<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/NCT03751163</url>
  </required_header>
  <id_info>
    <org_study_id>008</org_study_id>
    <nct_id>NCT03751163</nct_id>
  </id_info>
  <brief_title>Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma</brief_title>
  <official_title>Randomized, Controlled, Double-blind Study of Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fakultas Kedokteran Universitas Indonesia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fakultas Kedokteran Universitas Indonesia</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>
      This study assess the effectiveness of oral tranexamic acid in combination with hydroquinone&#xD;
      cream in the treatment of melasma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hydroquinone (HQ) is considered the gold standard depigmenting agent for melasma,&#xD;
      nevertheless, many patients are recalcitrant to this treatment.&#xD;
&#xD;
      Recent studies have shown that tranexamic acid, a plasmin inhibitor, can prevent UV-induced&#xD;
      pigmentation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 16, 2016</start_date>
  <completion_date type="Actual">April 2, 2017</completion_date>
  <primary_completion_date type="Actual">April 2, 2017</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline mMASI Score at week 12</measure>
    <time_frame>Baseline, week 2, 12, 24</time_frame>
    <description>modified Melasma Area and Severity Index (mMASI) score was performed by rating darkness and area of involvement of 4 areas of the face (forehead, right malar, left malar, chin)&#xD;
Scoring system: A, Area of involvement rated 0 to 6: 0 indicates absent;&#xD;
1, &lt;10%; 2, 10% to 29%; 3, 30% to 49%; 4, 50% to 69%; 5, 70% to 89%; 6, 90% to 100%. D, Darkness rated 0 to 4: 0 indicates absent; 1, slight; 2, mild; 3, marked; 4, severe. b Total mMASI score range is 0 to 24 and calculated by adding scores for 4 areas of the face.&#xD;
Forehead (0.3xAxD) + Right Malar (0.3xAxD) + Left Malar (0.3xAxD) + Chin (0.1xAxD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Melanin index</measure>
    <time_frame>Baseline, week 2, 12, 24</time_frame>
    <description>difference in pigmentation readings between involved and adjacent uninvolved skin, was measured using a mexameter.&#xD;
Mexameter is a simple, rapid, and completely non-invasive instrument which measures skin pigmentation. The device has a probe which is gently pressed on the skin and painlessly records the level of pigmentation using a range of 1-1000, with 1 corresponding to white and 1000 to black.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Melasma</condition>
  <arm_group>
    <arm_group_label>Study</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid Oral Product</intervention_name>
    <description>Encapsulated tranexamic acid 250 mg</description>
    <arm_group_label>Study</arm_group_label>
    <other_name>TA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroquinone 4% Cream</intervention_name>
    <description>Hydroquinone 4% Cream</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Study</arm_group_label>
    <other_name>HQ</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sunscreen</intervention_name>
    <description>Sunscreen SPF 30</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Study</arm_group_label>
    <other_name>Sun Protection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Encapsulated placebo</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  moderate melasma (subject with mMASI score of 5 to 7.9),&#xD;
&#xD;
          -  severe melasma (subject with mMASI score ≥ 8),&#xD;
&#xD;
          -  willing to follow up for 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women,&#xD;
&#xD;
          -  nursing women,&#xD;
&#xD;
          -  women on exogenous hormones&#xD;
&#xD;
          -  current treatment with blood thinners,&#xD;
&#xD;
          -  had a history of thrombosis,&#xD;
&#xD;
          -  had an abnormal kidney function,&#xD;
&#xD;
          -  use of topical hydroquinone within 3 months of study enrollment,&#xD;
&#xD;
          -  use of topical steroids, vitamin A analogs, chemical peels within 1 month of study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fakultas Kedokteran Universitas Indonesia</investigator_affiliation>
    <investigator_full_name>Nahla Shihab</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>melasma</keyword>
  <keyword>tranexamic acid</keyword>
  <keyword>hydroquinone</keyword>
  <keyword>mMASI</keyword>
  <keyword>mexameter</keyword>
  <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>Sunscreening Agents</mesh_term>
    <mesh_term>Tranexamic Acid</mesh_term>
    <mesh_term>Hydroquinone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03751163
org study id: 008
nct id: NCT03751163
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study assess the effectiveness of oral tranexamic acid in combination with hydroquinone
      cream in the treatment of melasma.
Hydroquinone (HQ) is considered the gold standard depigmenting agent for melasma,
      nevertheless, many patients are recalcitrant to this treatment.

      Recent studies have shown that tranexamic acid, a plasmin inhibitor, can prevent UV-induced
      pigmentation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from Baseline mMASI Score at week 12
time frame: Baseline, week 2, 12, 24
description: modified Melasma Area and Severity Index (mMASI) score was performed by rating darkness and area of involvement of 4 areas of the face (forehead, right malar, left malar, chin)
Scoring system: A, Area of involvement rated 0 to 6: 0 indicates absent;
1, <10%; 2, 10% to 29%; 3, 30% to 49%; 4, 50% to 69%; 5, 70% to 89%; 6, 90% to 100%. D, Darkness rated 0 to 4: 0 indicates absent; 1, slight; 2, mild; 3, marked; 4, severe. b Total mMASI score range is 0 to 24 and calculated by adding scores for 4 areas of the face.
Forehead (0.3xAxD) + Right Malar (0.3xAxD) + Left Malar (0.3xAxD) + Chin (0.1xAxD)
measure: Melanin index
time frame: Baseline, week 2, 12, 24
description: difference in pigmentation readings between involved and adjacent uninvolved skin, was measured using a mexameter.
Mexameter is a simple, rapid, and completely non-invasive instrument which measures skin pigmentation. The device has a probe which is gently pressed on the skin and painlessly records the level of pigmentation using a range of 1-1000, with 1 corresponding to white and 1000 to black.
arm group label: Study
arm group type: Active Comparator
description: Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
arm group label: Control
arm group type: Placebo Comparator
description: Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
intervention type: Drug
intervention name: Tranexamic Acid Oral Product
description: Encapsulated tranexamic acid 250 mg
arm group label: Study
other name: TA
intervention type: Drug
intervention name: Hydroquinone 4% Cream
description: Hydroquinone 4% Cream
arm group label: Control
arm group label: Study
other name: HQ
intervention type: Other
intervention name: Sunscreen
description: Sunscreen SPF 30
arm group label: Control
arm group label: Study
other name: Sun Protection
intervention type: Device
intervention name: Placebo
description: Encapsulated placebo
arm group label: Control
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 64 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Fakultas Kedokteran Universitas Indonesia
investigator full name: Nahla Shihab
investigator title: Principal Investigator
mesh term: Melanosis
mesh term: Sunscreening Agents
mesh term: Tranexamic Acid
mesh term: Hydroquinone