We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694810
First Posted: September 27, 2012
Last Update Posted: January 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novan, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]
    Cutaneous tolerability using a 4 point (0-3) assessment tool


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


Other Outcome Measures:
  • Change in Microbiology [ Time Frame: baseline and 4 weeks ]
    P. Acnes counts


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT01694810     History of Changes
Other Study ID Numbers: NI-AC002
First Submitted: September 25, 2012
First Posted: September 27, 2012
Last Update Posted: January 4, 2017
Last Verified: January 2014

Keywords provided by Novan, Inc.:
acne vulgaris

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