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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active drug | Experimental |
| |
| Vehicle alone | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAB001 | Drug | nail lacquer, once daily, 52 weeks |
| |
| Vehicle alone |
| Measure | Description | Time Frame |
|---|---|---|
| Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure. | Week 56 after 52 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kent Allenby, MD | Promius Pharma | Study Director |
| Joanne Fraser, PhD | Promius Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arkansas | 85032 | United States | |||
| T. Joseph Raoof, MD, Inc. |
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| Drug |
nail lacquer, once daily, 52 weeks |
|
| Encino |
| California |
| 91436 |
| United States |
| Skin Surgery Medical Group, Inc. | San Diego | California | 92117 | United States |
| Longmont Medical Research Network | Longmont | Colorado | 80501 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Internaional Dermatology Research, Inc. | Miami | Florida | 33144 | United States |
| MedaPhase, Inc. | Newnan | Georgia | 30263 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Northwest Clinical Trials | Boise | Idaho | 83704 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Gerard Furst, DPM, PLLC | East Setauket | New York | 11733 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Mazur Foot and Ankle | Salisbury | North Carolina | 28144 | United States |
| Radiant Research | Cincinnati | Ohio | 45249 | United States |
| Oregon Dermatology & Research Network | Portland | Oregon | 97210 | United States |
| Temple University - School of Podiatric Medicine | Philadelphia | Pennsylvania | 19107 | United States |
| Carolina Dermatology of Greenville, PA | Greenville | South Carolina | 29681 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Ashton Podiatry Associates, PA | Dallas | Texas | 75243 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78229 | United States |
| Instituto Dermatologica | Santo Domingo | Dominican Republic |
| Instituto Dermatologico | Santo Domingo | Dominican Republic |
| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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