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Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01694810
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.

Study Description
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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).

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : September 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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Arm Intervention/treatment
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
Other Name: NVN1000
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
Other Name: NVN1000
Placebo Comparator: Vehicle Topical Gel
Vehicle Topical Gel once daily for 4 weeks
 Drug: Vehicle Topical Gel
Vehicle Topical Gel applied once daily
Other Name: Vehicle
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
Other Name: NVN1000


Outcome Measures
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Primary Outcome Measures :
  1. Cutaneous Tolerability [ Time Frame: 4 weeks ]
    Cutaneous tolerability using a 4 point (0-3) assessment tool


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


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Pennsylvania
KGL, Inc
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
Novan, Inc.
Investigators
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Principal Investigator: James J Leyden, MD KGL, Inc.
More Information
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Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT01694810     History of Changes
Other Study ID Numbers: NI-AC002
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Keywords provided by Novan, Inc.:
acne vulgaris
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases