A Phase 1, 3 Day Study of Safety and Tolerability of NVN1000 Topical Gel in Healthy Volunteers

A Phase One, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN10000 Topical Gel in Healthy Volunteers

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.

Once daily application of 8% NVN1000 Topical Gel to the forehead, followed 15 minutes later by application of a commercially available moisturizer

Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging.

Assess safety through the comparison of adverse events between groups (lab assessments, physical exams and vital signs).

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.

Inclusion Criteria: Healthy Male and Females > 18 years of age High degree of fluorescence of facial skin under Wood's lamp Exclusion Criteria: Acute or chronic skin disorders Topical or systemic antibiotics within 4 weeks of study enrollment Use of medication that increases risk of methemoglobinemia or influences P. acnes counts Subjects with medical illnesses, anemia, elevated methemoglobin Women who are pregnant, nursing or planning a pregnancy