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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
  Purpose

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 Intervention Phase
Distal and Lateral Subungual Onychomycosis
 Drug: Luliconazole Solution, 10%
Drug: Vehicle Solution
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Topica Pharmaceuticals:

Primary Outcome Measures:
  • The proportion of subjects who achieve complete cure of the target great toenail [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431820

  Show 28 Study Locations
Sponsors and Collaborators
Topica Pharmaceuticals
  More Information

Additional Information:
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]  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Topica Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01431820     History of Changes
Obsolete Identifiers: NCT01428856
Other Study ID Numbers: TP-1009-S
Study First Received: September 8, 2011
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013