Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02022215

Enrollment

304

Registered

2013-12-27

Start date

2013-12-19

Completion date

2016-03-01

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onychomycosis

Brief 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.

Interventions

DRUGME1111 Solution, Low strength

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

DRUGME1111 Solution, High strength

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

DRUGMatching Vehicle Solution

Matching Vehicle Solution, applied once daily for 48 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026