A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail

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.

Timeline

Start

2015-02-17

Primary completion

2016-10-18

Completion

2017-07-07

Publications

• Elewski B, Brand S, Degenhardt T, Curelop S, Pollak R, Schotzinger R, Tavakkol A. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of VT-1161 oral tablets in the treatment of patients with distal and lateral subungual onychomycosis of the toenail. Br J Dermatol. 2021 Feb;184(2):270-280. doi: 10.1111/bjd.19224. Epub 2020 Jul 13.

Drugs

Indications