Back to resultsTopical Gel Anti-Fungal Agent for Tinea Unguium
Primary Purpose
Onychomycosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Organogel of naftifine, 2%
Organogel of terbinafine, 2%
Organogel of naftifine, 6%
Organogel of terbinafine, 6%
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis focused on measuring tinea unguium, onychomycosis
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
- Genova Clinical Research, Inc.
- Greater Miami Skin and Laser Center
- Washington University
- Northwest Cutaneous research
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00253305
Brief Title
Topical Gel Anti-Fungal Agent for Tinea Unguium
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 Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
MediQuest Therapeutics
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
tinea unguium, onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
75 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Organogel of naftifine, 2%
Intervention Type
Drug
Intervention Name(s)
Organogel of terbinafine, 2%
Intervention Type
Drug
Intervention Name(s)
Organogel of naftifine, 6%
Intervention Type
Drug
Intervention Name(s)
Organogel of terbinafine, 6%
Primary Outcome Measure Information:
Title
Quanitative improvement in toenail appearance.
Title
Assessment of dermatophyte culture and KOH examination.
Title
Frequency and severity of adverse events.
Secondary Outcome Measure Information:
Title
Time to achieve 90% and 100% clearance of fungus from nail.
Title
Assessment of treatment success.
Title
Assessment of mycological success.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Genova Clinical Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Greater Miami Skin and Laser Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Northwest Cutaneous research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
12. IPD Sharing Statement
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Topical Gel Anti-Fungal Agent for Tinea Unguium
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