Efficacy of Topical Nanoemulsion (NB-002) for the Treatment of Distal Subungual Onychomycosis: A Randomized, Double-Blind, Vehicle-Controlled Trial

In a study from March 2010, a novel topical antifungal agent, NB-002, was evaluated for its efficacy in treating distal subungual onychomycosis (DSO) in a randomized, double-blind, vehicle-controlled trial. The study included 227 subjects aged 18 to 75 with mild to moderate DSO, defined as ≤50% nail involvement at baseline. Subjects were randomized to receive different concentrations of NB-002 or a vehicle, applied to all toenails and adjacent skin for 42 weeks. The results showed that 4 to 8 weeks posttreatment, mycologic cure rates (negative dermatophyte culture and KOH microscopy) for the NB-002 treatment groups ranged from 25.0% to 31.7%, compared to 8.8% for the vehicle group. Effective treatment rates (mycologic cure plus ≤10% disease involvement or ≥5mm of new nail growth) ranged from 4.2% to 16.9% for NB-002 groups versus 5.3% for the vehicle group. The study concluded that NB-002 demonstrated clear antifungal activity and clinically significant nail clearing, suggesting it as a potential new topical treatment for DSO with an excellent safety profile.