Ta. Syed et al., Treatment of toenail onychomycosis with 2% butenafine and 5% Melaleuca alternifolia (tea tree) oil in cream, TR MED I H, 4(4), 1999, pp. 284-287
The prevalence of onychomycosis, a superficial fungal infection that destro
ys the entire nail unit, is rising, with no satisfactory cure. The objectiv
e 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 ony
chomycosis in a cohort. Sixty outpatients (39 M, 21 F) aged 18-80 years (me
an 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 med
icated cream were cured, as opposed to none in the placebo group. Four pati
ents 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 plac
ebo participants.