<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/NCT04456257</url>
  </required_header>
  <id_info>
    <org_study_id>Si 591/2561</org_study_id>
    <nct_id>NCT04456257</nct_id>
  </id_info>
  <brief_title>The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae</brief_title>
  <official_title>The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the efficacy and safety of a fractional 1,064 nm&#xD;
      picosecond laser for the treatment of striae alba.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Striae distensae are atrophic dermal scars that can cause psychosocial distress on affected&#xD;
      patients. Despite numerous available therapeutic modalities, no gold standard therapy has&#xD;
      been established. Picosecond lasers are a newer advancement in lasers that have primarily&#xD;
      used in the treatment of tattoos. A fractional 1064-nm picosecond laser has recently become&#xD;
      available for the treatment of pigmentation and skin rejuvenation. The main mechanism of&#xD;
      action is tissue ablation via laser induced optical breakdown (LIOB) which occur when pulse&#xD;
      intensity is high enough to strip electrons and generating plasma, the plasma absorbs the&#xD;
      remaining laser energy forming a cavitation bubble within the dermis which has been&#xD;
      demonstrated to improve fine wrinkles and acne scar through the stimulation of collagen&#xD;
      formation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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 striae roughness by Antera 3D image</measure>
    <time_frame>change from baseline in striae roughness score at 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in average Melanin index by Antera 3D image</measure>
    <time_frame>change from baseline in average melanin index at 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in melanin variation index by Antera 3D image</measure>
    <time_frame>change from baseline in melanin variation index at 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigator assessment scores</measure>
    <time_frame>Baseline, 1, 3 and 6 months after final treatment</time_frame>
    <description>Clinical improvement was evaluated by comparing pre and post photographs by 2 independent investigators.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction scores</measure>
    <time_frame>Baseline, 1, 3, and 6 months after final treatment</time_frame>
    <description>patient satisfaction questionnaire was done by grading on a scale of 0 to 4; 0: no improvement, 1: &lt;25% improvement, 2: 25-50% improvement, 3: 51-75% improvement, 4: &gt; 75% improvement</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Striae Alba</condition>
  <arm_group>
    <arm_group_label>Fractional Picosecond 1,064 nm laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects with abdominal striae alba were treated with a fractional picosecond 1,064 nm laser</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>fractional picosecond 1,064 nm laser</intervention_name>
    <description>The parameter of laser was 8-mm spot size, 0.6 mJ/cm2, 750 ps, 10 Hz, 2 passes. The treatment was done in every 4 weeks for 4 sessions.</description>
    <arm_group_label>Fractional Picosecond 1,064 nm laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Striae alba on abdomen for more than 3 months&#xD;
&#xD;
          -  Fitzpatrick skin type III-V&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and breastfeeding&#xD;
&#xD;
          -  Previous topical treatment, filler injection, chemical peel or laser treatment within&#xD;
             6 months before starting the study&#xD;
&#xD;
          -  History of using Isotretinoin&#xD;
&#xD;
          -  Photosensitive dermatoses, Infection, eczema&#xD;
&#xD;
          -  Past history or family history of malignancy&#xD;
&#xD;
          -  History of herpes infection&#xD;
&#xD;
          -  History of hypertrophic scar or keloid, connective tissue disease&#xD;
&#xD;
          -  History of collagen or elastin disease&#xD;
&#xD;
          -  History of smoking&#xD;
&#xD;
          -  Significant fluctuations in weight in the past 6 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Woraphong Manuskiatti, M.D.</last_name>
    <phone>+66819150555</phone>
    <email>doctorlaser@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Arisa Kaewkes, M.D.</last_name>
    <phone>+66895710956</phone>
    <email>searisa@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Medicine, Siriraj hospital, Mahidol University</name>
      <address>
        <city>Bangkok Noi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Woraphong Manuskiatti, M.D.</last_name>
      <phone>+6624199922</phone>
      <email>doctorlaser@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Arisa Kaewkes, M.D.</last_name>
      <phone>+66895710956</phone>
      <email>searisa@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</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>
  <keyword>striae alba, fractional picosecond laser, stretch marks</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Striae Distensae</mesh_term>
  </condition_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/NCT04456257
org study id: Si 591/2561
nct id: NCT04456257
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objective of this study is to evaluate the efficacy and safety of a fractional 1,064 nm
      picosecond laser for the treatment of striae alba.
Striae distensae are atrophic dermal scars that can cause psychosocial distress on affected
      patients. Despite numerous available therapeutic modalities, no gold standard therapy has
      been established. Picosecond lasers are a newer advancement in lasers that have primarily
      used in the treatment of tattoos. A fractional 1064-nm picosecond laser has recently become
      available for the treatment of pigmentation and skin rejuvenation. The main mechanism of
      action is tissue ablation via laser induced optical breakdown (LIOB) which occur when pulse
      intensity is high enough to strip electrons and generating plasma, the plasma absorbs the
      remaining laser energy forming a cavitation bubble within the dermis which has been
      demonstrated to improve fine wrinkles and acne scar through the stimulation of collagen
      formation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in striae roughness by Antera 3D image
time frame: change from baseline in striae roughness score at 6 months
measure: Change in average Melanin index by Antera 3D image
time frame: change from baseline in average melanin index at 6 months
measure: Change in melanin variation index by Antera 3D image
time frame: change from baseline in melanin variation index at 6 months
measure: Investigator assessment scores
time frame: Baseline, 1, 3 and 6 months after final treatment
description: Clinical improvement was evaluated by comparing pre and post photographs by 2 independent investigators.
measure: Patient satisfaction scores
time frame: Baseline, 1, 3, and 6 months after final treatment
description: patient satisfaction questionnaire was done by grading on a scale of 0 to 4; 0: no improvement, 1: <25% improvement, 2: 25-50% improvement, 3: 51-75% improvement, 4: > 75% improvement
arm group label: Fractional Picosecond 1,064 nm laser
arm group type: Experimental
description: The subjects with abdominal striae alba were treated with a fractional picosecond 1,064 nm laser
intervention type: Device
intervention name: fractional picosecond 1,064 nm laser
description: The parameter of laser was 8-mm spot size, 0.6 mJ/cm2, 750 ps, 10 Hz, 2 passes. The treatment was done in every 4 weeks for 4 sessions.
arm group label: Fractional Picosecond 1,064 nm laser
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Woraphong Manuskiatti, M.D.
phone: +66819150555
email: doctorlaser@gmail.com
last name: Arisa Kaewkes, M.D.
phone: +66895710956
email: searisa@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Woraphong Manuskiatti, M.D.
investigator title: Professor
mesh term: Striae Distensae