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/NCT05997654</url>
    </required_header>
    <id_info>
      <org_study_id>EN22-0300-01</org_study_id>
      <nct_id>NCT05997654</nct_id>
    </id_info>
    <brief_title>Evaluation of the Safety and Effectiveness of the Investigational Product in Improvement of the Appearance of Wrinkles and General Aspect of the Skin</brief_title>
    <official_title>Evaluation of the Safety and Effectiveness of the Investigational Product in Improvement of the Appearance of Wrinkles and General Aspect of the Skin - Clinical, Instrumental and Subjective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Silimed Industria de Implantes Ltda</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Medcin Instituto da Pele Ltda</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Silimed Industria de Implantes Ltda</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 study investigates the safety and effectiveness of SILIMED® brand MEDGEL ANTIAGE with&#xD;
        indication for improvement of the appearance of wrinkles and general aspects of the skin.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 17, 2023</start_date>
    <completion_date type="Actual">July 6, 2023</completion_date>
    <primary_completion_date type="Actual">July 6, 2023</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Frequency of adverse events</measure>
      <time_frame>28 days</time_frame>
      <description>Absence of risk of irritation and capture sensations of discomfort in the studied population through dermatological clinical evaluations before and after continuous use of the experimental product.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in skin hydration</measure>
      <time_frame>1h, 2h, 4h, 6h, 8h and after 28 days</time_frame>
      <description>Evaluate the effectiveness in changing skin hydration, through measurements by the CORNEOMETER® equipment after 1h, 2h, 4h, 6h and 8h of product contact with the skin and after 28 days of continuous use.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>% of change in melanic and vascular dark circles</measure>
      <time_frame>Before use and after 28 days of continuous use</time_frame>
      <description>Evaluate the effectiveness of the investigational product in changing % of melanic and vascular dark circles through photographic recording by the VISIA® equipment and image analysis by Image Pro Plus, before use (D0) and after continuous use (D28).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in skin firmness and elasticity</measure>
      <time_frame>Before use and after 28 days of continuous use</time_frame>
      <description>Evaluate the effectiveness of the investigational product in changing skin firmness and elasticity through instrumental measurements by the CUTOMETER® equipment, before use (D0) and after continuous use (D28).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in furrows and wrinkles depth</measure>
      <time_frame>Before use and after 28 days of continuous use</time_frame>
      <description>Evaluate the effectiveness of the investigational product in changing furrows and wrinkles depth through photographic records by the PRIMOS® equipment, before use (D0) and after continuous use (D28).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction assessed by a subjective questionnaire using a standardized 05-point scale</measure>
      <time_frame>Before use and after 28 days of continuous use</time_frame>
      <description>Evaluate the satisfaction with the investigational product from the point of view of the target population through a subjective questionnaire using a standardized 05-point scale answered before (D0) and after continuous use (D28).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">33</enrollment>
    <condition>Skin Aging</condition>
    <arm_group>
      <arm_group_label>Instrumental procedures and safety and efficacy assessments</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group I: 23 participants who will undergo instrumental procedures, perceived efficacy questionnaires and clinical assessments of safety and efficacy.&#xD;
  Group II: 10 participants who will only perform perceived efficacy questionnaires and clinical assessments of safety and efficacy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MEDGEL ANTIAGE</intervention_name>
      <description>The MEDGEL ANTIAGE is a medical grade silicone plate, biocompatible.</description>
      <arm_group_label>Instrumental procedures and safety and efficacy assessments</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants aged between 30 and 55 years old;&#xD;
  &#xD;
            -  Participants with all skin types (normal, dry, combination and oily);&#xD;
  &#xD;
            -  Participants with mild to moderate signs of aging, according to Lanier's&#xD;
               classification;&#xD;
  &#xD;
            -  Participants with melanic and/or vascular dark circles;&#xD;
  &#xD;
            -  Participants with bags around their eyes;&#xD;
  &#xD;
            -  Users of products from the same category;&#xD;
  &#xD;
            -  Intact skin in the product analysis region (face);&#xD;
  &#xD;
            -  Participants who agree NOT to use any other topical products on the test area during&#xD;
               the study period;&#xD;
  &#xD;
            -  Agreement to comply with the trial procedures and to attend the clinic on the&#xD;
               specified days and times;&#xD;
  &#xD;
            -  Understand, consent and sign the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants diagnosed with COVID-19 in the last 4 weeks or showing symptoms such as&#xD;
               fever, dry cough, tiredness, body aches or other discomfort;&#xD;
  &#xD;
            -  Pregnancy/lactation or intention to become pregnant during the study period;&#xD;
  &#xD;
            -  Use of the following topical or systemic medications: immunosuppressants,&#xD;
               antihistamines, non-steroidal anti-inflammatory drugs, and corticoids up to 30 days&#xD;
               before selection or considering immunosuppressants, the interval should be 3 months&#xD;
               before selection;&#xD;
  &#xD;
            -  Atopic or allergic history of health products;&#xD;
  &#xD;
            -  Pathologies and/or active skin lesions (local and/or disseminated) in the assessment&#xD;
               area;&#xD;
  &#xD;
            -  Skin marks in the experimental area that interfere with the evaluation of possible&#xD;
               skin reactions (vascular malformations, scars, increased hairiness, large amounts of&#xD;
               nevus, sunburn);&#xD;
  &#xD;
            -  Immunosuppression by drugs or active diseases;&#xD;
  &#xD;
            -  Decompensated endocrinopathies;&#xD;
  &#xD;
            -  Participants with known congenital or acquired immunodeficiency;&#xD;
  &#xD;
            -  Relevant medical history or current evidence of alcohol or other drug abuse;&#xD;
  &#xD;
            -  Known history or suspected intolerance to products in the same category&#xD;
  &#xD;
            -  Intense sun exposure up to 15 days before the assessment;&#xD;
  &#xD;
            -  Aesthetic or dermatological treatment in the evaluation area up to 04 weeks before&#xD;
               selection;&#xD;
  &#xD;
            -  Professionals directly involved in carrying out this study;&#xD;
  &#xD;
            -  Other conditions considered by the evaluating physician as reasonable for&#xD;
               disqualification from participating in the study. If yes, it should be described in&#xD;
               observation in the clinical record&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Medcin Instituto da Pele Ltda</name>
        <address>
          <city>Osasco</city>
          <state>São Paulo</state>
          <zip>06023-070</zip>
          <country>Brazil</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT05997654
  org study id: EN22-0300-01
  nct id: NCT05997654
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study investigates the safety and effectiveness of SILIMED® brand MEDGEL ANTIAGE with
        indication for improvement of the appearance of wrinkles and general aspects of the skin.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Frequency of adverse events
  time frame: 28 days
  description: Absence of risk of irritation and capture sensations of discomfort in the studied population through dermatological clinical evaluations before and after continuous use of the experimental product.
  measure: Change in skin hydration
  time frame: 1h, 2h, 4h, 6h, 8h and after 28 days
  description: Evaluate the effectiveness in changing skin hydration, through measurements by the CORNEOMETER® equipment after 1h, 2h, 4h, 6h and 8h of product contact with the skin and after 28 days of continuous use.
  measure: % of change in melanic and vascular dark circles
  time frame: Before use and after 28 days of continuous use
  description: Evaluate the effectiveness of the investigational product in changing % of melanic and vascular dark circles through photographic recording by the VISIA® equipment and image analysis by Image Pro Plus, before use (D0) and after continuous use (D28).
  measure: Change in skin firmness and elasticity
  time frame: Before use and after 28 days of continuous use
  description: Evaluate the effectiveness of the investigational product in changing skin firmness and elasticity through instrumental measurements by the CUTOMETER® equipment, before use (D0) and after continuous use (D28).
  measure: Change in furrows and wrinkles depth
  time frame: Before use and after 28 days of continuous use
  description: Evaluate the effectiveness of the investigational product in changing furrows and wrinkles depth through photographic records by the PRIMOS® equipment, before use (D0) and after continuous use (D28).
  measure: Satisfaction assessed by a subjective questionnaire using a standardized 05-point scale
  time frame: Before use and after 28 days of continuous use
  description: Evaluate the satisfaction with the investigational product from the point of view of the target population through a subjective questionnaire using a standardized 05-point scale answered before (D0) and after continuous use (D28).
  arm group label: Instrumental procedures and safety and efficacy assessments
  arm group type: Experimental
  description: Group I: 23 participants who will undergo instrumental procedures, perceived efficacy questionnaires and clinical assessments of safety and efficacy.
  Group II: 10 participants who will only perform perceived efficacy questionnaires and clinical assessments of safety and efficacy.
  intervention type: Device
  intervention name: MEDGEL ANTIAGE
  description: The MEDGEL ANTIAGE is a medical grade silicone plate, biocompatible.
  arm group label: Instrumental procedures and safety and efficacy assessments
  criteria: 
  gender: Female
  minimum age: 30 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Brazil
  responsible party type: Sponsor
  sharing ipd: No