<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/NCT03277287</url>
  </required_header>
  <id_info>
    <org_study_id>CO2 laser in cleft lip scar</org_study_id>
    <nct_id>NCT03277287</nct_id>
  </id_info>
  <brief_title>Assessment of Fractional CO2 Laser in Treatment of Post-surgical Scarring of Cleft Lip</brief_title>
  <official_title>Assessment of Fractional CO2 Laser in Treatment of Post-surgical Scarring of Cleft Lip</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <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>
      This is a prospective comparative study on 120 patients divided to three groups. Group A: 40&#xD;
      patients laser will be applied 3 weeks post-surgical. Group B: 40 patients laser will be&#xD;
      applied 3 months post surgical. Group C: 40 patients as a control not treated with laser from&#xD;
      2017 to 2020 which will be conducted on patients with post-surgical cleft lip repair scaring.&#xD;
&#xD;
      All patients will have 5-7 sessions with 4 weeks interval.&#xD;
&#xD;
      Photographic documentation and evaluation of the scar will occur every 4 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The carbon dioxide laser (CO2 Laser) was one of the earliest gas lasers to be developed. It&#xD;
      was invented by Kumar Patel of Bell Labs in 1964.&#xD;
&#xD;
      CO2 laser is the highest power continuous wave lasers that are currently available which&#xD;
      produces a beam of infrared light with the principal wavelength bands centering on 9.4 and&#xD;
      10.6 micrometers. Patel, C. K. N. (1964).&#xD;
&#xD;
      When CO2 beam of light is selectively applied to the skin, it heats and vaporizes various&#xD;
      layers of skin, instantly treating damaged skin and wrinkles while smoothing out the surface&#xD;
      of the skin.&#xD;
&#xD;
      The skin remodeling occurs with new skin and collagen growth. The healing typically involves&#xD;
      an open surface which takes weeks to heal and typically results in loss of the baseline&#xD;
      pigmentation leading to variable lightening of skin. Dover, J. S. (2012) Fractional CO2 laser&#xD;
      resurfacing is a revolutionary delivery system that provides dramatic skin improvement&#xD;
      without surgery. Matrix combines the benefits of CO2 laser by using micro laser columns&#xD;
      &quot;points of light&quot; to treat the epidermis and dermal layers of your skin.&#xD;
&#xD;
      Bernstein et al, (1997) Cleft lip is a form of lip malformation that occurs very early in&#xD;
      pregnancy, the incidence of cleft lip in the population is approximately 0.5-2 in 1000 live&#xD;
      births. Male children are affected more often than female children.&#xD;
&#xD;
      Michalski AM et al, (2015). Because each cleft is unique, definitive repair of the cleft lip&#xD;
      should be individualized as Mirault, Le Mesurier, Tennison, and Millard.&#xD;
&#xD;
      Stal S et al, (2009)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">February 15, 2020</completion_date>
  <primary_completion_date type="Actual">January 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>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Prospective comparative study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vancouver scar scale</measure>
    <time_frame>5 -7 months</time_frame>
    <description>It assess four variables:vascularity , height/thickness , pigmentation , pliability</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale</measure>
    <time_frame>5-7 months</time_frame>
    <description>This depends on 5 independent medical and nonmedical personnel rating results on a graded scale 0-10</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Cleft Lip Post-surgical Scar</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fractional CO2 laser will be applied on cleft lip scar 3 weeks post-surgical</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fractional CO2 laser will be applied on cleft lip scar 3 months post-surgical</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Fractional CO2 laser</intervention_name>
    <description>Fractional CO2 laser will be applied in cleft lip scar to assess and evaluate the later appearance of the scar</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any age with acceptable scar which would not need further revision.&#xD;
&#xD;
          -  Group A: three weeks after repair &amp; group B: three months after repair with no&#xD;
             hypertrophy, erythema or any other scar complication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any case with deformity needing further surgical interference.&#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_official>
    <last_name>Wagdi Ali, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed Elshazly, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mohamed shadad</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>April 17, 2020</last_update_submitted>
  <last_update_submitted_qc>April 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed Shadad Rateb Mohamed</investigator_full_name>
    <investigator_title>Resident doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cleft Lip</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03277287
org study id: CO2 laser in cleft lip scar
nct id: NCT03277287
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a prospective comparative study on 120 patients divided to three groups. Group A: 40
      patients laser will be applied 3 weeks post-surgical. Group B: 40 patients laser will be
      applied 3 months post surgical. Group C: 40 patients as a control not treated with laser from
      2017 to 2020 which will be conducted on patients with post-surgical cleft lip repair scaring.

      All patients will have 5-7 sessions with 4 weeks interval.

      Photographic documentation and evaluation of the scar will occur every 4 weeks.
The carbon dioxide laser (CO2 Laser) was one of the earliest gas lasers to be developed. It
      was invented by Kumar Patel of Bell Labs in 1964.

      CO2 laser is the highest power continuous wave lasers that are currently available which
      produces a beam of infrared light with the principal wavelength bands centering on 9.4 and
      10.6 micrometers. Patel, C. K. N. (1964).

      When CO2 beam of light is selectively applied to the skin, it heats and vaporizes various
      layers of skin, instantly treating damaged skin and wrinkles while smoothing out the surface
      of the skin.

      The skin remodeling occurs with new skin and collagen growth. The healing typically involves
      an open surface which takes weeks to heal and typically results in loss of the baseline
      pigmentation leading to variable lightening of skin. Dover, J. S. (2012) Fractional CO2 laser
      resurfacing is a revolutionary delivery system that provides dramatic skin improvement
      without surgery. Matrix combines the benefits of CO2 laser by using micro laser columns
      "points of light" to treat the epidermis and dermal layers of your skin.

      Bernstein et al, (1997) Cleft lip is a form of lip malformation that occurs very early in
      pregnancy, the incidence of cleft lip in the population is approximately 0.5-2 in 1000 live
      births. Male children are affected more often than female children.

      Michalski AM et al, (2015). Because each cleft is unique, definitive repair of the cleft lip
      should be individualized as Mirault, Le Mesurier, Tennison, and Millard.

      Stal S et al, (2009)
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Prospective comparative study
primary purpose: Treatment
masking: Single (Participant)
measure: Vancouver scar scale
time frame: 5 -7 months
description: It assess four variables:vascularity , height/thickness , pigmentation , pliability
measure: Visual analogue scale
time frame: 5-7 months
description: This depends on 5 independent medical and nonmedical personnel rating results on a graded scale 0-10
arm group label: Group A
arm group type: Experimental
description: Fractional CO2 laser will be applied on cleft lip scar 3 weeks post-surgical
arm group label: Group B
arm group type: Experimental
description: Fractional CO2 laser will be applied on cleft lip scar 3 months post-surgical
arm group label: Group C
arm group type: No Intervention
description: No intervention
intervention type: Radiation
intervention name: Fractional CO2 laser
description: Fractional CO2 laser will be applied in cleft lip scar to assess and evaluate the later appearance of the scar
arm group label: Group A
arm group label: Group B
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Wagdi Ali, Dr
role: Study Director
affiliation: Assiut University
last name: Mohamed Elshazly, Prof.
role: Principal Investigator
affiliation: Assiut University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed Shadad Rateb Mohamed
investigator title: Resident doctor
mesh term: Cleft Lip
sharing ipd: Yes