Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.
ClinicalTrials.gov Identifier:
NCT01694810
First received: September 25, 2012
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Acne Vulgaris
Drug: 2% NVN1000 Topical Gel
Drug: 4% NVN1000 Topical Gel
Drug: 8% NVN1000 Topical Gel
Drug: Vehicle Topical Gel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1 Multiple Dose, Single-Center, Observer-Blind Parallel Group Study Evaluating Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Novan, Inc.:

Primary Outcome Measures:
  • Cutaneous Tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Cutaneous tolerability using a 4 point (0-3) assessment tool


Secondary Outcome Measures:
  • Safety [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Safety assessments include physical examinations with vital signs, laboratory testing


Other Outcome Measures:
  • Change in Microbiology [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    P. Acnes counts


Estimated Enrollment: 60
Study Start Date: September 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2% NVN1000 Topical Gel
2% NVN1000 Topical Gel once daily for 4 weeks
Drug: 2% NVN1000 Topical Gel
2% NVN1000 Topical Gel once daily for 4 weeks
Experimental: 4% NVN1000 Topical Gel
4% NVN1000 4% Topical Gel once daily for 4 weeks
Drug: 4% NVN1000 Topical Gel
4% NVN 1000 4% Topical Gel applied once daily 4 weeks
Placebo Comparator: Vehicle Topical Gel
Vehicle Topical Gel once daily for 4 weeks
Drug: Vehicle Topical Gel
Vehicle Topical Gel applied once daily
Experimental: 8% NVN1000 Topical Gel
8% NVN1000 8% Topical Gel applied once daily for 4 weeks
Drug: 8% NVN1000 Topical Gel
8% NVN1000 Topical Gel applied once daily for 4 weeks

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694810

Locations
United States, Pennsylvania
KGL, Inc
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
Novan, Inc.
Investigators
Principal Investigator: James J Leyden, MD KGL, Inc.
  More Information

No publications provided

Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT01694810     History of Changes
Other Study ID Numbers: NI-AC002
Study First Received: September 25, 2012
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novan, Inc.:
acne vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on October 16, 2014