FDA Alert

Topical Treatment for Molluscum Contagiosum in Adults, Children Approved by FDA

Jessica Ganga

The FDA has approved the first treatment for molluscum contagiosum in adults and pediatric patients aged 2 years and older. Cantharidin is a topical treatment that can be used on the skin and is administered to patients only by their health care providers.

Molluscum contagiosum is a viral skin infection that causes white, pink, or flesh-colored bumps to appear on the skin that may itch or become irritated. The bumps can happen alone or in groups anywhere on a person’s skin.

The approval of cantharidin follows two double-blind, randomized, placebo-controlled trials that tested the efficacy of treatment. In total, 528 participants aged 2 years to 60 years old with molluscum contagiosum were randomized to receive either treatment with cantharidin or placebo. Participants received treatment at 21-day intervals until bumps on the skin were completely cleared or for a maximum of four applications.

Overall, 54% of subjects treated with cantharidin achieved complete clearance of all treated molluscum bumps by day 84—the primary efficacy endpoint. This result was compared to the 13% of subjects treated with placebo that achieved the same endpoint.

The most common adverse events to cantharidin at the application site included blistering, pain, itching, scabbing, reddening, discoloration, dryness, swelling, and erosion of the skin. The treatment should not be administered orally as life-threatening or fatal toxicities may occur.



FDA approves first treatment for molluscum contagiosum. News release. US Food and Drug Administration; July 24, 2023. Accessed July 26, 2023.