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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Topica Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01431820
First received: September 8, 2011
Last updated: November 2, 2015
Last verified: November 2015
September 8, 2011
November 2, 2015
May 2012
June 2014   (Final data collection date for primary outcome measure)
The proportion of subjects who achieve complete cure of the target great toenail [ Time Frame: Week 52 ]
The proportion of subjects who achieve clear nail or ≥ 3 mm clear nail growth of the target great toenail [ Time Frame: Day 196 ]
Complete list of historical versions of study NCT01431820 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Distal and Lateral Subungual Onychomycosis
  • Drug: Luliconazole Solution, 10%
    Topical
  • Drug: Vehicle Solution
    Topical
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
334
August 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01431820
TP-1009-S
No
Not Provided
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Topica Pharmaceuticals
Topica Pharmaceuticals
Not Provided
Not Provided
Topica Pharmaceuticals
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP