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

ClinicalTrials.gov ID: NCT01431820

Public ClinicalTrials.gov record NCT01431820. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 4:13 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01431820
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Topica Pharmaceuticals; Industry
Enrollment: 334 participants

Conditions and interventions

Conditions

Distal and Lateral Subungual Onychomycosis

Interventions

Luliconazole Solution, 10% Drug
Vehicle Solution Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 70 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 30, 2012
Primary completion: May 31, 2014
Completion: Jul 31, 2014
Last update posted: Nov 29, 2015

2012 – 2014

United States locations

U.S. sites: 28
U.S. states: 19
U.S. cities: 26

Facility	City	State	ZIP	Site status
Not listed	Phoenix	Arizona	85050	—
Not listed	Los Angeles	California	90045	—
Not listed	San Diego	California	92119	—
Not listed	San Diego	California	92123	—
Not listed	Denver	Colorado	80210	—
Not listed	Aventura	Florida	33180	—
Not listed	Miami	Florida	33175	—
Not listed	Boise	Idaho	83704	—
Not listed	Evansville	Indiana	47714	—
Not listed	Louisville	Kentucky	40202	—
Not listed	Baltimore	Maryland	21214	—
Not listed	Detroit	Michigan	48202	—
Not listed	Fridley	Minnesota	55432	—
Not listed	Albuquerque	New Mexico	87106	—
Not listed	East Setauket	New York	11733	—
Not listed	Rochester	New York	14623	—
Not listed	Cincinnati	Ohio	45249	—
Not listed	Portland	Oregon	97210	—
Not listed	Portland	Oregon	97223	—
Not listed	Knoxville	Tennessee	37922	—
Not listed	Nashville	Tennessee	37215	—
Not listed	Austin	Texas	78759	—
Not listed	College Station	Texas	77840	—
Not listed	Dallas	Texas	75243	—
Not listed	San Antonio	Texas	78229	—
Not listed	Salt Lake City	Utah	84117	—
Not listed	Lynchburg	Virginia	24501	—
Not listed	Madison	Wisconsin	53719	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01431820, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 29, 2015 · Synced Sep 6, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01431820 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →