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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00253305
Other study ID # MQT-05-001
Secondary ID
Status Completed
Phase Phase 2
First received November 13, 2005
Last updated May 29, 2007
Start date September 2005

Study information

Verified date May 2007
Source MediQuest Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Organogel of naftifine, 2%

Organogel of terbinafine, 2%

Organogel of naftifine, 6%

Organogel of terbinafine, 6%


Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States Greater Miami Skin and Laser Center Miami Beach Florida
United States Northwest Cutaneous research Portland Oregon
United States Washington University St. Louis Missouri
United States Genova Clinical Research, Inc. Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
MediQuest Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quanitative improvement in toenail appearance.
Primary Assessment of dermatophyte culture and KOH examination.
Primary Frequency and severity of adverse events.
Secondary Time to achieve 90% and 100% clearance of fungus from nail.
Secondary Assessment of treatment success.
Secondary Assessment of mycological success.
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