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 Wks
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 | 468 |
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 - good general health as assessed by the 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 |
---|---|---|---|
Dominican Republic | Instituto Dermatologica | Santo Domingo | |
Dominican Republic | Instituto Dermatologico | Santo Domingo | |
United States | Northwest Clinical Trials | Boise | Idaho |
United States | Radiant Research | Cincinnati | Ohio |
United States | Ashton Podiatry Associates, PA | Dallas | Texas |
United States | Gerard Furst, DPM, PLLC | East Setauket | New York |
United States | T. Joseph Raoof, MD, Inc. | Encino | California |
United States | Minnesota Clinical Study Center | Fridley | Minnesota |
United States | Carolina Dermatology of Greenville, PA | Greenville | South Carolina |
United States | Dermatology Consulting Services | High Point | North Carolina |
United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
United States | Longmont Medical Research Network | Longmont | Colorado |
United States | Internaional Dermatology Research, Inc. | Miami | Florida |
United States | Coastal Carolina Research Center | Mt. Pleasant | South Carolina |
United States | Tennessee Clinical Research Center | Nashville | Tennessee |
United States | MedaPhase, Inc. | Newnan | Georgia |
United States | Temple University - School of Podiatric Medicine | Philadelphia | Pennsylvania |
United States | Oregon Dermatology & Research Network | Portland | Oregon |
United States | Wake Research Associates | Raleigh | North Carolina |
United States | Mazur Foot and Ankle | Salisbury | North Carolina |
United States | Progressive Clinical Research | San Antonio | Texas |
United States | Skin Surgery Medical Group, Inc. | San Diego | California |
United States | Clinical Research Atlanta | Stockbridge | Georgia |
Lead Sponsor | Collaborator |
---|---|
Promius Pharma, LLC |
United States, Dominican Republic,
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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