Efficacy and safety of terbinafine for nondermatophyte and mixed nondermatophyte and dermatophyte toenail onychomycosis

Ninety-seven healthy male and female subjects, 18-70 years of age, entered a randomized, double-blind, placebo-controlled, multicenter study conducted over a 24-week treatment period and a 72-week follow-up (study week 96) pe riod without treatment. Subjects received: (1) terbinafine 250 mg for 12 we eks followed by placebo for 12 weeks; (2) terbinafine 250 mg for 24 weeks; or (3) placebo for 24 weeks. Clinical and mycologic evaluations of a target toenail were performed befor e, during, and after the treatment period. Evaluations consisted of measure ments of nail growth, unaffected nail length, and estimated percentage of n ail involvement. Cultures and KOH microscopy were used for mycologic evalua tions. The primary efficacy variable was effective treatment, defined as negative mycology and either no nail involvement or at least 5 mm of new unaffected nail growth at 48 weeks. Complete cure, the secondary variable, was defined as negative mycology and zero nail involvement at 48 weeks. Overall effica cy was assessed after 12, 18, and 24 weeks of therapy and every 6 weeks up to week 48 by both investigator and subject using a five-point scale (excel lent, very good, good, fair, and poor). Adverse events were assessed after 4, 8, 12, 18, and 24 weeks of treatment and after a 6 week follow-up period with no treatment. Adverse events were graded by severity (mild, moderate, or severe) and relationship to the stud y drug (not related, remote or unlikely, possibly, probably, or definitely) .