Short term treatment of dermatophyte onychomycosis with terbinafine.

Abstract

OBJECTIVE:

To evaluate the effect of short term treatment with terbinafine on dermatophytosis.

DESIGN:

Multicentre, randomised, double blind placebo controlled trial of 250 mg/day terbinafine for 12 weeks in dermatophyte onychomycosis.

SETTING:

Eight dermatology centres in the United Kingdom.

PATIENTS:

112 patients (mean age 44, range 19-78), 99 with mycologically proved toenail infections and 13 with fingernail infections, of whom eight were subsequently excluded and 19 failed to complete the study.

INTERVENTION:

Terbinafine 250 mg daily or placebo for 12 weeks. Follow up for 36 weeks after stopping treatment.

MAIN OUTCOME MEASURES:

Mycological cure (negative results on microscopy and culture) and clinical cure at the end of follow up, adverse events, and biochemical and haematological variables at monthly intervals during treatment.

RESULTS:

After follow up 82% (37/45) (95% confidence interval 68% to 92%) mycological cure and 69% clinical cure were recorded for evaluable patients treated with terbinafine for toenail infection and 71% (5/7) (30% to 96%) mycological cure and clinical cure for those treated for fingernail infection. The corresponding values for those treated with placebo were 12% (3% to 31%) mycological cure and no clinical cure for toenail infections and 33% (1% to 91%) mycological cure and no clinical cure for fingernail infections. On an intention to treat basis for toenail infections the figures were 73% (38/52) (58% to 85%) mycological cure for terbinafine compared with 6% (0% to 30%) for placebo (p less than 0.007). Two withdrawals were related to adverse events with terbinafine, and there were no significant abnormal laboratory test results.

CONCLUSION:

12 weeks' terbinafine is effective and safe treatment for nail dermatophytosis.

• Authors: M J Goodfield, L Andrew, E G Evans
• Journal: BMJ (Clinical research ed.) (BMJ) Vol. 304 Issue 6835 Pg. 1151-4 (May 02 1992) ISSN: 0959-8138 [Print] England
• PMID: 1392793 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antifungal Agents
• Naphthalenes
• Terbinafine

Topics

• Adult
• Aged
• Antifungal Agents (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Male
• Middle Aged
• Naphthalenes (administration & dosage, adverse effects, therapeutic use)
• Onychomycosis (drug therapy)
• Terbinafine
• Time Factors