NCT01694810

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Novan, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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).

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	2% NVN1000 Topical Gel	2% NVN1000 Topical Gel once daily for 4 weeks
DRUG	4% NVN1000 Topical Gel	4% NVN1000 4% Topical Gel applied once daily 4 weeks
DRUG	8% NVN1000 Topical Gel	8% NVN1000 Topical Gel applied once daily for 4 weeks
DRUG	Vehicle Topical Gel	Vehicle Topical Gel applied once daily

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-09-27
• Last updated: 2020-01-30

Locations

1 site across 1 country: United States