<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/NCT04481178</url>
  </required_header>
  <id_info>
    <org_study_id>si347/2020</org_study_id>
    <nct_id>NCT04481178</nct_id>
  </id_info>
  <brief_title>A Retrospective Study on Laser Treatment of Nevus of Ota in Thai Patients</brief_title>
  <official_title>A Retrospective Study on Laser Treatment of Nevus of Ota in Thai Patients</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>
      A retrospective study on efficacy and complication of laser treatment (Q-switched Nd:YAG and&#xD;
      picosecond laser) of nevus of Ota in Thai patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nevus of Ota is a benign dermal melanocytic nevus found most commonly in Asians. About 50-60%&#xD;
      of all cases have the age of onset at birth or within the first year of life, others appear&#xD;
      before puberty. It typically presents as a unilateral mottled blue-gray macules and patches&#xD;
      distributed along the first and second branches of trigeminal nerve. Due to its marked&#xD;
      hyperpigmentation on the face which does not resolved spontaneously, patients may experience&#xD;
      psychosocial disturbances and often seek for treatments. Based on selective photothermolysis&#xD;
      theory, Q-switched lasers (ruby 694nm, alexandrite 755nm, Nd:YAG 1064nm) have been used for&#xD;
      the treatment of nevus of Ota with a success rate of 95% after 6-8 sessions. Reported&#xD;
      complications from the lasers are hypopigmentation(15.3%), hyperpigmentation(2.9%), texture&#xD;
      changes (2.9%), and scarring (1.9%). Siriraj Skin Laser Center provides laser treatment for&#xD;
      nevus of Ota using mainly Q-switched Nd:YAG laser and Picosecond laser. The study of efficacy&#xD;
      and complications of Q-switched Nd:YAG and Picosecond laser in the treatment of Nevus of Ota&#xD;
      in Thai patients has never been reported. Therefore, we conduct a retrospective study on&#xD;
      efficacy and complication of laser treatment (Q-switched Nd:YAG and picosecond laser) of&#xD;
      nevus of Ota in Thai patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 15, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of laser treatment in paitients with Nevus of Ota</measure>
    <time_frame>2008-2018</time_frame>
    <description>Fading of lesions after treatment by chart review</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication of laser such as hyperpigmentation, hypopigmentation, and scars</measure>
    <time_frame>2008-2018</time_frame>
    <description>Complication of laser such as hyperpigmentation, hypopigmentation, and scars</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse rate after laser treatment</measure>
    <time_frame>2008-2018</time_frame>
    <description>rate of recurrence after treatment</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">79</enrollment>
  <condition>Focus on Laser Treatment of Nevus of Ota in Thai Patients</condition>
  <arm_group>
    <arm_group_label>patients with nevus of Ota</arm_group_label>
    <description>patients with nevus of Ota who had been treated with laser at Siriraj hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laser (QS, Picosecond laser)</intervention_name>
    <description>QS-Nd Yag Laser, Picosecond laser</description>
    <arm_group_label>patients with nevus of Ota</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with Nevus of Ota&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with Nevus of Ota&#xD;
&#xD;
          -  Complete data between January 2008 - December 2018&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incomplete data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Prof. Woraphong Manuskiatti, M.D.</last_name>
    <phone>+6624197000</phone>
    <phone_ext>4333</phone_ext>
    <email>woraphong.man@mahidol.ac.th</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Petchlada Achavanuntakul, M.D.</last_name>
    <phone>+66896789944</phone>
    <email>Petchlada.acha@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Medicine Siriraj Hospital</name>
      <address>
        <city>Bangkoknoi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <contact>
      <last_name>Woraphong Manuskiatti, M.D.</last_name>
      <phone>662-419-4333</phone>
      <email>siwmn@mahidol.ac.th</email>
    </contact>
    <contact_backup>
      <last_name>Rungsima Wanitphakdeedecha, M.D.</last_name>
      <phone>662-419-9922</phone>
      <email>sirwn@mahidol.ac.th</email>
    </contact_backup>
    <investigator>
      <last_name>Woraphong Manuskiatti, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rungsima Wanitphakdeedecha, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sasima Eimpunth, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Petchlada Achavanuntakul, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>September 11, 2020</last_update_submitted>
  <last_update_submitted_qc>September 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 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>Nevus of Ota, laser treatment, Thai</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nevus</mesh_term>
    <mesh_term>Nevus of Ota</mesh_term>
  </condition_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/NCT04481178
org study id: si347/2020
nct id: NCT04481178
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A retrospective study on efficacy and complication of laser treatment (Q-switched Nd:YAG and
      picosecond laser) of nevus of Ota in Thai patients
Nevus of Ota is a benign dermal melanocytic nevus found most commonly in Asians. About 50-60%
      of all cases have the age of onset at birth or within the first year of life, others appear
      before puberty. It typically presents as a unilateral mottled blue-gray macules and patches
      distributed along the first and second branches of trigeminal nerve. Due to its marked
      hyperpigmentation on the face which does not resolved spontaneously, patients may experience
      psychosocial disturbances and often seek for treatments. Based on selective photothermolysis
      theory, Q-switched lasers (ruby 694nm, alexandrite 755nm, Nd:YAG 1064nm) have been used for
      the treatment of nevus of Ota with a success rate of 95% after 6-8 sessions. Reported
      complications from the lasers are hypopigmentation(15.3%), hyperpigmentation(2.9%), texture
      changes (2.9%), and scarring (1.9%). Siriraj Skin Laser Center provides laser treatment for
      nevus of Ota using mainly Q-switched Nd:YAG laser and Picosecond laser. The study of efficacy
      and complications of Q-switched Nd:YAG and Picosecond laser in the treatment of Nevus of Ota
      in Thai patients has never been reported. Therefore, we conduct a retrospective study on
      efficacy and complication of laser treatment (Q-switched Nd:YAG and picosecond laser) of
      nevus of Ota in Thai patients.
observational model: Other
time perspective: Retrospective
measure: Efficacy of laser treatment in paitients with Nevus of Ota
time frame: 2008-2018
description: Fading of lesions after treatment by chart review
measure: Complication of laser such as hyperpigmentation, hypopigmentation, and scars
time frame: 2008-2018
description: Complication of laser such as hyperpigmentation, hypopigmentation, and scars
measure: Relapse rate after laser treatment
time frame: 2008-2018
description: rate of recurrence after treatment
arm group label: patients with nevus of Ota
description: patients with nevus of Ota who had been treated with laser at Siriraj hospital
intervention type: Other
intervention name: Laser (QS, Picosecond laser)
description: QS-Nd Yag Laser, Picosecond laser
arm group label: patients with nevus of Ota
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Prof. Woraphong Manuskiatti, M.D.
phone: +6624197000
phone ext: 4333
email: woraphong.man@mahidol.ac.th
last name: Petchlada Achavanuntakul, M.D.
phone: +66896789944
email: Petchlada.acha@gmail.com
facility: 
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
mesh term: Nevus
mesh term: Nevus of Ota
sharing ipd: No