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

Trop Med Int Health. 1999 Apr;4(4):284-7. doi: 10.1046/j.1365-3156.1999.00396.x.

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • 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
  • Foot Dermatoses / drug therapy
  • Foot Dermatoses / microbiology
  • Humans
  • Male
  • Middle Aged
  • Naphthalenes / therapeutic use*
  • Oils, Volatile / therapeutic use*
  • Ointments
  • Onychomycosis / diagnosis
  • Onychomycosis / drug therapy*
  • Onychomycosis / microbiology
  • Plant Oils / therapeutic use*
  • Tea Tree Oil
  • Treatment Outcome

Substances

  • Anti-Infective Agents, Local
  • Antifungal Agents
  • Benzylamines
  • Drug Combinations
  • Naphthalenes
  • Oils, Volatile
  • Ointments
  • Plant Oils
  • Tea Tree Oil
  • butenafine