<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/NCT04470466</url>
  </required_header>
  <id_info>
    <org_study_id>las49</org_study_id>
    <nct_id>NCT04470466</nct_id>
  </id_info>
  <brief_title>Short Pulse and Q-switched ND-YAG Laser With Topical Carbon Versus Fractional CO2 Laser for Enlarged Facial Pores</brief_title>
  <official_title>Short Pulse and Q-switched ND-YAG Laser With Topical Carbon Versus Fractional CO2 Laser in Treatment of Enlarged Facial Pores: A Split-face Comparative Study</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>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Facial pores are visible topographic features of the skin that reflect openings of&#xD;
      pilosebaceous follicles, that may be enlarged causing distress to some individuals. Many&#xD;
      patients desire treatment for this condition, which can be an early sign of skin aging.&#xD;
      Therapeutic modalities include intense pulsed light, radiofrequency, dermabrasion, oral and&#xD;
      topical retinoids, as well as chemical peeling. Lasers, as fractional CO2, short pulse and&#xD;
      Q-switched Nd-YAG, can potentially be used in treatment of wide pores.&#xD;
&#xD;
      This study aims at the assessment and comparison of therapy with short pulsed and Q-switched&#xD;
      Nd-YAG laser plus topical carbon with fractional CO2 laser in the management of wide facial&#xD;
      pores.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      topical carbon cream will be applied to one side of the face in patients with wide facial&#xD;
      pores, followed by 2 passes of short pulse 1064 ND:YAG laser, then one pass of Q-switched&#xD;
      ND-YAG laser.&#xD;
&#xD;
      fractional CO2 laser will be performed to the other half of the face. the patients will&#xD;
      receive 2 treatment sessions&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 19, 2020</start_date>
  <completion_date type="Actual">October 12, 2020</completion_date>
  <primary_completion_date type="Actual">October 12, 2020</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>the percentage of decrease in size of enlarged facial pores assessed clinically and by dermoscopy</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Skin Lesion</condition>
  <arm_group>
    <arm_group_label>short pulse and Q-switched ND-YAG laser with topical carbon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Fractional CO2 Laser</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>short pulse and Q-switched ND-YAG laser with topical carbon</intervention_name>
    <description>application of topical carbon cream, followed by two passes of short pulse 1064 ND-YAG, then one pass of Q-switched 1064 ND-YAG on one side of the face</description>
    <arm_group_label>short pulse and Q-switched ND-YAG laser with topical carbon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>fractional CO2 laser</intervention_name>
    <description>single pass of fractional CO2 laser on the other side of the face</description>
    <arm_group_label>Fractional CO2 Laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who are more than 18 years old with the large facial pores and are aware&#xD;
             of their problem and seeking treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Previous laser therapy, chemical peeling, microdermabrasion or cosmetic procedure&#xD;
             for the face.&#xD;
&#xD;
               -  Patients with any contraindication to laser therapy such as photosensitive&#xD;
                  diseases, skin malignancies, patients on oral retinoids.&#xD;
&#xD;
               -  Keloid-forming tendency.&#xD;
&#xD;
               -  Local or systemic treatment for skin pores in the previous 3 months&#xD;
&#xD;
               -  Connective tissue disease or the use of immunosuppressive medications.&#xD;
&#xD;
               -  Pregnancy.&#xD;
&#xD;
               -  Present or past history of herpes labialis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kasr Alainy</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>October 13, 2020</last_update_submitted>
  <last_update_submitted_qc>October 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Dina Saadi</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <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/NCT04470466
org study id: las49
nct id: NCT04470466
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
Facial pores are visible topographic features of the skin that reflect openings of
      pilosebaceous follicles, that may be enlarged causing distress to some individuals. Many
      patients desire treatment for this condition, which can be an early sign of skin aging.
      Therapeutic modalities include intense pulsed light, radiofrequency, dermabrasion, oral and
      topical retinoids, as well as chemical peeling. Lasers, as fractional CO2, short pulse and
      Q-switched Nd-YAG, can potentially be used in treatment of wide pores.

      This study aims at the assessment and comparison of therapy with short pulsed and Q-switched
      Nd-YAG laser plus topical carbon with fractional CO2 laser in the management of wide facial
      pores.
topical carbon cream will be applied to one side of the face in patients with wide facial
      pores, followed by 2 passes of short pulse 1064 ND:YAG laser, then one pass of Q-switched
      ND-YAG laser.

      fractional CO2 laser will be performed to the other half of the face. the patients will
      receive 2 treatment sessions
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: the percentage of decrease in size of enlarged facial pores assessed clinically and by dermoscopy
time frame: 2 months
arm group label: short pulse and Q-switched ND-YAG laser with topical carbon
arm group type: Active Comparator
arm group label: Fractional CO2 Laser
arm group type: Active Comparator
intervention type: Device
intervention name: short pulse and Q-switched ND-YAG laser with topical carbon
description: application of topical carbon cream, followed by two passes of short pulse 1064 ND-YAG, then one pass of Q-switched 1064 ND-YAG on one side of the face
arm group label: short pulse and Q-switched ND-YAG laser with topical carbon
intervention type: Device
intervention name: fractional CO2 laser
description: single pass of fractional CO2 laser on the other side of the face
arm group label: Fractional CO2 Laser
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Dina Saadi
investigator title: principal investigator
sharing ipd: No