A Randomized, Open-label, Active-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride (HCl) Formulation Versus 5% Amorolfine Nail Lacquer for 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis

NCT00459537 Phase 3 COMPLETED Results posted

This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks.

Details

Lead sponsor	Novartis
Phase	Phase 3
Status	COMPLETED
Enrolment	1029
Start date	2007-03
Completion	2009-01

Conditions

• Onychomycosis

Interventions

• terbinafine hydrogen chloride
• amorolfine nail lacquer

Primary outcomes

• Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks — Week 52
  Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
• Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks. — Week 52
  Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.

Countries

Finland, France, Germany, Hungary, Iceland, Norway, Poland, Russia, Spain, Turkey (Türkiye)