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Clinical Trial
. 1999 Apr;4(4):284-7.
doi: 10.1046/j.1365-3156.1999.00396.x.

Treatment of Toenail Onychomycosis With 2% Butenafine and 5% Melaleuca Alternifolia (Tea Tree) Oil in Cream

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Clinical Trial

Treatment of Toenail Onychomycosis With 2% Butenafine and 5% Melaleuca Alternifolia (Tea Tree) Oil in Cream

T A Syed et al. Trop Med Int Health. .
Free article

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.

Comment in

  • Contact dermatitis due to tea tree oil.
    Bruynzeel DP. Bruynzeel DP. Trop Med Int Health. 1999 Sep;4(9):630. doi: 10.1046/j.1365-3156.1999.00462.x. Trop Med Int Health. 1999. PMID: 10540304 No abstract available.

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