Oral terbinafine in toenail dermatophytosis. A double-blind, placebo-controlled multicenter study with 12 months' follow-up.

Abstract

The treatment of onychomycosis has previously often been protracted and unsuccessful. Terbinafine has been shown to be effective in short-term regimens. In this double-blind, placebo-controlled study, 148 patients with toenail dermatophytosis were randomized to treatment with either 250 mg terbinafine daily or placebo for 3 months. An additional treatment was given for 3 months to patients whose infection had not responded. The patients were followed clinically and mycologically through 12 months. After 3 months 82% of the terbinafine-treated group, versus 5% of the placebo group, showed significant improvement, i.e. negative culture and growth of unaffected nail more than 2 mm (p = < 0.0001). After 12 months clinical and mycological cure was seen in 40% of the patients treated with terbinafine for 3 or 6 months, while 67-81% were clinically cured, but with positive microscopy. Side-effects occurred in 13.5% of the terbinafine group, versus 5.4% of the placebo group, and were mild. 250 mg terbinafine daily for 3 months was significantly more effective than placebo. The efficacy did not appear to improve with additional treatment for 3 months.

Antifungal Selection for the Treatment of Onychomycosis: Patient Considerations and Outcomes

“…Pivotal randomized control trials (RCT) demonstrate the efficacy of terbinafine for onychomycosis treatment, [29][30][31][32][33][34][35][36][61][62][63][64][65][66] with mycological and complete cure rates of 70% and 38%, respectively. 67 In the IRON-CLAD trial (N=504) of toenail onychomycosis in patients ages 18-75 years-old treated with terbinafine 250mg for 12 weeks, with or without nail debridement, efficacy was greater in the debridement group; mycological cure was 67.6% vs 62.6% (95% CI-4.0-1.3), clinical cure was 55.3% vs 52.3% (95% CI −6.0-1.2), and complete cure was 37.8% vs 32.5% (95% CI −3.0-1.4) with debridement vs without, respectively.…”