Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: 2% NVN1000 Topical Gel; Drug: 4% NVN1000 Topical Gel; Drug: Vehicle Topical Gel; Drug: 8% NVN1000 Topical Gel

• Registration Number: NCT01694810
• Lead Sponsor: Novan, Inc.

Brief 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).

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-27
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2% NVN1000 Topical Gel	2% NVN1000 Topical Gel	2% NVN1000 Topical Gel once daily for 4 weeks
4% NVN1000 Topical Gel	4% NVN1000 Topical Gel	4% NVN1000 4% Topical Gel once daily for 4 weeks
Vehicle Topical Gel	Vehicle Topical Gel	Vehicle Topical Gel once daily for 4 weeks
8% NVN1000 Topical Gel	8% NVN1000 Topical Gel	8% NVN1000 8% Topical Gel applied once daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Cutaneous tolerability Evaluation	4 weeks	Cutaneous tolerability evaluations to include erythema, scaling, dryness, puritus and burning/stinging using a 4-category scale with scores ranging from 0-3 (0=none, 1=mild, 2=moderate, 3 - severe).

Secondary Outcome Measures

Name	Time	Method
Safety Assessment	4 weeks	Change from baseline in Bilirubin Direct, Bilirubin Total, Creatinine (umol/ L)

Trial Locations

Locations (1)

KGL, Inc; 🇺🇸 Broomall, Pennsylvania, United States