Topical Gel Anti-Fungal Agent for Tinea Unguium
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00253305 |
Recruitment Status :
Completed
First Posted : November 15, 2005
Last Update Posted : May 30, 2007
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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 Type : | Interventional (Clinical Trial) |
Enrollment : | 75 participants |
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 : | September 2005 |

- Quanitative improvement in toenail appearance.
- Assessment of dermatophyte culture and KOH examination.
- Frequency and severity of adverse events.
- Time to achieve 90% and 100% clearance of fungus from nail.
- Assessment of treatment success.
- Assessment of mycological success.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253305
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 |
ClinicalTrials.gov Identifier: | NCT00253305 |
Other Study ID Numbers: |
MQT-05-001 |
First Posted: | November 15, 2005 Key Record Dates |
Last Update Posted: | May 30, 2007 |
Last Verified: | May 2007 |
tinea unguium onychomycosis |
Onychomycosis Tinea Dermatomycoses Skin Diseases, Infectious Infection Mycoses Nail Diseases |
Skin Diseases Terbinafine Naftifine Antifungal Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |