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/NCT06021275</url>
    </required_header>
    <id_info>
      <org_study_id>Scar 1</org_study_id>
      <nct_id>NCT06021275</nct_id>
    </id_info>
    <brief_title>Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars</brief_title>
    <official_title>Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Recently, few studies have attempted to test the regenerative effects of human insulin&#xD;
        application by microneedling on atrophic scars versus other topical preparations. However,&#xD;
        the scars were limited etiologically to acne scars. In addition, a lack of inclusion of a&#xD;
        control group instead of comparing topical preparations with insulin was also a limitation to&#xD;
        these studies. A control group consisting of microneedling alone would have served as a&#xD;
        better comparison in order to determine whether the effects of microneedling are augmented by&#xD;
        topical protein-rich preparations.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Scar</measure>
      <time_frame>4 months</time_frame>
      <description>According the different scar assessment scores (e.g.POSAS score - The Patient and Observer Scar Assessment Scale score, range from 6 to 60, the higher the score the worse the scar, lowering in the score denotes improvement )</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Scars</condition>
    <condition>Insulin</condition>
    <arm_group>
      <arm_group_label>Microneedling with topical application of regular insulin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Microneedling only</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Microneedling with topical application of regular insulin</intervention_name>
      <description>Microneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group</description>
      <arm_group_label>Microneedling with topical application of regular insulin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Microneedling with topical application of saline</intervention_name>
      <description>Microneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group</description>
      <arm_group_label>Microneedling only</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients aged 12 to 60 years&#xD;
  &#xD;
            2. Atrophic scars (traumatic or surgical)&#xD;
  &#xD;
            3. Completely healed scars&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with a tendency or history of hypertrophic or keloidal scars&#xD;
  &#xD;
            2. Patients who received treatment for their scar in the past 3 months&#xD;
  &#xD;
            3. Diabetic patients or those with a history of Dysglycemia&#xD;
  &#xD;
            4. Pregnant, or lactating females&#xD;
  &#xD;
            5. Patients with active infection at the site of scar&#xD;
  &#xD;
            6. Patients currently receiving isotretinoin treatment or in the past month&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dalia I Halwag, PhD, MD</last_name>
      <phone>+00201224489473</phone>
      <email>daliahalwag@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Alexandria University, Faculty of Medicine</name>
        <address>
          <city>Alexandria</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dalia I Halwag, PhD, MD</last_name>
        <phone>+0201224489473</phone>
        <email>daliahalwag@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Alexandria University</investigator_affiliation>
      <investigator_full_name>Dalia Ibrahim Halwag</investigator_full_name>
      <investigator_title>Lecturer and Consultant of Dermatology, Venereology and Andrology, Faculty of Medicine</investigator_title>
    </responsible_party>
    <keyword>Insulin</keyword>
    <keyword>scars</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cicatrix</mesh_term>
      <mesh_term>Atrophy</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Insulin</mesh_term>
      <mesh_term>Insulin, Globin Zinc</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Study protocol after finishing all the research and publishing the research</ipd_description>
    </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/NCT06021275
  org study id: Scar 1
  nct id: NCT06021275
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Recently, few studies have attempted to test the regenerative effects of human insulin
        application by microneedling on atrophic scars versus other topical preparations. However,
        the scars were limited etiologically to acne scars. In addition, a lack of inclusion of a
        control group instead of comparing topical preparations with insulin was also a limitation to
        these studies. A control group consisting of microneedling alone would have served as a
        better comparison in order to determine whether the effects of microneedling are augmented by
        topical protein-rich preparations.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Change in Scar
  time frame: 4 months
  description: According the different scar assessment scores (e.g.POSAS score - The Patient and Observer Scar Assessment Scale score, range from 6 to 60, the higher the score the worse the scar, lowering in the score denotes improvement )
  arm group label: Microneedling with topical application of regular insulin
  arm group type: Active Comparator
  arm group label: Microneedling only
  arm group type: Active Comparator
  intervention type: Other
  intervention name: Microneedling with topical application of regular insulin
  description: Microneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group
  arm group label: Microneedling with topical application of regular insulin
  intervention type: Other
  intervention name: Microneedling with topical application of saline
  description: Microneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group
  arm group label: Microneedling only
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Dalia I Halwag, PhD, MD
  phone: +00201224489473
  email: daliahalwag@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Alexandria University
  investigator full name: Dalia Ibrahim Halwag
  investigator title: Lecturer and Consultant of Dermatology, Venereology and Andrology, Faculty of Medicine
  mesh term: Cicatrix
  mesh term: Atrophy
  mesh term: Insulin
  mesh term: Insulin, Globin Zinc
  sharing ipd: No
  ipd description: Study protocol after finishing all the research and publishing the research