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

OBJECTIVE: TO determine the effectiveness and safety of seqaential pulse th erapy with itraconazole and terbinafine for treating onychomycosis of the f ingernails. DESIGN/METHODS: Open, prospective, multicenter, non-industry-sponsored stud y lasting up to 48 weeks, which recruited patients from outpatient dermatol ogy clinics in North America. A total of 20 patients with onychomycosis of the fingernails were treated with sequential pulse therapy consisting of on e pulse of itraconazole (200 mg twice daily for 1 week) followed 3 weeks la ter by a pulse of terbinafine (250 mg twice daily for 1 week). Patients wer e evaluated 4 months from the start of treatment, and if there was mycologi cal evidence of onychomycosis, a supplemental or 'booster' pulse of itracon azole was offered to the patient. The final follow-up observation was carri ed 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 co mplete cure (clinical and mycological cure). RESULTS: There were 14 patients with fingernail onychomycosis owing to Tric hophyton rubrum and six with Candida onychomycosis. At week 26 from the sta rt of therapy there was mycological cure in 19 of 20 patients. One of the p atients with Candida onychomycosis was still clinically affected with mycol ogical evidence of disease and was therefore offered an extra pulse of itra conazole, which resulted in a subsequent cure. At weeks 39-48 from the star t 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 a ll patients completed therapy with no dropouts. CONCLUSION: Sequential itraconazole-terbinafine pulse therapy was effective , safe and associated with a high compliance.