Clinical trial NCT01431820: Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Distal and Lateral Subungual Onychomycosis
Keywords: Onychomycosis
Toenail Fungus
luliconazole
Antifungal
Topical
Lead sponsor: Topica Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-09-12
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The proportion of subjects who achieve complete cure of the target great toenail
timeFrame: Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Aventura
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Evansville
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: Albuquerque
country: United States
state: New Mexico
city: East Setauket
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Knoxville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Lynchburg
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
Study officials:
References: