Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

Phase 2

Completed

• Conditions: Onychomycosis
• Interventions: Drug: ME1111 Solution, High strength; Drug: Matching Vehicle Solution; Drug: ME1111 Solution, Low strength

• Registration Number: NCT02022215
• Lead Sponsor: Meiji Seika Pharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-15
• Study Start: 2013-12-19
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Primary Completion: 2015-10-28
• Study Completion: 2016-03-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ME1111 Solution, High strength	ME1111 Solution, High strength	-
Matching Vehicle Solution	Matching Vehicle Solution	-
ME1111 Solution, Low strength	ME1111 Solution, Low strength	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.
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.
Number of Adverse events	Up to Week 48, Week 52, EOS