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Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ME1111 Solution, Low strength
ME1111 Solution, High strength
Matching Vehicle Solution
Sponsored by
Meiji Seika Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ME1111 Solution, Low strength

ME1111 Solution, High strength

Matching Vehicle Solution

Arm Description

Outcomes

Primary Outcome Measures

Complete cure rate at 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
complete or almost complete cure:5 % or less clinical involvement of the target great toenail and mycologic cure.
Number of Adverse events
Local Tolerability Assessments
Local Tolerability Assessments:Burning/Stinging, Pruritus, Dryness, Scaling, Erythema, General Irritation, Induration/Edema, Oozing/crusting.

Full Information

First Posted
December 15, 2013
Last Updated
March 22, 2017
Sponsor
Meiji Seika Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02022215
Brief Title
Efficacy and Safety Study of ME1111 in Patients With Onychomycosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 19, 2013 (Actual)
Primary Completion Date
October 28, 2015 (Actual)
Study Completion Date
March 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meiji Seika Pharma Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ME1111 Solution, Low strength
Arm Type
Experimental
Arm Title
ME1111 Solution, High strength
Arm Type
Experimental
Arm Title
Matching Vehicle Solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ME1111 Solution, Low strength
Intervention Description
ME1111 Solution, Low strength, applied once daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
ME1111 Solution, High strength
Intervention Description
ME1111 Solution, High strength, applied once daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Matching Vehicle Solution
Intervention Description
Matching Vehicle Solution, applied once daily for 48 weeks
Primary Outcome Measure Information:
Title
Complete cure rate at Week 52
Description
complete cure :clear (zero %) clinical involvement of the target great toenail and mycologic cure.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Complete or almost complete cure rate at Week 52
Description
complete or almost complete cure:5 % or less clinical involvement of the target great toenail and mycologic cure.
Time Frame
Week 52
Title
Number of Adverse events
Time Frame
Up to Week 48, Week 52, EOS
Title
Local Tolerability Assessments
Description
Local Tolerability Assessments:Burning/Stinging, Pruritus, Dryness, Scaling, Erythema, General Irritation, Induration/Edema, Oozing/crusting.
Time Frame
Up to Week 48, Week 52, EOS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meiji Study Director
Organizational Affiliation
Meiji Seika Pharma Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Encinitas
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Santa Rosa
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Miramar
State/Province
Florida
Country
United States
City
Newnan
State/Province
Georgia
Country
United States
City
Boise
State/Province
Idaho
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Clinton Twp
State/Province
Michigan
Country
United States
City
Fridley
State/Province
Minnesota
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Mount Pleasant
State/Province
South Carolina
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
College Station
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Lynchburg
State/Province
Virginia
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Spokane
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

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