Clinical trial NCT02022215: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Onychomycosis
Lead sponsor: Meiji Seika Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-27
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Complete cure rate at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Complete or almost complete cure rate at Week 52
timeFrame: Week 52
measure: Number of Adverse events
timeFrame: Up to Week 48, Week 52, EOS
measure: Local Tolerability Assessments
timeFrame: Up to Week 48, Week 52, EOS
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Encinitas
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Miramar
country: United States
state: Florida
city: Newnan
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Evansville
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Clinton Township
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Mount Pleasant
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Lynchburg
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Meiji Seika Pharma Co., Ltd.
name: Meiji Study Director
role: STUDY_DIRECTOR
References: