Randomised double blind comparison of terbinafine and itraconazole for treatment of toenail tinea infection. Seventh Lamisil German Onychomycosis Study Group.

OBJECTIVE

To compare the efficacy and tolerability of terbinafine and itraconazole in the treatment of toenail tinea unguium.

DESIGN

Multicentre, double blind, parallel group study.

SETTING

17 university hospitals, one army hospital, and five dermatology practices.

PATIENTS: 195 patients with clinically suspected toenail tinea and growth of dermatophytes in baseline culture; data on 86 patients in the terbinafine group and 84 patients in the itraconazole group were fully evaluated for efficacy.

INTERVENTIONS: Daily dose of 250 mg terbinafine or 200 mg itraconazole for 12 weeks, with follow up for a further 40 weeks.

MAIN OUTCOME MEASURES: Mycological cure (negative results on microscopy and culture) and clinical improvement (length and area of unaffected nail) at week 52 or at discontinuation of treatment.

RESULTS

At the end of the study mycological cure rates were 81% (70 out of 86) for terbinafine and 63% (53 out of 84) for itraconazole (2P < 0.01). Negative culture was achieved in 92% (79 out of 86) in the terbinafine group and 67% (56 out of 84) in the itraconazole group (2P < 0.0001). Length of unaffected nail was 9.44 mm in the terbinafine group and 7.85 mm in the itraconazole group (2P < 0.05).

CONCLUSION

Terbinafine is more effective than itraconazole in the treatment of toenail tinea infection.