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CompletedNCT01431820SOLUTIONUpdated Nov 30, 2015

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

A Phase 2/3 interventional study of Luliconazole Solution, 10% and Vehicle Solution in Distal and Lateral Subungual Onychomycosis, sponsored by Topica Pharmaceuticals. Completed at 28 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-11-30.

Sponsored by Topica Pharmaceuticals · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
334
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Distal and Lateral Subungual Onychomycosis

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Keywords

  • Onychomycosis
  • Toenail Fungus
  • luliconazole
  • Antifungal
  • Topical
03

In context

Onychomycosis

147 studies on the registry are indexed under Onychomycosis; 13 are open to participants now.

This study's enrollment of 334 is above the median of 56 across 134 interventional studies indexed under Onychomycosis.

Browse Onychomycosis studies →

Lead sponsor

Topica Pharmaceuticals is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
334 participants (actual)

Study arms

  • Experimental
    Luliconazole Solution, 10% Regimen 1

    Drug: Luliconazole Solution, 10%

  • Experimental
    Luliconazole Solution, 10% Regimen 2

    Drug: Luliconazole Solution, 10%

  • Placebo comparator
    Vehicle Solution Regimen 1

    Drug: Vehicle Solution

  • Placebo comparator
    Vehicle Solution Regimen 2

    Drug: Vehicle Solution

Interventions

  • DrugLuliconazole Solution, 10%

    Topical

  • DrugVehicle Solution

    Topical

06

What researchers measure

Primary outcomes

  1. The proportion of subjects who achieve complete cure of the target great toenail

    Time frame: Week 52

07

Study locations

28 sites
  • Phoenix, Arizona 85050, United States
  • Los Angeles, California 90045, United States
  • San Diego, California 92119, United States
  • San Diego, California 92123, United States
  • Denver, Colorado 80210, United States
  • Aventura, Florida 33180, United States
  • Miami, Florida 33175, United States
  • Boise, Idaho 83704, United States
  • Evansville, Indiana 47714, United States
  • Louisville, Kentucky 40202, United States
  • Baltimore, Maryland 21214, United States
  • Detroit, Michigan 48202, United States
  • Fridley, Minnesota 55432, United States
  • Albuquerque, New Mexico 87106, United States
  • East Setauket, New York 11733, United States
  • Rochester, New York 14623, United States
  • Cincinnati, Ohio 45249, United States
  • Portland, Oregon 97210, United States
  • Portland, Oregon 97223, United States
  • Knoxville, Tennessee 37922, United States
  • Nashville, Tennessee 37215, United States
  • Austin, Texas 78759, United States
  • College Station, Texas 77840, United States
  • Dallas, Texas 75243, United States
  • San Antonio, Texas 78229, United States
  • Salt Lake City, Utah 84117, United States
  • Lynchburg, Virginia 24501, United States
  • Madison, Wisconsin 53719, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01431820
Lead sponsor
Topica Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 12, 2011
Start date
May 2012
Primary completion
Jun 2014
Completion
Aug 2014
Last update
Nov 30, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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