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Topical Gel Anti-Fungal Agent for Tinea Unguium
This study has been completed.
Sponsor:
MediQuest Therapeutics
Information provided by:
MediQuest Therapeutics
ClinicalTrials.gov Identifier:
NCT00253305
First received: November 13, 2005
Last updated: May 29, 2007
Last verified: May 2007
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Purpose
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 | Intervention | 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 Type: | Interventional |
| Study Design: | 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. |
Resource links provided by NLM:
Further study details as provided by MediQuest Therapeutics:
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.
| Estimated Enrollment: | 75 |
| Study Start Date: | September 2005 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253305
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253305
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arizona | |
| Genova Clinical Research, Inc. | |
| Tucson, Arizona, United States, 85741 | |
| United States, Florida | |
| Greater Miami Skin and Laser Center | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Oregon | |
| Northwest Cutaneous research | |
| Portland, Oregon, United States, 97210 | |
Sponsors and Collaborators
MediQuest Therapeutics
More Information
| ClinicalTrials.gov Identifier: | NCT00253305 History of Changes |
| Other Study ID Numbers: |
MQT-05-001 |
| Study First Received: | November 13, 2005 |
| Last Updated: | May 29, 2007 |
Keywords provided by MediQuest Therapeutics:
|
tinea unguium onychomycosis |
Additional relevant MeSH terms:
|
Onychomycosis Tinea Dermatomycoses Skin Diseases, Infectious Infection Mycoses Nail Diseases Skin Diseases Terbinafine Naftifine Antifungal Agents Miconazole |
Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP3A Inhibitors |
ClinicalTrials.gov processed this record on August 18, 2017