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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 |
| |
| Placebo control |
| 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 |
|---|---|---|---|---|---|---|
| Radiant Research, Inc. | Tucson | Arizona | 85710 | United States | ||
| Associated Foot & Ankle Specialists, LLC |
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| Drug |
nail lacquer, once daily, 52 weeks |
|
| Phoenix |
| Arkansas |
| 85015 |
| United States |
| Family Foot Health Center | Rogers | Arkansas | 72758 | United States |
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States |
| UCSF Dermatology Research | San Francisco | California | 94115 | United States |
| Avail Clinical Research | DeLand | Florida | 32720 | United States |
| North Florida Dermatology Association | Jacksonville | Florida | 32204 | United States |
| Altus Research | Lake Worth | Florida | 33461 | United States |
| Lake Washington Foot and Ankle Center | Melbourne | Florida | 32935 | United States |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | United States |
| Radiant Research, Inc. | Pinellas Park | Florida | 33781 | United States |
| Deaconess Clinic Downtown | Evansville | Indiana | 47713 | United States |
| Michigan Center for Skin Care Research | Clinton Township | Michigan | 48038 | United States |
| Department of Veteran's Affairs | Minneapolis | Minnesota | 55417 | United States |
| Pinkas Lebovits | New York | New York | 10019 | United States |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | United States |
| Care Plus Podiatry, PC | Wading River | New York | 11792 | United States |
| Oregon Medical Research Center, PC | Portland | Oregon | 97223 | United States |
| Radiant Research, Inc. | Greer | South Carolina | 29651 | United States |
| The Skin Wellness Center, PC | Knoxville | Tennessee | 37922 | United States |
| Research Across America | Plano | Texas | 75093 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78229 | United States |
| Dermatology Research Center | Salt Lake City | Utah | 84124 | United States |
| Coastal Podiatry, Inc. | Virginia Beach | Virginia | 23464 | United States |
| Madison Skin and Research, Inc. | Madison | Wisconsin | 53719 | United States |
| 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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