CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 129 enrolled
Drug / intervention
Amorolfine +2 moredrug
Likely dose
Terbinafine 250 mgfrom 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.

Search/NCT01851590
NCT01851590Phase 4Completed
CompareCT.gov

Efficacy of Topical Resin Lacquer, Amorolfine, and Oral Terbinafine for Treating Toenail Onychomycosis: a Prospective, Randomized, Controlled, Investigator-blinded, Parallel-group Clinical Trial

Helsinki University Central Hospital·interventional·Posted May 10, 2013·Updated Nov 30, 2015

In Brief

A Phase 4 clinical trial evaluating Resin Lacquer, Amorolfine, and 1 other intervention for Onychomycosis. Completed, enrolled 129 participants across 2 sites.

Detailed Summary

The current study is conducted to corroborate the previous observational clinical trial with more valid methods and a more clinically relevant experimental design. This study aims to compare efficacy, safety, and cost between topically administered 30% resin lacquer for the treatment of dermatophyte toenail onychomycosis and the current "best practices": topical 5% amorolfine and systemic terbinafine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOnychomycosis
CountriesFinland
CollaboratorsRepolar Pharmaceuticals Oy

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2013
Enrollment StartOct 1, 2013
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.1 years ago

Interventions

Resin Lacquerdevice

30% Resin Lacquer is applied once daily for 9 months (Abicin®) in toenail onychomycosis.

Amorolfinedrug

5% Amorolfine Lacquer is applied once weekly for 9 months (Loceryl®) in toenail onychomycosis.

Terbinafinedrug

250 mg of Terbinafine is taken orally once daily for 3 months (Generics) in toenail onychomycosis.