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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: July 9, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431820

  Show 28 Study Locations
Sponsors and Collaborators
Topica Pharmaceuticals
  More Information

Additional Information:
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: July 9, 2014
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
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014