Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Onychomycosis

Intervention / Treatment
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* Drug: ME1111 Solution, Low strength
* Drug: ME1111 Solution, High strength
* Drug: Matching Vehicle Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ME1111 Solution, Low strength<br> | Drug: ME1111 Solution, Low strength<br>* ME1111 Solution, Low strength, applied once daily for 48 weeks<br>|
| Experimental: ME1111 Solution, High strength<br> | Drug: ME1111 Solution, High strength<br>* ME1111 Solution, High strength, applied once daily for 48 weeks<br>|
| Placebo Comparator: Matching Vehicle Solution<br> | Drug: Matching Vehicle Solution<br>* Matching Vehicle Solution, applied once daily for 48 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete cure rate at Week 52 | complete cure :clear (zero %) clinical involvement of the target great toenail and mycologic cure. | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete or almost complete cure rate at Week 52 | complete or almost complete cure:5 % or less clinical involvement of the target great toenail and mycologic cure. | Week 52 | 
| Number of Adverse events |  | Up to Week 48, Week 52, EOS | 
| Local Tolerability Assessments | Local Tolerability Assessments:Burning/Stinging, Pruritus, Dryness, Scaling, Erythema, General Irritation, Induration/Edema, Oozing/crusting. | Up to Week 48, Week 52, EOS |