NCT00253305

Topical Gel Anti-Fungal Agent for Tinea Unguium

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (planned)
• Sponsor: MediQuest Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	Organogel of naftifine, 2%
DRUG	Organogel of terbinafine, 2%
DRUG	Organogel of naftifine, 6%
DRUG	Organogel of terbinafine, 6%

Timeline

• Start date: 2005-09-01
• First posted: 2005-11-15
• Last updated: 2007-05-30

Locations

5 sites across 1 country: United States