Rapid Visible Improvements in Onychomycosis: An Open-Label Clinical Investigation of Kerasal Nail^TM  

作　　者：Jiun Yit Pan Chris Lixian Tan Anders Toft 

机构地区：[1]National Skin Centre, Singapore City, Singapore [2]Division of Dermatology, National University Hospital, Singapore City, Singapore [3]Moberg Pharma AB, Bromma, Sweden

出　　处：《Journal of Cosmetics, Dermatological Sciences and Applications》2017年第1期57-66,共10页化妆品、皮肤病及应用期刊（英文）

摘　　要：Traditional treatments for onychomycosis, a fungal disease primarily affecting the toenails, are associated with poor tolerability or inadequate efficacy. Moreover, because many patients find onychomycosis embarrassing, achieving rapid cosmetic improvements is desirable. Kerasal NailTM is a marketed topical treatment containing propylene glycol, urea and lactic acid. The ability of Kerasal Nail to improve the appearance of an affected nail was investigated in a 4-week open-label study. Patients aged ≥21 years and with 25% to 75% of a big toenail or thumbnail (the “target” nail) affected by clinically suspected onychomycosis (n = 65) were instructed to apply Kerasal Nail to all their affected nails once daily for 4 weeks. After 1, 2 and 4 weeks of treatment, they assessed the appearance of the target nail on a 4-point scale, with a score of ≥2 indicating a minimum of some improvement. They also assessed the nail for improvements in thickening, discoloration, brittleness and softness. Adverse events (AEs) occurring between administration of the first dose of Kerasal Nail and the end of the 4-week treatment period were recorded. 85% of patients (95% confidence interval [CI] 74 to 92) achieved some improvement in the target nail at 4 weeks. Improvement of the target nail was reported by 65% of patients (95% CI 52 to 76) after 1 week of treatment and by 82% of patients (95% CI 70 to 90) after 2 weeks. 55% of patients achieved some improvement in discoloration in the first week of treatment. After 4 weeks of treatment, discoloration, thickening, brittleness and softness were each improved in more than half of patients. Treatment-related AEs were limited to two cases of administration site pain. Overall treatment compliance was 99%. In summary, Kerasal Nail produced very rapid improvements in nail appearance in patients with onychomycosis and was well tolerated.Traditional treatments for onychomycosis, a fungal disease primarily affecting the toenails, are associated with poor tolerability or inadequate efficacy. Moreover, because many patients find onychomycosis embarrassing, achieving rapid cosmetic improvements is desirable. Kerasal NailTM is a marketed topical treatment containing propylene glycol, urea and lactic acid. The ability of Kerasal Nail to improve the appearance of an affected nail was investigated in a 4-week open-label study. Patients aged ≥21 years and with 25% to 75% of a big toenail or thumbnail (the “target” nail) affected by clinically suspected onychomycosis (n = 65) were instructed to apply Kerasal Nail to all their affected nails once daily for 4 weeks. After 1, 2 and 4 weeks of treatment, they assessed the appearance of the target nail on a 4-point scale, with a score of ≥2 indicating a minimum of some improvement. They also assessed the nail for improvements in thickening, discoloration, brittleness and softness. Adverse events (AEs) occurring between administration of the first dose of Kerasal Nail and the end of the 4-week treatment period were recorded. 85% of patients (95% confidence interval [CI] 74 to 92) achieved some improvement in the target nail at 4 weeks. Improvement of the target nail was reported by 65% of patients (95% CI 52 to 76) after 1 week of treatment and by 82% of patients (95% CI 70 to 90) after 2 weeks. 55% of patients achieved some improvement in discoloration in the first week of treatment. After 4 weeks of treatment, discoloration, thickening, brittleness and softness were each improved in more than half of patients. Treatment-related AEs were limited to two cases of administration site pain. Overall treatment compliance was 99%. In summary, Kerasal Nail produced very rapid improvements in nail appearance in patients with onychomycosis and was well tolerated.

关 键 词：ONYCHOMYCOSIS Kerasal NAIL ASIAN TOPICAL 4 Weeks 

分 类 号：R73[医药卫生—肿瘤]