviral treatment, in controlling molluscum contagiosum (MC) infections in patients with and without atopic dermatitis (AD).
It involved a combined analysis of three Phase 3 clinical trials, where patients applied berdazimer or a placebo daily for 12 weeks, measuring the complete clearance of lesions as the primary outcome.
Results indicated higher clearance rates for berdazimer compared to the placebo in both subgroups, though some application-site adverse effects were noted, particularly in patients with concurrent AD.
An out-of-office treatment for molluscum contagiosum is needed, and this study evaluates the effectiveness and safety of berdazimer gel, 10.3%, compared to a placebo vehicle over 12 weeks.
A total of 1,598 patients participated, with berdazimer showing a significantly higher complete clearance rate (30.0%) compared to the vehicle (19.8%), and it was effective across various subgroups.
While berdazimer demonstrated positive outcomes, it also caused mild to moderate local skin reactions, like pain and redness, and the study's limitations included a focus only on US patients and no follow-up beyond 12 weeks.
Berdazimer gel (10.3%) is a new topical treatment designed for molluscum contagiosum (MC), a common skin infection, and was tested for safety and effectiveness in a 12-week study.
The trial involved 34 patients aged 2 to 12 years, most having around 50 MC lesions, and found that the gel had minimal systemic absorption with only mild adverse effects reported.
Overall, the gel was considered well-tolerated, showing promising results without significant complications or high absorption rates.