Berdazimer gel 10.3 % found effective in clearing molluscum lesions in phase 3 SIMPLE clinical trial
United States: According to findings from phase 3 B-SIMPLE clinical trials, new data presented during the annual meeting of the American Academy of Dermatology (AAD) 2023, berdazimer gel 10.3 % will be the first potential drug by the US Food and Drug Administration (FDA) for molluscum in January 2024
It is already known that Berdazimer gel 10.3% is a topical nitric oxide for the management of molluscum contagiosum, a highly contagious viral infection of the skin in Phase 3 development.
Researchers have assessed the safety of berdazimer gel 10.3% in three phase 3 molluscum studies B-SIMPLE 1, 2 and 4.
Trial B-SIMPLE-1, 2 and 4 were randomized double-blind and evaluated the safety and efficacy of the application of berdazimer gel 10.3% once daily or vehicle gel for 12 weeks.
The researchers have included children of ≥6 months of age with a history of 3-70 molluscum lesions. They set Safety endpoints as the incidence of treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs).
The study results could be summarised as follows:
- A total of 1596 patients were enrolled with a mean age of 6.7 years.
- 50.6% of patients were male
- The mean lesion count was 20.2, and the n value of 916:680 berdazimer:vehicle
- Patients with ≥1 TEAE were shown as 46.7% (428) vs 24.9% (169); most were mild 24.0% (220) vs 17.4% (118) or moderate 21.0% (192) vs 6.9% (47) in severity.
- The most frequent TEAEs were application site pain, erythema, and pruritus, constituting 18.7% vs 4.9%, 11.9% vs 1.6% and 5.7% vs 1.0%.
- TEAEs leading to study drug discontinuation were few: 4.6% (42) vs 0.7% (5).
- TEAEs related to the study drug: 36.7% (336) vs 11.9% (81); none were serious.
- LSRs were more frequent in berdazimer with an LSR score ≥1 of 66.9% vs 40.7%
The main author, John C. Browning, said that, “This gel provides complete lesion clearance in 30.0% of all treated patients by week 12, versus just 19.8% of patients receiving vehicle with Odds ratio of 1.75. The complete clearance rate in children aged 6 to <12 years is 31.1% complete with berdazimer gel, versus just 14.0% among the pediatric vehicle arm.”
The overall safety and tolerability of berdazimer gel 10.3% was demonstrated in B-SIMPLE Phase 3 program.
Further reading:
Safety of Berdazimer Gel 10.3% in the Treatment of Molluscum Contagiosum: Integrated Results from the B-SIMPLE Phase 3 Program
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