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/NCT06001463</url>
    </required_header>
    <id_info>
      <org_study_id>CS1 20015</org_study_id>
      <nct_id>NCT06001463</nct_id>
    </id_info>
    <brief_title>Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis</brief_title>
    <official_title>CSMed Wound Dressing on Radiation Dermatitis Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chung Shan Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chung Shan Medical University</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>
        Investigate the effects of CSMed® for preventing and managing radiation dermatitis in&#xD;
        patients with Breast cancer and Head-Neck cancer receiving radiotherapy (≥50 Gy).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A prospective study was conducted at the University Hospital Medical Center. The patient&#xD;
        received part of the breast/neck skin CSMed® dressing or clinical routine skin care. Record&#xD;
        the difference between the part of the skin with dressing and undressed skin for each&#xD;
        patient. The severity of acute radiation dermatitis was graded using the RTOG clinical&#xD;
        scoring standard. From the beginning of the treatment to 4 weeks after the end of the&#xD;
        treatment, skin pain, itching, local fever and tightness, as well as skin healing time were&#xD;
        collected every week.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2020</start_date>
    <completion_date type="Actual">May 31, 2021</completion_date>
    <primary_completion_date type="Actual">May 31, 2021</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Severity of acute radiation dermatitis</measure>
      <time_frame>4 weeks</time_frame>
      <description>The severity of radiation dermatitis can be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1 to 5.&#xD;
  NCI CTCAE grade 1 - Faint erythema with dry desquamation. NCI CTCAE grade 2 - Moderate dermatitis is characterized by moderate to brisk erythema and patchy, moist desquamation mostly confined to skin folds and creases.&#xD;
  NCI CTCAE grade 3 - There is confluent, moist desquamation in locations other than skin folds.&#xD;
  NCI CTCAE grade 4 - This is characterized by skin necrosis or ulceration of full-thickness dermis.&#xD;
  NCI CTCAE grade 5 - Death due to dermatitis alone is a very rare event.&#xD;
  Radiologists performed radiation therapy according to the needs of clinical diseases. Evaluate and record the case after radiotherapy at 4 weeks, and end the research record.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Radiation Dermatitis</condition>
    <arm_group>
      <arm_group_label>reduce the severity, and enhance healing of radiation dermatitis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CSMed Dressing</intervention_name>
      <description>Half of the irradiated area was covered with CSMed® and the other half was under routine treatment. An irradiated area of 11cm*14cm with best fit or easy accessibility was chosen for CSMed® dressing application. The area without dressing was treated with routine skin care in each patient.</description>
      <arm_group_label>reduce the severity, and enhance healing of radiation dermatitis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients receiving radiation therapy (including undamaged skin and RTOG grade 1&#xD;
               dermatitis).&#xD;
  &#xD;
            -  Patients who voluntarily agree to participate in the trial and sign the subject's&#xD;
               consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with dermatitis and burns not caused by radiation therapy.&#xD;
  &#xD;
            -  Involuntary patients without signed consent.&#xD;
  &#xD;
            -  Those who are allergic to the ingredients in this product.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Chung Shan Medical University</name>
        <address>
          <city>Taichung</city>
          <zip>408025</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 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 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chung Shan Medical University</investigator_affiliation>
      <investigator_full_name>Yueh-Chun Lee</investigator_full_name>
      <investigator_title>Radiation Oncology Attending Physician</investigator_title>
    </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>
    <patient_data>
      <sharing_ipd>No</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/NCT06001463
  org study id: CS1 20015
  nct id: NCT06001463
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Investigate the effects of CSMed® for preventing and managing radiation dermatitis in
        patients with Breast cancer and Head-Neck cancer receiving radiotherapy (≥50 Gy).
  A prospective study was conducted at the University Hospital Medical Center. The patient
        received part of the breast/neck skin CSMed® dressing or clinical routine skin care. Record
        the difference between the part of the skin with dressing and undressed skin for each
        patient. The severity of acute radiation dermatitis was graded using the RTOG clinical
        scoring standard. From the beginning of the treatment to 4 weeks after the end of the
        treatment, skin pain, itching, local fever and tightness, as well as skin healing time were
        collected every week.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Severity of acute radiation dermatitis
  time frame: 4 weeks
  description: The severity of radiation dermatitis can be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1 to 5.
  NCI CTCAE grade 1 - Faint erythema with dry desquamation. NCI CTCAE grade 2 - Moderate dermatitis is characterized by moderate to brisk erythema and patchy, moist desquamation mostly confined to skin folds and creases.
  NCI CTCAE grade 3 - There is confluent, moist desquamation in locations other than skin folds.
  NCI CTCAE grade 4 - This is characterized by skin necrosis or ulceration of full-thickness dermis.
  NCI CTCAE grade 5 - Death due to dermatitis alone is a very rare event.
  Radiologists performed radiation therapy according to the needs of clinical diseases. Evaluate and record the case after radiotherapy at 4 weeks, and end the research record.
  arm group label: reduce the severity, and enhance healing of radiation dermatitis
  arm group type: Experimental
  description: The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care.
  intervention type: Drug
  intervention name: CSMed Dressing
  description: Half of the irradiated area was covered with CSMed® and the other half was under routine treatment. An irradiated area of 11cm*14cm with best fit or easy accessibility was chosen for CSMed® dressing application. The area without dressing was treated with routine skin care in each patient.
  arm group label: reduce the severity, and enhance healing of radiation dermatitis
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: Chung Shan Medical University
  investigator full name: Yueh-Chun Lee
  investigator title: Radiation Oncology Attending Physician
  mesh term: Dermatitis
  mesh term: Radiodermatitis
  sharing ipd: No