Amy S Paller er al.
- February 2024 - Pediatric Dermatology - org/10.1111/pde.15575
The recent FDA approval of berdazimer gel (10.3%) for the treatment of molluscum contagiosum (MC) in individuals older than 1 year heralds an advance in the fight against this widespread and infectious skin condition. Phase III study B-SIMPLE4 demonstrates the efficacy of berdazimer gel in improving the resolution of MC lesions within 12 weeks, along with a favorable safety profile characterized predominantly by mild discomfort at the site of application and mild to moderate erythema.
Three Phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group studies (B-SIMPLE ) enrolled patients 6 months of age and older with 3 to 70 mollusks. Berdazimer or vehicle was applied once daily to all lesions for 12 weeks. Patients with concomitant AD or a history of AD/eczema were classified as AD+ subgroup (AD- when absent).
Of the 1,598 patients enrolled, 209 (13.1%) were AD+. Mean lesion count at baseline was higher in AD+ (26.4) than in AD- (19.3). Complete clearance rates were higher at week 12 for berdazimer than vehicle in the AD+ (n = 209; 35.0% vs. 27.4%) and AD- (n = 1389 ; 29.1% vs. 18.9%) studies. Adverse events in the AD+ study were application site pain (21.6% with berdazimer vs. 11.9% with vehicle), dermatitis (12.8% vs. 2.4%) and erythema (9.6% vs. 7.1%).
Patients with AD atopic dermatitis treated with vehicle demonstrated higher rates of complete wound healing and 90% resolution than their counterparts without AD. This unexpected result calls for a reassessment of spontaneous improvement in AD patients with MC and suggests that consistent skin hydration, which is inherent to vehicle administration, may promote skin barrier function and potentially facilitate resolution of MC lesions.