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/NCT06040983</url>
    </required_header>
    <id_info>
      <org_study_id>CMUH112-REC1-001</org_study_id>
      <nct_id>NCT06040983</nct_id>
    </id_info>
    <brief_title>Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing</brief_title>
    <official_title>Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China Medical University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China Medical University Hospital</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>
        Breast cancer is the top one incidence of cancer in women. Whole breast radiation therapy&#xD;
        plays an indispensable role in the course of breast cancer treatment, and the radiation&#xD;
        dermatitis is the major side effect affected quality of life. Radiation dermatitis can be&#xD;
        divided into acute and chronic. Severe acute radiation dermatitis affects the quality of life&#xD;
        of patients during the course of treatment, and may cause treatment interruption and affect&#xD;
        the efficacy. Chronic radiation dermatitis may cause irreversible skin problems, and lead to&#xD;
        so-called &quot;radiation-irritated skin&quot; (radiation-irritated skin) seriously affects the quality&#xD;
        of life of breast cancer patients after treatment.&#xD;
  &#xD;
        This study will enroll 30 breast cancer patients who received whole breast radiation therapy&#xD;
        after breast conserving surgery. Subject will receive FR-101 chest dressing and be instructed&#xD;
        to use the product on the target skin area accepted radiation therapy once every 2 days,&#xD;
        taking care of avoiding applications from 1 to 4 h before treatment to prevent &quot;Build-up&quot;&#xD;
        effect.&#xD;
  &#xD;
        Subjects will need to come back to clinics for assessment weekly during radiotherapy, 2 weeks&#xD;
        after radiotherapy, and 6 weeks after radiotherapy. The evaluation includes physical&#xD;
        examinations, questionnaire surveys, skin observation and measurements, and photographs. The&#xD;
        total study time is at least 3 months. The target area of radiation-irritated skin condition&#xD;
        will be observed and graded according to CTCAE rate. The skin physiological parameters will&#xD;
        be detected by MoistureMeter SC, Vapometer, SkinColorCatch and HX-YL001 infrared thermometer.&#xD;
  &#xD;
        Statistical analysis of skin physiological parameters is used to evaluate the efficacy of&#xD;
        FR-101 chest dressing on the prevention of acute radiation dermatitis after radiotherapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Worst skin toxicity during treatment and until 2 weeks after according to CTCAE grading.</measure>
      <time_frame>1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later</time_frame>
      <description>Skin toxicity at the radiotherapy site will be assessed by investigator and NCI CTCAE v5.0 will be used for grading, on a scale of:&#xD;
  Grade 1 (faint erythema or dry desquamation);&#xD;
  Grade 2 (moderate to brisk erythema;patchy moist desquamation,mostly confined to skin foldsand creases; moderate edema);&#xD;
  Grade 3 (moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion);&#xD;
  Grade 4 (life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated);&#xD;
  Grade 5 (death)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To compare the skin moisture percentage.</measure>
      <time_frame>1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later</time_frame>
      <description>To compare the skin moisture percentage at the radiotherapy site and normal site from baseline to follow-up visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the skin trans-epidermal water loss.</measure>
      <time_frame>1-Week (Day0), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later</time_frame>
      <description>To compare the skin trans-epidermal water loss at the radiotherapy site and normal site from baseline to follow-up visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the skin temperature of target region.</measure>
      <time_frame>1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later</time_frame>
      <description>To compare the skin temperature of target region at the radiotherapy site and normal site from baseline to follow-up visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The score of quality of life with the Skindex-16 questionnaire.</measure>
      <time_frame>1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later</time_frame>
      <description>The score of quality of life will be assessed using the Skindex-16 questionnaire every two weeks. Participants answer 16 questions on a scale from 0 (not at all) to 6 (always). The quality of life is calculated by summing the scores for all questions, resulting in a maximum of 96 and a minimum of 0; higher scores indicate a more impaired quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Median time to G2 radiation dermatitis development</measure>
      <time_frame>1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later</time_frame>
      <description>Median time to G2 radiation dermatitis development according to CTCAE.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Radiation Dermatitis</condition>
    <arm_group>
      <arm_group_label>FR-101 Dressing use</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subject will use FR-101 chest dressing on the target skin area accepted radiation therapy once every 2 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>FR-101 Chest Dressing</intervention_name>
      <description>Subject will receive FR-101 chest dressing and be instructed to use the product on the target skin area accepted radiation therapy once every 2 days, taking care of avoiding applications from 1 to 4 h before treatment to prevent &quot;Build-up&quot; effect. If the application time is longer than the recommendation, discomfort may happen depending on subject's condition.</description>
      <arm_group_label>FR-101 Dressing use</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants must be males or non-pregnant females at least 20 years of age.&#xD;
  &#xD;
            -  Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which&#xD;
               were treated by operation with or without adjuvant or neoadjuvant hormonal treatment.&#xD;
  &#xD;
            -  Patients were scheduled to receive five sessions of radiotherapy per week (1 session&#xD;
               per day) for at least four weeks using standard irradiation fraction (with at least&#xD;
               1.8 Gy per session) for total dose of at least 45 Gy or hypofraction irradiation&#xD;
               fraction(with 2.66 Gy per session) for total dose of at least 42.56 Gy.&#xD;
  &#xD;
            -  Participant must give informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Bilateral breast cancer&#xD;
  &#xD;
            -  Previous radiotherapy to the chest&#xD;
  &#xD;
            -  Chemotherapy concurrent with radiation treatment&#xD;
  &#xD;
            -  Prior breast reconstructions, implants, and/or expanders&#xD;
  &#xD;
            -  Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia)&#xD;
  &#xD;
            -  Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections or&#xD;
               systemic lupus erythematosus (SLE)&#xD;
  &#xD;
            -  Participation in any clinical trial in the prior 30 days from baseline.&#xD;
  &#xD;
            -  Any condition that, in the judgement of the investigator could impose hazards to the&#xD;
               patient if study therapy is initiated or affect the participation of the patient in&#xD;
               the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>China Medical University Hospital</investigator_affiliation>
      <investigator_full_name>Chih-Ying Liao</investigator_full_name>
      <investigator_title>Attending physician</investigator_title>
    </responsible_party>
    <keyword>radiation-irritated skin</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>
    <!-- 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/NCT06040983
  org study id: CMUH112-REC1-001
  nct id: NCT06040983
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Breast cancer is the top one incidence of cancer in women. Whole breast radiation therapy
        plays an indispensable role in the course of breast cancer treatment, and the radiation
        dermatitis is the major side effect affected quality of life. Radiation dermatitis can be
        divided into acute and chronic. Severe acute radiation dermatitis affects the quality of life
        of patients during the course of treatment, and may cause treatment interruption and affect
        the efficacy. Chronic radiation dermatitis may cause irreversible skin problems, and lead to
        so-called "radiation-irritated skin" (radiation-irritated skin) seriously affects the quality
        of life of breast cancer patients after treatment.
  
        This study will enroll 30 breast cancer patients who received whole breast radiation therapy
        after breast conserving surgery. Subject will receive FR-101 chest dressing and be instructed
        to use the product on the target skin area accepted radiation therapy once every 2 days,
        taking care of avoiding applications from 1 to 4 h before treatment to prevent "Build-up"
        effect.
  
        Subjects will need to come back to clinics for assessment weekly during radiotherapy, 2 weeks
        after radiotherapy, and 6 weeks after radiotherapy. The evaluation includes physical
        examinations, questionnaire surveys, skin observation and measurements, and photographs. The
        total study time is at least 3 months. The target area of radiation-irritated skin condition
        will be observed and graded according to CTCAE rate. The skin physiological parameters will
        be detected by MoistureMeter SC, Vapometer, SkinColorCatch and HX-YL001 infrared thermometer.
  
        Statistical analysis of skin physiological parameters is used to evaluate the efficacy of
        FR-101 chest dressing on the prevention of acute radiation dermatitis after radiotherapy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Worst skin toxicity during treatment and until 2 weeks after according to CTCAE grading.
  time frame: 1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later
  description: Skin toxicity at the radiotherapy site will be assessed by investigator and NCI CTCAE v5.0 will be used for grading, on a scale of:
  Grade 1 (faint erythema or dry desquamation);
  Grade 2 (moderate to brisk erythema;patchy moist desquamation,mostly confined to skin foldsand creases; moderate edema);
  Grade 3 (moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion);
  Grade 4 (life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated);
  Grade 5 (death)
  measure: To compare the skin moisture percentage.
  time frame: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
  description: To compare the skin moisture percentage at the radiotherapy site and normal site from baseline to follow-up visit.
  measure: To compare the skin trans-epidermal water loss.
  time frame: 1-Week (Day0), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
  description: To compare the skin trans-epidermal water loss at the radiotherapy site and normal site from baseline to follow-up visit.
  measure: To compare the skin temperature of target region.
  time frame: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
  description: To compare the skin temperature of target region at the radiotherapy site and normal site from baseline to follow-up visit.
  measure: The score of quality of life with the Skindex-16 questionnaire.
  time frame: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
  description: The score of quality of life will be assessed using the Skindex-16 questionnaire every two weeks. Participants answer 16 questions on a scale from 0 (not at all) to 6 (always). The quality of life is calculated by summing the scores for all questions, resulting in a maximum of 96 and a minimum of 0; higher scores indicate a more impaired quality of life.
  measure: Median time to G2 radiation dermatitis development
  time frame: 1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
  description: Median time to G2 radiation dermatitis development according to CTCAE.
  arm group label: FR-101 Dressing use
  arm group type: Experimental
  description: Subject will use FR-101 chest dressing on the target skin area accepted radiation therapy once every 2 days.
  intervention type: Device
  intervention name: FR-101 Chest Dressing
  description: Subject will receive FR-101 chest dressing and be instructed to use the product on the target skin area accepted radiation therapy once every 2 days, taking care of avoiding applications from 1 to 4 h before treatment to prevent "Build-up" effect. If the application time is longer than the recommendation, discomfort may happen depending on subject's condition.
  arm group label: FR-101 Dressing use
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: China Medical University Hospital
  investigator full name: Chih-Ying Liao
  investigator title: Attending physician
  mesh term: Dermatitis
  mesh term: Radiodermatitis