A Randomized, Placebo- and Active-Controlled, Parallel-Group, Multicenter, Investigator-Blinded Study of Four Treatment Regimens of Posaconazole in Adults with Toenail Onychomycosis

The study investigated the efficacy of different dosages and treatment durations of posaconazole (POS) compared to terbinafine (TERB) and placebo in treating toenail onychomycosis in 218 adults. Subjects were randomized into six groups, with approximately 36 in each, and received either POS oral suspension at 100, 200, or 400 mg daily for 24 weeks, 400 mg daily for 12 weeks, TERB 250-mg tablets daily for 12 weeks, or placebo for 24 weeks. The primary endpoint was complete cure at week 48, defined as negative mycology and 0% nail involvement. Results showed that complete cure rates at week 48 were significantly higher than placebo for all POS and TERB regimens (22.9% for POS 100 mg/24 weeks, 54.1% for 200 mg/24 weeks, 45.5% for 400 mg/24 weeks, 20% for 400 mg/12 weeks, and 37.1% for TERB/12 weeks). Adverse events were mostly mild to moderate, with the most common reason for discontinuation being transient increases in liver function tests (LFTs), which normalized upon treatment cessation. A total of 12 (6%) subjects discontinued due to adverse events. The study concluded that posaconazole warrants further consideration as a new treatment for onychomycosis.