xml: <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/NCT05985265</url>
    </required_header>
    <id_info>
      <org_study_id>nano fat injection</org_study_id>
      <nct_id>NCT05985265</nct_id>
    </id_info>
    <brief_title>Nano Fat Injection With or Without Fractional Carbon Dioxide Laser in Acne Scars</brief_title>
    <official_title>Assessment of Nano Fat Grafting Combined With Fractional Carbon Dioxide Laser Resurfacing Versus Nano Fat Grafting Alone in Atrophic Facial Acne Scars</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut 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>
        Assessment of nano fat grafting combined with carbon dioxide laser resurfacing versus nano&#xD;
        fat grafting alone in treating facial atrophic acne scars&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Acne scars is a world wide problem .though lots of treatment exists still mo gold standard&#xD;
        for treatment of acne scars in this study.&#xD;
  &#xD;
        Assessment of nano fat grafting combined with carbon dioxide laser resurfacing versus nano&#xD;
        fat grafting alone in treating facial atrophic acne scars&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">May 29, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 29, 2024</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>Clinical assessment of acne scar severity</measure>
      <time_frame>up to 24 weeks</time_frame>
      <description>as assessed using the Goodman and Baron Qualitative scar grading system before and after treatment on both sides of face, to determine the number of patients achieving two grades improvement vs one grade or no improvement</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physician global assessment</measure>
      <time_frame>up to 24 weeks</time_frame>
      <description>two blinded observers will compare the before and after photographs separately on each facial side and will evaluate the improvement on a quartile grading scale as: poor,&lt;25% improvement; fair, 25%-50% improvement; good, 51%-75% improvement; and excellent, &gt;75% improvement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>percent of reduction in scar count</measure>
      <time_frame>up to 24 weeks</time_frame>
      <description>count of the total and different types of acne scars was performed, before and after treatment on both sides of the face, and the percent of reduction was calculated</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>1 year</time_frame>
      <description>Patients will rate their overall satisfaction on a quartile grading system: 0, unsatisfied; 1, slightly satisfied; 2, satisfied; and 3, very satisfied</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>1 year</time_frame>
      <description>erythema, edema, crusting, pigmentary changes, ecchymosis, and scarring, will be recorded</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Acne Scars - Atrophic</condition>
    <arm_group>
      <arm_group_label>Nano fat grafting and fractional carbon dioxide laser resurfacing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>treating of atrophic acne scars with nano fat and fractional carbon dioxide laser</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Fat grafting</intervention_name>
      <description>Nano fat grafting followed by fractional carbon dioxide laser resurfacing</description>
      <arm_group_label>Nano fat grafting and fractional carbon dioxide laser resurfacing</arm_group_label>
      <other_name>fractional carbon dioxide laser resurfacing</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients older than 18 years who attend the Outpatient Clinics of Dermatology and&#xD;
               Plastic Surgery Departments, Assiut University Hospital, with moderate to severe&#xD;
               atrophic facial acne scars on both cheeks, as assessed using the Goodman and Baron&#xD;
               Qualitative scar grading system (12), will be enrolled in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  include: pregnancy or lactation; active acne, history of deep chemical peeling or&#xD;
               filler injection in the previous 6 months, history of keloid or hypertrophic scar&#xD;
               formation; use of isotretinoin in the previous 6 months; active infection in the&#xD;
               treatment area; bleeding tendencies; history of herpes simplex or herpes zoster&#xD;
               infection on the face; and patients with unrealistic expectations.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>youssef S farrag, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Plastic Surgery, professor</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Wael S Ibraheem, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Plastic Surgery , Assistant lecture</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>mohammed H Abdelhafez, MBBS</last_name>
      <phone>+201099068855</phone>
      <email>Dr.m.zayan@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>sara M Awad, MD</last_name>
      <phone>+201023102094</phone>
      <email>saramawad@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Faculty of Medicine, Assiut University</name>
        <address>
          <city>Assiut</city>
          <zip>71111</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Mohammed H Abdelhafez, MBBS</last_name>
        <phone>+201099068855</phone>
        <phone_ext>0882315377</phone_ext>
        <email>Dr.m.Zayan2@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x.</citation>
      <PMID>17199653</PMID>
    </reference>
    <results_reference>
      <citation>Jacob CI, Dover JS, Kaminer MS. Acne scarring: a classification system and review of treatment options. J Am Acad Dermatol. 2001 Jul;45(1):109-17. doi: 10.1067/mjd.2001.113451.</citation>
      <PMID>11423843</PMID>
    </results_reference>
    <results_reference>
      <citation>Chan NP, Ho SG, Yeung CK, Shek SY, Chan HH. Fractional ablative carbon dioxide laser resurfacing for skin rejuvenation and acne scars in Asians. Lasers Surg Med. 2010 Nov;42(9):615-23. doi: 10.1002/lsm.20974.</citation>
      <PMID>20976801</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>November 15, 2022</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Mohammed Hisham Zayan</investigator_full_name>
      <investigator_title>resident plastic surgery department</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrophy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985265
  org study id: nano fat injection
  nct id: NCT05985265
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Assessment of nano fat grafting combined with carbon dioxide laser resurfacing versus nano
        fat grafting alone in treating facial atrophic acne scars
  Acne scars is a world wide problem .though lots of treatment exists still mo gold standard
        for treatment of acne scars in this study.
  
        Assessment of nano fat grafting combined with carbon dioxide laser resurfacing versus nano
        fat grafting alone in treating facial atrophic acne scars
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Clinical assessment of acne scar severity
  time frame: up to 24 weeks
  description: as assessed using the Goodman and Baron Qualitative scar grading system before and after treatment on both sides of face, to determine the number of patients achieving two grades improvement vs one grade or no improvement
  measure: Physician global assessment
  time frame: up to 24 weeks
  description: two blinded observers will compare the before and after photographs separately on each facial side and will evaluate the improvement on a quartile grading scale as: poor,<25% improvement; fair, 25%-50% improvement; good, 51%-75% improvement; and excellent, >75% improvement.
  measure: percent of reduction in scar count
  time frame: up to 24 weeks
  description: count of the total and different types of acne scars was performed, before and after treatment on both sides of the face, and the percent of reduction was calculated
  measure: Patient satisfaction
  time frame: 1 year
  description: Patients will rate their overall satisfaction on a quartile grading system: 0, unsatisfied; 1, slightly satisfied; 2, satisfied; and 3, very satisfied
  measure: Adverse events
  time frame: 1 year
  description: erythema, edema, crusting, pigmentary changes, ecchymosis, and scarring, will be recorded
  arm group label: Nano fat grafting and fractional carbon dioxide laser resurfacing
  arm group type: Experimental
  description: treating of atrophic acne scars with nano fat and fractional carbon dioxide laser
  intervention type: Procedure
  intervention name: Fat grafting
  description: Nano fat grafting followed by fractional carbon dioxide laser resurfacing
  arm group label: Nano fat grafting and fractional carbon dioxide laser resurfacing
  other name: fractional carbon dioxide laser resurfacing
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: youssef S farrag, MD
  role: Principal Investigator
  affiliation: Department of Plastic Surgery, professor
  last name: Wael S Ibraheem, MD
  role: Principal Investigator
  affiliation: Department of Plastic Surgery , Assistant lecture
  last name: mohammed H Abdelhafez, MBBS
  phone: +201099068855
  email: Dr.m.zayan@gmail.com
  last name: sara M Awad, MD
  phone: +201023102094
  email: saramawad@gmail.com
  facility: 
  contact: 
  country: Egypt
  citation: Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x.
  PMID: 17199653
  citation: Jacob CI, Dover JS, Kaminer MS. Acne scarring: a classification system and review of treatment options. J Am Acad Dermatol. 2001 Jul;45(1):109-17. doi: 10.1067/mjd.2001.113451.
  PMID: 11423843
  citation: Chan NP, Ho SG, Yeung CK, Shek SY, Chan HH. Fractional ablative carbon dioxide laser resurfacing for skin rejuvenation and acne scars in Asians. Lasers Surg Med. 2010 Nov;42(9):615-23. doi: 10.1002/lsm.20974.
  PMID: 20976801
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Mohammed Hisham Zayan
  investigator title: resident plastic surgery department
  mesh term: Atrophy
  sharing ipd: No