<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/NCT03009903</url>
  </required_header>
  <id_info>
    <org_study_id>MBC-CL-01-2016</org_study_id>
    <nct_id>NCT03009903</nct_id>
  </id_info>
  <brief_title>Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage</brief_title>
  <official_title>Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage Using Pore Strips in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MBcure Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MBcure Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes&#xD;
      bacteria and phage strains using pore strips on up to 400 human subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes&#xD;
      bacteria and phage strains using pore strips on up to 400 human subjects. An additional P.&#xD;
      acnes visual detection method (VISIOPOR ® PP34N) will be used in this study as per PI&#xD;
      decision to explore whether there is a correlation between P. acnes bacterial presence and&#xD;
      fluorescent signal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Detection and analysis of facial P. acnes presence</measure>
    <time_frame>Day 0 and week 8 (optional)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessing correlation between phage and P. acnes using: a. Demographic Questionnaire b. Visual Supportive Methodology (VISIOPOR ® PP34N) as per PI decision.</measure>
    <time_frame>Day 0 and week 8 (optional</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Acne</condition>
  <arm_group>
    <arm_group_label>P. acne subjects</arm_group_label>
    <description>14-50 year of age, P. acne diagnosed subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>None P. acne subjects</arm_group_label>
    <description>14-50 year of age, none P. acne diagnosed subjects</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be male or female, ages 14-50. Healthy subjects and acne diagnosed subjects.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults between 14 to 50 years of age inclusive at the time of signing the informed&#xD;
             consent&#xD;
&#xD;
          2. Able to provide written informed consent&#xD;
&#xD;
          3. Subjects who are willing to undergo pore strip treatment using the cosmetically&#xD;
             acceptable pore strip product&#xD;
&#xD;
          4. Subjects who are willing to provide comprehensive demographic data using&#xD;
             questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unwilling or unable to follow the procedures outlined in the protocol&#xD;
&#xD;
          2. Subjects treated with isotretinoin or tretinion during the 6 months prior to visit 1&#xD;
&#xD;
          3. Subjects treated with immunosuppressant agents&#xD;
&#xD;
          4. Pregnant subjects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Shapiro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maccabi Healthcare Services, Israel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jonathan Shapiro, MD</last_name>
    <phone>972.50.5759516</phone>
    <email>jonmidi@gmail.com</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>December 30, 2016</last_update_submitted>
  <last_update_submitted_qc>December 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>2 sites to be activated. Dr. Shapiro is considered as PI in both sites</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/NCT03009903
org study id: MBC-CL-01-2016
nct id: NCT03009903
lead sponsor: 
has dmc: No
This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes
      bacteria and phage strains using pore strips on up to 400 human subjects.
This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes
      bacteria and phage strains using pore strips on up to 400 human subjects. An additional P.
      acnes visual detection method (VISIOPOR ® PP34N) will be used in this study as per PI
      decision to explore whether there is a correlation between P. acnes bacterial presence and
      fluorescent signal.
measure: Detection and analysis of facial P. acnes presence
time frame: Day 0 and week 8 (optional)
measure: Assessing correlation between phage and P. acnes using: a. Demographic Questionnaire b. Visual Supportive Methodology (VISIOPOR ® PP34N) as per PI decision.
time frame: Day 0 and week 8 (optional
arm group label: P. acne subjects
description: 14-50 year of age, P. acne diagnosed subjects
arm group label: None P. acne subjects
description: 14-50 year of age, none P. acne diagnosed subjects
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan Shapiro, MD
role: Principal Investigator
affiliation: Maccabi Healthcare Services, Israel
last name: Jonathan Shapiro, MD
phone: 972.50.5759516
email: jonmidi@gmail.com
responsible party type: Sponsor
mesh term: Acne Vulgaris
sharing ipd: No
ipd description: 2 sites to be activated. Dr. Shapiro is considered as PI in both sites