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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
Author(s) -
Emtestam L.,
Kaaman T.,
Rensfeldt K.
Publication year - 2012
Publication title -
mycoses
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.13
H-Index - 69
eISSN - 1439-0507
pISSN - 0933-7407
DOI - 10.1111/j.1439-0507.2012.02215.x
Subject(s) - placebo , tolerability , medicine , nail (fastener) , clinical endpoint , nail disease , double blind , surgery , placebo controlled study , dermatology , clinical trial , adverse effect , complication , pathology , materials science , alternative medicine , metallurgy
Summary 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 26 weeks) 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 week 2 ( 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.