A Phase 1, 3 Day Study of Safety and Tolerability of NVN1000 Topical Gel in Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT01755247|
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : January 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Topical Gel Vehicle Drug: 8% NVN1000 Topical Gel Drug: 8% NVN1000 Topical Gel and moisturizer||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||December 2012|
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
- Cutaneous tolerability [ Time Frame: 3 days ]Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging.
- Safety [ Time Frame: 3 Days ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755247
|United States, Pennsylvania|
|Broomall, Pennsylvania, United States, 19008|
|Principal Investigator:||James J Leyden||KGL, Inc.|