Treatment of distal subungual onychomycosis with a topical preparation of urea, propylene glycol and lactic acid: Results of a 24-week, double-blind, placebo-controlled study

Abstract

Onychomycosis is difficult to cure as this requires eradication of the primary infection and protection of new areas of growth from reinfection. A new topical treatment (K101) has been developed. The aim of this study was to assess the efficacy, safety and tolerability of K101 treatment of distal subungual onychomycosis. This was a 24-week (plus 2-week washout), multicentre, randomised, double-blind, placebo-controlled study in 493 patients with distal subungual onychomycosis (K101, n=346; placebo, n=147), stratified according to degree of nail involvement. More patients with ≤50% nail involvement achieved the primary endpoint (mycological cure after 26weeks) in the K101 group (27.2%) than placebo (10.4%; P=0.0012). Proportions for patients with 51-75% involvement were 19.1% for K101 and 7.0% for placebo (not significant). More patients applying K101 than placebo judged that their condition had improved from week2 (P=0.0148) to week 24 (P=0.0004). No safety issues were identified. K101 provides early visible improvements in nail appearance and a clinically meaningful antifungal activity. © 2012 Blackwell Verlag GmbH.