<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/NCT03035955</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00014511</org_study_id>
    <nct_id>NCT03035955</nct_id>
  </id_info>
  <brief_title>Azelaic Acid on Demodex Counts in Rosacea</brief_title>
  <official_title>The Effect of Azelaic Acid (Financea Gel 15%) on Demodex Folliculorum Counts in Adult Subjects With Mild to Moderate Papulopustular Rosacea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to measure the effects of azelaic acid on Demodex folliculorum&#xD;
      counts and disease condition via a split face design in approximately twenty patients with&#xD;
      mild to moderate rosacea. The investigators hypothesize that treatment of rosacea with&#xD;
      azelaic acid will lead to a decreased Demodex folliculorum count as well as an improvement in&#xD;
      lesion count and redness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a split face, randomized, single blind, single center study. Male and female&#xD;
      (non-pregnant, non-nursing) subjects, age 18 or greater, with mild to moderate papulopustular&#xD;
      facial rosacea, with bilateral facial involvement, and no more than two nodules will be&#xD;
      enrolled. Subjects will be randomized 1:1 by the study coordinator using a standard&#xD;
      randomization table to receive azelaic acid twice daily on either the left side or the right&#xD;
      side of the face and no treatment on the other side of the face. Subjects must have a&#xD;
      positive Demodex folliculorum standardized skin surface biopsy, defined at &gt;5 mites cm at&#xD;
      Screening/Baseline on at least one of two different SSSB specimens on bilateral sides of the&#xD;
      face. The SSSB test location will ideally be on the cheek, but may be done in the most&#xD;
      disease involved area. Subjects will be seen at Screening/Baseline, Week 1 and Week 4.&#xD;
      Standard topical washout periods will be observed. At each visit, rosacea will be evaluated&#xD;
      by lesion count, IGA and two Demodex SSSB tests done on each side of the face. Safety will be&#xD;
      monitored at each visit using the Investigator Skin Irritation Assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">February 2, 2012</completion_date>
  <primary_completion_date type="Actual">February 2, 2012</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <intervention_model_description>This is a split face, randomized, single blind, single center study. Male and female (non-pregnant, non-nursing) subjects, age 18 or greater, with mild to moderate papulopustular (based on Investigator Global Assessment) facial rosacea, with bilateral facial involvement, and no more than two nodules will be enrolled. Subjects will be randomized 1:1 by the study coordinator using a standard randomization table to receive azelaic acid (Finacea® Gel, 15%) twice daily on either the left side or the right side of the face and no treatment on the other side of the face.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The investigator is blinded to which side of face is using the azelaeic acid treatetment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Demodex Count</measure>
    <time_frame>Week 4</time_frame>
    <description>number of demodex at Baseline and Week 4. Only Week 4 reported</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Rosacea</condition>
  <arm_group>
    <arm_group_label>Azelaic acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>azelaic acid (Finacea® Gel, 15%) twice daily on either the left side or the right side of the face and no treatment on the other side of the face</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no treatment on the other side of the face</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azelaic acid</intervention_name>
    <description>15% gel twice daily for four weeks to one side of face</description>
    <arm_group_label>Azelaic acid</arm_group_label>
    <other_name>Finacea Gel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects, ages 18 and over, with mild to moderate paulopustular&#xD;
             rosacea with bilateral facila involvement, who agrees to participate and provide&#xD;
             written consent.&#xD;
&#xD;
          -  Positive Demodex folliculorum SSSB, defined as &gt;5 mites/cm on at least on of two&#xD;
             different SSSB specimens on bilateral sides of teh face.&#xD;
&#xD;
          -  Have an IGA of mild to moderate rosacea, rating between 2 and 5.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of topical therapy for rosacea or other skin conditions on the face within two&#xD;
             weeks of Baseline.&#xD;
&#xD;
          -  Use of oral medications for the treatment of rosacea that have been started or altered&#xD;
             within the past three months.&#xD;
&#xD;
          -  Presence of a concurrent medical condition or skin condition, which is determined by&#xD;
             the investigator to potentially interfere with study outcomes or patient assessments.&#xD;
&#xD;
          -  Subjects with known allergy or sensitivity to azelaic acid gel or components therein,&#xD;
             such as propylene glycol.&#xD;
&#xD;
          -  Subjects with known allergy or sensitivity to cyanoacrylates or formaldehyde.&#xD;
&#xD;
          -  Presence of more than two nodules.&#xD;
&#xD;
          -  Female subjects who are not postmenopausal for at least 1 year, surgically sterile or&#xD;
             willing to practice effective contraception during the study. Reliable methods of&#xD;
             birth control are: abstinence, oral contraceptives, intrauterine device, DepoProvera,&#xD;
             tubal ligation or vasectomy of the partner in a monogamous relationship. An&#xD;
             acceptable, though less reliable, method involves the careful use of condoms and&#xD;
             spermicidal foam or gel and/or a cervical cap or sponge. Nursing mothers, pregnant&#xD;
             women and women planning to become pregnant while on study are to be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan Fleischer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences Department of Dermatology</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 19, 2012</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <results_first_submitted>February 28, 2017</results_first_submitted>
  <results_first_submitted_qc>April 17, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 30, 2017</results_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rosacea</keyword>
  <keyword>Wake Forest</keyword>
  <keyword>Demodex</keyword>
  <keyword>Finacea Gel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rosacea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azelaic acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Azelaic Acid Left/No Treatment Right</title>
          <description>azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face&#xD;
Azelaic acid: 15% gel twice daily for four weeks to the left side of face</description>
        </group>
        <group group_id="P2">
          <title>Azelaic Acid Right/No Treatment Left</title>
          <description>azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face&#xD;
Azelaic acid: 15% gel twice daily for four weeks to the right side of face</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Azelaic Acid Left/No Treatment Right</title>
          <description>azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face</description>
        </group>
        <group group_id="B2">
          <title>Azelaic Acid Right/No Treatment Left</title>
          <description>azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Demodex Count</title>
        <description>number of demodex at Baseline and Week 4. Only Week 4 reported</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Azelaic Acid Left/no Treatment Right</title>
            <description>azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face</description>
          </group>
          <group group_id="O2">
            <title>Azelaic Acid Right /no Treatment Left</title>
            <description>azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face</description>
          </group>
        </group_list>
        <measure>
          <title>Demodex Count</title>
          <description>number of demodex at Baseline and Week 4. Only Week 4 reported</description>
          <units>number of demodex</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Azelaic Acid</title>
          <description>azelaic acid (Finacea® Gel, 15%) twice daily on either the left side or the right side of the face and no treatment on the other side of the face&#xD;
Azelaic acid: 15% gel twice daily for four weeks to one side of face</description>
        </group>
        <group group_id="E2">
          <title>no Treatment</title>
          <description>no treatment on the other side of the face</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director of Clinical Trials</name_or_title>
      <organization>WakeForest</organization>
      <phone>336-716-3775</phone>
    </point_of_contact>
  </clinical_results>
</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/NCT03035955
org study id: IRB00014511
nct id: NCT03035955
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to measure the effects of azelaic acid on Demodex folliculorum
      counts and disease condition via a split face design in approximately twenty patients with
      mild to moderate rosacea. The investigators hypothesize that treatment of rosacea with
      azelaic acid will lead to a decreased Demodex folliculorum count as well as an improvement in
      lesion count and redness.
This is a split face, randomized, single blind, single center study. Male and female
      (non-pregnant, non-nursing) subjects, age 18 or greater, with mild to moderate papulopustular
      facial rosacea, with bilateral facial involvement, and no more than two nodules will be
      enrolled. Subjects will be randomized 1:1 by the study coordinator using a standard
      randomization table to receive azelaic acid twice daily on either the left side or the right
      side of the face and no treatment on the other side of the face. Subjects must have a
      positive Demodex folliculorum standardized skin surface biopsy, defined at >5 mites cm at
      Screening/Baseline on at least one of two different SSSB specimens on bilateral sides of the
      face. The SSSB test location will ideally be on the cheek, but may be done in the most
      disease involved area. Subjects will be seen at Screening/Baseline, Week 1 and Week 4.
      Standard topical washout periods will be observed. At each visit, rosacea will be evaluated
      by lesion count, IGA and two Demodex SSSB tests done on each side of the face. Safety will be
      monitored at each visit using the Investigator Skin Irritation Assessment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a split face, randomized, single blind, single center study. Male and female (non-pregnant, non-nursing) subjects, age 18 or greater, with mild to moderate papulopustular (based on Investigator Global Assessment) facial rosacea, with bilateral facial involvement, and no more than two nodules will be enrolled. Subjects will be randomized 1:1 by the study coordinator using a standard randomization table to receive azelaic acid (Finacea® Gel, 15%) twice daily on either the left side or the right side of the face and no treatment on the other side of the face.
primary purpose: Treatment
masking: Single (Investigator)
masking description: The investigator is blinded to which side of face is using the azelaeic acid treatetment
measure: Demodex Count
time frame: Week 4
description: number of demodex at Baseline and Week 4. Only Week 4 reported
arm group label: Azelaic acid
arm group type: Active Comparator
description: azelaic acid (Finacea® Gel, 15%) twice daily on either the left side or the right side of the face and no treatment on the other side of the face
arm group label: no treatment
arm group type: No Intervention
description: no treatment on the other side of the face
intervention type: Drug
intervention name: Azelaic acid
description: 15% gel twice daily for four weeks to one side of face
arm group label: Azelaic acid
other name: Finacea Gel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Alan Fleischer, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Rosacea
mesh term: Azelaic acid
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 