A Phase 1, 3 Day Study of Safety and 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.
Drug: Topical Gel Vehicle
Drug: 8% NVN1000 Topical Gel
Drug: 8% NVN1000 Topical Gel and moisturizer
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase One, Single-Center, Open-Label, Randomized, Parllel Group, 3 Day Study Evaluating the Safety and Cutaneous Toleraility of NVN10000 Topical Gel in Healthy Volunteers|
- Cutaneous tolerability [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging.
- Safety [ Time Frame: 3 Days ] [ Designated as safety issue: Yes ]Safety assessments include the change from baseline in percent methemoglobin, adverse events, and physical exams, including vital signs.
- Propionobactium acnes counts [ Time Frame: 3 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: Topical Gel Vehicle
Once daily application of topical gel vehicle to forehead for 3 days
|Drug: Topical Gel Vehicle|
Active Comparator: 8% NVN1000 Topical Gel
Once daily application of 8% NVN1000 Topical Gel to the forehead for 3 days
|Drug: 8% NVN1000 Topical Gel|
Active Comparator: 8% NVN1000 Topical Gel and moisturizer
Once daily application of 8% NVN1000 Topical Gel to the forehead, followed 15 minutes later by application of a commercially available moisturizer
|Drug: 8% NVN1000 Topical Gel and moisturizer|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755247
|United States, Pennsylvania|
|Broomall, Pennsylvania, United States, 19008|
|Principal Investigator:||James J Leyden||KGL, Inc.|