Topical Gel Anti-Fungal Agent for Tinea Unguium
Information source: MediQuest Therapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Onychomycosis
Intervention: Organogel of naftifine, 2% (Drug); Organogel of terbinafine, 2% (Drug); Organogel of naftifine, 6% (Drug); Organogel of terbinafine, 6% (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: MediQuest Therapeutics
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Quanitative improvement in toenail appearance.Assessment of dermatophyte culture and KOH examination. Frequency and severity of adverse events.
Secondary outcome: Time to achieve 90% and 100% clearance of fungus from nail.Assessment of treatment success. Assessment of mycological success.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Alabama at Birmingham, Birmingham, Alabama 35233, United States
Genova Clinical Research, Inc., Tucson, Arizona 85741, United States
Greater Miami Skin and Laser Center, Miami Beach, Florida 33140, United States
Washington University, St. Louis, Missouri 63110, United States
Northwest Cutaneous research, Portland, Oregon 97210, United States
Additional Information
Starting date: September 2005
Last updated: May 29, 2007
|
