MedTrace Logo

Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis

NCT01851590 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2015-11-30

Study results available
· View outcomes & findings →

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.

Conditions

  • Onychomycosis

Interventions

DEVICE

Resin Lacquer

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

DRUG

Amorolfine

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

DRUG

Terbinafine

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

Sponsors & Collaborators

  • Repolar Pharmaceuticals Oy

    collaborator INDUSTRY

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Janne J. Jokinen, MD, PhD · Department of Cardiac Surgery, Heart and Lung Centre, Helsinki University Hospital, FI-00029, Helsinki, Finland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Finland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01851590 on ClinicalTrials.gov