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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Topica Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01431820
First received: September 8, 2011
Last updated: October 6, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Distal and Lateral Subungual Onychomycosis
Drug: Luliconazole Solution, 10%
Drug: Vehicle Solution
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Topica Pharmaceuticals:

Primary Outcome Measures:
  • The proportion of subjects who achieve complete cure of the target great toenail [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment: 334
Study Start Date: May 2012
Study Completion Date: August 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431820

  Hide Study 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, 97223
Portland, Oregon, United States, 97210
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:
No publications provided

Responsible Party: Topica Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01431820     History of Changes
Obsolete Identifiers: NCT01428856
Other Study ID Numbers: TP-1009-S
Study First Received: September 8, 2011
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Topica Pharmaceuticals:
Onychomycosis
Toenail Fungus
luliconazole
Antifungal
Topical

Additional relevant MeSH terms:
Onychomycosis
Dermatomycoses
Infection
Mycoses
Nail Diseases
Skin Diseases
Skin Diseases, Infectious
Tinea
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014