<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/NCT04471948</url>
  </required_header>
  <id_info>
    <org_study_id>Si379/2019</org_study_id>
    <nct_id>NCT04471948</nct_id>
  </id_info>
  <brief_title>The Safety and Efficacy of 1064-nm Picosecond Laser With Microlens Array for Pore Tightening; a Pilot Study</brief_title>
  <official_title>The Safety and Efficacy of 1064-nm Picosecond Laser 1064 With Microlens Array for Pore Tightening; a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety and efficacy of 1064-nm Picosecond&#xD;
      laser 1064 With Microlens Array for Pore tightening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Safety and Efficacy of Picosecond laser 1064 Nanometers With Microlens Array for Pore&#xD;
      tightening; a Pilot Study Primary outcome : pore size Secondary outcome : side effect,&#xD;
      patient satisfaction, global evaluation the patient recieved laser treament once a month for&#xD;
      3 months and then follow up after last treatment at 1, 3 ,6 month&#xD;
&#xD;
      Enlarged facial pores is one of the skin signs in photoaging. There are 3 major clinical&#xD;
      causes of enlarged facial pores: highs sebum excretion, decreased elasticity around pores and&#xD;
      increased hair follicle volume. Possible causative factors of enlarged facial pores include&#xD;
      many exogenous and endogenous factors include genetic predisposition, seborrhea and chronic&#xD;
      ultraviolet light exposure. Picosecond laser are new device which has been used in skin&#xD;
      rejuvenation. The main mechanism of action is laser induced optical breakdown (LIOB).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 7, 2020</start_date>
  <completion_date type="Anticipated">March 7, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 7, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pore size by Antera 3D image</measure>
    <time_frame>change from baseline in pore size at 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Enlarged Pores</condition>
  <arm_group>
    <arm_group_label>Fractional picosecond laser 1,064 nm laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 arm The subjects with enlarged pores were treated with fractional picosecond laser 1,064 nm laser</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fractional picosecond 1064 nm laser</intervention_name>
    <description>The parameter of laser was 8 mm spot size, 0.8 mJ/CM2, 750 ps, 5 Hz, 2 passes The treatment was done in every 4 weeks for 3 sessions.</description>
    <arm_group_label>Fractional picosecond laser 1,064 nm laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both male and female age 25-40 years&#xD;
&#xD;
          -  No underlying disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of retinoid or other keratolytic drugs used within 6 months before enrolled&#xD;
&#xD;
          -  History of keloid&#xD;
&#xD;
          -  photosensitivity&#xD;
&#xD;
          -  Immunocompromised host&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>woraphong Manuskiatti, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>woraphong Manuskiatti, M.D.</last_name>
    <phone>02-419-1000</phone>
    <email>doctorlaser@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Siriwan palawisuth, M.D.</last_name>
    <phone>02-419-1000</phone>
    <email>siriwan_monk@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Dermatology, Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Woraphong Manuskiatti, M.D.</last_name>
      <phone>081-915-0555</phone>
      <email>doctorlaser@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Siriwan Palawisuth, M.D.</last_name>
      <phone>089-022-4215</phone>
      <email>siriwan_monk@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Woraphong Manuskiatti, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rungsima Wanitphakdeedacha, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Siriwan Palawisuth, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chalermkwan Apinuntham, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>March 11, 2021</last_update_submitted>
  <last_update_submitted_qc>March 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Woraphong Manuskiatti, M.D.</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT04471948
org study id: Si379/2019
nct id: NCT04471948
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to evaluate the safety and efficacy of 1064-nm Picosecond
      laser 1064 With Microlens Array for Pore tightening.
The Safety and Efficacy of Picosecond laser 1064 Nanometers With Microlens Array for Pore
      tightening; a Pilot Study Primary outcome : pore size Secondary outcome : side effect,
      patient satisfaction, global evaluation the patient recieved laser treament once a month for
      3 months and then follow up after last treatment at 1, 3 ,6 month

      Enlarged facial pores is one of the skin signs in photoaging. There are 3 major clinical
      causes of enlarged facial pores: highs sebum excretion, decreased elasticity around pores and
      increased hair follicle volume. Possible causative factors of enlarged facial pores include
      many exogenous and endogenous factors include genetic predisposition, seborrhea and chronic
      ultraviolet light exposure. Picosecond laser are new device which has been used in skin
      rejuvenation. The main mechanism of action is laser induced optical breakdown (LIOB).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in pore size by Antera 3D image
time frame: change from baseline in pore size at 6 months
arm group label: Fractional picosecond laser 1,064 nm laser
arm group type: Experimental
description: 1 arm The subjects with enlarged pores were treated with fractional picosecond laser 1,064 nm laser
intervention type: Device
intervention name: Fractional picosecond 1064 nm laser
description: The parameter of laser was 8 mm spot size, 0.8 mJ/CM2, 750 ps, 5 Hz, 2 passes The treatment was done in every 4 weeks for 3 sessions.
arm group label: Fractional picosecond laser 1,064 nm laser
criteria: 
gender: All
minimum age: 25 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: woraphong Manuskiatti, M.D.
role: Principal Investigator
affiliation: Mahidol University
last name: woraphong Manuskiatti, M.D.
phone: 02-419-1000
email: doctorlaser@gmail.com
last name: Siriwan palawisuth, M.D.
phone: 02-419-1000
email: siriwan_monk@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Woraphong Manuskiatti, M.D.
investigator title: Professor