Once daily Topical berdazimer a novel approach for treating Molluscum contagiosum: JAMA

USA: Berdazimer gel, a novel topical nitric oxide-releasing medication, demonstrated favourable efficacy and safety in patients with molluscum contagiosum (MC), states a phase 3 randomized clinical trial data published in the JAMA Dermatology.

Globally, the incidence of molluscum contagiosum (MC) is estimated to be between 2% and 8% with the greatest among children 1 to 14 years of age. Highly contagious, MC is a viral infection that may persist for months to years, with lesions appearing and/or spreading to different areas of the body over time, generating a substantial health care burden and quality-of-life concerns. Thus, control of lesion persistence and spread is a cornerstone of therapeutic success and is indicated by complete lesion clearance. Available treatment options may require multiple clinic visits and may be painful. Nitric oxide functions as both a short-lived immune modulator and a direct broad-spectrum antimicrobial agent to provide localized immunity against foreign organisms. Berdazimer gel, 10.3% (SB206; Novan Inc) topical nitric oxide-releasing agent is under investigation as a first-in-class therapy for the treatment of MC.

Browning JC., Texas Dermatology and Laser Specialists, San Antonio and colleagues conducted a study to assess the efficacy and safety of berdazimer gel, 10.3%, a topical nitric oxide-releasing medication, in the treatment of MC.

Researchers enrolled a total of 891 participants(6 months or older) with 3 to 70 raised MC lesions for a clinical trial (B-SIMPLE4) conducted in 55 clinics. Patients were randomized, 444 to berdazimer and 447 to vehicle. Patients with sexually transmitted MC or with MC only in the periocular area were excluded. The primary efficacy endpoint 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.

Key findings of the trial data,

• 32.4% of the patients in the berdazimer group achieved complete clearance of MC lesions compared to 19.7% in the vehicle group ( P < .001).

• 14.4% of the berdazimer group discontinued treatment because of MC clearance compared to 8.9% 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% of the berdazimer group and 0.7% of the vehicle group

• The most common local skin reaction was mild to moderate erythema.

The authors conclude that berdazimer, applied topically once daily for 12 weeks by patients or caregivers, was significantly more effective than vehicle in achieving complete lesion clearance and reduced lesion counts. It was also well tolerated by patients.

Berdazimer may provide a topical prescription alternative to other therapies used for this highly contagious and psychosocially challenging skin condition, the authors wrote.

Topical berdazimer gel achieved complete clearance in MC lesions

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