Berdazimer gel reduces molluscum contagiosum lesions in children

An analysis of three randomized controlled trials (RCTs) has shown the efficacy and safety of berdazimer gel, a topical, antiviral, nitric oxide-releasing medication, in the treatment of molluscum contagiosum (MC) lesions in patients aged 6 months and older. Application-site pain and erythema are the most common adverse events (AEs) related to treatment.

“If approved, berdazimer gel 10.3% has the potential to significantly change clinical practice approach as the first self- or caregiver-applied topical prescription medication indicated for MC,” the researchers said.

In the said trials, patients ≥6 months with 3-70 mollusca applied berdazimer gel 10.3% or vehicle once daily to all MC lesions for 12 weeks. Efficacy was evaluated by the number of patients achieving either complete or partial lesion clearance at week 12. In terms of safety, the researchers assessed AEs through week 24 and local skin reactions through week 12.

A total of 1,598 patients were included, of whom 917 received berdazimer and 681 vehicle. At week 12, berdazimer achieved better complete clearance rates than vehicle (30.0 percent vs 19.8 percent; odds ratio, 1.75, 95 percent confidence interval, 1.38-2.23; p<0.001). [J Am Acad Dermatol 2024;90:299-308]

The favourable efficacy for berdazimer was consistent across most subgroups, including age, sex, baseline lesion count, and disease duration. Likewise, berdazimer delivered positive outcomes for partial clearance.

For safety, the most common AEs reported were local skin reactions, such as application-site pain (18.7 percent vs 4.8 percent) and erythema (11.7 percent vs 1.3 percent), most of which were mild to moderate in severity.

Three trials

The first two RCTs assessing the efficacy of berdazimer gel, B-SIMPLE 1 and 2, found a consistent positive efficacy trend but did not achieve significance for the primary endpoint. To address this, B-SIMPLE 4 was carried out as the pivotal study. [JAMA Dermatol 2022;158:871-878; https://clinicaltrials.gov/study/NCT03927716?cond=mollusucum&term=Novan&rank=4&tab=results; https://clinicaltrials.gov/study/NCT03927703?cond=mollusucum&term=Novan&rank=3&tab=results]

“In this integrated analysis, topical berdazimer gel 10.3% applied once daily to MC lesions was statistically superior to vehicle in achieving complete clearance after 12 weeks of treatment, consistent with B-SIMPLE 4,” the researchers said. “A significant treatment effect was demonstrated as early as week 4.”

In subgroup analyses, however, some patients such as Black or African Americans and those aged 12 to <18 years fell short of achieving complete clearance at week 12.

“About two-thirds of integrated study patients had a MC duration from onset of symptoms of ≥6 months with the average time since onset [of] 12 months,” the researchers said. “Favourable lesion clearance occurred in the berdazimer group regardless of duration of onset of MC symptoms, suggesting increased treatment effect over vehicle.”

This study was limited by the enrolment of patients from the US only and the absence of formal efficacy or safety assessments beyond week 12.

In addition, “[a]lthough antiviral effects of berdazimer have been demonstrated, the exact mechanism of action in the treatment of MC is unknown,” according to the researchers. [J Am Acad Dermatol 2020;82:887-894; JID Innov 2021;1100019; J Drugs Dermatol 2018;17:1100-1105]