Topical berdazimer gel safe and effective therapy for molluscum contagiosum: JAMA

Molluscum contagiosum (MC) is a highly contagious skin condition. Lesions may persist for months to years, and no US Food and Drug Administration–approved medications are currently available in the US.

A study was conducted to assess the efficacy and safety of berdazimer gel, 10.3%, a novel topical nitric oxide-releasing medication, in the treatment of Molluscum contagiosum.

This was a multicenter, vehicle-controlled, double-blind, phase 3 randomized clinical trial (B-SIMPLE4) conducted in 55 clinics (mostly dermatology and pediatric) in the US from September 1, 2020, to July 21, 2021. Eligible participants were 6 months or older and had from 3 to 70 raised MC lesions. Patients with sexually transmitted Molluscum contagiosum or with Molluscum contagiosum only in the periocular area were excluded.

Patients were randomized to treatment with berdazimer gel, 10.3%, or vehicle gel, applied as a thin layer to all lesions once daily for 12 weeks. The primary efficacy end point was complete clearance of all MC lesions at week 12. Safety and tolerability measures included adverse event frequency and severity, and assessment of local skin reactions and scarring. Data analyses were performed from August 31, 2021, to September 14, 2021.

The Results of the study are:

• A total of 891 participants were randomized, 444 to berdazimer, 10.3% and 447 to vehicle
• In the intention-to-treat population, 88.5% (393 patients) in the berdazimer group and 88.8% in the vehicle group had a lesion count performed at week 12.
• At week 12, 32.4% (144 patients) in the berdazimer group achieved complete clearance of MC lesions compared with 19.7% (88 patients) in the vehicle group with 14.4% (64 patients) of the berdazimer group discontinuing treatment because of Molluscum contagiosum clearance compared with 8.9% (40 patients) of the vehicle group.
• Adverse event rates were low.
• The most common adverse events were application-site pain and erythema, mostly mild in severity. Adverse events leading to discontinuation affected 4.1% (18 patients) of the berdazimer group and 0.7% (3 patients) of the vehicle group.
• The most common local skin reaction was mild to moderate erythema.

Thus, use of berdazimer gel, 10.3%, for MC appears to demonstrate favorable efficacy and safety with low adverse event rates.

Reference:

Browning JC, Enloe C, Cartwright M, et al. Efficacy and Safety of Topical Nitric Oxide−Releasing Berdazimer Gel in Patients With Molluscum Contagiosum: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. Published online July 13, 2022. doi:10.1001/jamadermatol.2022.2721

Keywords:

Efficacy, Safety, Topical, Nitric Oxide, Releasing, Berdazimer, Gel, Patients, Molluscum, Contagiosum, jama dermatology, John C. Browning, Carolyn Enloe, Martina Cartwright, Adelaide Hebert, Amy S. Paller, David Hebert, Elaine Kearney Kowalewski, Tomoko Maeda-Chubachi