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A Phase I, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers
This is a 3 day study to assess safety and tolerability of a new topical gel product, NVN1000 with and without the application of a commercially available moisturizer in approximately 15 healthy subjects. The test product will be applied to the forehead of healthy volunteers once daily for 3 days. One group of subjects will have a moisturizer applied to the same area 15 minutes after the test gel was applied and one group of subjects will be treated with the gel vehicle which does not contain the active product. The hypothesis is that the application of moisturizer will not effect safety or local tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Gel Vehicle | Placebo Comparator | Once daily application of topical gel vehicle to forehead for 3 days |
|
| 8% NVN1000 Topical Gel | Active Comparator | Once daily application of 8% NVN1000 Topical Gel to the forehead for 3 days |
|
| 8% NVN1000 Topical Gel and moisturizer | Active Comparator | Once daily application of 8% NVN1000 Topical Gel to the forehead, followed 15 minutes later by application of a commercially available moisturizer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Gel Vehicle | Drug |
|
| |
| 8% NVN1000 Topical Gel |
| Measure | Description | Time Frame |
|---|---|---|
| Cutaneous tolerability | Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety comparison | Assess safety through the comparison of adverse events between groups (lab assessments, physical exams and vital signs). | 3 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Propionibacterium acnes counts | P. acnes counts will be obtained at Baseline, Day 1, and Day 3. The change in P acnes counts over time by treatment group will be assessed. | 3 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James J Leyden | KGL, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGL, Inc | Broomall | Pennsylvania | 19008 | United States |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D005782 | Gels |
| C000709171 | berdazimer sodium |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Drug |
|
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| 8% NVN1000 Topical Gel and moisturizer | Drug |
|
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