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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

British Journal of Dermatology Jul 22, 2020

Elewski B, Brand S, Degenhardt T, et al. - Researchers investigated the safety and efficacy of four dosing regimens of orally administered VT ‐1161 vs placebo in cases with moderate‐to‐severe distal and lateral subungual onychomycosis of the toenail. In this phase II, randomized, double‐blind, placebo‐controlled, multicentre study, they randomized 259 patients aged 18–70 years who had 25%–75% mycotic involvement to five treatment groups. Participants were provided 300 mg VT ‐1161 as a 2‐week daily dose, followed by a once‐weekly dose for either 10 or 22 weeks, or 600 mg VT ‐1161 as a 2‐week daily dose, followed by a once‐weekly dose for either 10 or 22 weeks. A nontreatment period of 36 weeks followed all treatments. Inclusion was performed of a matching placebo arm. The complete cure rates were 0% in the placebo group and ranged from 32% to 42% in the VT ‐1161 treatment groups. Findings indicate a high nail clearance rates and a favorable safety profile in correlation with VT ‐1161 treatment. The identified characteristics of VT ‐1161 look promising for managing this chronic and difficult‐to‐treat condition.

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