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/NCT06016803</url>
    </required_header>
    <id_info>
      <org_study_id>RL3010A2022001</org_study_id>
      <nct_id>NCT06016803</nct_id>
    </id_info>
    <brief_title>Evaluation of the Tolerance of the Medical Device RL3010A - DP0378 in Children and Adults Presenting a Superficial Wound After a Dermatological Procedure</brief_title>
    <official_title>Evaluation of the Tolerance of the Medical Device RL3010A - DP0378 in Children and Adults Presenting a Superficial Wound After a Dermatological Procedure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pierre Fabre Dermo Cosmetique</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pierre Fabre Dermo Cosmetique</source>
    <oversight_info>
      <has_dmc>Yes</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 CE-marketed medical device class IIa RL3010A - DP0378 developed by Pierre Fabre&#xD;
        Laboratories is indicated in the treatment of superficial wounds and abrasions. It forms a&#xD;
        protective layer on the surface of wounds maintaining a moist environment improving the&#xD;
        healing process thanks to its moisturizing and film-forming effect.&#xD;
  &#xD;
        Through this study, the overall tolerance of the medical device will be evaluated in subjects&#xD;
        presenting a superficial wound after having undergone a dermatological procedure as&#xD;
        cryotherapy, laser (laser Nd Yag, fractional laser C02), Intense Pulse Light (IPL) or skin&#xD;
        lesion excision for which stitches were removed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This open-labelled study will be conducted as a monocentric study, in children and adults&#xD;
        presenting a superficial wound after having undergone a dermatological act.&#xD;
  &#xD;
        To assess the global tolerance of the medical device RL3010A - DP0378 in subjects presenting&#xD;
        a superficial wound after having undergone a dermatological procedure, after 7 days of twice&#xD;
        daily applications under normal conditions of use&#xD;
  &#xD;
        3 visits are planned:&#xD;
  &#xD;
          -  Visit 1: Inclusion (D1)&#xD;
  &#xD;
          -  Visit 2: Intermediate visit (D3)&#xD;
  &#xD;
          -  Visit 3: Final visit (D8)&#xD;
  &#xD;
        The maximal duration of participation for a subject is 8 days, from the inclusion visit&#xD;
        (visit 1) to the end of the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To assess the global tolerance of the medical device RL3010A - DP0378 in subjects presenting a superficial wound after having undergone a dermatological procedure, after 7 days of twice daily applications under normal conditions of use</measure>
      <time_frame>Day 8</time_frame>
      <description>Global tolerance with 5 levels ranked from best to worst : Excellent (No functional nor physical signs related to the investigational product observed or reported by the subjects) - Very good - Good - Moderate - Bad</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To assess the evolution of the physical signs of local tolerance at the site of product application on the wound</measure>
      <time_frame>Day 1 before and immediately after the test product application (10 to 30 minutes), at Day 3 and at Day 8.</time_frame>
      <description>Physical signs with 5 levels ranked from best to worst : None - Very mild - Mild - Moderate - Severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the evolution of the functional signs of local tolerance at the site of product application on the wound</measure>
      <time_frame>Day 1 before and immediately after the test product application (10 to 30 minutes), at Day 3 and at Day 8.</time_frame>
      <description>Functional signs with 5 levels ranked from best to worst : None - Very mild - Mild - Moderate - Severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the repairing efficacy of the product</measure>
      <time_frame>Day 3 and Day 8</time_frame>
      <description>Scale with 4 levels ranked from worst to best : Not effective - Little effective - Effective - Very effective</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the soothing efficacy of the product</measure>
      <time_frame>Day 3 and Day 8</time_frame>
      <description>Sacle with 4 levels ranked from worst to best : Not effective - Little effective - Effective - Very effective</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the soothing efficacy of the product</measure>
      <time_frame>Day 1 before and immediately after the test product application, at Day 3 and at Day 8</time_frame>
      <description>Discomfort sensations with NRS ranging from 0 (None) to 10 (Hugely). Higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate subjects' global satisfaction as regards to the use the medical device RL3010A - DP0378.</measure>
      <time_frame>Day 3 and Day 8</time_frame>
      <description>Global satisfaction through a specific questionnaire (Conditions of use, organoleptic properties, effects, and others will be assessed).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the compliance of the subjects to product application.</measure>
      <time_frame>About 8 days</time_frame>
      <description>The subject / subject's parent(s) will report in his/her diary the applications of investigational product and any omissions or changes in the frequency.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Skin Abrasion</condition>
    <condition>Superficial Wound</condition>
    <arm_group>
      <arm_group_label>Subjects having undergone a Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group applying the tested medical device</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Subjects having undergone a Laser or IPL procedure for dermatological or aesthetical indications</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group applying the tested medical device</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Subjects having undergone a skin lesion excision for which stitches were removed</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group applying the tested medical device</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Cicatryl (RL3010A - DP0378)</intervention_name>
      <description>Tested product is applied twice a day. The maximum duration of application is 7 days.</description>
      <arm_group_label>Subjects having undergone a Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation</arm_group_label>
      <arm_group_label>Subjects having undergone a Laser or IPL procedure for dermatological or aesthetical indications</arm_group_label>
      <arm_group_label>Subjects having undergone a skin lesion excision for which stitches were removed</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject who just undergone (the same day) a dermatological procedure, done according&#xD;
               to the investigator's usual practices:&#xD;
  &#xD;
                 -  Group 1: Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation&#xD;
  &#xD;
                 -  Group 2: Laser (laser Nd Yag, fractional laser C02) or Intense pulse Light (IPL)&#xD;
                    procedure for dermatological or aesthetical indications (including tattoo removal&#xD;
                    and depilation)&#xD;
  &#xD;
                 -  Group 3: Skin lesion excision for which stitches were removed&#xD;
  &#xD;
            -  Subject with a superficial wound after the dermatological procedure&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Criteria related to the skin condition :&#xD;
  &#xD;
            -  Subject having received artificial UV exposure, excessive or prolonged exposure to&#xD;
               natural sunlight on the studied area within 4 weeks before the inclusion visit or&#xD;
               planning to be exposed to artificial UV, excessive or prolonged natural sunlight&#xD;
               during the study&#xD;
  &#xD;
            -  Subject having a skin disease, skin abnormalities, or dermatological condition on the&#xD;
               studied area other than the indication of the dermatological procedure liable to&#xD;
               interfere with the study assessments (including infectious or inflammatory dermatosis,&#xD;
               photodermatosis, etc.)&#xD;
  &#xD;
            -  Subject with a known history of allergy or contact dermatitis caused by any of the&#xD;
               ingredients of the tested product, antiseptic, dressing or latex (if used by the&#xD;
               center)&#xD;
  &#xD;
            -  Subject with healing disorders&#xD;
  &#xD;
            -  Subject with coagulation disorders&#xD;
  &#xD;
            -  Knowledge of Acquired Immunodeficiency Syndrome or Infectious (acute) Hepatitis&#xD;
  &#xD;
            -  Other acute, chronic or progressive disease or medical history considered by the&#xD;
               investigator hazardous for the subject or incompatible with the study or liable to&#xD;
               interfere with the study assessments&#xD;
  &#xD;
          Criteria related to treatments and/or products :&#xD;
  &#xD;
            -  Systemic corticosteroid treatment in the 4 weeks prior to the inclusion visit or&#xD;
               ongoing or planned to be started during the study&#xD;
  &#xD;
            -  Systemic antibiotics treatment in the 2 weeks prior to the inclusion visit, ongoing or&#xD;
               planned to be started during the study&#xD;
  &#xD;
            -  Systemic treatments that may affects homeostasis (anticoagulant therapy, platelet&#xD;
               aggregation inhibitor) in the 4 weeks prior to the inclusion visit, ongoing or planned&#xD;
               to be started during the study&#xD;
  &#xD;
            -  Any other systemic treatment that may affect the healing process, or incompatible with&#xD;
               the study or liable to interfere with the study assessments according to the&#xD;
               investigator, in the weeks prior to the inclusion visit, ongoing or planned to be&#xD;
               started during the study&#xD;
  &#xD;
            -  Topical steroid, non-steroid anti-inflammatory, immunomodulator and antibiotics&#xD;
               treatments applied on the tested area in the 2 weeks prior to the inclusion visit,&#xD;
               ongoing or planned to be started during the study&#xD;
  &#xD;
            -  Any topical repairing treatment or product applied on the tested area between the&#xD;
               dermatological procedure (stitch removal for group 3) and the inclusion visit&#xD;
  &#xD;
            -  Any other topical treatment on the tested area that may affect the healing process, or&#xD;
               incompatible with the study or liable to interfere with the study assessments&#xD;
               according to the investigator, in the weeks prior to the inclusion visit, ongoing or&#xD;
               planned to be started during the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Adeline BACQUEY</last_name>
      <phone>+33562877753</phone>
      <email>adeline.bacquey@pierre-fabre.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Christophe CHAMARD</last_name>
      <phone>+33562488566</phone>
      <email>christophe.chamard@pierre-fabre.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 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 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Wound healing</keyword>
    <keyword>Medical device</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</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/NCT06016803
  org study id: RL3010A2022001
  nct id: NCT06016803
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The CE-marketed medical device class IIa RL3010A - DP0378 developed by Pierre Fabre
        Laboratories is indicated in the treatment of superficial wounds and abrasions. It forms a
        protective layer on the surface of wounds maintaining a moist environment improving the
        healing process thanks to its moisturizing and film-forming effect.
  
        Through this study, the overall tolerance of the medical device will be evaluated in subjects
        presenting a superficial wound after having undergone a dermatological procedure as
        cryotherapy, laser (laser Nd Yag, fractional laser C02), Intense Pulse Light (IPL) or skin
        lesion excision for which stitches were removed.
  This open-labelled study will be conducted as a monocentric study, in children and adults
        presenting a superficial wound after having undergone a dermatological act.
  
        To assess the global tolerance of the medical device RL3010A - DP0378 in subjects presenting
        a superficial wound after having undergone a dermatological procedure, after 7 days of twice
        daily applications under normal conditions of use
  
        3 visits are planned:
  
          -  Visit 1: Inclusion (D1)
  
          -  Visit 2: Intermediate visit (D3)
  
          -  Visit 3: Final visit (D8)
  
        The maximal duration of participation for a subject is 8 days, from the inclusion visit
        (visit 1) to the end of the study.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: To assess the global tolerance of the medical device RL3010A - DP0378 in subjects presenting a superficial wound after having undergone a dermatological procedure, after 7 days of twice daily applications under normal conditions of use
  time frame: Day 8
  description: Global tolerance with 5 levels ranked from best to worst : Excellent (No functional nor physical signs related to the investigational product observed or reported by the subjects) - Very good - Good - Moderate - Bad
  measure: To assess the evolution of the physical signs of local tolerance at the site of product application on the wound
  time frame: Day 1 before and immediately after the test product application (10 to 30 minutes), at Day 3 and at Day 8.
  description: Physical signs with 5 levels ranked from best to worst : None - Very mild - Mild - Moderate - Severe
  measure: To assess the evolution of the functional signs of local tolerance at the site of product application on the wound
  time frame: Day 1 before and immediately after the test product application (10 to 30 minutes), at Day 3 and at Day 8.
  description: Functional signs with 5 levels ranked from best to worst : None - Very mild - Mild - Moderate - Severe
  measure: To assess the repairing efficacy of the product
  time frame: Day 3 and Day 8
  description: Scale with 4 levels ranked from worst to best : Not effective - Little effective - Effective - Very effective
  measure: To assess the soothing efficacy of the product
  time frame: Day 3 and Day 8
  description: Sacle with 4 levels ranked from worst to best : Not effective - Little effective - Effective - Very effective
  measure: To assess the soothing efficacy of the product
  time frame: Day 1 before and immediately after the test product application, at Day 3 and at Day 8
  description: Discomfort sensations with NRS ranging from 0 (None) to 10 (Hugely). Higher scores mean a worse outcome.
  measure: To evaluate subjects' global satisfaction as regards to the use the medical device RL3010A - DP0378.
  time frame: Day 3 and Day 8
  description: Global satisfaction through a specific questionnaire (Conditions of use, organoleptic properties, effects, and others will be assessed).
  measure: To evaluate the compliance of the subjects to product application.
  time frame: About 8 days
  description: The subject / subject's parent(s) will report in his/her diary the applications of investigational product and any omissions or changes in the frequency.
  arm group label: Subjects having undergone a Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation
  arm group type: Experimental
  description: Group applying the tested medical device
  arm group label: Subjects having undergone a Laser or IPL procedure for dermatological or aesthetical indications
  arm group type: Experimental
  description: Group applying the tested medical device
  arm group label: Subjects having undergone a skin lesion excision for which stitches were removed
  arm group type: Experimental
  description: Group applying the tested medical device
  intervention type: Device
  intervention name: Cicatryl (RL3010A - DP0378)
  description: Tested product is applied twice a day. The maximum duration of application is 7 days.
  arm group label: Subjects having undergone a Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation
  arm group label: Subjects having undergone a Laser or IPL procedure for dermatological or aesthetical indications
  arm group label: Subjects having undergone a skin lesion excision for which stitches were removed
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Adeline BACQUEY
  phone: +33562877753
  email: adeline.bacquey@pierre-fabre.com
  last name: Christophe CHAMARD
  phone: +33562488566
  email: christophe.chamard@pierre-fabre.com
  responsible party type: Sponsor
  mesh term: Wounds and Injuries