Efficacy of itraconazole, terbinafine, fluconazole, griseofulvin and ketoconazole in the treatment of Scopulariopsis brevicaulis causing onychomycosis of the toes

Background: Scopulariopsis brevicaulis is a common non-dermatophyte mould t hat can cause onychomycosis. Objective: To evaluate the efficacy and safety of the oral antifungal agents griseofulvin, ketoconazole, itraconazole, fl uconazole and terbinafine in the treatment of S. brevicaulis. Patients and Methods: In a prospective, comparative, parallel-group, single-blinded, ran domized, non-industry-sponsored study, patients with toe onychomycosis caus ed by S. brevicaulis sp. were randomized and treated with one of 5 oral ant ifungal agents, i.e. griseofulvin, ketoconazole, itraconazole (pulse), fluc onazole or terbinafine. The treatment regimens were: griseofulvin 600 mg tw ice daily for 12 months, ketoconazole 200 mg daily for 4 months, itraconazo le pulse therapy given for 3 pulses, with each pulse consisting of 200 mg t wice daily for 1 week with 3 weeks off between successive pulses, terbinafi ne 250 mg daily for 12 weeks and fluconazole 150 mg daily for 12 weeks. Res ults: There were 59 patients (48 males, 11 females, mean age 35.6 years, ra nge 25-53 years). All patients had clinical evidence of distal and lateral onychomycosis, with moderate to severe disease of the target nail. Between the treatment groups there was no significant difference in the mean age of the patients or the mean area of involvement with onychomycosis at baselin e. The efficacy parameters were clinical cure (CC) and mycological cure (MC ). At month 12 after the start of treatment, the response was: griseofulvin , CC 3/11, MC 0/11, CC + MC 0/11; ketoconazole, CC 10/12, MC 8/12, CC + MC 8/12; itraconazole, CC 12/12, MC 12/12, CC + MC 12/12; terbinafine, CC 12/1 2, MC 11/12, CC + MC 11/12, and fluconazole, CC 8/12, MC 8/12, CC + MC 8/12 . Adverse effects consisted of: griseofulvin, gastro-intestinal symptoms, a llergic reaction, photodermatitis, hepatic and renal dysfunction in 11 pati ents with discontinuation of treatment in 3 patients; ketoconazole, hepatic dysfunction but no symptomatic changes in 2 patients; itraconazole, nausea and vomiting in 2 patients; terbinafine, taste disturbance in 2 patients, nausea in 3 patients, and fluconazole, severe gastro-intestinal events in 5 patients. None of the patients receiving ketoconazole, itraconazole, terbi nafine or fluconazole discontinued treatment. Conclusions: Itraconazole and terbinafine demonstrate efficacy against some cases of S. brevicaulis toe onychomycosis. These agents also appear to be safe in the course of therapy for toe onychomycosis. Griseofulvin is ineffective against toe onychomycos is caused by S. brevicaulis. Ketoconazole is not recommended for toe onycho mycosis given its potential for adverse effects, particularly with the avai lability of the newer antifungal agents. Copyright (C) 2001 S. Karger AG, B asel.