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

Distal and Lateral Subungual Onychomycosis Clinical Trial

— SOLUTION  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431820
• Other study ID #: TP-1009-S
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 8, 2011
• Last updated: November 2, 2015
• Start date: May 2012
• Est. completion date: August 2014

Study information

• Verified date: November 2015
• Source: Topica Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01428856

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal and Lateral Subungual Onychomycosis
• Onychomycosis

Intervention

Drug:
• Luliconazole Solution, 10%
Topical
• Vehicle Solution
Topical

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Topica Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects who achieve complete cure of the target great toenail		Week 52	No

External Links

•   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]