Topical Gel Anti-Fungal Agent for Tinea Unguium

Completed · Phase 2

Conditions studied: Onychomycosis

In brief

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.

Key facts

Study ID

NCT00253305

Run by

MediQuest Therapeutics

People needed

75

Starts

2005-09-01

Last updated by the study team

2007-05-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Genova Clinical Research, Inc. — Tucson, Arizona, United States
• Greater Miami Skin and Laser Center — Miami Beach, Florida, United States
• Washington University — St Louis, Missouri, United States
• Northwest Cutaneous research — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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