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

• ClinicalTrials.gov Identifier: NCT01431820
• Recruitment Status: Completed
• First Posted: September 12, 2011
• Last Update Posted: November 30, 2015
• Sponsor: Topica Pharmaceuticals
• Information provided by (Responsible Party): Topica Pharmaceuticals

Study Description

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

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Luliconazole Solution, 10% Regimen 1	Drug: Luliconazole Solution, 10%; Topical
Experimental: Luliconazole Solution, 10% Regimen 2	Drug: Luliconazole Solution, 10%; Topical
Placebo Comparator: Vehicle Solution Regimen 1	Drug: Vehicle Solution; Topical
Placebo Comparator: Vehicle Solution Regimen 2	Drug: Vehicle Solution; Topical

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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

More Information

Additional Information:

Safety and Tolerability of Luliconazole Solution, 10% in Patients with Moderate to Severe Distal Subungual Onychomycosis. Jones T, Tavakkol A. Antimicrob Agents Chemother. 2013 Apr 1. [Epub ahead of print] 

• Responsible Party: Topica Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01431820
• Obsolete Identifiers: NCT01428856
• Other Study ID Numbers: TP-1009-S
• First Posted: September 12, 2011
• Last Update Posted: November 30, 2015
• Last Verified: November 2015

Keywords provided by Topica Pharmaceuticals:

Onychomycosis; Toenail Fungus; luliconazole; Antifungal; Topical

Additional relevant MeSH terms:

Onychomycosis; Luliconazole; Tinea; Dermatomycoses; Skin Diseases, Infectious; Infection; Mycoses; Nail Diseases; Skin Diseases; Pharmaceutical Solutions; Antifungal Agents; Anti-Infective Agents