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Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

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.
 
ClinicalTrials.gov Identifier: NCT01694810
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.

Tracking Information
First Submitted Date  ICMJE September 25, 2012
First Posted Date  ICMJE September 27, 2012
Last Update Posted Date January 30, 2020
Study Start Date  ICMJE September 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
Cutaneous tolerability Evaluation [ Time Frame: 4 weeks ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2012)
Cutaneous Tolerability [ Time Frame: 4 weeks ]
Cutaneous tolerability using a 4 point (0-3) assessment tool
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Comparison of adverse events between groups.
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in HCT (L/L)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in HGB, MCHC (g/L)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in % methemoglobin (%)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in % Basophils (%)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in % Eosinophils (%)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in % Lymphocytes (%)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in MCH (pg)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in MCV, MPV (fL)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in % Monocytes (%)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in % Neutrophils (%)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in Platelet Count, WBC (10 ^ 9/L)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in % RDW (%)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in RBC (10 ^ 12/L)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in Albumin, Protein, Total (g/L)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in Alkaline Phosphatase, ALT, AST, (U/L)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in Bicarbonate, Bun, Calcium, Chloride, Glucose, Phosphorus, Potassium, Sodium (mmol/L)
  • Safety Assessment [ Time Frame: 4 weeks ]
    Change from baseline in Bilirubin Direct, Bilirubin Total, Creatinine (umol/ L)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2012)
Safety [ Time Frame: 4 weeks ]
Safety assessments include physical examinations with vital signs, laboratory testing
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: September 26, 2012)
Change in Microbiology [ Time Frame: baseline and 4 weeks ]
P. Acnes counts
 
Descriptive Information
Brief Title  ICMJE Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers
Official Title  ICMJE A Phase 1 Multiple Dose, Single-Center, Observer-Blind Parallel Group Study Evaluating Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: 2% NVN1000 Topical Gel
    2% NVN1000 Topical Gel once daily for 4 weeks
    Other Name: NVN1000
  • Drug: 4% NVN1000 Topical Gel
    4% NVN1000 4% Topical Gel applied once daily 4 weeks
    Other Name: NVN1000
  • Drug: 8% NVN1000 Topical Gel
    8% NVN1000 Topical Gel applied once daily for 4 weeks
    Other Name: NVN1000
  • Drug: Vehicle Topical Gel
    Vehicle Topical Gel applied once daily
    Other Name: Vehicle
Study Arms  ICMJE
  • Experimental: 2% NVN1000 Topical Gel
    2% NVN1000 Topical Gel once daily for 4 weeks
    Intervention: Drug: 2% NVN1000 Topical Gel
  • Experimental: 4% NVN1000 Topical Gel
    4% NVN1000 4% Topical Gel once daily for 4 weeks
    Intervention: Drug: 4% NVN1000 Topical Gel
  • Placebo Comparator: Vehicle Topical Gel
    Vehicle Topical Gel once daily for 4 weeks
    Intervention: Drug: Vehicle Topical Gel
  • Experimental: 8% NVN1000 Topical Gel
    8% NVN1000 8% Topical Gel applied once daily for 4 weeks
    Intervention: Drug: 8% NVN1000 Topical Gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01694810
Other Study ID Numbers  ICMJE NI-AC002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novan, Inc.
Study Sponsor  ICMJE Novan, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James J Leyden, MD KGL, Inc.
PRS Account Novan, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP