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Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meiji Seika Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02022215
First received: December 15, 2013
Last updated: March 22, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Onychomycosis Drug: ME1111 Solution, Low strength Drug: ME1111 Solution, High strength Drug: Matching Vehicle Solution Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official 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

Further study details as provided by Meiji Seika Pharma Co., Ltd.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • Number of Adverse events [ Time Frame: Up to Week 48, Week 52, EOS ]
  • 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.


Enrollment: 304
Actual Study Start Date: December 19, 2013
Study Completion Date: March 1, 2016
Primary Completion Date: October 28, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ME1111 Solution, Low strength Drug: ME1111 Solution, Low strength
ME1111 Solution, Low strength, applied once daily for 48 weeks
Experimental: ME1111 Solution, High strength Drug: ME1111 Solution, High strength
ME1111 Solution, High strength, applied once daily for 48 weeks
Placebo Comparator: Matching Vehicle Solution Drug: Matching Vehicle Solution
Matching Vehicle Solution, applied once daily for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022215

  Show 31 Study Locations
Sponsors and Collaborators
Meiji Seika Pharma Co., Ltd.
Investigators
Study Director: Meiji Study Director Meiji Seika Pharma Co., Ltd.
  More Information

Responsible Party: Meiji Seika Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT02022215     History of Changes
Other Study ID Numbers: ME1111-2
Study First Received: December 15, 2013
Last Updated: March 22, 2017

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on June 23, 2017