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Sponsored by: |
MediQuest Therapeutics |
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Information provided by: | MediQuest Therapeutics |
ClinicalTrials.gov Identifier: | NCT00253305 |
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 |
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Onychomycosis |
Drug: Organogel of naftifine, 2% Drug: Organogel of terbinafine, 2% Drug: Organogel of naftifine, 6% Drug: Organogel of terbinafine, 6% |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 75 |
Study Start Date: | September 2005 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | MQT-05-001 |
Study First Received: | November 13, 2005 |
Last Updated: | May 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00253305 |
Health Authority: | United States: Food and Drug Administration |
tinea unguium onychomycosis |
Mycoses Skin Diseases, Infectious Onychomycosis Naftifine Skin Diseases Clotrimazole |
Miconazole Tioconazole Tinea Terbinafine Dermatomycoses |
Anti-Infective Agents Anti-Infective Agents, Local Nail Diseases Molecular Mechanisms of Pharmacological Action Antifungal Agents |
Therapeutic Uses Enzyme Inhibitors Infection Pharmacologic Actions |