Onychomycosis Clinical Trial
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.
NCT number | NCT00253305 |
Other study ID # | MQT-05-001 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | November 13, 2005 |
Last updated | May 29, 2007 |
Start date | September 2005 |
Verified date | May 2007 |
Source | MediQuest Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Greater Miami Skin and Laser Center | Miami Beach | Florida |
United States | Northwest Cutaneous research | Portland | Oregon |
United States | Washington University | St. Louis | Missouri |
United States | Genova Clinical Research, Inc. | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
MediQuest Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quanitative improvement in toenail appearance. | |||
Primary | Assessment of dermatophyte culture and KOH examination. | |||
Primary | Frequency and severity of adverse events. | |||
Secondary | Time to achieve 90% and 100% clearance of fungus from nail. | |||
Secondary | Assessment of treatment success. | |||
Secondary | Assessment of mycological success. |
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