<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/NCT03304873</url>
  </required_header>
  <id_info>
    <org_study_id>17-00907</org_study_id>
    <nct_id>NCT03304873</nct_id>
  </id_info>
  <brief_title>Retapamulin as a Decolonizing Agent for MRSA</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Retapamulin as a Topical Decolonizing Agent for Mupirocin Resistant Methicillin Resistant Staphylococcus Aureus (MRSA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the efficacy of retapamulin to reduce carriage of&#xD;
      MRSA via a randomized, double-blind, placebo-controlled clinical study testing retapamulin&#xD;
      among patients with confirmed mupirocin-resistant nasal and/or rectal MRSA colonization. The&#xD;
      sample size will include 27 subjects in each of the two arms of the study (retapamulin versus&#xD;
      placebo) for a total of 54 subjects. Participants who are found to be nasal and/or rectal&#xD;
      colonized with MRSA will be randomized to receive either retapamulin or placebo applied&#xD;
      nasally and rectally for a total of 5 days. Nasal and rectal swabs will be collected at&#xD;
      pre-defined time points during study duration (screening swab, swab one week after completion&#xD;
      of topical therapy, swab 4 weeks after completion of topical therapy) to assess MRSA&#xD;
      colonization status. The colonization rates of both groups will be assessed via Fisher's&#xD;
      Exact Test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">March 18, 2019</completion_date>
  <primary_completion_date type="Actual">February 13, 2019</primary_completion_date>
  <phase>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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo</measure>
    <time_frame>1 Week</time_frame>
    <description>Study visit for nasal/peri-rectal swabs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo</measure>
    <time_frame>4 Weeks</time_frame>
    <description>Study visit for nasal/peri-rectal swabs</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>MRSA</condition>
  <arm_group>
    <arm_group_label>Retapamulin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo used will be a triple purified pharmaceutical grade white petrolatum</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Retapamulin</intervention_name>
    <description>Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%).</description>
    <arm_group_label>Retapamulin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Ointment</intervention_name>
    <description>The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Admission to the general pediatric floor and pediatric intensive care units at NYU&#xD;
             Langone Medical Center or visit to study team members at ODA clinic (Park Ave&#xD;
             locations) in Williamsburg Brooklyn.&#xD;
&#xD;
          2. Ages 9 months to 17 years&#xD;
&#xD;
          3. Residing in the zip codes which reflect Orthodox Jewish neighborhoods where there is a&#xD;
             current outbreak of this strain of MRSA.&#xD;
&#xD;
          4. Nasal and/or rectal culture positive for mupirocin-resistant methicillin-resistant&#xD;
             Staphylococcus aureus (MRSA)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        An individual who meets any of the following criteria will be excluded from participation&#xD;
        in this study:&#xD;
&#xD;
          1. Pregnant or lactating&#xD;
&#xD;
          2. Unable to appropriately consent&#xD;
&#xD;
          3. Open sores in either of the study sites (nares or rectum)&#xD;
&#xD;
          4. Recent surgical procedure to either study site (nares or rectum)&#xD;
&#xD;
          5. Concurrent use of Rifampin or Trimethoprim/Sulfamethoxazole&#xD;
&#xD;
          6. Current active MRSA infection&#xD;
&#xD;
          7. Immunocompromised&#xD;
&#xD;
          8. Presence of endotracheal tube, tracheostomy tube or other foreign body in upper airway&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Months</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Lighter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <results_first_submitted>February 24, 2020</results_first_submitted>
  <results_first_submitted_qc>March 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 19, 2020</results_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rectal MRSA</keyword>
  <keyword>mupirocin-resistant nasal MRSA</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retapamulin</mesh_term>
  </intervention_browse>
  <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>June 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03304873/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Retapamulin</title>
          <description>Thin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days.&#xD;
Retapamulin: Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%).</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>The placebo used will be a triple purified pharmaceutical grade white petrolatum&#xD;
Placebo Ointment: The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Retapamulin</title>
          <description>Thin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days.&#xD;
Retapamulin: Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%).</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>The placebo used will be a triple purified pharmaceutical grade white petrolatum&#xD;
Placebo Ointment: The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.</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="23"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="47"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="23"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.9" lower_limit="0.75" upper_limit="12"/>
                    <measurement group_id="B2" value="3.5" lower_limit="0.75" upper_limit="14"/>
                    <measurement group_id="B3" value="3.5" lower_limit="0.75" upper_limit="14"/>
                  </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="23"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="19"/>
                  </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 group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_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="23"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo</title>
        <description>Study visit for nasal/peri-rectal swabs</description>
        <time_frame>1 Week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Retapamulin</title>
            <description>Thin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days.&#xD;
Retapamulin: Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>The placebo used will be a triple purified pharmaceutical grade white petrolatum&#xD;
Placebo Ointment: The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo</title>
          <description>Study visit for nasal/peri-rectal swabs</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0004</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo</title>
        <description>Study visit for nasal/peri-rectal swabs</description>
        <time_frame>4 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Retapamulin</title>
            <description>Thin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days.&#xD;
Retapamulin: Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>The placebo used will be a triple purified pharmaceutical grade white petrolatum&#xD;
Placebo Ointment: The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo</title>
          <description>Study visit for nasal/peri-rectal swabs</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.99</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>While on study protocol, which includes while using randomized medication and throughout follow-up (about 6 weeks).</time_frame>
      <desc>Known risks or adverse reactions from this drug use are minimal and include local application site irritation (pruritus, erythema, stinging). In clinical studies, this was found to occur in &lt; 2% of patients. This information is listed in the package insert for retapamulin. It is expected not to pose greater than minimal risk to participants. Side effects of Retapamulin are not commonly expected and are reported to subside with the discontinuation of the drug without expected long term risks.</desc>
      <group_list>
        <group group_id="E1">
          <title>Retapamulin</title>
          <description>Thin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days.&#xD;
Retapamulin: Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%).</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>The placebo used will be a triple purified pharmaceutical grade white petrolatum&#xD;
Placebo Ointment: The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.</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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Local application site irritation</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </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>Jennifer Lighter, MD</name_or_title>
      <organization>NYU Grossman School of Medicine</organization>
      <phone>212-263-5454</phone>
      <email>Jennifer.Lighter@nyulangone.org</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/NCT03304873
org study id: 17-00907
nct id: NCT03304873
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to investigate the efficacy of retapamulin to reduce carriage of
      MRSA via a randomized, double-blind, placebo-controlled clinical study testing retapamulin
      among patients with confirmed mupirocin-resistant nasal and/or rectal MRSA colonization. The
      sample size will include 27 subjects in each of the two arms of the study (retapamulin versus
      placebo) for a total of 54 subjects. Participants who are found to be nasal and/or rectal
      colonized with MRSA will be randomized to receive either retapamulin or placebo applied
      nasally and rectally for a total of 5 days. Nasal and rectal swabs will be collected at
      pre-defined time points during study duration (screening swab, swab one week after completion
      of topical therapy, swab 4 weeks after completion of topical therapy) to assess MRSA
      colonization status. The colonization rates of both groups will be assessed via Fisher's
      Exact Test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo
time frame: 1 Week
description: Study visit for nasal/peri-rectal swabs
measure: Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo
time frame: 4 Weeks
description: Study visit for nasal/peri-rectal swabs
arm group label: Retapamulin
arm group type: Experimental
description: Thin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days.
arm group label: Placebo
arm group type: Placebo Comparator
description: The placebo used will be a triple purified pharmaceutical grade white petrolatum
intervention type: Drug
intervention name: Retapamulin
description: Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%).
arm group label: Retapamulin
intervention type: Drug
intervention name: Placebo Ointment
description: The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.
arm group label: Placebo
criteria: 
gender: All
minimum age: 9 Months
maximum age: 17 Years
healthy volunteers: No
last name: Jennifer Lighter, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Retapamulin
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 