xml: <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/NCT06016361</url>
    </required_header>
    <id_info>
      <org_study_id>PR-23809</org_study_id>
      <nct_id>NCT06016361</nct_id>
    </id_info>
    <brief_title>Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy</brief_title>
    <official_title>Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Entrinsic Bioscience Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Entrinsic Bioscience Inc.</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>
        The goal of this clinical study is to evaluate a novel amino acid based moisturizing cream as&#xD;
        part of the daily standard skincare regimen recommended during radiation therapy. The main&#xD;
        aim of this study is to assess if the investigational product can improve skin redness&#xD;
        associated with radiation therapy. Participants will apply a moisturizer daily during the&#xD;
        course of their prescribed radiation therapy for breast cancer. Researchers will compare&#xD;
        against the standard of care.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">March 18, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 18, 2024</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>Supportive Care</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reduction in Erythema</measure>
      <time_frame>Up to 12 weeks</time_frame>
      <description>Evaluation of skin redness (both severity and size) with ScarletRed technology</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Erythema</condition>
    <condition>Radiation Therapy, Secondary Skin Reactions</condition>
    <arm_group>
      <arm_group_label>Standard of Care</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Standard of Care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Investigational Product</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Investigational product</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>VS-200Cr</intervention_name>
      <description>Topical cream with moisturizing factors.</description>
      <arm_group_label>Investigational Product</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard of care</intervention_name>
      <description>AAD recommended course of care.</description>
      <arm_group_label>Standard of Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provision of signed and dated informed consent form.&#xD;
  &#xD;
            -  Aged over 18 years old.&#xD;
  &#xD;
            -  Has been diagnosed with breast cancer and prescribed radiotherapy as a part of their&#xD;
               cancer treatment.&#xD;
  &#xD;
            -  Planned radiotherapy, as prescribed by the oncologist, is expected to provide a total&#xD;
               radiation dose of up to 60 gray within the first 4 weeks of treatment.&#xD;
  &#xD;
            -  Be able to adhere to proposed daily wound/site care as proposed by the protocol in&#xD;
               line with the AADs recommendations.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pre-existing skin conditions which in the opinion of the investigator could impact on&#xD;
               the integrity of the study or compromise the safety of the patient (i.e., active&#xD;
               eczema, psoriasis, or an open wound over the planned site of radiation).&#xD;
  &#xD;
            -  Have a concurrent medical condition or poor functional baseline which in the opinion&#xD;
               of the investigator would make them unsuitable or able to fully comply with the study&#xD;
               protocol.&#xD;
  &#xD;
            -  Are pregnant or actively breast feeding.&#xD;
  &#xD;
            -  Known allergic reactions to ingredients of the Investigational Product or the Standard&#xD;
               of Care.&#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_contact>
      <last_name>Samantha Niles, MS</last_name>
      <phone>7818815165</phone>
      <email>sniles@entrinsic.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Robert Kenefick, PhD</last_name>
      <phone>7818815165</phone>
      <email>rkenefick@entrinsic.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Advocate Radiation Oncology</name>
        <address>
          <city>Fort Myers</city>
          <state>Florida</state>
          <zip>33908</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Samantha Niles, MS</last_name>
        <phone>781-881-5165</phone>
        <email>sniles@entrinsic.com</email>
      </contact>
      <investigator>
        <last_name>Todd Pezzi, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</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>Erythema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016361
  org study id: PR-23809
  nct id: NCT06016361
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical study is to evaluate a novel amino acid based moisturizing cream as
        part of the daily standard skincare regimen recommended during radiation therapy. The main
        aim of this study is to assess if the investigational product can improve skin redness
        associated with radiation therapy. Participants will apply a moisturizer daily during the
        course of their prescribed radiation therapy for breast cancer. Researchers will compare
        against the standard of care.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Reduction in Erythema
  time frame: Up to 12 weeks
  description: Evaluation of skin redness (both severity and size) with ScarletRed technology
  arm group label: Standard of Care
  arm group type: Sham Comparator
  description: Standard of Care
  arm group label: Investigational Product
  arm group type: Active Comparator
  description: Investigational product
  intervention type: Other
  intervention name: VS-200Cr
  description: Topical cream with moisturizing factors.
  arm group label: Investigational Product
  intervention type: Other
  intervention name: Standard of care
  description: AAD recommended course of care.
  arm group label: Standard of Care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Samantha Niles, MS
  phone: 7818815165
  email: sniles@entrinsic.com
  last name: Robert Kenefick, PhD
  phone: 7818815165
  email: rkenefick@entrinsic.com
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Erythema
  sharing ipd: Undecided