<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/NCT04481802</url>
  </required_header>
  <id_info>
    <org_study_id>RadiaAce001</org_study_id>
    <nct_id>NCT04481802</nct_id>
  </id_info>
  <brief_title>The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients</brief_title>
  <official_title>The Effect of RadiaAce Gel Versus Biafine in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AceTech</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AceTech</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radiation dermatitis (RD) is one of the most common side effects of Radiation therapy (RT)&#xD;
      and 95% of patients receiving RT may experience some form of radiation dermatitis.&#xD;
&#xD;
      A wide variety of topical, oral, and intravenous agents are used to prevent/treat Radiation&#xD;
      dermatitis but currently there is no gold standard in the prevention and management of this&#xD;
      condition and no treatment can be explicitly recommended.&#xD;
&#xD;
      RadiaAce Gel is a wound dressing Hydrogel (Acemannan Hydrogel) for the management of RD which&#xD;
      provides optimal moist wound environment necessary to the healing process.&#xD;
&#xD;
      Based on its composition as well as the supporting data on safety and performance of the&#xD;
      functional ingredient Acemannan in wound healing, RadiaAce may well be suited to complement&#xD;
      the prevention and therapy of radiation dermatitis.&#xD;
&#xD;
      The primary aim of the study is to evaluate the safety and performance of RadiaAce as compare&#xD;
      to Biafine in reducing the proportion of breast cancer patients that experience grade 2 or&#xD;
      higher RD as measured by the RTOG scoring system&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 14, 2021</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skin assessment (RD grade)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain (VAS)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Dermatitis-related pain is assessed with a visual analogue scale (VAS) self-assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient's assessment of the skin condition (DLQI questioner)</measure>
    <time_frame>10 weeks</time_frame>
    <description>The Patients perspective is captured by the Dermatology Life Quality Index (DLQI)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Radiation Dermatitis</condition>
  <arm_group>
    <arm_group_label>RadiaAce gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RadiaAce Gel is a clear, non-oily Hydrogel wound dressing for the management of Radiation Dermatitis which provides optimal moist wound environment necessary to the healing process. RadiaAce gel contains Acemannan, a high molecular polysaccharide obtained from the inner gel of Aloe Vera leaves and it is considered the main functional component of Aloe vera (Sahu et al. 2013).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biafine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>one of the standard skin care in radiation oncology, this treatment was chosen as the comparator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RadiaAce gel</intervention_name>
    <description>Patients will apply the RadiaAce to the treatment area starting 5 days before radiation treatment. The Hydrogel/cream will be applied three times a day with a minimum of four hours between applications. Treatments will be used through the course of RT and for 6 days after the last fraction of radiation.</description>
    <arm_group_label>RadiaAce gel</arm_group_label>
    <other_name>Acemannan hydrogel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biafine</intervention_name>
    <description>Patients will apply the Biafine to the treatment area starting 5 days before radiation treatment. The Hydrogel/cream will be applied three times a day with a minimum of four hours between applications. Treatments will be used through the course of RT and for 6 days after the last fraction of radiation.</description>
    <arm_group_label>Biafine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female patients&#xD;
&#xD;
          2. Age &gt; 18&#xD;
&#xD;
          3. Patients with histologically-confirmed diagnosis of breast cancer&#xD;
&#xD;
          4. Patients after breast lumpectomy and that scheduled to receive radiotherapy&#xD;
&#xD;
          5. Patients to receive minimum of 40.05 Gy to primary field&#xD;
&#xD;
          6. Must be able to comply with treatment schedule&#xD;
&#xD;
          7. Study-specific signed informed consent prior to randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inflammatory or connective tissue disorders of the skin&#xD;
&#xD;
          2. Mental incompetence, including psychological or addictive disorders which would&#xD;
             preclude completion of questionnaires&#xD;
&#xD;
          3. Previous radiation therapy to the breast&#xD;
&#xD;
          4. Tumour involvement of the skin&#xD;
&#xD;
          5. Rash, ulceration or open wound in treatment field&#xD;
&#xD;
          6. Known skin allergy or sensitivity to Aloe Vera or Biafine&#xD;
&#xD;
          7. Current lactation&#xD;
&#xD;
          8. Pregnancy&#xD;
&#xD;
          9. Any other reason that, in the opinion of the investigator, prevents the subject from&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meirav Ben David, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director of radiotherapy Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sivan Luder, VP R&amp;D</last_name>
    <phone>0508490794</phone>
    <email>Sivan@acemanan-tech.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dana Shwartz, CA</last_name>
    <phone>+972507509103</phone>
    <email>dana@acemanan-tech.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assuta</name>
      <address>
        <city>Tel Aviv</city>
        <state>Tel Aviv District</state>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hava Evelyn Klotz</last_name>
      <phone>+972-542196153</phone>
      <email>havakl@assuta.co.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 20, 2021</last_update_submitted>
  <last_update_submitted_qc>July 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Radiation dermatitis</keyword>
  <keyword>breast cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <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>Acemannan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04481802
org study id: RadiaAce001
nct id: NCT04481802
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Radiation dermatitis (RD) is one of the most common side effects of Radiation therapy (RT)
      and 95% of patients receiving RT may experience some form of radiation dermatitis.

      A wide variety of topical, oral, and intravenous agents are used to prevent/treat Radiation
      dermatitis but currently there is no gold standard in the prevention and management of this
      condition and no treatment can be explicitly recommended.

      RadiaAce Gel is a wound dressing Hydrogel (Acemannan Hydrogel) for the management of RD which
      provides optimal moist wound environment necessary to the healing process.

      Based on its composition as well as the supporting data on safety and performance of the
      functional ingredient Acemannan in wound healing, RadiaAce may well be suited to complement
      the prevention and therapy of radiation dermatitis.

      The primary aim of the study is to evaluate the safety and performance of RadiaAce as compare
      to Biafine in reducing the proportion of breast cancer patients that experience grade 2 or
      higher RD as measured by the RTOG scoring system
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Skin assessment (RD grade)
time frame: 10 weeks
description: Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring
measure: Pain (VAS)
time frame: 10 weeks
description: Dermatitis-related pain is assessed with a visual analogue scale (VAS) self-assessment
measure: Patient's assessment of the skin condition (DLQI questioner)
time frame: 10 weeks
description: The Patients perspective is captured by the Dermatology Life Quality Index (DLQI)
arm group label: RadiaAce gel
arm group type: Experimental
description: RadiaAce Gel is a clear, non-oily Hydrogel wound dressing for the management of Radiation Dermatitis which provides optimal moist wound environment necessary to the healing process. RadiaAce gel contains Acemannan, a high molecular polysaccharide obtained from the inner gel of Aloe Vera leaves and it is considered the main functional component of Aloe vera (Sahu et al. 2013).
arm group label: Biafine
arm group type: Active Comparator
description: one of the standard skin care in radiation oncology, this treatment was chosen as the comparator.
intervention type: Device
intervention name: RadiaAce gel
description: Patients will apply the RadiaAce to the treatment area starting 5 days before radiation treatment. The Hydrogel/cream will be applied three times a day with a minimum of four hours between applications. Treatments will be used through the course of RT and for 6 days after the last fraction of radiation.
arm group label: RadiaAce gel
other name: Acemannan hydrogel
intervention type: Device
intervention name: Biafine
description: Patients will apply the Biafine to the treatment area starting 5 days before radiation treatment. The Hydrogel/cream will be applied three times a day with a minimum of four hours between applications. Treatments will be used through the course of RT and for 6 days after the last fraction of radiation.
arm group label: Biafine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: Meirav Ben David, MD
role: Principal Investigator
affiliation: Director of radiotherapy Institute
last name: Sivan Luder, VP R&D
phone: 0508490794
email: Sivan@acemanan-tech.com
last name: Dana Shwartz, CA
phone: +972507509103
email: dana@acemanan-tech.com
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Dermatitis
mesh term: Radiodermatitis
mesh term: Acemannan
sharing ipd: No