A 12-week treatment for dermatophyte toe onychomycosis: terbinafine 250 mg/day vs. itraconazole 200 mg/day--a double-blind comparative trial

• Published in: British journal of dermatology (1951) Vol. 134 Suppl 46; p. 16
• Main Authors: De Backer, M, De Keyser, P, De Vroey, C, Lesaffre, E
• Format: Journal Article
• Language: English
• Published: England 01.06.1996
• Subjects: Administration, Oral; Antifungal Agents - administration & dosage; Antifungal Agents - therapeutic use; Double-Blind Method; Drug Administration Schedule; Foot Dermatoses - drug therapy; Humans; Itraconazole - administration & dosage; Itraconazole - therapeutic use; Naphthalenes - administration & dosage; Naphthalenes - therapeutic use; Onychomycosis - drug therapy; Terbinafine
• ISSN: 0007-0963

Lamisil (terbinafine) 250 mg daily and itraconazole 200 mg daily were compared in the treatment of dermatophyte toe onychomycosis over 12 weeks in a double-blind randomized clinical trial. At the end of follow-up (week 48) treatment with Lamisil led to negative mycology in 73% of patients compared with 45.8% in the itraconazole group (P < 0.0001). Globally the clinical symptoms of the target nail improved, a response which was in favour of Lamisil (P = 0.001). The percentages of patients who were clinically totally cured or who presented with only minimal symptoms were 76.3% for the Lamisil-treated group compared with 58.1% in the itraconazole group. The unaffected nail length for big toes was significantly higher in the Lamisil-treated group (9.1 mm vs. 7.7 mm; P = 0.0298). Onycholysis was also less in the Lamisil group (P = 0.001). We conclude that 12 weeks' continuous oral therapy leads to higher cure rates with Lamisil than with itraconazole and that both drugs are equally well tolerated.