Ciclopirox topical solution, 8% combined with oral terbinafine to treat onychomycosis: a randomized, evaluator-blinded study.
This randomized, evaluator-blind, 3-arm parallel, comparator controlled, multicenter pilot study evaluated the safety and efficacy of ciclopirox nail lacquer topical solution, 8% in combination with oral terbinafine for the treatment of moderate to severe toenail onychomycosis (> or =60% disease involvement of target nail and/or lunula/matrix involvement) (N = 73). Patients were randomized to 1 of 3 treatment arms: ciclopirox nail lacquer once daily for 48 weeks plus 4 weeks of terbinafine 250 mg/day, followed by 4 weeks of rest (no terbinafine), then another 4 weeks of terbinafine 250 mg/day (PLs); ciclopirox nail lacquer once daily for 48 weeks plus terbinafine 250 mg/day for 12 weeks (PL12); or terbinafine 250 mg/day for 12 weeks ( L12). At week 48, mycological cure (negative microscopy and culture) occurred in 66.7% (14/21) (PL8), 70.4% (19/27) (PL12), and 56.0% (14/25) ( L12) of patients confirmed dermatophyte positive, respectively (P: not significant). At this time point, effective cure (simultaneous mycological cure and > or =90% reduction in the disease area) was observed in 40.0% (8/20), 33.3% (8/24), and 34.8% (8/23) of patients, respectively (P: not significant). The PLs regimen was well-tolerated and had high compliance. The data suggest that combination therapy (PL8) may be an alternative regimen to continuous terbinafine ( L12) in the treatment of moderate to severe dermatophyte toenail onychomycosis.[1]References
- Ciclopirox topical solution, 8% combined with oral terbinafine to treat onychomycosis: a randomized, evaluator-blinded study. Gupta, A.K. Journal of drugs in dermatology : JDD. (2005) [Pubmed]
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