<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/NCT03228927</url>
  </required_header>
  <id_info>
    <org_study_id>713</org_study_id>
    <nct_id>NCT03228927</nct_id>
  </id_info>
  <brief_title>Characterization of the Facial and Gut Microbiome in Rosacea</brief_title>
  <official_title>Characterization of the Facial and Gut Microbiome in Identical and Fraternal Twins With Rosacea; Comparison to Healthy Controls</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Acne Cure Alliance</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Acne Cure Alliance</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Questionnaires will be completed by each member of the twin set. A board-certified&#xD;
      dermatologist will examine each member to categorize the type and severity of their rosacea.&#xD;
      The facial and gut microbiome will be sampled and sent for microbial analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Twin set subjects will be administered a questionnaire regarding demographics (age,&#xD;
           gender, state of residence, time lived together, birth order), rosacea duration, prior&#xD;
           rosacea treatment, diet (and similarity of diet to twin), co-morbidities, signs and&#xD;
           symptoms suggestive of cardiovascular or gastrointestinal disease/disorder.&#xD;
&#xD;
        2. Subjects will be examined by a board-certified dermatologist and global assessment,&#xD;
           inflammatory counts and clinician's erythema score will be performed. Eyes will be&#xD;
           examined for signs of ocular rosacea.&#xD;
&#xD;
        3. Facial microbiome sampling will be performed on-site utilizing a kit manufactured by&#xD;
           UBiome. The skin with active rosacea will be swabbed and the swab immediately placed in&#xD;
           sample medium. The tube is then shipped to the manufacturer for 16s rRNA shotgun&#xD;
           metagenomics to identify resident bacterial genera and species. (16) This can be&#xD;
           compared to their extensive library of normal controls, to the other member of the twin&#xD;
           set and to acne subjects.&#xD;
&#xD;
        4. Subjects will be given a fecal microbiome kit for home sampling. Feces obtained from&#xD;
           toilet paper is collected and placed in the sample medium. Subjects can either ship&#xD;
           directly or return to the study site for shipping.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 5, 2017</start_date>
  <completion_date type="Anticipated">August 6, 2017</completion_date>
  <primary_completion_date type="Anticipated">August 6, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Characterization of the facial and fecal microbiome of monozygotic or dizygotic twins with facial rosacea</measure>
    <time_frame>Single sampling of facial microbiome done on site over a 2-day Festival August 5 and 6, 2017.</time_frame>
    <description>Characterization of the facial and fecal microbiome in monozygotic or dizygotic twins concordant or discordant for rosacea compared to a) each other, b) microbiome library of age-matched controls</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Rosacea</condition>
  <arm_group>
    <arm_group_label>twin A</arm_group_label>
    <description>Sampling of the facial and fecal microbiome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>twin B</arm_group_label>
    <description>Sampling of the facial and fecal microbiome</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>comparison of twin A to twin B</intervention_name>
    <description>Comparison of Twin A to Twin B</description>
    <arm_group_label>twin A</arm_group_label>
    <arm_group_label>twin B</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      skin swab and fecal sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Attendees at the Twins Days Festival Monozygotic or dizygotic twin sets Facial Rosacea&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Presenting with monozygotic or dizygotic twin&#xD;
&#xD;
          2. One or both twins with facial rosacea&#xD;
&#xD;
          3. Willingness to allow facial and fecal samples to be analyzed -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non-twin siblings&#xD;
&#xD;
          2. Absence of facial rosacea in both twins -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Acne Cure Alliance</investigator_affiliation>
    <investigator_full_name>Hilary Baldwin</investigator_full_name>
    <investigator_title>Medical Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rosacea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share any IPD with other researchers</ipd_description>
  </patient_data>
  <!-- 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/NCT03228927
org study id: 713
nct id: NCT03228927
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Questionnaires will be completed by each member of the twin set. A board-certified
      dermatologist will examine each member to categorize the type and severity of their rosacea.
      The facial and gut microbiome will be sampled and sent for microbial analysis.
1. Twin set subjects will be administered a questionnaire regarding demographics (age,
           gender, state of residence, time lived together, birth order), rosacea duration, prior
           rosacea treatment, diet (and similarity of diet to twin), co-morbidities, signs and
           symptoms suggestive of cardiovascular or gastrointestinal disease/disorder.

        2. Subjects will be examined by a board-certified dermatologist and global assessment,
           inflammatory counts and clinician's erythema score will be performed. Eyes will be
           examined for signs of ocular rosacea.

        3. Facial microbiome sampling will be performed on-site utilizing a kit manufactured by
           UBiome. The skin with active rosacea will be swabbed and the swab immediately placed in
           sample medium. The tube is then shipped to the manufacturer for 16s rRNA shotgun
           metagenomics to identify resident bacterial genera and species. (16) This can be
           compared to their extensive library of normal controls, to the other member of the twin
           set and to acne subjects.

        4. Subjects will be given a fecal microbiome kit for home sampling. Feces obtained from
           toilet paper is collected and placed in the sample medium. Subjects can either ship
           directly or return to the study site for shipping.
observational model: Cohort
time perspective: Cross-Sectional
measure: Characterization of the facial and fecal microbiome of monozygotic or dizygotic twins with facial rosacea
time frame: Single sampling of facial microbiome done on site over a 2-day Festival August 5 and 6, 2017.
description: Characterization of the facial and fecal microbiome in monozygotic or dizygotic twins concordant or discordant for rosacea compared to a) each other, b) microbiome library of age-matched controls
arm group label: twin A
description: Sampling of the facial and fecal microbiome
arm group label: twin B
description: Sampling of the facial and fecal microbiome
intervention type: Other
intervention name: comparison of twin A to twin B
description: Comparison of Twin A to Twin B
arm group label: twin A
arm group label: twin B
skin swab and fecal sample
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: The Acne Cure Alliance
investigator full name: Hilary Baldwin
investigator title: Medical Director
mesh term: Rosacea
sharing ipd: No
ipd description: There is no plan to share any IPD with other researchers