Onychomycosis Clinical Trial
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.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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