Overview

This trial is active, not recruiting.

Condition onychomycosis
Treatments me1111 solution, low strength, me1111 solution, high strength, matching vehicle solution
Phase phase 2
Sponsor Meiji Seika Pharma Co., Ltd.
Start date December 2013
End date October 2015
Trial size 300 participants
Trial identifier NCT02022215, ME1111-2

Summary

The purpose of the study is to determine the safety and efficacy of high and low strength of ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
me1111 solution, low strength
ME1111 Solution, Low strength, applied once daily for 48 weeks
(Experimental)
me1111 solution, high strength
ME1111 Solution, High strength, applied once daily for 48 weeks
(Placebo Comparator)
matching vehicle solution
Matching Vehicle Solution, applied once daily for 48 weeks

Primary Outcomes

Measure
Complete cure rate at Week 52
time frame: Week 52

Secondary Outcomes

Measure
Complete or almost complete cure rate at Week 52
time frame: Week 52
Number of Adverse events
time frame: Up to Week 48, Week 52, EOS
Local Tolerability Assessments
time frame: Up to Week 48, Week 52, EOS

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Mild to moderate distal lateral subungual onychomycosis - A positive potassium hydroxide (KOH) microscopy - A positive fungal culture for a dermatophyte - Good general health Exclusion Criteria: - Uncontrolled diabetes - Onychomycosis of the fingernails - Prior use of antifungal drugs (Failure to complete the specified washout period) - History of HIV, Hepatitis B or Hepatitis C - Diagnosis of psoriasis or history of psoriasis - Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study - Pregnancy/lactation

Additional Information

Official title A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Dose-Ranging Study to Investigate the Efficacy and Safety of ME1111 in Patients With Mild to Moderate Onychomycosis
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Meiji Seika Pharma Co., Ltd..