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/NCT06010810</url>
    </required_header>
    <id_info>
      <org_study_id>23040463</org_study_id>
      <nct_id>NCT06010810</nct_id>
    </id_info>
    <brief_title>The Effectiveness of 3% Topical Tranexamic Acid Compared to 4% Topical Hydroquinone as Therapy of Melasma</brief_title>
    <official_title>The Effectiveness of 3% Topical Tranexamic Acid Compared to 4% Topical Hydroquinone as Therapy of Melasma</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>
        The goal of this clinical trial is to compare 3% Topical Tranexamic Acid with 4% Topical&#xD;
        Hydroquinone as Therapy of Melasma in Patients with Skin Type III-V. The main question[s] it&#xD;
        aims to answer are:&#xD;
  &#xD;
          1. Is there a greater decrease in mMASI score after application of 3% topical tranexamic&#xD;
             acid compared to 4% hydroquinone in melasma patients with skin type III - V?&#xD;
  &#xD;
          2. Is there a greater decrease in mexameter score after application of 3% topical&#xD;
             tranexamic acid compared to 4% hydroquinone in melasma patients with skin type III - V?&#xD;
  &#xD;
          3. Are there any side effects of topical therapy of 3% tranexamic acid cream on melasma&#xD;
             patients with skin types III - V? Participants with melasma diagnostic will apply the&#xD;
             tranexamic acid cream and hydroquinone cream on both sides of the face differently.&#xD;
             Researchers will compare by measuring the mexameter score and mMasi score to see if&#xD;
             there any decrease in both sides of the face.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 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>mMasi score</measure>
      <time_frame>2 months</time_frame>
      <description>Decrease in mMasi score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mexameter score</measure>
      <time_frame>2 months</time_frame>
      <description>Decrease in Mexamater score</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Melasma</condition>
    <arm_group>
      <arm_group_label>3 % Topical Tranexamic Acid</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive 3% Topical Tranexamic Acid, on half of the face, twice a day for a total duration of 2 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>4 % Topical Hydroquinone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive 4% Topical Hydroquinone, on half of the face, twice a day for a total duration of 2 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>3 % Topical Tranexamic Acid</intervention_name>
      <description>Patient will be given 3% Topical Tranexamic Acid, on half of the face, twice a day for 2 months</description>
      <arm_group_label>3 % Topical Tranexamic Acid</arm_group_label>
      <arm_group_label>4 % Topical Hydroquinone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>4% Topical Hidroquinone</intervention_name>
      <description>Patient will be given 3% Topical Hidroquinone, on half of the face, twice a day for 2 months</description>
      <arm_group_label>3 % Topical Tranexamic Acid</arm_group_label>
      <arm_group_label>4 % Topical Hydroquinone</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female patients diagnosed with melasma.&#xD;
  &#xD;
            -  18-60 years old.&#xD;
  &#xD;
            -  Fitzpatrick skin type III to V.&#xD;
  &#xD;
            -  Willing to be a research subject (SP) and sign a consent sheet. research (informed&#xD;
               consent).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Are pregnant and/or breastfeeding&#xD;
  &#xD;
            -  History of taking hormonal contraceptives in the last 6 months&#xD;
  &#xD;
            -  History of topical melasma therapy: corticosteroids, tretinoin, hydroquinone, and&#xD;
               Another therapy that lightens the skin in the last 2 weeks.&#xD;
  &#xD;
            -  Use oral systemic therapy or injection in melasma, such as oral acid tranexamic, oral&#xD;
               antioxidant, vitamin C injection, and glutathione injection in 4 last week.&#xD;
  &#xD;
            -  History of superficial peeling therapy in the last 4 weeks.&#xD;
  &#xD;
            -  History of deep peeling, laser or mechanical abrasion therapy in the last 6 months.&#xD;
  &#xD;
            -  Use drugs that are photosensitizers such as phenytoin, tetracycline, spironolactone,&#xD;
               and carbamazepine.&#xD;
  &#xD;
            -  History of bleeding disorders or being on blood-thinning therapy&#xD;
  &#xD;
            -  Allergy to tranexamic acid&#xD;
  &#xD;
            -  Difficulty in complying with treatment.&#xD;
  &#xD;
            -  Are experiencing symptoms of COVID-19, such as fever, cough, sore throat, loss of&#xD;
               sense of taste or smell, red eyes, diarrhea, rash on the skin&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nevi Yasnova, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of medicine, University of Indonesia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nevi Yasnova, MD</last_name>
      <phone>+62 823-8875-4322</phone>
      <email>ny.dvui@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yasnova</last_name>
    </overall_contact_backup>
    <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>Nevi Yasnova</last_name>
        <phone>+6282388754322</phone>
        <email>ny.dvui@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <results_reference>
      <citation>El-Husseiny R, Rakha N, Sallam M. Efficacy and safety of tranexamic acid 5% cream vs hydroquinone 4% cream in treating melasma: A split-face comparative clinical, histopathological, and antera 3D camera study. Dermatol Ther. 2020 Nov;33(6):e14240. doi: 10.1111/dth.14240. Epub 2020 Sep 14.</citation>
      <PMID>32856757</PMID>
    </results_reference>
    <results_reference>
      <citation>Atefi N, Dalvand B, Ghassemi M, Mehran G, Heydarian A. Therapeutic Effects of Topical Tranexamic Acid in Comparison with Hydroquinone in Treatment of Women with Melasma. Dermatol Ther (Heidelb). 2017 Sep;7(3):417-424. doi: 10.1007/s13555-017-0195-0. Epub 2017 Jul 26.</citation>
      <PMID>28748406</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indonesia University</investigator_affiliation>
      <investigator_full_name>Nevi Yasnova</investigator_full_name>
      <investigator_title>Medical Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Melanosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tranexamic Acid</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/NCT06010810
  org study id: 23040463
  nct id: NCT06010810
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare 3% Topical Tranexamic Acid with 4% Topical
        Hydroquinone as Therapy of Melasma in Patients with Skin Type III-V. The main question[s] it
        aims to answer are:
  
          1. Is there a greater decrease in mMASI score after application of 3% topical tranexamic
             acid compared to 4% hydroquinone in melasma patients with skin type III - V?
  
          2. Is there a greater decrease in mexameter score after application of 3% topical
             tranexamic acid compared to 4% hydroquinone in melasma patients with skin type III - V?
  
          3. Are there any side effects of topical therapy of 3% tranexamic acid cream on melasma
             patients with skin types III - V? Participants with melasma diagnostic will apply the
             tranexamic acid cream and hydroquinone cream on both sides of the face differently.
             Researchers will compare by measuring the mexameter score and mMasi score to see if
             there any decrease in both sides of the face.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: mMasi score
  time frame: 2 months
  description: Decrease in mMasi score
  measure: Mexameter score
  time frame: 2 months
  description: Decrease in Mexamater score
  arm group label: 3 % Topical Tranexamic Acid
  arm group type: Experimental
  description: Patients will receive 3% Topical Tranexamic Acid, on half of the face, twice a day for a total duration of 2 months
  arm group label: 4 % Topical Hydroquinone
  arm group type: Experimental
  description: Patients will receive 4% Topical Hydroquinone, on half of the face, twice a day for a total duration of 2 months.
  intervention type: Drug
  intervention name: 3 % Topical Tranexamic Acid
  description: Patient will be given 3% Topical Tranexamic Acid, on half of the face, twice a day for 2 months
  arm group label: 3 % Topical Tranexamic Acid
  arm group label: 4 % Topical Hydroquinone
  intervention type: Drug
  intervention name: 4% Topical Hidroquinone
  description: Patient will be given 3% Topical Hidroquinone, on half of the face, twice a day for 2 months
  arm group label: 3 % Topical Tranexamic Acid
  arm group label: 4 % Topical Hydroquinone
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Nevi Yasnova, MD
  role: Principal Investigator
  affiliation: Faculty of medicine, University of Indonesia
  last name: Nevi Yasnova, MD
  phone: +62 823-8875-4322
  email: ny.dvui@gmail.com
  last name: Yasnova
  facility: 
  status: Recruiting
  contact: 
  country: Indonesia
  citation: El-Husseiny R, Rakha N, Sallam M. Efficacy and safety of tranexamic acid 5% cream vs hydroquinone 4% cream in treating melasma: A split-face comparative clinical, histopathological, and antera 3D camera study. Dermatol Ther. 2020 Nov;33(6):e14240. doi: 10.1111/dth.14240. Epub 2020 Sep 14.
  PMID: 32856757
  citation: Atefi N, Dalvand B, Ghassemi M, Mehran G, Heydarian A. Therapeutic Effects of Topical Tranexamic Acid in Comparison with Hydroquinone in Treatment of Women with Melasma. Dermatol Ther (Heidelb). 2017 Sep;7(3):417-424. doi: 10.1007/s13555-017-0195-0. Epub 2017 Jul 26.
  PMID: 28748406
  responsible party type: Principal Investigator
  investigator affiliation: Indonesia University
  investigator full name: Nevi Yasnova
  investigator title: Medical Doctor
  mesh term: Melanosis
  mesh term: Tranexamic Acid
  sharing ipd: No