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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|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|
- Quanitative improvement in toenail appearance.
- Assessment of dermatophyte culture and KOH examination.
- Frequency and severity of adverse events.
- Time to achieve 90% and 100% clearance of fungus from nail.
- Assessment of treatment success.
- Assessment of mycological success.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253305
|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|
|St. Louis, Missouri, United States, 63110|
|United States, Oregon|
|Northwest Cutaneous research|
|Portland, Oregon, United States, 97210|