Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

Phase 2CompletedNCT02022215

Meiji Seika Pharma Co., Ltd.304 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

304

Conditions

Onychomycosis

Interventions

ME1111 Solution, Low strengthDRUG

ME1111 Solution, Low strength, applied once daily for 48 weeks

ME1111 Solution, High strengthDRUG

ME1111 Solution, High strength, applied once daily for 48 weeks

Matching Vehicle SolutionDRUG

Matching Vehicle Solution, applied once daily for 48 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (31)

Unnamed facility

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Complete cure rate at Week 52

complete cure :clear (zero %) clinical involvement of the target great toenail and mycologic cure.

Time frame: Week 52

Secondary Outcomes

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.

Time frame: Week 52

Number of Adverse events

Time frame: 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.

Time frame: Up to Week 48, Week 52, EOS

Data from ClinicalTrials.gov

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