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Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis (SOLUTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01431820
Recruitment Status : Completed
First Posted : September 12, 2011
Last Update Posted : November 30, 2015
Information provided by (Responsible Party):
Topica Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Distal and Lateral Subungual Onychomycosis Drug: Luliconazole Solution, 10% Drug: Vehicle Solution Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Luliconazole Solution, 10% With Two Dosing Regimens in Distal Subungual Onychomycosis of the Toenails: A Randomized, Double-Blind, Vehicle-Controlled, Phase 2B/3 Study
Study Start Date : May 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Luliconazole Solution, 10% Regimen 1 Drug: Luliconazole Solution, 10%

Experimental: Luliconazole Solution, 10% Regimen 2 Drug: Luliconazole Solution, 10%

Placebo Comparator: Vehicle Solution Regimen 1 Drug: Vehicle Solution

Placebo Comparator: Vehicle Solution Regimen 2 Drug: Vehicle Solution

Primary Outcome Measures :
  1. The proportion of subjects who achieve complete cure of the target great toenail [ Time Frame: Week 52 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01431820

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United States, Arizona
Phoenix, Arizona, United States, 85050
United States, California
Los Angeles, California, United States, 90045
San Diego, California, United States, 92119
San Diego, California, United States, 92123
United States, Colorado
Denver, Colorado, United States, 80210
United States, Florida
Aventura, Florida, United States, 33180
Miami, Florida, United States, 33175
United States, Idaho
Boise, Idaho, United States, 83704
United States, Indiana
Evansville, Indiana, United States, 47714
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Maryland
Baltimore, Maryland, United States, 21214
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Minnesota
Fridley, Minnesota, United States, 55432
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
East Setauket, New York, United States, 11733
Rochester, New York, United States, 14623
United States, Ohio
Cincinnati, Ohio, United States, 45249
United States, Oregon
Portland, Oregon, United States, 97210
Portland, Oregon, United States, 97223
United States, Tennessee
Knoxville, Tennessee, United States, 37922
Nashville, Tennessee, United States, 37215
United States, Texas
Austin, Texas, United States, 78759
College Station, Texas, United States, 77840
Dallas, Texas, United States, 75243
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84117
United States, Virginia
Lynchburg, Virginia, United States, 24501
United States, Wisconsin
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
Topica Pharmaceuticals
Additional Information:
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Responsible Party: Topica Pharmaceuticals Identifier: NCT01431820    
Obsolete Identifiers: NCT01428856
Other Study ID Numbers: TP-1009-S
First Posted: September 12, 2011    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015
Keywords provided by Topica Pharmaceuticals:
Toenail Fungus
Additional relevant MeSH terms:
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Skin Diseases, Infectious
Nail Diseases
Skin Diseases
Pharmaceutical Solutions
Antifungal Agents
Anti-Infective Agents