A Trial Involving Treatment of BB2603 in Subjects With Distal Subungual Onychomycosis of the Toenail
Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
This study will be a multicenter, international, randomized, vehicle-controlled,
parallel-group, double-blinded study. Subjects who are eligible to participate with a
confirmed diagnosis of Distal Subungual onychomycosis (DSO) of the toenail will be randomized
and participate in one of the following treatment groups: BB2603-1: 0.01% terbinafine/0.03%
polyhexanide formulation, or BB2603-3: 0.03% terbinafine/0.09% polyhexanide formulation, or
BB2603-10: 0.1% terbinafine/0.3% polyhexanide formulation, or Vehicle: 0.3% polyhexanide/20%
ethanol/water formulation. The subject in each treatment group will be treated twice daily
(BID) for 12 weeks and then complete a 28-day post-treatment visit.