<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/NCT01701466</url>
  </required_header>
  <id_info>
    <org_study_id>11-053</org_study_id>
    <nct_id>NCT01701466</nct_id>
    <nct_alias>NCT01470872</nct_alias>
  </id_info>
  <brief_title>Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis</brief_title>
  <official_title>A Phase II Study Designed to Evaluate the Value of Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sir Mortimer B. Davis - Jewish General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Avario Healthcare Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sir Mortimer B. Davis - Jewish General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether NeoVIDERM is effective at preventing&#xD;
      radiation dermatitis in patients receiving external beam radiation therapy to the head and&#xD;
      neck or breast areas.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>December 2011</start_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum skin toxicity</measure>
    <time_frame>7 weeks post beginning of radiation treatments</time_frame>
    <description>The objective of this study is to determine the occurrence and degree of acute skin toxicity in patients receiving radical radiation therapy with preventive application of neoVIDERM compared to patients treated with institutional standard skin care.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Head and Neck Cancer</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Arm B: standard of care plus NeoVIDERM cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will apply NeoVIDERM cream to the treatment area everyday one week before starting radiotherapy, throughout treatment and for two weeks post treatment. Patients will also perform standard of care skin treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm A: standard skin care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be asked to apply Aveeno cream twice a day starting the day of their treatment until two weeks after the end of their treatments. If they develop dry desquamation, they will be asked to apply Flamazine twice a day until dermatitis resolves.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aveeno cream</intervention_name>
    <description>Twice a day</description>
    <arm_group_label>Arm A: standard skin care</arm_group_label>
    <arm_group_label>Arm B: standard of care plus NeoVIDERM cream</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Flamazine cream</intervention_name>
    <description>Twice a day, when there is dry desquamation</description>
    <arm_group_label>Arm A: standard skin care</arm_group_label>
    <arm_group_label>Arm B: standard of care plus NeoVIDERM cream</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NeoVIDERM cream</intervention_name>
    <description>Three times a day</description>
    <arm_group_label>Arm B: standard of care plus NeoVIDERM cream</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria: For patients receiving radiation to the breast&#xD;
&#xD;
          1. Patients receiving a dose of at least 50 Gy in 25 fractions with concomitant&#xD;
             chemotherapy or treated with the McGill technique.&#xD;
&#xD;
          2. Patients able to understand and sign an informed consent form.&#xD;
&#xD;
          3. Patients that do not have active connective tissue disorders.&#xD;
&#xD;
          4. Patients 18 years or older.&#xD;
&#xD;
          5. Patients that did not receive any previous radiation.&#xD;
&#xD;
          6. Patients that do not have any known allergy to any ingredients of the NeoVIDERM cream&#xD;
&#xD;
          7. Patients need to be able to apply the creams themselves or have help with applying the&#xD;
             creams.&#xD;
&#xD;
        Inclusion criteria: For patients receiving radiation to the head and neck&#xD;
&#xD;
          1. Patients receiving radiotherapy on fields that include both sides of the neck&#xD;
&#xD;
          2. Patients able to understand and sign an informed consent form.&#xD;
&#xD;
          3. Patients that do not have active connective tissue disorders.&#xD;
&#xD;
          4. Patients 18 years or older.&#xD;
&#xD;
          5. Patients that did not receive any previous radiation.&#xD;
&#xD;
          6. Patients that do not have any known allergy to any ingredients of the NeoVIDERM cream&#xD;
&#xD;
          7. Patients need to be able to apply the creams themselves or have help with applying the&#xD;
             creams.&#xD;
&#xD;
        Exclusion criteria: For patients receiving radiation to the breast or the head and neck&#xD;
&#xD;
          1. Patients that have a type V or type VI skin type according to the Fitzpatrick scale&#xD;
             (because these patients will likely have less radiodermatitis and if they do, it will&#xD;
             be harder to evaluate it).&#xD;
&#xD;
             The Fitzpatrick Scale:&#xD;
&#xD;
               -  Type I (scores 0-7) White; very fair; freckles. Always burns, never tans&#xD;
&#xD;
               -  Type II (scores 8-16) White; fair. Usually burns, tans with difficulty&#xD;
&#xD;
               -  Type III (scores 17-25) Beige; very common. Sometimes mild burn, gradually tans&#xD;
&#xD;
               -  Type IV (scores 25-30) Beige with a brown tint; typical Mediterranean Caucasian&#xD;
                  skin.&#xD;
&#xD;
             Rarely burns, tans with ease&#xD;
&#xD;
               -  Type V (scores over 30) Dark brown. Very rarely burns, tans very easily&#xD;
&#xD;
               -  Type VI Black. Never burns, tans very easily&#xD;
&#xD;
          2. Allergic to any ingredient in Neoviderm cream&#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>Te Vuong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jewish General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>May 22, 2015</last_update_submitted>
  <last_update_submitted_qc>May 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sir Mortimer B. Davis - Jewish General Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Te Vuong</investigator_full_name>
    <investigator_title>Director Radiation-oncology department</investigator_title>
  </responsible_party>
  <keyword>Patients</keyword>
  <keyword>with</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Silver Sulfadiazine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01701466
org study id: 11-053
nct id: NCT01701466
nct alias: NCT01470872
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether NeoVIDERM is effective at preventing
      radiation dermatitis in patients receiving external beam radiation therapy to the head and
      neck or breast areas.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Maximum skin toxicity
time frame: 7 weeks post beginning of radiation treatments
description: The objective of this study is to determine the occurrence and degree of acute skin toxicity in patients receiving radical radiation therapy with preventive application of neoVIDERM compared to patients treated with institutional standard skin care.
arm group label: Arm B: standard of care plus NeoVIDERM cream
arm group type: Experimental
description: Patients will apply NeoVIDERM cream to the treatment area everyday one week before starting radiotherapy, throughout treatment and for two weeks post treatment. Patients will also perform standard of care skin treatment.
arm group label: Arm A: standard skin care
arm group type: Active Comparator
description: Patients will be asked to apply Aveeno cream twice a day starting the day of their treatment until two weeks after the end of their treatments. If they develop dry desquamation, they will be asked to apply Flamazine twice a day until dermatitis resolves.
intervention type: Other
intervention name: Aveeno cream
description: Twice a day
arm group label: Arm A: standard skin care
arm group label: Arm B: standard of care plus NeoVIDERM cream
intervention type: Other
intervention name: Flamazine cream
description: Twice a day, when there is dry desquamation
arm group label: Arm A: standard skin care
arm group label: Arm B: standard of care plus NeoVIDERM cream
intervention type: Other
intervention name: NeoVIDERM cream
description: Three times a day
arm group label: Arm B: standard of care plus NeoVIDERM cream
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Te Vuong, MD
role: Principal Investigator
affiliation: Jewish General Hospital
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Sir Mortimer B. Davis - Jewish General Hospital
investigator full name: Dr. Te Vuong
investigator title: Director Radiation-oncology department
mesh term: Dermatitis
mesh term: Radiodermatitis
mesh term: Silver Sulfadiazine