Sequential pulse therapy with itraconazole and terbinafine to treat onychomycosis of the fingernails

Abstract

OBJECTIVE: To determine the effectiveness and safety of sequential pulse therapy with itraconazole and terbinafine for treating onychomycosis of the fingernails. DESIGN/METHODS: Open, prospective, multicenter, non-industry-sponsored study lasting up to 48 weeks, which recruited patients from outpatient dermatology clinics in North America. A total of 20 patients with onychomycosis of the fingernails were treated with sequential pulse therapy consisting of one pulse of itraconazole (200 mg twice daily for 1 week) followed 3 weeks later by a pulse of terbinafine (250 mg twice daily for 1 week). Patients were evaluated 4 months from the start of treatment, and if there was mycological evidence of onychomycosis, a supplemental or 'booster' pulse of itraconazole was offered to the patient. The final follow-up observation was carried out 39-48 weeks from the start of therapy. The outcomes evaluated were mycological cure (negative light microscopy and culture), clinical cure (nail appears completely or totally normal) and complete cure (clinical and mycological cure). RESULTS: There were 14 patients with fingernail onychomycosis owing to Trichophyton rubrum and six with Candida onychomycosis. At week 26 from the start of therapy there was mycological cure in 19 of 20 patients. One of the patients with Candida onychomycosis was still clinically affected with mycological evidence of disease and was therefore offered an extra pulse of itraconazole, which resulted in a subsequent cure. At weeks 39-48 from the start of therapy there was mycological cure, clinical cure and complete cure in all 20 patients. Gastrointestinal side effects and headache were reported by three patients and one patient, respectively. These were transient and all patients completed therapy with no dropouts. CONCLUSION: Sequential itraconazole-terbinafine pulse therapy was effective, safe and associated with a high compliance. ( J Dermatol Treat (2000) 11: 151-154)

• Candida Species Dermatophytes Fingernails Itraconazole Onychomycosis Pulse Sequential Terbinafine Therapy