<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/NCT02250430</url>
  </required_header>
  <id_info>
    <org_study_id>NI-AC102</org_study_id>
    <nct_id>NCT02250430</nct_id>
  </id_info>
  <brief_title>A Phase 1 Study Assessing Local Cutaneous Effects of SB204</brief_title>
  <official_title>A Phase 1, Single-Center, Split-Face Study Assessing Local Cutaneous Effects After Application of SB204 2% and SB204 4% 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>
      In this study, color (erythema) and pH will be measured on 3 consecutive days after&#xD;
      application of 2 doses of SB204 to the cheeks of healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is to evaluate local cutaneous effects, including intensity and duration of&#xD;
      erythema and changes in pH following 5 applications (twice daily for two days and once daily&#xD;
      on the third day) of SB204 2% and SB204 4% twice daily to the face for 3 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intensity of erythema following application of SB204 2% and SB204 4%.</measure>
    <time_frame>3 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of erythema following application of SB204 2% and SB204 4%.</measure>
    <time_frame>3 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>pH on the surface of the skin after topical application of 2 concentrations of SB204</measure>
    <time_frame>3 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Topical SB204</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical application of SB204 2% and 4% twice daily for 2 days and once on Day 3</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SB204</intervention_name>
    <description>Applied topically twice a day on days 1, 2 and 3 to left and right cheeks</description>
    <arm_group_label>Topical SB204</arm_group_label>
    <other_name>NVN1000</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or nursing&#xD;
&#xD;
          -  Subject with known sensitivity to a component of the test materials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stuart Lessin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KGL, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KGL</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>November 2018</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>November 15, 2018</last_update_submitted>
  <last_update_submitted_qc>November 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acne</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/NCT02250430
org study id: NI-AC102
nct id: NCT02250430
lead sponsor: 
has dmc: No
In this study, color (erythema) and pH will be measured on 3 consecutive days after
      application of 2 doses of SB204 to the cheeks of healthy volunteers.
This study is to evaluate local cutaneous effects, including intensity and duration of
      erythema and changes in pH following 5 applications (twice daily for two days and once daily
      on the third day) of SB204 2% and SB204 4% twice daily to the face for 3 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intensity of erythema following application of SB204 2% and SB204 4%.
time frame: 3 days
measure: Duration of erythema following application of SB204 2% and SB204 4%.
time frame: 3 days
measure: pH on the surface of the skin after topical application of 2 concentrations of SB204
time frame: 3 days
arm group label: Topical SB204
arm group type: Experimental
description: Topical application of SB204 2% and 4% twice daily for 2 days and once on Day 3
intervention type: Drug
intervention name: SB204
description: Applied topically twice a day on days 1, 2 and 3 to left and right cheeks
arm group label: Topical SB204
other name: NVN1000
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stuart Lessin, MD
role: Principal Investigator
affiliation: KGL, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris