Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Meiji Seika Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02022215
First received: December 15, 2013
Last updated: August 27, 2014
Last verified: August 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Local Tolerability Assessments [ Time Frame: Up to Week 48, Week 52, EOS ] [ Designated as safety issue: Yes ]
    Local Tolerability Assessments:Burning/Stinging, Pruritus, Dryness, Scaling, Erythema, General Irritation, Induration/Edema, Oozing/crusting.


Estimated Enrollment: 300
Study Start Date: December 2013
Estimated Primary Completion Date: September 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
Genders Eligible for Study:   Both
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 Chair: Mitsuharu Egawa Meiji Seika Pharma Co., Ltd.
  More Information

No publications provided

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: August 27, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 27, 2014