<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/NCT03255980</url>
  </required_header>
  <id_info>
    <org_study_id>HD01-16-30</org_study_id>
    <nct_id>NCT03255980</nct_id>
  </id_info>
  <brief_title>Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®</brief_title>
  <official_title>Monocenter, Open Label Clinical Investigation on the Treatment With Xonrid®, a Medical Device for the Prevention and Treatment of Radiotherapy-induced Dermatitis, in Breast and Head &amp; Neck Cancer Patients Receiving Curative Treatment.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinn Healthcare SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helsinn Healthcare SA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</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>
      To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation&#xD;
      dermatitis in breast and head &amp; neck cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this clinical investigation is to evaluate if the use of Xonrid® in the prevention&#xD;
      and treatment of G2 radiation dermatitis in breast and head &amp; neck cancer patients can be a&#xD;
      valid support, when compared to the Standard of Care as defined by MASCC (Multinational&#xD;
      Association for Supportive Care in Cancer) guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2017</start_date>
  <completion_date type="Actual">January 22, 2020</completion_date>
  <primary_completion_date type="Actual">February 20, 2019</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>
    <intervention_model_description>MONOCENTER, OPEN LABEL CLINICAL INVESTIGATION</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5</measure>
    <time_frame>5 weeks over 7 weeks</time_frame>
    <description>The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis &lt; G2) at week 5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Median Time to G2 Radiodermatitis Development</measure>
    <time_frame>5 weeks over 7 weeks</time_frame>
    <description>Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients Without G2 Radiation Dermatitis at Week 6 for Both Cancer Sites, at Week 7 for Head &amp; Neck Cancer and 2 Weeks After the Last Radiation for Both Cancer Sites</measure>
    <time_frame>5 weeks over 7 weeks</time_frame>
    <description>Definition of RD grade according to CTCAE v4.0 Scale by trained physicinans</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation</measure>
    <time_frame>6 weeks over 7 weeks</time_frame>
    <description>Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation for both cancer sites, at week 7 for head &amp; neck cancer and 2 weeks after the last radiation for both cancer sites.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.</measure>
    <time_frame>Follow-up: 2 weeks after the completion of radiation treatment</time_frame>
    <description>The changes in skin erythema and pigmentation, according to the ITA (individual Typological Angle) degrees measured throughout the study by the Investigators.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation</measure>
    <time_frame>weekly during teratment (7 weeks)</time_frame>
    <description>Changes of skin characteristics in terms of TEWL according to the progression of the Radiotherapy and consequent erythema</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Mean and Worst Score of Skindex-16 Questionnaire</measure>
    <time_frame>5 weeks over 7 weeks</time_frame>
    <description>Evaluate the patient's QoL changes occurred during the RT trough the validated self-assessed questionnaire Skindex-16</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Compliance to Experimental Treatment, Assessed Through the Number of Daily Product Applications Reported on the Patient's Diary, Compared to the Amount of Used Product</measure>
    <time_frame>5 weeks over 7 weeks</time_frame>
    <description>Compliance is based on the total amount ( weight) of Xonrid used over the treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale</measure>
    <time_frame>6 weeks over 7 weeks</time_frame>
    <description>Global patient's satisfaction recorded by the Linkert Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Radiodermatitis</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Xonrid®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Xonrid® is a medical device for radiation dermatitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of care suggested by MASCC guidelines</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Xonrid® gel</intervention_name>
    <description>Water based gel for the management of toxicity skin symptoms induced by Radiotherapy</description>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_label>Xonrid®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines</description>
    <arm_group_label>Xonrid®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female which are 18 years of age or older&#xD;
&#xD;
          2. Performance status &lt; 2&#xD;
&#xD;
          3. Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus&#xD;
             and salivary glands or breast cancer, planned to receive a total dose of at least 50&#xD;
             Gy&#xD;
&#xD;
          4. Postoperative or curative radiation treatment&#xD;
&#xD;
          5. Concurrent chemotherapy is accepted, in head &amp; neck cancer patients&#xD;
&#xD;
          6. Patients willing and able to give signed informed consent and, in the opinion of the&#xD;
             Investigator, to comply with the Clinical Investigation Plan tests and procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating women&#xD;
&#xD;
          2. Planned to receive concurrent cetuximab&#xD;
&#xD;
          3. Previous radiation therapy on the head and neck area or breast and thorax areas&#xD;
&#xD;
          4. Cutaneous and connective diseases (i.e. lupus erythematosus or scleroderma)&#xD;
&#xD;
          5. Systemic diseases known to delay the skin healing process such as diabetes mellitus or&#xD;
             severe renal failure&#xD;
&#xD;
          6. Use of a tissue-equivalent bolus&#xD;
&#xD;
          7. Use of over-the-counter topical medications containing steroids&#xD;
&#xD;
          8. Presence of rashes or unhealed wounds in the radiation field&#xD;
&#xD;
          9. Recent sun exposure&#xD;
&#xD;
         10. Mental conditions that could adversely affect patients' adherence to the study.&#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>Orlandi Ester, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Nazionale dei Tumori</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <results_first_submitted>November 19, 2020</results_first_submitted>
  <results_first_submitted_qc>November 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 16, 2020</results_first_posted>
  <last_update_submitted>November 19, 2020</last_update_submitted>
  <last_update_submitted_qc>November 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 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>Dermatitis</mesh_term>
    <mesh_term>Radiodermatitis</mesh_term>
  </condition_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>February 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03255980/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>December 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03255980/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>FPI: June 2017 LPO: July 2018</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Breast Cancer Group: Xonrid+SOC</title>
          <description>Patients treated with the device under evaluation and according to MASCC guidelines</description>
        </group>
        <group group_id="P2">
          <title>Breast Cancer Group: SOC</title>
          <description>Patients treated with Standard of Care according to MASCC guidelines</description>
        </group>
        <group group_id="P3">
          <title>Head and Neck Cancer Group: Xonrid + SOC</title>
          <description>H&amp;N Patients treated with the device under evaluation and according to MASCC guidelines</description>
        </group>
        <group group_id="P4">
          <title>Head and Neck Cancer Group: SOC</title>
          <description>H&amp;N Cancer Patients treated with Standard of Care according to MASCC guidelines</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Grade =&gt;3 Skin Toxicity</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of compliance to study or assessmen</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Descriptive statistics of all relevant variables were performed</population>
      <group_list>
        <group group_id="B1">
          <title>Breast Cancer Group: Xonrid+SOC</title>
          <description>Patients treated with the device under evaluation and according to MASCC guidelines</description>
        </group>
        <group group_id="B2">
          <title>Breast Cancer Group: SOC</title>
          <description>Patients treated with Standard of Care according to MASCC guidelines</description>
        </group>
        <group group_id="B3">
          <title>Head and Neck Cancer Group: Xonrid + SOC</title>
          <description>H&amp;N Patients treated with the device under evaluation and according to MASCC guidelines</description>
        </group>
        <group group_id="B4">
          <title>Head and Neck Cancer Group: SOC</title>
          <description>H&amp;N Cancer Patients treated with Standard of Care according to MASCC guidelines</description>
        </group>
        <group group_id="B5">
          <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="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="20"/>
            <count group_id="B4" value="20"/>
            <count group_id="B5" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.56" spread="4.80"/>
                    <measurement group_id="B2" value="49.01" spread="4.54"/>
                    <measurement group_id="B3" value="55.73" spread="12.46"/>
                    <measurement group_id="B4" value="59.49" spread="12.34"/>
                    <measurement group_id="B5" value="53.45" spread="8.52"/>
                  </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="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Caucasian</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="80"/>
                  </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>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5</title>
        <description>The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis &lt; G2) at week 5</description>
        <time_frame>5 weeks over 7 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Breast Cancer Group: Xonrid+SOC</title>
            <description>Patients treated with the device under evaluation and according to MASCC guidelines</description>
          </group>
          <group group_id="O2">
            <title>Breast Cancer Group: SOC</title>
            <description>Patients with Breast Cancer treated with Standard of Care according to MASCC guidelines</description>
          </group>
          <group group_id="O3">
            <title>Head and Neck Cancer Group: Xonrid + SOC</title>
            <description>H&amp;N Patients treated with the device under evaluation and according to MASCC guidelines</description>
          </group>
          <group group_id="O4">
            <title>Head and Neck Cancer Group: SOC</title>
            <description>H&amp;N Cancer Patients treated with Standard of Care according to MASCC guidelines</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5</title>
          <description>The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis &lt; G2) at week 5</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to G2 Radiodermatitis Development</title>
        <description>Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation</description>
        <time_frame>5 weeks over 7 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Patients Without G2 Radiation Dermatitis at Week 6 for Both Cancer Sites, at Week 7 for Head &amp; Neck Cancer and 2 Weeks After the Last Radiation for Both Cancer Sites</title>
        <description>Definition of RD grade according to CTCAE v4.0 Scale by trained physicinans</description>
        <time_frame>5 weeks over 7 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation</title>
        <description>Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation for both cancer sites, at week 7 for head &amp; neck cancer and 2 weeks after the last radiation for both cancer sites.</description>
        <time_frame>6 weeks over 7 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.</title>
        <description>The changes in skin erythema and pigmentation, according to the ITA (individual Typological Angle) degrees measured throughout the study by the Investigators.</description>
        <time_frame>Follow-up: 2 weeks after the completion of radiation treatment</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation</title>
        <description>Changes of skin characteristics in terms of TEWL according to the progression of the Radiotherapy and consequent erythema</description>
        <time_frame>weekly during teratment (7 weeks)</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Mean and Worst Score of Skindex-16 Questionnaire</title>
        <description>Evaluate the patient's QoL changes occurred during the RT trough the validated self-assessed questionnaire Skindex-16</description>
        <time_frame>5 weeks over 7 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Compliance to Experimental Treatment, Assessed Through the Number of Daily Product Applications Reported on the Patient's Diary, Compared to the Amount of Used Product</title>
        <description>Compliance is based on the total amount ( weight) of Xonrid used over the treatment period</description>
        <time_frame>5 weeks over 7 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale</title>
        <description>Global patient's satisfaction recorded by the Linkert Scale</description>
        <time_frame>6 weeks over 7 weeks</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>13 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Breast Cancer: Xonrid® +SOC</title>
          <description>Xonrid® is a medical device for radiation dermatitis&#xD;
Xonrid® gel: Water based gel for the management of toxicity skin symptoms induced by Radiotherapy&#xD;
Standard of Care: Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines</description>
        </group>
        <group group_id="E2">
          <title>Breast Cancer: Standard Of Care</title>
          <description>Standard of care suggested by MASCC guidelines</description>
        </group>
        <group group_id="E3">
          <title>Head and Neck Cancer: Xonrid + SOC</title>
          <description>Xonrid® is a medical device for radiation dermatitis&#xD;
Xonrid® gel: Water based gel for the management of toxicity skin symptoms induced by Radiotherapy&#xD;
Standard of Care: Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines</description>
        </group>
        <group group_id="E4">
          <title>Head and Neck Cancer: Standard of Care</title>
          <description>Standard of care suggested by MASCC guidelines</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (21.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>pruritus</sub_title>
                <description>Hypersensitivity</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA (21.1)</default_vocab>
        <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="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Ear Infection</sub_title>
                <description>Infections - pathogen unspecified</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS 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. Fabio Macchi</name_or_title>
      <organization>Helsinn Healthcare SA</organization>
      <phone>0041919852121</phone>
      <email>fabio.macchi@helsinn.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/NCT03255980
org study id: HD01-16-30
nct id: NCT03255980
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation
      dermatitis in breast and head & neck cancer patients.
The aim of this clinical investigation is to evaluate if the use of Xonrid® in the prevention
      and treatment of G2 radiation dermatitis in breast and head & neck cancer patients can be a
      valid support, when compared to the Standard of Care as defined by MASCC (Multinational
      Association for Supportive Care in Cancer) guidelines.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: MONOCENTER, OPEN LABEL CLINICAL INVESTIGATION
primary purpose: Other
masking: None (Open Label)
measure: Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5
time frame: 5 weeks over 7 weeks
description: The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis < G2) at week 5
measure: Median Time to G2 Radiodermatitis Development
time frame: 5 weeks over 7 weeks
description: Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation
measure: The Proportion of Patients Without G2 Radiation Dermatitis at Week 6 for Both Cancer Sites, at Week 7 for Head & Neck Cancer and 2 Weeks After the Last Radiation for Both Cancer Sites
time frame: 5 weeks over 7 weeks
description: Definition of RD grade according to CTCAE v4.0 Scale by trained physicinans
measure: The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation
time frame: 6 weeks over 7 weeks
description: Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation for both cancer sites, at week 7 for head & neck cancer and 2 weeks after the last radiation for both cancer sites.
measure: The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.
time frame: Follow-up: 2 weeks after the completion of radiation treatment
description: The changes in skin erythema and pigmentation, according to the ITA (individual Typological Angle) degrees measured throughout the study by the Investigators.
measure: The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation
time frame: weekly during teratment (7 weeks)
description: Changes of skin characteristics in terms of TEWL according to the progression of the Radiotherapy and consequent erythema
measure: The Mean and Worst Score of Skindex-16 Questionnaire
time frame: 5 weeks over 7 weeks
description: Evaluate the patient's QoL changes occurred during the RT trough the validated self-assessed questionnaire Skindex-16
measure: The Compliance to Experimental Treatment, Assessed Through the Number of Daily Product Applications Reported on the Patient's Diary, Compared to the Amount of Used Product
time frame: 5 weeks over 7 weeks
description: Compliance is based on the total amount ( weight) of Xonrid used over the treatment period
measure: The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale
time frame: 6 weeks over 7 weeks
description: Global patient's satisfaction recorded by the Linkert Scale
arm group label: Xonrid®
arm group type: Experimental
description: Xonrid® is a medical device for radiation dermatitis
arm group label: Standard of Care
arm group type: Active Comparator
description: Standard of care suggested by MASCC guidelines
intervention type: Device
intervention name: Xonrid® gel
description: Water based gel for the management of toxicity skin symptoms induced by Radiotherapy
arm group label: Standard of Care
arm group label: Xonrid®
intervention type: Other
intervention name: Standard of Care
description: Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines
arm group label: Xonrid®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Orlandi Ester, MD
role: Principal Investigator
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Dermatitis
mesh term: Radiodermatitis
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 