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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novan, Inc.

Criteria

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