Berdazimer gel shows efficacy in molluscum contagiosum
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Patients with molluscum contagiosum treated with topical berdazimer gel had positive efficacy rates, according to a phase 3 clinical trial.
“Currently, there are no FDA-approved medications for molluscum treatment,” Tomoko Maeda-Chubachi, MD, PhD, chief medical officer of Novan, told Healio. “The results show that berdazimer gel 10.3% was more effective than vehicle in B-SIMPLE4, the largest molluscum clinical trial ever conducted.”
The multicenter, double-blind, vehicle-controlled, parallel-group B-SIMPLE4 randomized clinical trial included 891 patients with molluscum contagiosum, aged 6 months and older, with three to 70 raised and palpable molluscum contagiosum lesions. Subjects were randomly assigned to receive either berdazimer gel (444) or vehicle (447) for 12 weeks.
A lesion count was conducted on 393 subjects in the berdazimer group and 397 subjects in the vehicle group at week 12. One hundred forty-four subjects (32.4%) in the treatment group achieved the primary efficacy endpoint of complete molluscum contagiosum lesion clearance compared with 88 subjects (19.7%) in the vehicle group (absolute difference, 12.7%; OR, 2.0; 95% CI, 1.5-2.8; P < .001).
Additionally, 193 subjects (43.5%) in the treatment group achieved the secondary efficacy endpoint of a lesion count of zero or one by week 12 compared with 110 subjects (24.6%) in the vehicle group (absolute difference, 18.9%; OR, 2.5; 95% CI; 1.9-3.4; P < .001).
A lesion count completed at week 8 on 393 subjects (88.5%) in the berdazimer group and 400 subjects (89.5%) in the vehicle group found complete clearance in 87 subjects (19.6%) and 52 subjects (11.6%) in the two respective groups (OR, 1.88; 95% CI, 1.3-2.8; P = .001).
The treatment was well tolerated overall, but at least one treatment-emergent adverse effect was reported by 191 subjects (43%) in the berdazimer group and 103 subjects (23%) in the vehicle group. Application site reaction was the most common reason for discontinuation.
“If FDA approved, berdazimer gel 10.3% would give physicians the option of writing a prescription allowing the molluscum patient to self-apply the gel instead of visiting the clinician’s office, often several times, to receive molluscum treatments that physically remove lesions through chemical or physical (curettage) procedures,” Maeda-Chubachi said.