Topical Gel Anti-Fungal Agent for Tinea Unguium

May 29, 2007 updated by: MediQuest Therapeutics

Phase IIB Efficacy and Safety Study of Four Topical Gel Formulations of Anti-Fungal Agents, MQX-5858, MQX-5859, MQX-5866, and MQX-5867, Versus Vehicle in the Treatment of Tinea Unguium.

The purpose of this study is to compare, in a controlled fashion, the response to two anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations in the treatment of subjects with distal subungual tinea unguium of the toenails (onychomycosis).

The formulation used as the vehicle for the active agents has been shown in earlier studies to facilitate the penetration of the active agent through fungally-infected nails. This study will examine dose-response and agent differences in terms of efficacy and safety.

Once the subject has qualified for the study, he/she will be randomly assigned to one of five study groups, dispensed appropriate study medication and instructed to apply one drop to the great toe designated for study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Genova Clinical Research, Inc.
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Greater Miami Skin and Laser Center
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Cutaneous Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of distal subungual tinuea unguium of one great toenail.
  • between 20 - 65% infected area for target nail
  • 2 mm of clear nail proximally on target nail
  • positive dermatophyte culture and positive KOH test
  • able to sign informed consent
  • understand requirements of study
  • females must be post-menopausal or agree to use approved contraceptives throughout the study

Exclusion Criteria:

  • patients with nails infected with organisms other than dermatophytes
  • patients with proximal subungual tinea unguium
  • patients with spikes of disease extending to nail matrix
  • patients with more than 5 infected nails
  • patients with confounding problems/ abnormalities of target nail
  • patients with screening lab values more than 20% of normal
  • patients with known hypersensitivity to test material components
  • patients requiring systemic medications that may interfere with study
  • patients with a poor history of compliance with study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quanitative improvement in toenail appearance.
Assessment of dermatophyte culture and KOH examination.
Frequency and severity of adverse events.

Secondary Outcome Measures

Outcome Measure
Time to achieve 90% and 100% clearance of fungus from nail.
Assessment of treatment success.
Assessment of mycological success.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MediQuest Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Registration Dates

First Submitted

November 13, 2005

First Submitted That Met QC Criteria

November 13, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Estimate)

May 30, 2007

Last Update Submitted That Met QC Criteria

May 29, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MQT-05-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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