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

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

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
Primary Completion Date : June 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431820


  Show 28 Study Locations
Sponsors and Collaborators
Topica Pharmaceuticals
More Information

Additional Information:
Responsible Party: Topica Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01431820     History of Changes
Obsolete Identifiers: NCT01428856
Other Study ID Numbers: TP-1009-S
First Posted: September 12, 2011    Key Record Dates
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
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Pharmaceutical Solutions