Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

A Phase 1 Multiple Dose, Single-Center, Observer-Blind Parallel Group Study Evaluating Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers

The study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of Propionibacterium acnes. The test product will be applied once daily for 4 weeks. Exploratory measures include whether the topical product decreases the amount of a bacteria associated with acne (P. acnes).

This is a single center, observer blinded, randomized, multiple dose study with 3 doses of NVN1000 and vehicle applied once daily for 4 weeks. There are 4 arms to the study (3 active and 1 vehicle).

Inclusion Criteria:

• Healthy male and female volunteers
• Age 18 or older
• High degree of fluorescence of facial skin under Wood's lamp

Exclusion Criteria:

• Acute or chronic skin disorders
• Use of topical or systemic antibiotics within 4 weeks of study
• Concomitant use of nitroglycerin or other nitric oxide donor drugs
• Females who are pregnant, planning pregnancy or breast feeding