A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel

Completed · Phase 1 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT01844739

Run by

Novan, Inc.

People needed

30

Starts

2013-04-01

Expected to finish

2013-06-01

Last updated by the study team

2018-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• KGL — Broomall, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.