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Completed

NCT Number: NCT02022215

Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

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.

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Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ME1111 Solution, Low strength

Drug

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

ME1111 Solution, High strength

Drug

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

Matching Vehicle Solution

Drug

Matching Vehicle Solution, applied once daily for 48 weeks

Primary outcomes

  1. Complete cure rate at Week 52

    Time frame: Week 52

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

Secondary outcomes

  1. Complete or almost complete cure rate at Week 52

    Time frame: Week 52

    complete or almost complete cure:5 % or less clinical involvement of the target great toenail and mycologic cure.

  2. Number of Adverse events

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

  3. Local Tolerability Assessments

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

    Local Tolerability Assessments:Burning/Stinging, Pruritus, Dryness, Scaling, Erythema, General Irritation, Induration/Edema, Oozing/crusting.

Sponsors and collaborators

Lead sponsor

Meiji Seika Pharma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 27, 2013
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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