Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

Completed · Phase 1

Conditions studied: Acne Vulgaris

In brief

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).

Key facts

Study ID

NCT01694810

Run by

Novan, Inc.

People needed

60

Starts

2012-09-01

Expected to finish

2012-11-01

Last updated by the study team

2020-01-30

Who can join

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

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• KGL, Inc — Broomall, Pennsylvania, United States

Full record on ClinicalTrials.gov

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