<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/NCT03257202</url>
  </required_header>
  <id_info>
    <org_study_id>HS-17-00319</org_study_id>
    <nct_id>NCT03257202</nct_id>
  </id_info>
  <brief_title>Topical Treatment and Prevalence of P. Acnes</brief_title>
  <official_title>Cutibacterium Acnes Persists Despite Topical Clindamycin and Benzoyl Peroxide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is about preventing surgical site infections of the shoulder. We hope to learn if&#xD;
      clindamycin alone, benzoyl peroxide alone, or clindamycin and benzoyl peroxide together can&#xD;
      affect growth of Propionibacterium acnes in the dermal layer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      P. acnes are skin pathogens known to cause surgical site infections despite proper&#xD;
      preoperative surgical preparation. Lee et al. showed 70% growth rate of P. acnes despite the&#xD;
      application of Choraprep prior to sampling. However, this study was limited as it failed to&#xD;
      utilize a control group and only investigated one preparatory technique. Meanwhile, there&#xD;
      remains to date no study investigating the effect of topical treatments. The purpose of this&#xD;
      study is to investigate how specific topical treatments affect growth in the dermal layer. 12&#xD;
      volunteers who are normal volunteers, students, or employees of USC will each receive 4 punch&#xD;
      biopsies from their back above the scapular spine, with each biopsy taken from a region of&#xD;
      the skin treated with a different topical (topical clindamycin alone, topical benzoyl&#xD;
      peroxide alone, topical clindamycin and benzoyl peroxide together, and a control). A 3df&#xD;
      overall test of the treatment indicators will test for any differences in positivity for P&#xD;
      Acnes among the treatments; pairwise comparisons among the treatments will adjust for&#xD;
      multiple comparisons. A two-tailed statistical test will be performed, testing at an alpha of&#xD;
      0.05, and analyses will also be performed based on hemolytic subtypes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Healthy volunteers</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms</measure>
    <time_frame>21 days</time_frame>
    <description>Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Surgical Site Infection</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No topical treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clindamycin alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>topical clindamycin alone using Clindamycin 1% Gel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Benzoyl peroxide alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clindamycin and benzoyl peroxide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clindamycin 1% Gel</intervention_name>
    <description>topical clindamycin</description>
    <arm_group_label>Clindamycin alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Benzoyl peroxide 5% gel</intervention_name>
    <description>topical benzoyl peroxide</description>
    <arm_group_label>Benzoyl peroxide alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BenzaClin 5%-1% Topical Gel</intervention_name>
    <description>Topical clindamycin and benzoyl peroxide together</description>
    <arm_group_label>Clindamycin and benzoyl peroxide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteer&#xD;
&#xD;
          -  age &gt; 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of antibiotic use in the last month&#xD;
&#xD;
          -  active acne on the back&#xD;
&#xD;
          -  non-English speakers (the study personnel do not have adequate training to converse&#xD;
             and consent in other languages)&#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>George R Hatch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keck School of Medicine of the University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dumville JC, McFarlane E, Edwards P, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD003949. doi: 10.1002/14651858.CD003949.pub3.</citation>
    <PMID>23543526</PMID>
  </reference>
  <reference>
    <citation>Mook WR, Garrigues GE. Diagnosis and Management of Periprosthetic Shoulder Infections. J Bone Joint Surg Am. 2014 Jun 4;96(11):956-965. doi: 10.2106/JBJS.M.00402. Epub 2014 Jun 4.</citation>
    <PMID>24897745</PMID>
  </reference>
  <reference>
    <citation>Matsen FA 3rd, Butler-Wu S, Carofino BC, Jette JL, Bertelsen A, Bumgarner R. Origin of propionibacterium in surgical wounds and evidence-based approach for culturing propionibacterium from surgical sites. J Bone Joint Surg Am. 2013 Dec 4;95(23):e1811-7. doi: 10.2106/JBJS.L.01733.</citation>
    <PMID>24306704</PMID>
  </reference>
  <reference>
    <citation>Lee MJ, Pottinger PS, Butler-Wu S, Bumgarner RE, Russ SM, Matsen FA 3rd. Propionibacterium persists in the skin despite standard surgical preparation. J Bone Joint Surg Am. 2014 Sep 3;96(17):1447-50. doi: 10.2106/JBJS.M.01474.</citation>
    <PMID>25187583</PMID>
  </reference>
  <reference>
    <citation>Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.</citation>
    <PMID>19651954</PMID>
  </reference>
  <reference>
    <citation>Wright TE, Boyle KK, Duquin TR, Crane JK. Propionibacterium acnes Susceptibility and Correlation with Hemolytic Phenotype. Infect Dis (Auckl). 2016 Oct 9;9:39-44. doi: 10.4137/IDRT.S40539. eCollection 2016.</citation>
    <PMID>27773990</PMID>
  </reference>
  <reference>
    <citation>Hibbard JS. Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. J Infus Nurs. 2005 May-Jun;28(3):194-207. doi: 10.1097/00129804-200505000-00008.</citation>
    <PMID>15912075</PMID>
  </reference>
  <reference>
    <citation>Butler-Wu SM, Burns EM, Pottinger PS, Magaret AS, Rakeman JL, Matsen FA 3rd, Cookson BT. Optimization of periprosthetic culture for diagnosis of Propionibacterium acnes prosthetic joint infection. J Clin Microbiol. 2011 Jul;49(7):2490-5. doi: 10.1128/JCM.00450-11. Epub 2011 May 4.</citation>
    <PMID>21543562</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <results_first_submitted>June 20, 2019</results_first_submitted>
  <results_first_submitted_qc>October 25, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 13, 2019</results_first_posted>
  <last_update_submitted>October 25, 2019</last_update_submitted>
  <last_update_submitted_qc>October 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>George F. Hatch</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Propionibacterium Acnes</keyword>
  <keyword>Surgical Site Infection</keyword>
  <keyword>Shoulder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound Infection</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clindamycin</mesh_term>
    <mesh_term>Clindamycin palmitate</mesh_term>
    <mesh_term>Clindamycin phosphate</mesh_term>
    <mesh_term>Benzoyl Peroxide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Yes Data will be shared as required with the USC Health Sciences Institutional Review Board. Participant data will be coded with coding identifiers kept separately by research personnel only and destroyed upon completion of the study.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>HS-17-00319</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://istar.usc.edu</doc_url>
    </study_doc>
    <study_doc>
      <doc_id>HS-17-00319</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>http://istar.usc.edu</doc_url>
    </study_doc>
  </study_docs>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03257202/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>All 12 patients received each of the 4 study arms.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>All Study Participants</title>
          <description>All study participants received all 4 treatments: control, Clindamycin alone, Benzyl peroxide alone, Clindamycin and Benzoyl Peroxide</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Negative Control&#xD;
Topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel&#xD;
Topical clindamycin alone using Clindamycin 1% Gel&#xD;
BenzaClin 5%-1% Topical Gel: Topical clindamycin and benzoyl peroxide together</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.4" lower_limit="26" upper_limit="40"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms</title>
        <description>Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.</description>
        <time_frame>21 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Negative Control</title>
            <description>The participants did not receive treatment in this quadrant.</description>
          </group>
          <group group_id="O2">
            <title>Benzoyl Peroxide 5% Topical Gel</title>
            <description>This quadrant on the participants' backs were treated with Benzoyl Peroxide 5% topical gel</description>
          </group>
          <group group_id="O3">
            <title>Clindamycin 1% Topical Gel</title>
            <description>This quadrant of the participants' back received Clindamycin 1% topical gel</description>
          </group>
          <group group_id="O4">
            <title>Clindamycin 1% Plus Benzoyl Peroxide 5% Topical Gel</title>
            <description>This quadrant on the study participants' backs were treated with Clindamycin 1% plus Benzoyl Peroxide 5% topical gel</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms</title>
          <description>Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>No topical treatment</description>
        </group>
        <group group_id="E2">
          <title>Clindamycin Alone</title>
          <description>topical clindamycin alone using Clindamycin 1% Gel&#xD;
Clindamycin 1% Gel: topical clindamycin</description>
        </group>
        <group group_id="E3">
          <title>Benzoyl Peroxide Alone</title>
          <description>topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel&#xD;
Benzoyl peroxide 5% gel: topical benzoyl peroxide</description>
        </group>
        <group group_id="E4">
          <title>Clindamycin and Benzoyl Peroxide</title>
          <description>Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel&#xD;
BenzaClin 5%-1% Topical Gel: Topical clindamycin and benzoyl peroxide together</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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </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>Dr. George Hatch</name_or_title>
      <organization>Keck Medical Center of USC</organization>
      <phone>323-442-5860</phone>
      <email>ghatch.md@gmail.com</email>
    </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/NCT03257202
org study id: HS-17-00319
nct id: NCT03257202
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study is about preventing surgical site infections of the shoulder. We hope to learn if
      clindamycin alone, benzoyl peroxide alone, or clindamycin and benzoyl peroxide together can
      affect growth of Propionibacterium acnes in the dermal layer.
P. acnes are skin pathogens known to cause surgical site infections despite proper
      preoperative surgical preparation. Lee et al. showed 70% growth rate of P. acnes despite the
      application of Choraprep prior to sampling. However, this study was limited as it failed to
      utilize a control group and only investigated one preparatory technique. Meanwhile, there
      remains to date no study investigating the effect of topical treatments. The purpose of this
      study is to investigate how specific topical treatments affect growth in the dermal layer. 12
      volunteers who are normal volunteers, students, or employees of USC will each receive 4 punch
      biopsies from their back above the scapular spine, with each biopsy taken from a region of
      the skin treated with a different topical (topical clindamycin alone, topical benzoyl
      peroxide alone, topical clindamycin and benzoyl peroxide together, and a control). A 3df
      overall test of the treatment indicators will test for any differences in positivity for P
      Acnes among the treatments; pairwise comparisons among the treatments will adjust for
      multiple comparisons. A two-tailed statistical test will be performed, testing at an alpha of
      0.05, and analyses will also be performed based on hemolytic subtypes.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: Healthy volunteers
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms
time frame: 21 days
description: Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.
arm group label: Control
arm group type: No Intervention
description: No topical treatment
arm group label: Clindamycin alone
arm group type: Experimental
description: topical clindamycin alone using Clindamycin 1% Gel
arm group label: Benzoyl peroxide alone
arm group type: Experimental
description: topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel
arm group label: Clindamycin and benzoyl peroxide
arm group type: Experimental
description: Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel
intervention type: Drug
intervention name: Clindamycin 1% Gel
description: topical clindamycin
arm group label: Clindamycin alone
intervention type: Drug
intervention name: Benzoyl peroxide 5% gel
description: topical benzoyl peroxide
arm group label: Benzoyl peroxide alone
intervention type: Drug
intervention name: BenzaClin 5%-1% Topical Gel
description: Topical clindamycin and benzoyl peroxide together
arm group label: Clindamycin and benzoyl peroxide
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: George R Hatch, MD
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
citation: Dumville JC, McFarlane E, Edwards P, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD003949. doi: 10.1002/14651858.CD003949.pub3.
PMID: 23543526
citation: Mook WR, Garrigues GE. Diagnosis and Management of Periprosthetic Shoulder Infections. J Bone Joint Surg Am. 2014 Jun 4;96(11):956-965. doi: 10.2106/JBJS.M.00402. Epub 2014 Jun 4.
PMID: 24897745
citation: Matsen FA 3rd, Butler-Wu S, Carofino BC, Jette JL, Bertelsen A, Bumgarner R. Origin of propionibacterium in surgical wounds and evidence-based approach for culturing propionibacterium from surgical sites. J Bone Joint Surg Am. 2013 Dec 4;95(23):e1811-7. doi: 10.2106/JBJS.L.01733.
PMID: 24306704
citation: Lee MJ, Pottinger PS, Butler-Wu S, Bumgarner RE, Russ SM, Matsen FA 3rd. Propionibacterium persists in the skin despite standard surgical preparation. J Bone Joint Surg Am. 2014 Sep 3;96(17):1447-50. doi: 10.2106/JBJS.M.01474.
PMID: 25187583
citation: Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.
PMID: 19651954
citation: Wright TE, Boyle KK, Duquin TR, Crane JK. Propionibacterium acnes Susceptibility and Correlation with Hemolytic Phenotype. Infect Dis (Auckl). 2016 Oct 9;9:39-44. doi: 10.4137/IDRT.S40539. eCollection 2016.
PMID: 27773990
citation: Hibbard JS. Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. J Infus Nurs. 2005 May-Jun;28(3):194-207. doi: 10.1097/00129804-200505000-00008.
PMID: 15912075
citation: Butler-Wu SM, Burns EM, Pottinger PS, Magaret AS, Rakeman JL, Matsen FA 3rd, Cookson BT. Optimization of periprosthetic culture for diagnosis of Propionibacterium acnes prosthetic joint infection. J Clin Microbiol. 2011 Jul;49(7):2490-5. doi: 10.1128/JCM.00450-11. Epub 2011 May 4.
PMID: 21543562
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: George F. Hatch
investigator title: Principal Investigator
mesh term: Surgical Wound Infection
mesh term: Clindamycin
mesh term: Clindamycin palmitate
mesh term: Clindamycin phosphate
mesh term: Benzoyl Peroxide
sharing ipd: Yes
ipd description: Yes Data will be shared as required with the USC Health Sciences Institutional Review Board. Participant data will be coded with coding identifiers kept separately by research personnel only and destroyed upon completion of the study.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
study doc: 
study doc: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 