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

NCT ID: NCT01431820

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Distal and Lateral Subungual Onychomycosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Luliconazole Solution, 10% Regimen 1

Group Type EXPERIMENTAL

Luliconazole Solution, 10%

Intervention Type DRUG

Topical

Luliconazole Solution, 10% Regimen 2

Group Type EXPERIMENTAL

Luliconazole Solution, 10%

Intervention Type DRUG

Topical

Vehicle Solution Regimen 1

Group Type PLACEBO_COMPARATOR

Vehicle Solution

Intervention Type DRUG

Topical

Vehicle Solution Regimen 2

Group Type PLACEBO_COMPARATOR

Vehicle Solution

Intervention Type DRUG

Topical

Interventions

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Luliconazole Solution, 10%

Topical

Intervention Type DRUG

Vehicle Solution

Topical

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Topica Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phoenix, Arizona, United States

Site Status

Los Angeles, California, United States

Site Status

San Diego, California, United States

Site Status

San Diego, California, United States

Site Status

Denver, Colorado, United States

Site Status

Aventura, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Boise, Idaho, United States

Site Status

Evansville, Indiana, United States

Site Status

Louisville, Kentucky, United States

Site Status

Baltimore, Maryland, United States

Site Status

Detroit, Michigan, United States

Site Status

Fridley, Minnesota, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

East Setauket, New York, United States

Site Status

Rochester, New York, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Portland, Oregon, United States

Site Status

Portland, Oregon, United States

Site Status

Knoxville, Tennessee, United States

Site Status

Nashville, Tennessee, United States

Site Status

Austin, Texas, United States

Site Status

College Station, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Lynchburg, Virginia, United States

Site Status

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/23545529

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. \[Epub ahead of print\]

Other Identifiers

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TP-1009-S

Identifier Type: -

Identifier Source: org_study_id

NCT01428856

Identifier Type: -

Identifier Source: nct_alias