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Topical Gel Anti-Fungal Agent for Tinea Unguium

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ClinicalTrials.gov Identifier: NCT00253305
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : May 30, 2007
Sponsor:
Information provided by:
MediQuest Therapeutics

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Onychomycosis Drug: Organogel of naftifine, 2% Drug: Organogel of terbinafine, 2% Drug: Organogel of naftifine, 6% Drug: Organogel of terbinafine, 6% Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : September 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Quanitative improvement in toenail appearance.
  2. Assessment of dermatophyte culture and KOH examination.
  3. Frequency and severity of adverse events.

Secondary Outcome Measures :
  1. Time to achieve 90% and 100% clearance of fungus from nail.
  2. Assessment of treatment success.
  3. Assessment of mycological success.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253305


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
Genova Clinical Research, Inc.
Tucson, Arizona, United States, 85741
United States, Florida
Greater Miami Skin and Laser Center
Miami Beach, Florida, United States, 33140
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Oregon
Northwest Cutaneous research
Portland, Oregon, United States, 97210
Sponsors and Collaborators
MediQuest Therapeutics
More Information
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ClinicalTrials.gov Identifier: NCT00253305    
Other Study ID Numbers: MQT-05-001
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: May 30, 2007
Last Verified: May 2007
Keywords provided by MediQuest Therapeutics:
tinea unguium
onychomycosis
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
 Skin Diseases
Terbinafine
Naftifine
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action