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This is a study to test the hypothesis that time to healing of a cold sore will be lower in the active treatment arm of the study when compared to the vehicle (placebo). Subjects with a history of cold sores will be enrolled and administered active treatment or placebo in a blinded manner. Subjects will then be followed to assess time to healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NB-001 (0.3%) | Experimental | NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and two surfactants: polysorbate (Tween) 20 and cetylpyridinium chloride (CPC). |
|
| Vehicle | Placebo Comparator | NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and one surfactant: polysorbate (Tween) 20. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NB-001 (0.3%) | Drug | Topical administration at least five times throughout the day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator. | Time to healing is the time from receiving the combination to unlock the medication and begin treatment to investigator assessed healing. | Time to healing will be assessed from treatment onset to resolution of symptoms (maximum of 16 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage | This analysis will be performed in the cohort of subjects whose primary lesion complex is assessed as being in the Prodrome (pain, burning, tingling, itching, redness, swelling, or a tight sensation of the lip), Erythema/Macule, Papule/Edema, or Aborted Stage by the investigator at the first post-treatment visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Safety and tolerability of NB-001 following topical administration as assessed by the number and severity of adverse events. | Safety and tolerability will be assessed from treatment onset to study close (expected average of 2 months) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research, Inc | Chandler | Arizona | 85224 | United States | ||
| Radiant Research, Inc |
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| ID | Term |
|---|---|
| D006560 | Herpes Labialis |
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C557530 | 5-((2-(6-Amino-9H-purin-9-yl) ethyl) amino)-1-pentanol |
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| Placebo |
| Drug |
|
| Proportion of subjects in whom the primary lesion complex does not progress will be assessed from treatment onset to resolution of symptoms (maximum of 16 days) |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Radiant Research, Inc. Chicago | Chicago | Illinois | 60654 | United States |
| Central Kentucky Research Associates, Inc. | Lexington | Kentucky | 40509 | United States |
| Radiant Research, Inc. | Edina | Minnesota | 55435 | United States |
| The Center for Pharmaceutical Research, P.C. | Kansas City | Missouri | 64114 | United States |
| Radiant Research, Inc. | St Louis | Missouri | 63141 | United States |
| Radiant Research, Inc. | Anderson | South Carolina | 29621 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Radiant Research, Inc. | San Antonio | Texas | 78229 | United States |
| New River Valley Research Institute | Christiansburg | Virginia | 24073 | United States |
| D017193 |
| Skin Diseases, Viral |
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |