<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/NCT04483856</url>
  </required_header>
  <id_info>
    <org_study_id>RELI/19/Der-Rdt/001</org_study_id>
    <nct_id>NCT04483856</nct_id>
  </id_info>
  <brief_title>Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis.</brief_title>
  <acronym>DRESDA</acronym>
  <official_title>Efficacy and Tolerability Evaluation of a Topical Medical Device Based on SHBF in Management of Radiodermatitis. An Observer-masked, Controlled Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Relife Italia S.r.l.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Relife Italia S.r.l.</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>
      This is a post marketing, interventional, randomized, single-center, prospective, controlled&#xD;
      study, for the evaluation of the clinical performance and tolerability of a cream-based&#xD;
      medical device (DermoRelizemaTM cream) in the management care of radiodermatitis in women&#xD;
      with breast cancer. Assessments and evaluations will be performed by a physician in a blind&#xD;
      fashion.&#xD;
&#xD;
      The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management&#xD;
      of the progression of RT-induced skin reactions and toxicity, using the grading system of the&#xD;
      Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer&#xD;
      (RTOG/ EORTC), at the conclusion of the treatment period&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a post marketing, interventional, randomized, single-center, prospective, controlled&#xD;
      study, for the evaluation of the clinical performance and tolerability of a cream-based&#xD;
      medical device (DermoRelizemaTM cream) in the management care of radiodermatitis in women&#xD;
      with breast cancer. Assessments and evaluations will be performed by a physician in a blind&#xD;
      fashion.&#xD;
&#xD;
      The aim of this clinical study is to collect controlled evidences of the effectiveness and&#xD;
      tolerability of DermoRelizemaTM cream in the management of RISRs in patients with breast&#xD;
      cancer who will start the treatment with the product about one week before the start of RT.&#xD;
&#xD;
      The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management&#xD;
      of the progression of RT-induced skin reactions and toxicity, using the grading system of the&#xD;
      Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer&#xD;
      (RTOG/ EORTC), at the conclusion of the treatment period&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2020</start_date>
  <completion_date type="Actual">February 16, 2023</completion_date>
  <primary_completion_date type="Actual">February 16, 2023</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>
    <intervention_model_description>This is a post marketing, interventional, randomized, single-center, prospective, controlled study. Assessments and evaluations will be performed by a physician in a blind fashion.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Assessments and evaluations will be performed by a physician in a blind fashion.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>progression of Radio therapy-induced skin reactions using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)</measure>
    <time_frame>two weeks after the last RT sessiont,day 35-42</time_frame>
    <description>Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression of Radio therapy-induced skin reactions using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)</measure>
    <time_frame>at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56</time_frame>
    <description>1. Evaluation of the effects of DermoRelizemaTM cream, in the management of the progression of RT-induced skin reactions and toxicity, using the (RTOG/ EORTC) at the conclusion of the radiotherapy treatment (V2) and at study end (V4)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the radiation symptoms reported by the patient in a dialy diary</measure>
    <time_frame>up to 1 year</time_frame>
    <description>2. Evaluation of dermatitis symptoms management (pain at site, itch at site, burning at site and tenderness at site)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>severity of Radio therapy-induced skin reactions using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)</measure>
    <time_frame>all study visits, day 21-28, day 35-42 and at the study end (day 49-56)</time_frame>
    <description>3. Evaluation of the severity of radiation dermatitis by the investigator using the RTOG/ EORTC, at visits 2, 3 and 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>severity of radiation dermatitis with Radiation Dermatitis Severity (RDS) scoring scale</measure>
    <time_frame>all study visits, day 21-28, day 35-42 and at the study end (day 49-56)</time_frame>
    <description>4. Evaluation of the severity of radiation dermatitis by the investigator using the Radiation Dermatitis Severity (RDS) scoring scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assessments of skin damage with OCT (Optical coherence tomography) through evaluation of physiological parameter</measure>
    <time_frame>all study visits, day 21-28, day 35-42 and at the study end (day 49-56)</time_frame>
    <description>Objective instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient opinion on cream with a Likert scale</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Overall patient's opinion on the products' pleasantness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's adherence to treatment by complete a dialy diary</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Patient's adherence to treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Adverse Events</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Occurrence of Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Radiodermatitis</condition>
  <condition>Dermatitis, Radiation-Induced</condition>
  <arm_group>
    <arm_group_label>DermoRelizema cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexeryl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DermoRelizema cream</intervention_name>
    <description>Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment</description>
    <arm_group_label>DermoRelizema cream</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dexeryl</intervention_name>
    <description>FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).</description>
    <arm_group_label>Dexeryl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who give their written consent for participation in the study and willing to&#xD;
             comply with all its procedures.&#xD;
&#xD;
          -  Age ≥18 years.&#xD;
&#xD;
          -  Women with breast cancer at any stage who have undergone quadrantectomy, for whom&#xD;
             hypofractionated adjuvant RT of the thoracic region is indicated.&#xD;
&#xD;
          -  RTOG/ EORTC radiodermatitis grade equal to 0 (zero) and good cutaneous trophism, in&#xD;
             the region to be treated, according to investigator's judgement.&#xD;
&#xD;
          -  Patients who are supposed to be cooperative with regard to compliance with&#xD;
             study-related constraints.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women (as not eligible to RT), and fertile women not following,&#xD;
             at the investigators' judgement, an adequate contraceptive method.&#xD;
&#xD;
          -  Subjects incapable of giving consent.&#xD;
&#xD;
          -  Concomitant inflammatory skin diseases in acute phase such as: atopic dermatitis,&#xD;
             contact dermatitis, psoriasis, lichen planus, pityriasis rosea.&#xD;
&#xD;
          -  Collagen vascular disease, vasculitis, scleroderma, dermatomyositis, or systemic lupus&#xD;
             erythematosus.&#xD;
&#xD;
          -  Unhealed surgical sites, breast infections.&#xD;
&#xD;
          -  Bilateral breast cancer or multiple neoplasia needing other independent RT treatments.&#xD;
&#xD;
          -  Prior breast reconstructions, implants, and/or expanders.&#xD;
&#xD;
          -  Known radio-sensitivity syndromes (e.g. ataxia-telangiectasia).&#xD;
&#xD;
          -  Known history of intolerance or hypersensitivity to any ingredient of the study&#xD;
             products.&#xD;
&#xD;
          -  Previous RT in the same or different location.&#xD;
&#xD;
          -  Topical pharmacological and medical device treatments on the skin region affected by&#xD;
             the RT, in the last 2 weeks.&#xD;
&#xD;
          -  Systemic or topical (including inhaled or intranasal) treatments containing&#xD;
             corticosteroids of any class in the 2 days preceding the enrolment.&#xD;
&#xD;
          -  Photo-therapy (PUVA, UVB) in the 2 weeks preceding the enrolment and/or planned to be&#xD;
             administered during the course of the study.&#xD;
&#xD;
          -  Participation in another clinical trial at the time of the randomization or within 28&#xD;
             days before randomization.&#xD;
&#xD;
          -  Patient's difficulties or problems, in the judgment of the investigator, in being&#xD;
             compliant with study procedures and requirements, including social or mental&#xD;
             constrains.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female patient with breast cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Modena University Hospital</name>
      <address>
        <city>Modena</city>
        <zip>41134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Radiodermatitis</keyword>
  <keyword>DermoRelizema cream</keyword>
  <keyword>DRESDA</keyword>
  <keyword>Sodium Hyaluronate Butyrate Formiate</keyword>
  <keyword>RELIFE</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>confidential information as per internal procedure of the Sponsor</ipd_description>
  </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/NCT04483856
org study id: RELI/19/Der-Rdt/001
nct id: NCT04483856
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a post marketing, interventional, randomized, single-center, prospective, controlled
      study, for the evaluation of the clinical performance and tolerability of a cream-based
      medical device (DermoRelizemaTM cream) in the management care of radiodermatitis in women
      with breast cancer. Assessments and evaluations will be performed by a physician in a blind
      fashion.

      The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management
      of the progression of RT-induced skin reactions and toxicity, using the grading system of the
      Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer
      (RTOG/ EORTC), at the conclusion of the treatment period
This is a post marketing, interventional, randomized, single-center, prospective, controlled
      study, for the evaluation of the clinical performance and tolerability of a cream-based
      medical device (DermoRelizemaTM cream) in the management care of radiodermatitis in women
      with breast cancer. Assessments and evaluations will be performed by a physician in a blind
      fashion.

      The aim of this clinical study is to collect controlled evidences of the effectiveness and
      tolerability of DermoRelizemaTM cream in the management of RISRs in patients with breast
      cancer who will start the treatment with the product about one week before the start of RT.

      The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management
      of the progression of RT-induced skin reactions and toxicity, using the grading system of the
      Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer
      (RTOG/ EORTC), at the conclusion of the treatment period
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a post marketing, interventional, randomized, single-center, prospective, controlled study. Assessments and evaluations will be performed by a physician in a blind fashion.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Assessments and evaluations will be performed by a physician in a blind fashion.
measure: progression of Radio therapy-induced skin reactions using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
time frame: two weeks after the last RT sessiont,day 35-42
description: Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity
measure: progression of Radio therapy-induced skin reactions using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
time frame: at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56
description: 1. Evaluation of the effects of DermoRelizemaTM cream, in the management of the progression of RT-induced skin reactions and toxicity, using the (RTOG/ EORTC) at the conclusion of the radiotherapy treatment (V2) and at study end (V4)
measure: Evaluation of the radiation symptoms reported by the patient in a dialy diary
time frame: up to 1 year
description: 2. Evaluation of dermatitis symptoms management (pain at site, itch at site, burning at site and tenderness at site)
measure: severity of Radio therapy-induced skin reactions using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
time frame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)
description: 3. Evaluation of the severity of radiation dermatitis by the investigator using the RTOG/ EORTC, at visits 2, 3 and 4
measure: severity of radiation dermatitis with Radiation Dermatitis Severity (RDS) scoring scale
time frame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)
description: 4. Evaluation of the severity of radiation dermatitis by the investigator using the Radiation Dermatitis Severity (RDS) scoring scale
measure: assessments of skin damage with OCT (Optical coherence tomography) through evaluation of physiological parameter
time frame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)
description: Objective instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters,
measure: Patient opinion on cream with a Likert scale
time frame: up to 1 year
description: Overall patient's opinion on the products' pleasantness
measure: Patient's adherence to treatment by complete a dialy diary
time frame: up to 1 year
description: Patient's adherence to treatment
measure: Occurrence of Adverse Events
time frame: up to 1 year
description: Occurrence of Adverse Events
arm group label: DermoRelizema cream
arm group type: Experimental
description: The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
arm group label: Dexeryl
arm group type: Active Comparator
description: The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
intervention type: Device
intervention name: DermoRelizema cream
description: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment
arm group label: DermoRelizema cream
intervention type: Device
intervention name: Dexeryl
description: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
arm group label: Dexeryl
criteria: 
gender: Female
gender based: Yes
gender description: female patient with breast cancer
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Dermatitis
mesh term: Radiodermatitis
sharing ipd: No
ipd description: confidential information as per internal procedure of the Sponsor