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A randomized, double-blind, vehicle-controlled, multicenter, parallel group study to assess the efficacy, safety, and tolerability of topical terbinafine hydrogen chloride (HCl) formulation for 24 or ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-003508-21

A randomized, double-blind, vehicle-controlled, multicenter, parallel group study to assess the efficacy, safety, and tolerability of topical terbinafine hydrogen chloride (HCl) formulation for 24 or 48 weeks of treatment in patients with mild to moderate toenail onychomycosis

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Extrait

To demonstrate the superiority of topical terbinafine HCl formulation vs. vehicle in terms of complete cure rate (refer to section 7.4) in patients with mild to moderate toenail onychomycosis at the end of study (i.e., 52 weeks after the initial application) after treating for 24 or 48 weeks.

Critère d'inclusion

  • Onychomycosis (mild to moderate)

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