Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

NCT01694810 | Completed Phase 1

• 1 other identifier: NI-AC002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Acne Vulgaris

Keywords

acne vulgaris

Outcome Measures

Primary Outcomes (1)

• Cutaneous tolerability Evaluation

  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).

  4 weeks

Secondary Outcomes (18)

• Safety Assessment

  4 weeks

• Safety Assessment

  4 weeks

• Safety Assessment

  4 weeks

• Safety Assessment

  4 weeks

• Safety Assessment

  4 weeks

Study Arms (4)

2% NVN1000 Topical Gel

EXPERIMENTAL

2% NVN1000 Topical Gel once daily for 4 weeks

Drug: 2% NVN1000 Topical Gel

4% NVN1000 Topical Gel

EXPERIMENTAL

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

Drug: 4% NVN1000 Topical Gel

Vehicle Topical Gel

PLACEBO COMPARATOR

Vehicle Topical Gel once daily for 4 weeks

Drug: Vehicle Topical Gel

8% NVN1000 Topical Gel

EXPERIMENTAL

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

Drug: 8% NVN1000 Topical Gel

Interventions

2% NVN1000 Topical Gel DRUG

2% NVN1000 Topical Gel once daily for 4 weeks

Also known as: NVN1000

2% NVN1000 Topical Gel

4% NVN1000 Topical Gel DRUG

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

Also known as: NVN1000

4% NVN1000 Topical Gel

8% NVN1000 Topical Gel DRUG

8% NVN1000 Topical Gel applied once daily for 4 weeks

Also known as: NVN1000

8% NVN1000 Topical Gel

Vehicle Topical Gel DRUG

Vehicle Topical Gel applied once daily

Also known as: Vehicle

Vehicle Topical Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Novan, Inc.: lead

Study Sites (1)

KGL, Inc

Broomall, Pennsylvania, 19008, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

berdazimer sodium

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• James J Leyden, MD

  KGL, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: September 27, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 30, 2020

Record last verified: 2020-01

Locations

US (1)