A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 2 week Phase 1 study of SB204 (NVN1000 Gel) in healthy adult volunteers with elevated Propionibacterium acnes (P. acnes) counts. Subjects will apply NVN1000 4% Gel or Vehicle Gel twice daily to their face. Assessments will include cutaneous tolerability, safety, and P. acnes counts.

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

Details

• Lead Sponsor: Novan, Inc.

Criteria

Inclusion Criteria:

• Healthy adult male or female volunteers

• If a woman of child-bearing potential, agrees to use effective method of birth control during the study and for 30 days after the final study visit

• Agree to refrain from use of antimicrobial topical products during study

Exclusion Criteria:

• Any skin disorders of acute or chronic nature including psoriasis, eczema, etc

• Female subjects who are pregnant, nursing, or planning to become pregnant

• Subjects who have used topical or systemic antibiotics, estrogens, drugs associated with methemoglobinemia, nitrate donors

• Subjects with baseline methemoglobin > 2%

• Subjects with clinically significant anemia