Onychomycosis Clinical Trial
Official title:
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenails for 52 Weeks
Verified date | July 2013 |
Source | Promius Pharma, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.
Status | Terminated |
Enrollment | 458 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - mild to moderate fungal infection of the toenail as assessed by study doctor - koh positive & dermatophyte culture positive at Visit 1 - general good health as assessed by study doctor Exclusion Criteria: - severe fungal toenail infection - prior use of antifungal drugs (wash-out allowed, duration varies on class) - significant confounding conditions as assessed by study doctor - pregnancy/lactation - must forego nail salon procedures during study for at least ~60 weeks |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Michigan Center for Skin Care Research | Clinton Township | Michigan |
United States | Avail Clinical Research | DeLand | Florida |
United States | Deaconess Clinic Downtown | Evansville | Indiana |
United States | Center for Dermatology Clinical Research, Inc. | Fremont | California |
United States | Radiant Research, Inc. | Greer | South Carolina |
United States | North Florida Dermatology Association | Jacksonville | Florida |
United States | The Skin Wellness Center, PC | Knoxville | Tennessee |
United States | Altus Research | Lake Worth | Florida |
United States | Madison Skin and Research, Inc. | Madison | Wisconsin |
United States | Lake Washington Foot and Ankle Center | Melbourne | Florida |
United States | Department of Veteran's Affairs | Minneapolis | Minnesota |
United States | Pinkas Lebovits | New York | New York |
United States | Park Avenue Dermatology | Orange Park | Florida |
United States | Associated Foot & Ankle Specialists, LLC | Phoenix | Arkansas |
United States | Radiant Research, Inc. | Pinellas Park | Florida |
United States | Research Across America | Plano | Texas |
United States | Oregon Medical Research Center, PC | Portland | Oregon |
United States | Skin Search of Rochester, Inc. | Rochester | New York |
United States | Family Foot Health Center | Rogers | Arkansas |
United States | Dermatology Research Center | Salt Lake City | Utah |
United States | Endeavor Clinical Trials | San Antonio | Texas |
United States | UCSF Dermatology Research | San Francisco | California |
United States | Radiant Research, Inc. | Tucson | Arizona |
United States | Coastal Podiatry, Inc. | Virginia Beach | Virginia |
United States | Care Plus Podiatry, PC | Wading River | New York |
Lead Sponsor | Collaborator |
---|---|
Promius Pharma, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure. | Week 56 after 52 weeks of treatment | No | |
Secondary | Proportion of subjects with effective treatment at week 56. Effective treatment defined as mycological cure and an IGA of 0 or 1 (clear or almost clear). | Week 56 | No |
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