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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.
AuthorsT A Syed, Z A Qureshi, S M Ali, S Ahmad, S A Ahmad
JournalTropical medicine & international health : TM & IH (Trop Med Int Health) Vol. 4 Issue 4 Pg. 284-7 (Apr 1999) ISSN: 1360-2276 [Print] England
PMID10357864 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Anti-Infective Agents, Local
  • Antifungal Agents
  • Benzylamines
  • Drug Combinations
  • Naphthalenes
  • Oils, Volatile
  • Ointments
  • Plant Oils
  • Tea Tree Oil
  • butenafine
Topics
  • Administration, Topical
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Infective Agents, Local (therapeutic use)
  • Antifungal Agents (therapeutic use)
  • Benzylamines (therapeutic use)
  • Debridement
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Foot Dermatoses (diagnosis, drug therapy, microbiology)
  • Humans
  • Male
  • Middle Aged
  • Naphthalenes (therapeutic use)
  • Oils, Volatile (therapeutic use)
  • Ointments
  • Onychomycosis (diagnosis, drug therapy, microbiology)
  • Plant Oils (therapeutic use)
  • Tea Tree Oil
  • Treatment Outcome

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