Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis
SOLUTION
1 other identifier
interventional
334
1 country
28
Brief Summary
The purpose of this study is to determine the safety and efficacy of a topical antifungal formulation, Luliconazole Solution, 10%, in the treatment of adults with onychomycosis of the toenails.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2012
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2011
CompletedFirst Posted
Study publicly available on registry
September 12, 2011
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedNovember 30, 2015
November 1, 2015
2.1 years
September 8, 2011
November 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of subjects who achieve complete cure of the target great toenail
Week 52
Study Arms (4)
Luliconazole Solution, 10% Regimen 1
EXPERIMENTALLuliconazole Solution, 10% Regimen 2
EXPERIMENTALVehicle Solution Regimen 1
PLACEBO COMPARATORVehicle Solution Regimen 2
PLACEBO COMPARATORInterventions
Topical
Eligibility Criteria
You may qualify if:
- Subjects of either gender, any race and between the ages of 18 and 70 inclusive
- Subjects with a clinical diagnosis with culture confirmation of distal subungual onychomycosis (DSO) - Subjects must be free of any disease that in the Investigator's opinion might interfere with the study evaluations or jeopardize the subject's safety
You may not qualify if:
- Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the solution
- Subjects who are currently participating or have recently participated in another investigational medication or device study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
Phoenix, Arizona, 85050, United States
Unknown Facility
Los Angeles, California, 90045, United States
Unknown Facility
San Diego, California, 92119, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Denver, Colorado, 80210, United States
Unknown Facility
Aventura, Florida, 33180, United States
Unknown Facility
Miami, Florida, 33175, United States
Unknown Facility
Boise, Idaho, 83704, United States
Unknown Facility
Evansville, Indiana, 47714, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Baltimore, Maryland, 21214, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Fridley, Minnesota, 55432, United States
Unknown Facility
Albuquerque, New Mexico, 87106, United States
Unknown Facility
East Setauket, New York, 11733, United States
Unknown Facility
Rochester, New York, 14623, United States
Unknown Facility
Cincinnati, Ohio, 45249, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Portland, Oregon, 97223, United States
Unknown Facility
Knoxville, Tennessee, 37922, United States
Unknown Facility
Nashville, Tennessee, 37215, United States
Unknown Facility
Austin, Texas, 78759, United States
Unknown Facility
College Station, Texas, 77840, United States
Unknown Facility
Dallas, Texas, 75243, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Salt Lake City, Utah, 84117, United States
Unknown Facility
Lynchburg, Virginia, 24501, United States
Unknown Facility
Madison, Wisconsin, 53719, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2011
First Posted
September 12, 2011
Study Start
May 1, 2012
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
November 30, 2015
Record last verified: 2015-11