<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01694810</url>
  </required_header>
  <id_info>
    <org_study_id>NI-AC002</org_study_id>
    <nct_id>NCT01694810</nct_id>
  </id_info>
  <brief_title>Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novan, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novan, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will assess safety and tolerability of different doses of topical gel containing a&#xD;
      new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of&#xD;
      healthy volunteers with high counts of Propionibacterium acnes. The test product will be&#xD;
      applied once daily for 4 weeks. Exploratory measures include whether the topical product&#xD;
      decreases the amount of a bacteria associated with acne (P. acnes).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center, observer blinded, randomized, multiple dose study with 3 doses of&#xD;
      NVN1000 and vehicle applied once daily for 4 weeks. There are 4 arms to the study (3 active&#xD;
      and 1 vehicle).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cutaneous tolerability Evaluation</measure>
    <time_frame>4 weeks</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Comparison of adverse events between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in HCT (L/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in HGB, MCHC (g/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in % methemoglobin (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in % Basophils (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in % Eosinophils (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in % Lymphocytes (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in MCH (pg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in MCV, MPV (fL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in % Monocytes (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in % Neutrophils (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in Platelet Count, WBC (10 ^ 9/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in % RDW (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in RBC (10 ^ 12/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in Albumin, Protein, Total (g/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in Alkaline Phosphatase, ALT, AST, (U/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in Bicarbonate, Bun, Calcium, Chloride, Glucose, Phosphorus, Potassium, Sodium (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change from baseline in Bilirubin Direct, Bilirubin Total, Creatinine (umol/ L)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>2% NVN1000 Topical Gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2% NVN1000 Topical Gel once daily for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4% NVN1000 Topical Gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4% NVN1000 4% Topical Gel once daily for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle Topical Gel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle Topical Gel once daily for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>8% NVN1000 Topical Gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8% NVN1000 8% Topical Gel applied once daily for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2% NVN1000 Topical Gel</intervention_name>
    <description>2% NVN1000 Topical Gel once daily for 4 weeks</description>
    <arm_group_label>2% NVN1000 Topical Gel</arm_group_label>
    <other_name>NVN1000</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>4% NVN1000 Topical Gel</intervention_name>
    <description>4% NVN1000 4% Topical Gel applied once daily 4 weeks</description>
    <arm_group_label>4% NVN1000 Topical Gel</arm_group_label>
    <other_name>NVN1000</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>8% NVN1000 Topical Gel</intervention_name>
    <description>8% NVN1000 Topical Gel applied once daily for 4 weeks</description>
    <arm_group_label>8% NVN1000 Topical Gel</arm_group_label>
    <other_name>NVN1000</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle Topical Gel</intervention_name>
    <description>Vehicle Topical Gel applied once daily</description>
    <arm_group_label>Vehicle Topical Gel</arm_group_label>
    <other_name>Vehicle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female volunteers&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  High degree of fluorescence of facial skin under Wood's lamp&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute or chronic skin disorders&#xD;
&#xD;
          -  Use of topical or systemic antibiotics within 4 weeks of study&#xD;
&#xD;
          -  Concomitant use of nitroglycerin or other nitric oxide donor drugs&#xD;
&#xD;
          -  Females who are pregnant, planning pregnancy or breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James J Leyden, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KGL, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KGL, Inc</name>
      <address>
        <city>Broomall</city>
        <state>Pennsylvania</state>
        <zip>19008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>January 28, 2020</last_update_submitted>
  <last_update_submitted_qc>January 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acne vulgaris</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01694810
org study id: NI-AC002
nct id: NCT01694810
lead sponsor: 
has dmc: No
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).
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Cutaneous tolerability Evaluation
time frame: 4 weeks
description: 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).
measure: Safety Assessment
time frame: 4 weeks
description: Comparison of adverse events between groups.
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in HCT (L/L)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in HGB, MCHC (g/L)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in % methemoglobin (%)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in % Basophils (%)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in % Eosinophils (%)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in % Lymphocytes (%)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in MCH (pg)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in MCV, MPV (fL)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in % Monocytes (%)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in % Neutrophils (%)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in Platelet Count, WBC (10 ^ 9/L)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in % RDW (%)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in RBC (10 ^ 12/L)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in Albumin, Protein, Total (g/L)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in Alkaline Phosphatase, ALT, AST, (U/L)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in Bicarbonate, Bun, Calcium, Chloride, Glucose, Phosphorus, Potassium, Sodium (mmol/L)
measure: Safety Assessment
time frame: 4 weeks
description: Change from baseline in Bilirubin Direct, Bilirubin Total, Creatinine (umol/ L)
arm group label: 2% NVN1000 Topical Gel
arm group type: Experimental
description: 2% NVN1000 Topical Gel once daily for 4 weeks
arm group label: 4% NVN1000 Topical Gel
arm group type: Experimental
description: 4% NVN1000 4% Topical Gel once daily for 4 weeks
arm group label: Vehicle Topical Gel
arm group type: Placebo Comparator
description: Vehicle Topical Gel once daily for 4 weeks
arm group label: 8% NVN1000 Topical Gel
arm group type: Experimental
description: 8% NVN1000 8% Topical Gel applied once daily for 4 weeks
intervention type: Drug
intervention name: 2% NVN1000 Topical Gel
description: 2% NVN1000 Topical Gel once daily for 4 weeks
arm group label: 2% NVN1000 Topical Gel
other name: NVN1000
intervention type: Drug
intervention name: 4% NVN1000 Topical Gel
description: 4% NVN1000 4% Topical Gel applied once daily 4 weeks
arm group label: 4% NVN1000 Topical Gel
other name: NVN1000
intervention type: Drug
intervention name: 8% NVN1000 Topical Gel
description: 8% NVN1000 Topical Gel applied once daily for 4 weeks
arm group label: 8% NVN1000 Topical Gel
other name: NVN1000
intervention type: Drug
intervention name: Vehicle Topical Gel
description: Vehicle Topical Gel applied once daily
arm group label: Vehicle Topical Gel
other name: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James J Leyden, MD
role: Principal Investigator
affiliation: KGL, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris