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

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds Tinea Infections

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 History of Changes
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 Miconazole	Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP3A Inhibitors

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