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Treatment of toenail onychomycosis with 2% butenafine and 5% Melaleuca alternifolia (tea tree) oil in cream

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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.

Keywords: Melaleuca alternifolia; butenafine; fungal infections; onychomycosis; pharmaceutical creams; tea tree oil; toenails

Document Type: Original Article


Affiliations: 1:  Department of Dermatology, University of California, San Francisco, USA 2:  University of the Punjab, Lahore, Pakistan 3:  Shan Hospital, Gulshan Iqbal, Karachi, Pakistan 4:  Komvux College, Borås, Sweden 5:  Windsor High School, Windsor, CA, USA

Publication date: April 1, 1999


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