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/NCT05989165</url>
    </required_header>
    <id_info>
      <org_study_id>23030294</org_study_id>
      <nct_id>NCT05989165</nct_id>
    </id_info>
    <brief_title>Effectiveness of Combination Therapy of Microneedling and Minoxidil in Androgenetic Alopecia of Indonesian Men</brief_title>
    <official_title>Effectiveness of Combination Therapy of Microneedling and Minoxidil in Androgenetic Alopecia of Indonesian Men</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indonesia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Indonesia University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare the effectiveness of combination therapy of&#xD;
        microneedling and minoxidil in androgenetic alopecia of Indonesian men. The main questions it&#xD;
        aims to answer are:&#xD;
  &#xD;
          -  Is there an increase in hair density with combination therapy of microneedling and&#xD;
             minoxidil versus minoxidil monotherapy?&#xD;
  &#xD;
          -  Is there an increase in hair diameter with combination therapy of microneedling and&#xD;
             minoxidil versus minoxidil monotherapy?&#xD;
  &#xD;
        Participants will be divided into 2 groups. The first one will receive minoxidil monotherapy,&#xD;
        and the second one will receive a combination therapy of microneedling and minoxidil.&#xD;
        Researchers will compare those 2 groups to see if there is a difference of effectiveness&#xD;
        based on hair density and diameter.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
    <phase>Phase 3</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>Density of hair</measure>
      <time_frame>12 weeks</time_frame>
      <description>Increase density of hair in alopecia androgenetic patient</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diameter of hair</measure>
      <time_frame>12 weeks</time_frame>
      <description>Increase diameter of hair in alopecia androgenetic patient</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Androgenetic Alopecia</condition>
    <arm_group>
      <arm_group_label>Minoxidil 5% solution</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive minoxidil 5%, twice a day, for a total duration of 12 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Combination therapy of microneedling and minoxidil 5% solution</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive a combination therapy of microneedling and minoxidil 5%. Minoxidil 5%, will be given twice a day for a total duration of 12 weeks. The microneedling treatment will be given every 4 weeks (week 0, week 4, week 8)for a total duration of 12 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Minoxidil 5% Topical Solution</intervention_name>
      <description>Patient will be given minoxidil 5% topical solution, twice a day for 12 weeks</description>
      <arm_group_label>Combination therapy of microneedling and minoxidil 5% solution</arm_group_label>
      <arm_group_label>Minoxidil 5% solution</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>microneedling</intervention_name>
      <description>Patient will be given microneedling treatment every 4 weeks</description>
      <arm_group_label>Combination therapy of microneedling and minoxidil 5% solution</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male&#xD;
  &#xD;
            -  Indonesian&#xD;
  &#xD;
            -  Age 18-59 years&#xD;
  &#xD;
            -  Diagnosis of androgenetic alopecia&#xD;
  &#xD;
            -  Hamilton-Norwood type III-IV&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Use of minoxidil or finasteride topical 1 month prior&#xD;
  &#xD;
            -  Use of minoxidil or finasteride oral 1 month prior&#xD;
  &#xD;
            -  Skin infection in the treatment area&#xD;
  &#xD;
            -  Cosmetic procedures for the treatment of alopecia androgenetic such as platelet rich&#xD;
               plasma, laser therapy,or microneedling 3 months prior&#xD;
  &#xD;
            -  History of keloid&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>59 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kara Adistri, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of medicine, University of Indonesia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kara Adistri, MD</last_name>
      <phone>+62881299069920</phone>
      <email>karaasantoso@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cipto Mangungkusumo Hospital</name>
        <address>
          <city>Jakarta</city>
          <state>DKI Jakarta</state>
          <zip>10430</zip>
          <country>Indonesia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kara Adistri</last_name>
        <phone>+6281299069920</phone>
        <email>karaasantoso@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <results_reference>
      <citation>Dhurat R, Sukesh M, Avhad G, Dandale A, Pal A, Pund P. A randomized evaluator blinded study of effect of microneedling in androgenetic alopecia: a pilot study. Int J Trichology. 2013 Jan;5(1):6-11. doi: 10.4103/0974-7753.114700.</citation>
      <PMID>23960389</PMID>
    </results_reference>
    <results_reference>
      <citation>Kumar MK, Inamadar AC, Palit A. A Randomized Controlled, Single-Observer Blinded Study to Determine the Efficacy of Topical Minoxidil plus Microneedling versus Topical Minoxidil Alone in the Treatment of Androgenetic Alopecia. J Cutan Aesthet Surg. 2018 Oct-Dec;11(4):211-216. doi: 10.4103/JCAS.JCAS_130_17.</citation>
      <PMID>30886475</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indonesia University</investigator_affiliation>
      <investigator_full_name>Kara Adistri</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alopecia</mesh_term>
      <mesh_term>Alopecia Areata</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Minoxidil</mesh_term>
    </intervention_browse>
    <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/NCT05989165
  org study id: 23030294
  nct id: NCT05989165
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to compare the effectiveness of combination therapy of
        microneedling and minoxidil in androgenetic alopecia of Indonesian men. The main questions it
        aims to answer are:
  
          -  Is there an increase in hair density with combination therapy of microneedling and
             minoxidil versus minoxidil monotherapy?
  
          -  Is there an increase in hair diameter with combination therapy of microneedling and
             minoxidil versus minoxidil monotherapy?
  
        Participants will be divided into 2 groups. The first one will receive minoxidil monotherapy,
        and the second one will receive a combination therapy of microneedling and minoxidil.
        Researchers will compare those 2 groups to see if there is a difference of effectiveness
        based on hair density and diameter.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Density of hair
  time frame: 12 weeks
  description: Increase density of hair in alopecia androgenetic patient
  measure: Diameter of hair
  time frame: 12 weeks
  description: Increase diameter of hair in alopecia androgenetic patient
  arm group label: Minoxidil 5% solution
  arm group type: Experimental
  description: Patients will receive minoxidil 5%, twice a day, for a total duration of 12 weeks.
  arm group label: Combination therapy of microneedling and minoxidil 5% solution
  arm group type: Experimental
  description: Patients will receive a combination therapy of microneedling and minoxidil 5%. Minoxidil 5%, will be given twice a day for a total duration of 12 weeks. The microneedling treatment will be given every 4 weeks (week 0, week 4, week 8)for a total duration of 12 weeks.
  intervention type: Drug
  intervention name: Minoxidil 5% Topical Solution
  description: Patient will be given minoxidil 5% topical solution, twice a day for 12 weeks
  arm group label: Combination therapy of microneedling and minoxidil 5% solution
  arm group label: Minoxidil 5% solution
  intervention type: Device
  intervention name: microneedling
  description: Patient will be given microneedling treatment every 4 weeks
  arm group label: Combination therapy of microneedling and minoxidil 5% solution
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 59 Years
  healthy volunteers: No
  last name: Kara Adistri, MD
  role: Principal Investigator
  affiliation: Faculty of medicine, University of Indonesia
  last name: Kara Adistri, MD
  phone: +62881299069920
  email: karaasantoso@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Indonesia
  citation: Dhurat R, Sukesh M, Avhad G, Dandale A, Pal A, Pund P. A randomized evaluator blinded study of effect of microneedling in androgenetic alopecia: a pilot study. Int J Trichology. 2013 Jan;5(1):6-11. doi: 10.4103/0974-7753.114700.
  PMID: 23960389
  citation: Kumar MK, Inamadar AC, Palit A. A Randomized Controlled, Single-Observer Blinded Study to Determine the Efficacy of Topical Minoxidil plus Microneedling versus Topical Minoxidil Alone in the Treatment of Androgenetic Alopecia. J Cutan Aesthet Surg. 2018 Oct-Dec;11(4):211-216. doi: 10.4103/JCAS.JCAS_130_17.
  PMID: 30886475
  responsible party type: Principal Investigator
  investigator affiliation: Indonesia University
  investigator full name: Kara Adistri
  investigator title: MD
  mesh term: Alopecia
  mesh term: Alopecia Areata
  mesh term: Minoxidil
  sharing ipd: No