<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/NCT02996097</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00082453</org_study_id>
    <nct_id>NCT02996097</nct_id>
  </id_info>
  <brief_title>Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids</brief_title>
  <official_title>Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effects of fractional carbon dioxide (CO2) laser&#xD;
      therapy immediately followed by intralesional steroid therapy against intralesional steroid&#xD;
      therapy alone for the treatment of keloids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intralesional corticosteroids remain the gold standard treatment for keloids. However, more&#xD;
      effective therapies are desperately desired. Ablative fractional laser (AFL) treatment&#xD;
      facilitates delivery of intralesional steroid more deeply and uniformly into the skin by&#xD;
      creating vertical channels. Recent studies have showed that fractional laser assisted steroid&#xD;
      therapy can be effective in the treatment of keloids. However the studies are lacking in&#xD;
      comparing this treatment modality to the gold standard of intralesional steroids.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Actual">June 15, 2018</completion_date>
  <primary_completion_date type="Actual">June 15, 2018</primary_completion_date>
  <phase>N/A</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)</measure>
    <time_frame>Once every 4 weeks for 16 weeks</time_frame>
    <description>Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)</measure>
    <time_frame>Once every 4 weeks for 16 weeks</time_frame>
    <description>Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Keloid</condition>
  <arm_group>
    <arm_group_label>CO2 ablative laser plus intralesional triamcinolone acetonide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. One lesion would be treated with fractional CO2 ablative laser followed with intralesional triamcinolone acetonide at 4 weeks intervals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intralesional triamcinolone acetonide alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A topical EMLA cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. The other chosen lesion would be treated with intralesional triamcinolone acetonide alone at 4 week intervals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The Lutronic electronic carbon dioxide (eCO2) Plus laser system</intervention_name>
    <description>CO2 ablative laser plus intralesional triamcinolone acetonide A topical EMLA cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. One lesion would be treated with fractional CO2 ablative laser followed with intralesional triamcinolone acetonide at 4 weeks intervals</description>
    <arm_group_label>CO2 ablative laser plus intralesional triamcinolone acetonide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intralesional Triamcinolone Acetonide</intervention_name>
    <arm_group_label>CO2 ablative laser plus intralesional triamcinolone acetonide</arm_group_label>
    <arm_group_label>Intralesional triamcinolone acetonide alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female older than 17 at the screening visit;&#xD;
&#xD;
          -  The subject is healthy, as determined by the investigator based on a medical&#xD;
             evaluation including medical history;&#xD;
&#xD;
          -  The subject has at least two keloids of comparative size and texture located on the&#xD;
             same general anatomic location (trunk or back);&#xD;
&#xD;
          -  The subject is willing and able to comply with the requirements of the protocol. In&#xD;
             particular, subject must adhere to the visits schedule and concomitant therapy. The&#xD;
             subject is willing to comply with the 4 week washout period;&#xD;
&#xD;
          -  The subject has understood and signed an Informed Consent Form approved by the&#xD;
             Institutional Review Board (IRB) prior to any investigational procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any subject who is meeting one or more of the following exclusion criteria at the screening&#xD;
        visit and/or at the baseline visit will not be included in this study:&#xD;
&#xD;
          -  The subject has an underlying known disease, a surgical or medical condition that in&#xD;
             the opinion of the investigator might put the subject at risk&#xD;
&#xD;
          -  The subject is pregnant or breastfeeding at the time of enrollment or is planning to&#xD;
             become pregnant at any point during the study period&#xD;
&#xD;
          -  The subject has a past history of coagulopathy&#xD;
&#xD;
          -  The subject has an underlying dermatological disease that in the opinion of the&#xD;
             investigator could interfere with the study evaluations&#xD;
&#xD;
          -  The subject has used prohibited topical or systemic treatments without sufficient&#xD;
             protocol-defined wash-out period prior to Baseline (checked at Screening and Baseline)&#xD;
             or is unwilling to refrain from use during the study&#xD;
&#xD;
          -  The subject is treated with anticoagulants or antiplatelet therapies&#xD;
&#xD;
          -  The subject has a known allergy or sensitivity to any local anesthetic drug (e.g. EMLA&#xD;
             or tetracaine 7%/lidocaine 23%) or a local antiseptic planned to be used for the&#xD;
             laser.&#xD;
&#xD;
          -  The subject is in an exclusion period from a previous study or is participating in&#xD;
             another clinical trial&#xD;
&#xD;
          -  The subject is an adult under guardianship or is hospitalized in a public or private&#xD;
             institution, or is deprived of freedom&#xD;
&#xD;
          -  The subject is unable to communicate or cooperate with the Investigator due to&#xD;
             language problems, poor mental development, or impaired cerebral function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ginette Okoye, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins School of Medicine, Department of Dermatology</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <results_first_submitted>April 1, 2019</results_first_submitted>
  <results_first_submitted_qc>April 1, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 25, 2019</results_first_posted>
  <last_update_submitted>December 14, 2020</last_update_submitted>
  <last_update_submitted_qc>December 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</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>Keloid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Triamcinolone diacetate</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 27, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT02996097/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 27, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT02996097/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide</title>
          <description>A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the Lutronic electronic carbon dioxide (eCO2) Plus fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide at 4 weeks intervals.</description>
        </group>
        <group group_id="P2">
          <title>Intralesional Triamcinolone Acetonide Only</title>
          <description>A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with intralesional triamcinolone acetonide only at 4 week intervals.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per Protocol Population</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
              </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="11"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>All enrolled participants had two keloids on them, each keloid selected for an intervention arm of the study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)</title>
        <description>Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.</description>
        <time_frame>Once every 4 weeks for 16 weeks</time_frame>
        <population>Analyzed 19 participants who completed the study (5 visits) in addition to the 3 participants who completed 3 of 5 visits to provide enough data for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide</title>
            <description>A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the Lutronic electronic carbon dioxide (eCO2) Plus fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide at 4 weeks intervals.</description>
          </group>
          <group group_id="O2">
            <title>Intralesional Triamcinolone Acetonide Only</title>
            <description>A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with intralesional triamcinolone acetonide only at 4 week intervals.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)</title>
          <description>Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.</description>
          <population>Analyzed 19 participants who completed the study (5 visits) in addition to the 3 participants who completed 3 of 5 visits to provide enough data for this analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.5" lower_limit="-12.2" upper_limit="-6"/>
                    <measurement group_id="O2" value="-8.9" lower_limit="-11.7" upper_limit="-6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)</title>
        <description>Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.</description>
        <time_frame>Once every 4 weeks for 16 weeks</time_frame>
        <population>Analyzed 19 participants who completed the study (5 visits) in addition to the 3 participants who completed 3 of 5 visits to provide enough data for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>CO2 Ablative Laser PLUS Intralesional Triamcinolone Acetonide</title>
            <description>A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the Lutronic electronic carbon dioxide (eCO2) Plus fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide at 4 weeks intervals.</description>
          </group>
          <group group_id="O2">
            <title>Intralesional Triamcinolone Acetonide Only</title>
            <description>A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with intralesional triamcinolone acetonide only at 4 week intervals.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)</title>
          <description>Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.</description>
          <population>Analyzed 19 participants who completed the study (5 visits) in addition to the 3 participants who completed 3 of 5 visits to provide enough data for this analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.6" lower_limit="-28.5" upper_limit="-16.7"/>
                    <measurement group_id="O2" value="-18.8" lower_limit="-24.5" upper_limit="-13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>14 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CO2 Ablative Laser +/- Intralesional Triamcinolone Acetonide</title>
          <description>2 keloids on each patient will be selected as treatment sites. A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the Lutronic electronic carbon dioxide (eCO2) Plus fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide at 4 weeks intervals. The other keloid will be treated with intralesional triamcinolone acetonide only at 4 week intervals.</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="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </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="30"/>
              </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. Ginette Okoye</name_or_title>
      <organization>Johns Hopkins School of Medicine</organization>
      <phone>9142158980</phone>
      <email>ginette.okoye@howard.edu</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/NCT02996097
org study id: IRB00082453
nct id: NCT02996097
lead sponsor: 
The purpose of this study is to compare the effects of fractional carbon dioxide (CO2) laser
      therapy immediately followed by intralesional steroid therapy against intralesional steroid
      therapy alone for the treatment of keloids.
Intralesional corticosteroids remain the gold standard treatment for keloids. However, more
      effective therapies are desperately desired. Ablative fractional laser (AFL) treatment
      facilitates delivery of intralesional steroid more deeply and uniformly into the skin by
      creating vertical channels. Recent studies have showed that fractional laser assisted steroid
      therapy can be effective in the treatment of keloids. However the studies are lacking in
      comparing this treatment modality to the gold standard of intralesional steroids.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)
time frame: Once every 4 weeks for 16 weeks
description: Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.
measure: Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)
time frame: Once every 4 weeks for 16 weeks
description: Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.
arm group label: CO2 ablative laser plus intralesional triamcinolone acetonide
arm group type: Experimental
description: A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. One lesion would be treated with fractional CO2 ablative laser followed with intralesional triamcinolone acetonide at 4 weeks intervals
arm group label: Intralesional triamcinolone acetonide alone
arm group type: Active Comparator
description: A topical EMLA cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. The other chosen lesion would be treated with intralesional triamcinolone acetonide alone at 4 week intervals.
intervention type: Device
intervention name: The Lutronic electronic carbon dioxide (eCO2) Plus laser system
description: CO2 ablative laser plus intralesional triamcinolone acetonide A topical EMLA cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. One lesion would be treated with fractional CO2 ablative laser followed with intralesional triamcinolone acetonide at 4 weeks intervals
arm group label: CO2 ablative laser plus intralesional triamcinolone acetonide
intervention type: Drug
intervention name: Intralesional Triamcinolone Acetonide
arm group label: CO2 ablative laser plus intralesional triamcinolone acetonide
arm group label: Intralesional triamcinolone acetonide alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ginette Okoye, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Keloid
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Triamcinolone diacetate
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 