<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/NCT03008655</url>
  </required_header>
  <id_info>
    <org_study_id>N201610008</org_study_id>
    <nct_id>NCT03008655</nct_id>
  </id_info>
  <brief_title>1064-nm Q-switched Nd:YAG Laser and Intradermal Tranexamic Acid for Melasma</brief_title>
  <official_title>A Split-face Comparison of Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Vitamin C vs Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Intradermal Tranexamic Acid Injection for Melasma:a Single Blinded, Randomised Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University WanFang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University WanFang Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND: Melasma is a chronic, often relapsing skin disorder, with poor long-term results&#xD;
      from all current therapies.Q switched 1064nm Nd:YAG laser and intradermal tranexamic acid&#xD;
      both showed efficacy on the treatment of melasma. However, no combination therapy of both be&#xD;
      reported.&#xD;
&#xD;
      OBJECTIVES: To compare the efficacy of low influence Q switched 1064nm Nd:YAG laser and low&#xD;
      influence Q switched 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection&#xD;
      for melasma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      METHODS: Twenty patients with melasma were included in a randomized controlled&#xD;
      observer-blinded study with split-face design. Each side of the face was randomly allocated&#xD;
      to either six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot&#xD;
      size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz) or low influence 1064nm Nd:YAG laser combined&#xD;
      with intradermal tranexamic acid injection.Complication Improvement of melasma was assessed&#xD;
      by Melasma area severity index (MASI),physician's global assessment (PhGA), MELASQOL scale,&#xD;
      patient's global assessment (PGA), and patient's satisfaction at baseline,6th week,10th week&#xD;
      after first treatment and 3 months, and 6 months after last treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Melasma area severity index (MASI)</measure>
    <time_frame>6 months after last treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life by MELASQOL scale</measure>
    <time_frame>6th week,10th week after first treatment and 3 months, and 6 months after last treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement by patient's global assessment (PGA),</measure>
    <time_frame>6th week,10th week after first treatment and 3 months, and 6 months after last treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction (VAS)</measure>
    <time_frame>6th week,10th week after first treatment and 3 months, and 6 months after last treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement by physician's global assessment (PhGA)</measure>
    <time_frame>6th week,10th week after first treatment and 3 months, and 6 months after last treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Melasma</condition>
  <arm_group>
    <arm_group_label>Nd-YAG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ND-YAG only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nd-YAG and intradermal tranexamic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nd-YAG combine with intradermal tranexamic acid</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>intradermal tranexamic acid</intervention_name>
    <description>intradermal tranexamic acid injection</description>
    <arm_group_label>Nd-YAG and intradermal tranexamic acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nd-YAG</intervention_name>
    <description>six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz)</description>
    <arm_group_label>Nd-YAG</arm_group_label>
    <arm_group_label>Nd-YAG and intradermal tranexamic acid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients &gt; 20 years old with refractory melasma to topical treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of keloid, active eczema, active acne in the face, history of facial eczema,&#xD;
             photosensitivity, use of isotretinoin in the past 6 months, pregnancy, and high&#xD;
             exposure to sunlight or UV light (UVA or UVB)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu Chen Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University WanFang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yu Chen Huang, MD</last_name>
    <phone>886970746772</phone>
    <email>dhist2002@yahoo.com.tw</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University WanFang Hospital</investigator_affiliation>
    <investigator_full_name>Huang Yu Chen</investigator_full_name>
    <investigator_title>Attending physician of Dermatology Department</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>


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/NCT03008655
org study id: N201610008
nct id: NCT03008655
lead sponsor: 
has dmc: No
BACKGROUND: Melasma is a chronic, often relapsing skin disorder, with poor long-term results
      from all current therapies.Q switched 1064nm Nd:YAG laser and intradermal tranexamic acid
      both showed efficacy on the treatment of melasma. However, no combination therapy of both be
      reported.

      OBJECTIVES: To compare the efficacy of low influence Q switched 1064nm Nd:YAG laser and low
      influence Q switched 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection
      for melasma.
METHODS: Twenty patients with melasma were included in a randomized controlled
      observer-blinded study with split-face design. Each side of the face was randomly allocated
      to either six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot
      size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz) or low influence 1064nm Nd:YAG laser combined
      with intradermal tranexamic acid injection.Complication Improvement of melasma was assessed
      by Melasma area severity index (MASI),physician's global assessment (PhGA), MELASQOL scale,
      patient's global assessment (PGA), and patient's satisfaction at baseline,6th week,10th week
      after first treatment and 3 months, and 6 months after last treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Melasma area severity index (MASI)
time frame: 6 months after last treatment
measure: Quality of life by MELASQOL scale
time frame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
measure: Improvement by patient's global assessment (PGA),
time frame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
measure: Patient's satisfaction (VAS)
time frame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
measure: Improvement by physician's global assessment (PhGA)
time frame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
arm group label: Nd-YAG
arm group type: Active Comparator
description: ND-YAG only
arm group label: Nd-YAG and intradermal tranexamic acid
arm group type: Experimental
description: Nd-YAG combine with intradermal tranexamic acid
intervention type: Procedure
intervention name: intradermal tranexamic acid
description: intradermal tranexamic acid injection
arm group label: Nd-YAG and intradermal tranexamic acid
intervention type: Device
intervention name: Nd-YAG
description: six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz)
arm group label: Nd-YAG
arm group label: Nd-YAG and intradermal tranexamic acid
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yu Chen Huang, MD
role: Principal Investigator
affiliation: Taipei Medical University WanFang Hospital
last name: Yu Chen Huang, MD
phone: 886970746772
email: dhist2002@yahoo.com.tw
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University WanFang Hospital
investigator full name: Huang Yu Chen
investigator title: Attending physician of Dermatology Department
mesh term: Melanosis
mesh term: Tranexamic Acid
sharing ipd: No