Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

Meiji Seika Pharma

Status and phase: Completed; Phase 2

Conditions: Onychomycosis

Treatments: Drug: Matching Vehicle Solution; Drug: ME1111 Solution, Low strength; Drug: ME1111 Solution, High strength

Study type: Interventional

Funder types: Industry

Identifiers

NCT02022215

ME1111-2

Details and patient eligibility

About

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.

Enrollment: 304 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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304 participants in 3 patient groups, including a placebo group

ME1111 Solution, Low strength

Experimental group

Treatment:

Drug: ME1111 Solution, Low strength

ME1111 Solution, High strength

Experimental group

Treatment:

Drug: ME1111 Solution, High strength

Matching Vehicle Solution

Placebo Comparator group

Treatment:

Drug: Matching Vehicle Solution