Traditional treatments for onychomycosis, a fungal disease primarily affecting\nthe toenails, are associated with poor tolerability or inadequate efficacy. Moreover,\nbecause many patients find onychomycosis embarrassing, achieving\nrapid cosmetic improvements is desirable. Kerasal NailTM is a marketed topical\ntreatment containing propylene glycol, urea and lactic acid. The ability of\nKerasal Nail to improve the appearance of an affected nail was investigated in\na 4-week open-label study. Patients aged ââ?°Â¥21 years and with 25% to 75% of a\nbig toenail or thumbnail (the ââ?¬Å?targetââ?¬Â nail) affected by clinically suspected\nonychomycosis (n = 65) were instructed to apply Kerasal Nail to all their\naffected nails once daily for 4 weeks. After 1, 2 and 4 weeks of treatment, they\nassessed the appearance of the target nail on a 4-point scale, with a score of ââ?°Â¥2\nindicating a minimum of some improvement. They also assessed the nail for\nimprovements in thickening, discoloration, brittleness and softness. Adverse\nevents (AEs) occurring between administration of the first dose of Kerasal\nNail and the end of the 4-week treatment period were recorded. 85% of patients\n(95% confidence interval [CI] 74 to 92) achieved some improvement in\nthe target nail at 4 weeks. Improvement of the target nail was reported by 65%\nof patients (95% CI 52 to 76) after 1 week of treatment and by 82% of patients\n(95% CI 70 to 90) after 2 weeks. 55% of patients achieved some improvement\nin discoloration in the first week of treatment. After 4 weeks of treatment,\ndiscoloration, thickening, brittleness and softness were each improved in more\nthan half of patients. Treatment-related AEs were limited to two cases of administration\nsite pain. Overall treatment compliance was 99%. In summary,\nKerasal Nail produced very rapid improvements in nail appearance in patients\nwith onychomycosis and was well tolerated.
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