Topical Gel Anti-Fungal Agent for Tinea Unguium
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.
Drug: Organogel of naftifine, 2%
Drug: Organogel of terbinafine, 2%
Drug: Organogel of naftifine, 6%
Drug: Organogel of terbinafine, 6%
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
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.|
- 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.
|Study Start Date:||September 2005|
|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|