Study: Important to weigh berdazimer gel benefits vs. risks in molluscum contagiosum

Key takeaways:

• After 8 weeks, more berdazimer-treated patients experienced lesion clearance vs. controls (17% vs. 10%).
• Berdazimer gel was associated with a higher incidence of application site adverse reactions.

Berdazimer gel benefits and risks should be considered when contemplating its usage for the treatment of molluscum contagiosum, according to a study.

“Molluscum contagiosum (MC) is a dermatological infection caused by a contagious double-stranded DNA virus that is transmitted through direct skin-to-skin contact,” Izabela Pera Calvi, MD, of the division of medicine at Immanuel Kant Baltic Federal University in Kaliningrad, Russia, and colleagues wrote. “Berdazimer free base gel 10.3%, referred to as berdazimer sodium 12% gel (SB206; Novan Inc.), is a topical agent under investigation as a potential therapy for treating MC.”

Berdazimer works by promoting a local release of nitric oxide, which may act as an antiviral in the treatment of MC. To evaluate the effects of berdazimer on MC, researchers conducted a meta-analysis, which included three reports and four randomized controlled trials totaling 1,854 patients, 59.6% of whom received berdazimer gel.

Results showed that 17% of the berdazimer group experienced complete lesion clearance compared with 10% of the control group after 8 weeks (RR = 1.73; 95% CI, 1.33-2.25). Similar results were seen between the berdazimer and control group at 12 weeks (30% vs. 20%; RR = 1.54; 95% CI, 1.3-1.83).

Additionally, a smaller proportion of patients using berdazimer gel experienced scarring from MC lesions compared with the control group (4% vs. 7%; RR = 0.59; 95% CI, 0.39-0.9).

On the other hand, berdazimer gel was associated with a higher incidence of application site adverse reactions, including erythema (12% vs. 1%; RR = 8.6; 95% CI, 4.52-16.35), exfoliation (5% vs. 0%; RR = 20.46; 95% CI, 5.17-81.05), pain (18% vs. 4%; RR = 3.99; 95% CI, 2.78-5.73), pruritus (6% vs. 1%; RR = 5.59; 95% CI, 2.7-11.61), dermatitis (5% vs. 1%; RR = 6.47; 95% CI, 2.61-16.01) and swelling (5% vs. 3%; RR = 2.06; 95% CI, 1.19-3.56).

“MC is a self-limiting condition that often resolves spontaneously, leading to an unsettled debate on whether active treatment is necessary and, if needed, which is the best approach,” the authors said.

Other potential therapies for MC include cryotherapy and curettage, however, their efficacies have not been clinically evaluated and compared with berdazimer in studies.

While many allow the condition to self-resolve, others are affected by the discomfort, spread and even stigma that the disease causes. According to the authors, berdazimer gel’s ability to quickly resolve MC and mitigate the risk for scarring must be weighed against the possible safety risks.

While berdazimer gel is not yet approved for the treatment of MC, the FDA accepted its new drug application in March of this year and has set a Prescription Drug User Fee Act goal date of Jan. 5, 2024.