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

ME1111-2

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.

2013-12-19

2015-10-28

2016-03-01

Completed

Early phase I

304

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 304, 'type': 'ACTUAL'}}

2024-03-18