Topical Gel Anti-Fungal Agent for Tinea Unguium

Sponsor

MediQuest Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00253305

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Onychomycosis	Drug: Organogel of naftifine, 2% Drug: Organogel of terbinafine, 2% Drug: Organogel of naftifine, 6% Drug: Organogel of terbinafine, 6%	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

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.

Study Start Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Time to achieve 90% and 100% clearance of fungus from nail. []
Assessment of treatment success. []
Assessment of mycological success. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	Genova Clinical Research, Inc.	Tucson	Arizona	United States	85741
3	Greater Miami Skin and Laser Center	Miami Beach	Florida	United States	33140
4	Washington University	St. Louis	Missouri	United States	63110
5	Northwest Cutaneous research	Portland	Oregon	United States	97210