BACKGROUND: Dermatophytic infections of the fingernail can be effectively treated with oral antifungal agents; however, a long duration of treatment, generally several months, is required for cure. OBJECTIVE: Our purpose was to compare the efficacies of short-duration treatment with terbinafine and griseofulvin in the management of fingernail dermatophytosis. METHODS: In this randomized, double-blind study 180 patients with fingernail dermatophytosis were treated with daily doses of either terbinafine, 250 mg/day, or microsized griseofulvin, 500 mg/day, for 12 weeks. Patients subsequently received placebo for 12 weeks and were observed for an additional 24 weeks. Drug efficacy was assessed by mycologic examination and measurement of the growth of unaffected nail. RESULTS: At the end of the study 76% of the group who received terbinafine and 39% of those who received griseofulvin were found to be completely cured (p = 0.001). Drug tolerability was equally good in both treatment groups, without any clinically relevant changes in laboratory biochemical values. CONCLUSION: Short-duration treatment (3 months) for fingernail dermatophytosis with terbinafine and griseofulvin is well tolerated. However, terbinafine was associated with a higher cure rate.
RCT Entities:
BACKGROUND:Dermatophytic infections of the fingernail can be effectively treated with oral antifungal agents; however, a long duration of treatment, generally several months, is required for cure. OBJECTIVE: Our purpose was to compare the efficacies of short-duration treatment with terbinafine and griseofulvin in the management of fingernail dermatophytosis. METHODS: In this randomized, double-blind study 180 patients with fingernail dermatophytosis were treated with daily doses of either terbinafine, 250 mg/day, or microsized griseofulvin, 500 mg/day, for 12 weeks. Patients subsequently received placebo for 12 weeks and were observed for an additional 24 weeks. Drug efficacy was assessed by mycologic examination and measurement of the growth of unaffected nail. RESULTS: At the end of the study 76% of the group who received terbinafine and 39% of those who received griseofulvin were found to be completely cured (p = 0.001). Drug tolerability was equally good in both treatment groups, without any clinically relevant changes in laboratory biochemical values. CONCLUSION: Short-duration treatment (3 months) for fingernail dermatophytosis with terbinafine and griseofulvin is well tolerated. However, terbinafine was associated with a higher cure rate.