Topical Gel Anti-Fungal Agent for Tinea Unguium
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.
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