<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/NCT03765021</url>
  </required_header>
  <id_info>
    <org_study_id>Dermatology 9</org_study_id>
    <nct_id>NCT03765021</nct_id>
  </id_info>
  <brief_title>Tranexamic Acid vs Fractional CO2 Laser in Post-acne Hyperpigmentation</brief_title>
  <official_title>Tranexamic Acid Versus Fractional CO2 Laser in Post-inflammatory Hyperpigmentation in Acne Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      comparing between the effect of intradermal injection of TXA and low power low density&#xD;
      fractional CO2 lasers on post acne hyperpigmentation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized controlled split-face study. One side of the face will be assigned to TXA&#xD;
      intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company),&#xD;
      the dose of 1 ml syringe with 100mg/ml. TXA will be prepared under sterile conditions.&#xD;
      Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The&#xD;
      injection will be repeated every two weeks for three months. The other side of the face will&#xD;
      be randomly assigned to low power fractional CO2 laser with a power of 12 watts, spacing 700&#xD;
      micrometers (low density), and dwell time 300 microsecond every four weeks for three months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</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>Double (Participant, Investigator)</masking>
    <masking_description>Method of randomization: using closed envelopes containing cards with fractional CO2 Rt and fractional CO2 Lt and the patient will draw one of them blindly.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of melanin index to assess change of post-acne hyperpigmentation</measure>
    <time_frame>3 months</time_frame>
    <description>the melanin index (MI) average is 1.10 +/-0.29 with higher values showing worse outcome. It will be measured using reflectance spectrophotometer in order to assess the degree of hyperpigmentation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of erythema index to assess change of post-acne hyperpigmentation</measure>
    <time_frame>3 months</time_frame>
    <description>the erythema index (EI) average is 1.29 +/- 0.38 with higher values showing worse outcome. It will be measured using reflectance spectrophotometer in order to assess the degree of erythema</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of post-acne hyperpigmentation index to assess change of post-acne hyperpigmentation</measure>
    <time_frame>3 months</time_frame>
    <description>the post-acne hyperpigmentation index (PAHPI) ranges from 6-22 with higher values showing worse outcome. It is a summation of three scores (Postinflammatory hyperpigmentation(PIH) lesion size, median lesion intensity compared with surrounding skin and the number of PIH lesions).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction score to assess change of post-acne hyperpigmentation</measure>
    <time_frame>3 months</time_frame>
    <description>It is a score ranging from 1-4 with improvement 0-25%=1, 26-50%= 2, 51-75%=3 and more than 75%=4 so higher values of patient satisfaction score showing better outcome</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Post Inflammatory Hyperpigmentation</condition>
  <arm_group>
    <arm_group_label>Tranexamic acid injection (Kapron)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One side of the face will be assigned to TXA intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will be prepared under sterile conditions. Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fractional CO2 laser resurfacing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The other side of the face will be randomly assigned to do low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <description>One side of the face will be assigned to TXA intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will prepared under sterile conditions. Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months.</description>
    <arm_group_label>Tranexamic acid injection (Kapron)</arm_group_label>
    <other_name>Kapron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fractional CO2 laser</intervention_name>
    <description>The other side of the face will be randomly assigned to low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.</description>
    <arm_group_label>Fractional CO2 laser resurfacing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Egyptians of both sexes.&#xD;
&#xD;
          -  Age &gt; 18.&#xD;
&#xD;
          -  Patients who can avoid sun exposure one week after sessions.&#xD;
&#xD;
          -  Patients who stopped taking systemic isotretinoin for more than six months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and lactation.&#xD;
&#xD;
          -  Concomitant use of anticoagulants.&#xD;
&#xD;
          -  Bleeding disorders.&#xD;
&#xD;
          -  Personal or family history of DVT or thromboembolic events.&#xD;
&#xD;
          -  Scarring and keloid tendency.&#xD;
&#xD;
          -  Active skin infection, active HSV.&#xD;
&#xD;
          -  History of photosensitivity or photosensitizing medication.&#xD;
&#xD;
          -  Occupational sun exposure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Maha Fathy Elmasry</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperpigmentation</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>
  <!-- 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/NCT03765021
org study id: Dermatology 9
nct id: NCT03765021
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
comparing between the effect of intradermal injection of TXA and low power low density
      fractional CO2 lasers on post acne hyperpigmentation
Randomized controlled split-face study. One side of the face will be assigned to TXA
      intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company),
      the dose of 1 ml syringe with 100mg/ml. TXA will be prepared under sterile conditions.
      Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The
      injection will be repeated every two weeks for three months. The other side of the face will
      be randomly assigned to low power fractional CO2 laser with a power of 12 watts, spacing 700
      micrometers (low density), and dwell time 300 microsecond every four weeks for three months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Method of randomization: using closed envelopes containing cards with fractional CO2 Rt and fractional CO2 Lt and the patient will draw one of them blindly.
measure: Measurement of melanin index to assess change of post-acne hyperpigmentation
time frame: 3 months
description: the melanin index (MI) average is 1.10 +/-0.29 with higher values showing worse outcome. It will be measured using reflectance spectrophotometer in order to assess the degree of hyperpigmentation
measure: Measurement of erythema index to assess change of post-acne hyperpigmentation
time frame: 3 months
description: the erythema index (EI) average is 1.29 +/- 0.38 with higher values showing worse outcome. It will be measured using reflectance spectrophotometer in order to assess the degree of erythema
measure: Measurement of post-acne hyperpigmentation index to assess change of post-acne hyperpigmentation
time frame: 3 months
description: the post-acne hyperpigmentation index (PAHPI) ranges from 6-22 with higher values showing worse outcome. It is a summation of three scores (Postinflammatory hyperpigmentation(PIH) lesion size, median lesion intensity compared with surrounding skin and the number of PIH lesions).
measure: Patient satisfaction score to assess change of post-acne hyperpigmentation
time frame: 3 months
description: It is a score ranging from 1-4 with improvement 0-25%=1, 26-50%= 2, 51-75%=3 and more than 75%=4 so higher values of patient satisfaction score showing better outcome
arm group label: Tranexamic acid injection (Kapron)
arm group type: Experimental
description: One side of the face will be assigned to TXA intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will be prepared under sterile conditions. Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months.
arm group label: Fractional CO2 laser resurfacing
arm group type: Active Comparator
description: The other side of the face will be randomly assigned to do low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.
intervention type: Drug
intervention name: Tranexamic Acid
description: One side of the face will be assigned to TXA intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will prepared under sterile conditions. Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months.
arm group label: Tranexamic acid injection (Kapron)
other name: Kapron
intervention type: Device
intervention name: Fractional CO2 laser
description: The other side of the face will be randomly assigned to low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.
arm group label: Fractional CO2 laser resurfacing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Maha Fathy Elmasry
investigator title: principal investigator
mesh term: Hyperpigmentation
mesh term: Tranexamic Acid