A 12-week treatment for dermatophyte toe onychomycosis: terbinafine 250 mg/day vs. itraconazole 200 mg/day--a double-blind comparative trial.
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.
De Backer
M
M
Sandoz Medical Department, Brussels, Belgium.
De Keyser
P
P
De Vroey
C
C
Lesaffre
E
E
D000284:Administration, Oral; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005533:Foot Dermatoses / Q000188:drug therapy; D006801:Humans; D017964:Itraconazole / Q000008:administration & dosage* / Q000627:therapeutic use; D009281:Naphthalenes / Q000008:administration & dosage* / Q000627:therapeutic use; D014009:Onychomycosis / Q000188:drug therapy*; D000077291:Terbinafine
D000935:Antifungal Agents; D009281:Naphthalenes; D017964:Itraconazole; D000077291:Terbinafine