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.

NCT00253305 Phase 2 COMPLETED

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.

Details

Lead sponsor	MediQuest Therapeutics
Phase	Phase 2
Status	COMPLETED
Enrolment	75
Start date	2005-09

Conditions

• Onychomycosis

Interventions

• Organogel of naftifine, 2%
• Organogel of terbinafine, 2%
• Organogel of naftifine, 6%
• Organogel of terbinafine, 6%

Primary outcomes

• Quanitative improvement in toenail appearance.
• Assessment of dermatophyte culture and KOH examination.
• Frequency and severity of adverse events.

Countries

United States