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/NCT06002854</url>
    </required_header>
    <id_info>
      <org_study_id>NO.F.2-81/2022-GENL/252/JPMC</org_study_id>
      <nct_id>NCT06002854</nct_id>
    </id_info>
    <brief_title>Comparison Of Outcome Of Microneedling With Autologous PRP Vs Microneedling With Topical Insulin In Treatment Of Post Acne Atrophic Scars.</brief_title>
    <official_title>Comparison Of The Outcome Of Treatment of Microneedling With Autologous Platelet- Rich -Plasma Versus Microneedling With Topical Insulin In The Treatment Of Post Acne Atrophic Scars.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jinnah Postgraduate Medical Centre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jinnah Postgraduate Medical Centre</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>
        Microneedling with topical INSULIN is a simple, effective tool for building body's new&#xD;
        collagen layers and thus an alternative to all erosive techniques such as lasers, peels. The&#xD;
        skin responds to fine punctures with the release of growth factors. 8 It is a safe procedure&#xD;
        that can be performed in the office without complications, with a good cost-benefit because&#xD;
        it is economically viable without any effect on patient's daily activities. 9&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Actual">February 1, 2023</completion_date>
    <primary_completion_date type="Actual">December 1, 2022</primary_completion_date>
    <phase>Phase 2</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Efficacy of Topical Insulin R with microneedling versus Platelets rich plasma in atrophic acne scars</measure>
      <time_frame>Efficacy will be assesed upto 4 months.</time_frame>
      <description>Efficacy will be assessed by using Goodman and Baron Qualitative Scar Grading System</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>ATROPHIC ACNE SCARS</condition>
    <arm_group>
      <arm_group_label>GROUP A Microneedling with PRP(platelete rich plasma)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>GROUP B Microneedling with topical INSULIN</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PRP( platelet rich plasma) and Insulin human</intervention_name>
      <description>Microneedling with autologus PRP reduces inflammationin acne scars. Insulin human is a new topical drug which is used nowadays for acne scars as it is more effective in producing collagen formation as well as new blood vessel formation</description>
      <arm_group_label>GROUP A Microneedling with PRP(platelete rich plasma)</arm_group_label>
      <arm_group_label>GROUP B Microneedling with topical INSULIN</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  postacne atrophic scars ≥ 2 on Goodman and Baron's acne scar-grading system&#xD;
  &#xD;
            -  Either gender.&#xD;
  &#xD;
            -  Age 20-50 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  lactation and pregnancy&#xD;
  &#xD;
            -  skin cancers and infection&#xD;
  &#xD;
            -  photosensitivity like SLE ,XP&#xD;
  &#xD;
            -  use of RETINOIDS in last 6 months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>KHADIJA ASADULLAH, MBBS</last_name>
      <role>Principal Investigator</role>
      <affiliation>JPMC</affiliation>
    </overall_official>
    <overall_official>
      <last_name>FAIZA INAM, FCPS</last_name>
      <role>Principal Investigator</role>
      <affiliation>JPMC</affiliation>
    </overall_official>
    <overall_official>
      <last_name>PARISA SANAWAR, FCPS</last_name>
      <role>Principal Investigator</role>
      <affiliation>JPMC</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>JPMC</name>
        <address>
          <city>Karachi</city>
          <state>Sindh</state>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>March 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Jinnah Postgraduate Medical Centre</investigator_affiliation>
      <investigator_full_name>Nazia Jabeen</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>
    <!-- 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/NCT06002854
  org study id: NO.F.2-81/2022-GENL/252/JPMC
  nct id: NCT06002854
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Microneedling with topical INSULIN is a simple, effective tool for building body's new
        collagen layers and thus an alternative to all erosive techniques such as lasers, peels. The
        skin responds to fine punctures with the release of growth factors. 8 It is a safe procedure
        that can be performed in the office without complications, with a good cost-benefit because
        it is economically viable without any effect on patient's daily activities. 9
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Efficacy of Topical Insulin R with microneedling versus Platelets rich plasma in atrophic acne scars
  time frame: Efficacy will be assesed upto 4 months.
  description: Efficacy will be assessed by using Goodman and Baron Qualitative Scar Grading System
  arm group label: GROUP A Microneedling with PRP(platelete rich plasma)
  arm group type: Experimental
  arm group label: GROUP B Microneedling with topical INSULIN
  arm group type: Experimental
  intervention type: Drug
  intervention name: PRP( platelet rich plasma) and Insulin human
  description: Microneedling with autologus PRP reduces inflammationin acne scars. Insulin human is a new topical drug which is used nowadays for acne scars as it is more effective in producing collagen formation as well as new blood vessel formation
  arm group label: GROUP A Microneedling with PRP(platelete rich plasma)
  arm group label: GROUP B Microneedling with topical INSULIN
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: KHADIJA ASADULLAH, MBBS
  role: Principal Investigator
  affiliation: JPMC
  last name: FAIZA INAM, FCPS
  role: Principal Investigator
  affiliation: JPMC
  last name: PARISA SANAWAR, FCPS
  role: Principal Investigator
  affiliation: JPMC
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Jinnah Postgraduate Medical Centre
  investigator full name: Nazia Jabeen
  investigator title: Principal Investigator
  mesh term: Atrophy
  mesh term: Insulin
  mesh term: Insulin, Globin Zinc