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

Primary Purpose

Distal and Lateral Subungual Onychomycosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Luliconazole Solution, 10%
Vehicle Solution
Sponsored by
Topica Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal and Lateral Subungual Onychomycosis focused on measuring Onychomycosis, Toenail Fungus, luliconazole, Antifungal, Topical

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Luliconazole Solution, 10% Regimen 1

Luliconazole Solution, 10% Regimen 2

Vehicle Solution Regimen 1

Vehicle Solution Regimen 2

Arm Description

Outcomes

Primary Outcome Measures

The proportion of subjects who achieve complete cure of the target great toenail

Secondary Outcome Measures

Full Information

First Posted
September 8, 2011
Last Updated
November 2, 2015
Sponsor
Topica Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01431820
Brief Title
Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis
Acronym
SOLUTION
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 Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Topica Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal and Lateral Subungual Onychomycosis
Keywords
Onychomycosis, Toenail Fungus, luliconazole, Antifungal, Topical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Luliconazole Solution, 10% Regimen 1
Arm Type
Experimental
Arm Title
Luliconazole Solution, 10% Regimen 2
Arm Type
Experimental
Arm Title
Vehicle Solution Regimen 1
Arm Type
Placebo Comparator
Arm Title
Vehicle Solution Regimen 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Luliconazole Solution, 10%
Intervention Description
Topical
Intervention Type
Drug
Intervention Name(s)
Vehicle Solution
Intervention Description
Topical
Primary Outcome Measure Information:
Title
The proportion of subjects who achieve complete cure of the target great toenail
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21214
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
City
College Station
State/Province
Texas
ZIP/Postal Code
77840
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23545529
Description
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]

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

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