Topical Gel Anti-Fungal Agent for Tinea Unguium - Full Text View

Purpose

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	Intervention	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 Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind 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.

Resource links provided by NLM:

MedlinePlus related topics: Molds Tinea Infections

Drug Information available for: Naftifine hydrochloride Terbinafine hydrochloride Terbinafine

U.S. FDA Resources

Further study details as provided by MediQuest Therapeutics:

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.


Estimated Enrollment:	75
Study Start Date:	September 2005

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253305

Locations


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

No publications provided


ClinicalTrials.gov Identifier:	NCT00253305 History of Changes
Other Study ID Numbers:	MQT-05-001
Study First Received:	November 13, 2005
Last Updated:	May 29, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by MediQuest Therapeutics:


tinea unguium onychomycosis

Additional relevant MeSH terms:


Onychomycosis Dermatomycoses Infection Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Tinea	Naftifine Terbinafine Anti-Infective Agents Antifungal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015