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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Topica Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01431820

First received: September 8, 2011

Last updated: May 13, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	September 8, 2011
Last Updated Date	May 13, 2013
Start Date ^ICMJE	May 2012
Estimated Primary Completion Date	July 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 28, 2011)	The proportion of subjects who achieve complete cure of the target great toenail [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: September 9, 2011)	The proportion of subjects who achieve clear nail or ≥ 3 mm clear nail growth of the target great toenail [ Time Frame: Day 196 ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01431820 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Distal and Lateral Subungual Onychomycosis
Intervention ^ICMJE	Drug: Luliconazole Solution, 10% Topical Drug: Vehicle Solution Topical
Study Arm (s)	Experimental: Luliconazole Solution, 10% Regimen 1 Intervention: Drug: Luliconazole Solution, 10% Experimental: Luliconazole Solution, 10% Regimen 2 Intervention: Drug: Luliconazole Solution, 10% Placebo Comparator: Vehicle Solution Regimen 1 Intervention: Drug: Vehicle Solution Placebo Comparator: Vehicle Solution Regimen 2 Intervention: Drug: Vehicle Solution
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	300
Estimated Completion Date	July 2014
Estimated Primary Completion Date	July 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01431820
Other Study ID Numbers ^ICMJE	TP-1009-S
Has Data Monitoring Committee	No
Responsible Party	Topica Pharmaceuticals
Study Sponsor ^ICMJE	Topica Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Topica Pharmaceuticals
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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