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/NCT05990400</url>
    </required_header>
    <id_info>
      <org_study_id>23030293</org_study_id>
      <nct_id>NCT05990400</nct_id>
    </id_info>
    <brief_title>Effectiveness and Safety of Topical Finasteride and Minoxidil Combination Compared to Topical Minoxidil for The Treatment of Male Androgenetic Alopecia</brief_title>
    <official_title>Effectiveness and Safety of Topical Finasteride and Minoxidil Combination Compared to Topical Minoxidil for The Treatment of Male Androgenetic Alopecia</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        A double-blind, randomized, controlled trial of 40 male patients with androgenetic alopecia&#xD;
        was conducted. All subject were randomized to receive either combination of minoxidil 5%&#xD;
        topical and finasteride 0,1% topical or minoxidil 5% topical&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All subject were randomized to receive either combination of minoxidil 5% topical and&#xD;
        finasteride 0,1% topical or minoxidil 5% topical The primary outcome was increase of the hair&#xD;
        density and hair diameter (mean thickness) measured by trichoscan Measurements were done at&#xD;
        baseline and every four weeks for twelve weeks. Additionally, side effects of therapy was&#xD;
        also measured.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
    <phase>Phase 2/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>
      <intervention_model_description>Eligible subjects were randomized to receive either combination of minoxidil 5% topical and finasteride 0,1% topical or minoxidil 5% topical. The allocation sequence was generated with a computer by an analyst.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>Triple (Participant, Investigator, Outcomes Assessor) The allocation sequence was generated with a computer by an analyst. The allocation sequence was concealed from the investigators, outcomes assessor, and subjects.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Hair density</measure>
      <time_frame>4 times of measurement in 3 months</time_frame>
      <description>Density of the hair is the number of hair strands per square inch of the scalp measured by trichoscan</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hair diameter (mean thickness)</measure>
      <time_frame>4 times of measurement in 3 months</time_frame>
      <description>Hair diameter is the midline of the hair shaft measured by trichoscan</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Side effects</measure>
      <time_frame>4 times of measurement in 3 months</time_frame>
      <description>Incidence of side effects</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Velus hair percentage ( hair rate vellus)</measure>
      <time_frame>4 times of measurement in 3 months</time_frame>
      <description>Vellus hair is a hair that is less than 30 micrometer in diameter, lacks a medulla hair, and is 2 cm in length measured by trichoscan</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal hair percentage (hair rate terminal)</measure>
      <time_frame>4 times of measurement in 3 months</time_frame>
      <description>Terminal hair is a hair that has a hair more than 60 micrometer, contains the medulla and can be up to 100 cm in length measured by trichoscan</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dermoscopy</measure>
      <time_frame>4 times of measurement in 3 months</time_frame>
      <description>Dermoscopy is a non-invasive technique that allows more detailed examination of the scalp and hair shaft under magnification</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Androgenetic Alopecia</condition>
    <arm_group>
      <arm_group_label>Combination of minoxidil 5% topical and finasteride 0,1% topical group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Combination of minoxidil 5% solutio and finasteride 0,1% solutio which has administered topically</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Minoxidil 5% topical group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Minoxidil 5% solutio which has administered topically</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Finasteride</intervention_name>
      <description>finasteride topical 0,1%</description>
      <arm_group_label>Combination of minoxidil 5% topical and finasteride 0,1% topical group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Minoxidil</intervention_name>
      <description>minoxidil topical 5%</description>
      <arm_group_label>Combination of minoxidil 5% topical and finasteride 0,1% topical group</arm_group_label>
      <arm_group_label>Minoxidil 5% topical group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male aged from 18-59 years diagnosed with androgenic alopecia&#xD;
  &#xD;
            2. Androgenic alopecia type III-V according to Hamilton-Norwood criteria&#xD;
  &#xD;
            3. Willing to participate in this research by signing the consent form after receiving an&#xD;
               explanation from the researcher&#xD;
  &#xD;
            4. Willing to not cutting the hair nor coloring the hair during the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Diagnosed with other infectious or inflammatory skin disease in the scalp&#xD;
  &#xD;
            2. Using oral medications or vitamins that aim to increase the amount of hair in the last&#xD;
               1 month&#xD;
  &#xD;
            3. Using topical medication that aim to increase the amount of hair in the last 2 weeks&#xD;
  &#xD;
            4. Undergoing cosmetic procedure for AGA therapy such as low-level laser therapy (LLLT)&#xD;
               procedures, platelet-rich plasma (PRP) injections, or microneedling within the last 3&#xD;
               months&#xD;
  &#xD;
            5. Have sexual disorder such as decreased libido&#xD;
  &#xD;
            6. Have a history of allergy or irritant contact dermatitis to the minoxidil and&#xD;
               finasteride&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>59 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Farah F Lubis, MD</last_name>
      <phone>081385088998</phone>
      <email>farahfaulinlubis@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Indonesia</name>
        <address>
          <city>Jakarta</city>
          <state>Other (Non U.s.)</state>
          <zip>10250</zip>
          <country>Indonesia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Farah F Lubis, MD</last_name>
        <phone>081385088998</phone>
        <email>farahfaulinlubis@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indonesia University</investigator_affiliation>
      <investigator_full_name>Farah Faulin Al Fauz Lubis</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <keyword>Finasteride topical</keyword>
    <keyword>Minoxidil topical</keyword>
    <keyword>Male androgenetic alopecia</keyword>
    <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>
      <mesh_term>Finasteride</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/NCT05990400
  org study id: 23030293
  nct id: NCT05990400
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A double-blind, randomized, controlled trial of 40 male patients with androgenetic alopecia
        was conducted. All subject were randomized to receive either combination of minoxidil 5%
        topical and finasteride 0,1% topical or minoxidil 5% topical
  All subject were randomized to receive either combination of minoxidil 5% topical and
        finasteride 0,1% topical or minoxidil 5% topical The primary outcome was increase of the hair
        density and hair diameter (mean thickness) measured by trichoscan Measurements were done at
        baseline and every four weeks for twelve weeks. Additionally, side effects of therapy was
        also measured.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Eligible subjects were randomized to receive either combination of minoxidil 5% topical and finasteride 0,1% topical or minoxidil 5% topical. The allocation sequence was generated with a computer by an analyst.
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: Triple (Participant, Investigator, Outcomes Assessor) The allocation sequence was generated with a computer by an analyst. The allocation sequence was concealed from the investigators, outcomes assessor, and subjects.
  measure: Hair density
  time frame: 4 times of measurement in 3 months
  description: Density of the hair is the number of hair strands per square inch of the scalp measured by trichoscan
  measure: Hair diameter (mean thickness)
  time frame: 4 times of measurement in 3 months
  description: Hair diameter is the midline of the hair shaft measured by trichoscan
  measure: Side effects
  time frame: 4 times of measurement in 3 months
  description: Incidence of side effects
  measure: Velus hair percentage ( hair rate vellus)
  time frame: 4 times of measurement in 3 months
  description: Vellus hair is a hair that is less than 30 micrometer in diameter, lacks a medulla hair, and is 2 cm in length measured by trichoscan
  measure: Terminal hair percentage (hair rate terminal)
  time frame: 4 times of measurement in 3 months
  description: Terminal hair is a hair that has a hair more than 60 micrometer, contains the medulla and can be up to 100 cm in length measured by trichoscan
  measure: Dermoscopy
  time frame: 4 times of measurement in 3 months
  description: Dermoscopy is a non-invasive technique that allows more detailed examination of the scalp and hair shaft under magnification
  arm group label: Combination of minoxidil 5% topical and finasteride 0,1% topical group
  arm group type: Experimental
  description: Combination of minoxidil 5% solutio and finasteride 0,1% solutio which has administered topically
  arm group label: Minoxidil 5% topical group
  arm group type: Active Comparator
  description: Minoxidil 5% solutio which has administered topically
  intervention type: Drug
  intervention name: Finasteride
  description: finasteride topical 0,1%
  arm group label: Combination of minoxidil 5% topical and finasteride 0,1% topical group
  intervention type: Drug
  intervention name: Minoxidil
  description: minoxidil topical 5%
  arm group label: Combination of minoxidil 5% topical and finasteride 0,1% topical group
  arm group label: Minoxidil 5% topical group
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 18 Years
  maximum age: 59 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Farah F Lubis, MD
  phone: 081385088998
  email: farahfaulinlubis@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Indonesia
  responsible party type: Principal Investigator
  investigator affiliation: Indonesia University
  investigator full name: Farah Faulin Al Fauz Lubis
  investigator title: MD
  mesh term: Alopecia
  mesh term: Alopecia Areata
  mesh term: Minoxidil
  mesh term: Finasteride
  sharing ipd: No