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

November 2, 2015 updated by: Topica Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

334

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85050
    • California
      • Los Angeles, California, United States, 90045
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92119
    • Colorado
      • Denver, Colorado, United States, 80210
    • Florida
      • Aventura, Florida, United States, 33180
      • Miami, Florida, United States, 33175
    • Idaho
      • Boise, Idaho, United States, 83704
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Maryland
      • Baltimore, Maryland, United States, 21214
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Fridley, Minnesota, United States, 55432
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • East Setauket, New York, United States, 11733
      • Rochester, New York, United States, 14623
    • Ohio
      • Cincinnati, Ohio, United States, 45249
    • Oregon
      • Portland, Oregon, United States, 97210
      • Portland, Oregon, United States, 97223
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
      • Nashville, Tennessee, United States, 37215
    • Texas
      • Austin, Texas, United States, 78759
      • College Station, Texas, United States, 77840
      • Dallas, Texas, United States, 75243
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84117
    • Virginia
      • Lynchburg, Virginia, United States, 24501
    • Wisconsin
      • Madison, Wisconsin, United States, 53719

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of subjects who achieve complete cure of the target great toenail
Time Frame: Week 52
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Topica Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 8, 2011

First Submitted That Met QC Criteria

September 9, 2011

First Posted (Estimate)

September 12, 2011

Study Record Updates

Last Update Posted (Estimate)

November 30, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-1009-S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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