At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,029 enrolled
Drug / intervention
terbinafine hydrogen chloride +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating terbinafine hydrogen chloride and amorolfine nail lacquer for Onychomycosis. Completed, enrolled 1,029 participants across 10 sites in 10 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOnychomycosis
CountriesFinland, France, Germany, Hungary, Iceland, Norway, Poland, Russia, Spain, Turkey (Türkiye)
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedApr 2007
Primary CompletionJan 2009
TodayJul 2026
First PostedApr 12, 2007
Enrollment StartMar 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.2 years ago
Interventions
terbinafine hydrogen chloridedrug
10 % terbinafine hydrogen chloride (HCL)
amorolfine nail lacquerdrug
5 % amorolfine nail lacquer