Conditions: Onychomycosis
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 259
Healthy volunteers: no

Brief summary:
Several properties of VT-1161 suggest that it might be a safer and more effective treatment for onychomycosis of the toenail (also known as toenail fungus) than other oral antifungal medicines.

This study will evaluate the effectiveness and safety of VT-1161 for the treatment of toenail onychomycosis and consists of a screening phase, a 24-week treatment phase in which the patient will take either active drug, placebo or a combination of the 2 (according to random assignment), an initial observational phase of 36 weeks and an additional observational study extension of 9 months.

The additional 9-month observational study extension was added with a protocol amendment and patient participation was optional.

Detailed description:

Arms:
arm 1: 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks arm 2: 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks arm 3: 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks arm 4: 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks arm 5: 4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks

Interventions: intervention 1: VT-1161 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: