Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

Novan

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: 4% NVN1000 Topical Gel; Drug: Vehicle Topical Gel; Drug: 2% NVN1000 Topical Gel; Drug: 8% NVN1000 Topical Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01694810

NI-AC002

Details and patient eligibility

About

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).

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups, including a placebo group

2% NVN1000 Topical Gel

Experimental group

Description:

2% NVN1000 Topical Gel once daily for 4 weeks

Treatment:

Drug: 2% NVN1000 Topical Gel

4% NVN1000 Topical Gel

Experimental group

Description:

4% NVN1000 4% Topical Gel once daily for 4 weeks

Treatment:

Drug: 4% NVN1000 Topical Gel

Vehicle Topical Gel

Placebo Comparator group

Description:

Vehicle Topical Gel once daily for 4 weeks

Treatment:

Drug: Vehicle Topical Gel

8% NVN1000 Topical Gel

Experimental group

Description:

8% NVN1000 8% Topical Gel applied once daily for 4 weeks

Treatment:

Drug: 8% NVN1000 Topical Gel