title: Treatment of toenail onychomycosis with 2% butenafine and 5% Melaleuca alternifolia (tea tree) oil in cream.
abstract: The prevalence of onychomycosis, a superficial fungal infection that destroys the entire nail unit, is rising, with no satisfactory cure. The objective of this randomized, double-blind, placebo-controlled study was to examine the clinical efficacy and tolerability of 2% butenafine hydrochloride and 5% Melaleuca alternifolia oil incorporated in a cream to manage toenail onychomycosis in a cohort. Sixty outpatients (39 M, 21 F) aged 18-80 years (mean 29.6) with 6-36 months duration of disease were randomized to two groups (40 and 20), active and placebo. After 16 weeks, 80% of patients using medicated cream were cured, as opposed to none in the placebo group. Four patients in the active treatment group experienced subjective mild inflammation without discontinuing treatment. During follow-up, no relapse occurred in cured patients and no improvement was seen in medication-resistant and placebo participants.
authors.affiliation: Department of Dermatology, University of California, San Francisco, USA. tasyed@itsa.ucsf.edu
authors.forename: T A
authors.initials: TA
authors.lastname: Syed
authors.forename: Z A
authors.initials: ZA
authors.lastname: Qureshi
authors.forename: S M
authors.initials: SM
authors.lastname: Ali
authors.forename: S
authors.initials: S
authors.lastname: Ahmad
authors.forename: S A
authors.initials: SA
authors.lastname: Ahmad
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000627:therapeutic use*; D001596:Benzylamines / Q000627:therapeutic use*; D003646:Debridement; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005533:Foot Dermatoses / Q000175:diagnosis / Q000188:drug therapy / Q000382:microbiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000627:therapeutic use*; D009822:Oils, Volatile / Q000627:therapeutic use*; D009824:Ointments; D014009:Onychomycosis / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D010938:Plant Oils / Q000627:therapeutic use*; D020947:Tea Tree Oil; D016896:Treatment Outcome
chemical_list: D000891:Anti-Infective Agents, Local; D000935:Antifungal Agents; D001596:Benzylamines; D004338:Drug Combinations; D009281:Naphthalenes; D009822:Oils, Volatile; D009824:Ointments; D010938:Plant Oils; D020947:Tea Tree Oil; C067594:butenafine