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.
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.
Department of Dermatology & Venereology, Karolinska University Hospital, Stockholm, Sweden. lennart.emtestam@ki.se
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Emtestam
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Kaaman
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Rensfeldt
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005533:Foot Dermatoses / Q000188:drug therapy*; D006801:Humans; D019344:Lactic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009262:Nails / Q000382:microbiology; D014009:Onychomycosis / Q000188:drug therapy*; D019946:Propylene Glycol / Q000008:administration & dosage* / Q000009:adverse effects; D014508:Urea / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
D000935:Antifungal Agents; D004338:Drug Combinations; D019344:Lactic Acid; D019946:Propylene Glycol; D014508:Urea