<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/NCT03807986</url>
  </required_header>
  <id_info>
    <org_study_id>Xiao FirstJinanU</org_study_id>
    <nct_id>NCT03807986</nct_id>
  </id_info>
  <brief_title>The Combination Therapy of Nanofat Grafting and PRP Compared With Microfat Grafting and PRP Synergy in Treating Striae Distensae</brief_title>
  <official_title>The Combination Therapy of Nanofat Grafting and Platelet-Rich Plasma Injection Compared With Microfat Grafting and Platelet-Rich Plasma Injection Synergy in Treating Striae Distensae</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Jinan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Science and Technology Program of Guangzhou,Guangzhou Sipintang Biological technology Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital of Jinan University</source>
  <oversight_info>
    <has_dmc>No</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>
      Striae distensae is caused by the fracture and damage of the elastic fibers and collagen&#xD;
      fibers, which is still a difficulty to overcome. Based on the studies demonstrated that&#xD;
      platelet-rich plasma(PRP) has positive effect on superficial scar, and nanofat and microfat&#xD;
      are effective in treating atrophic scar. So in this clinical trial, the investigators are&#xD;
      going to treat striae distensae by using two combination therapies. One is nanofat grafting&#xD;
      and PRP injection synergy, and the other one is treated by microfat grafting with PRP&#xD;
      injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants were randomly assigned into two groups. Group A is treated by nanofat&#xD;
      grafting once every three months for 2 times combined with PRP injection once a month for 6&#xD;
      times. Group B will be treated by microfat grafting onceevery three months for 2 times&#xD;
      combined with PRP injection once a month for 6 times. The participants were asked to come&#xD;
      back 1、3、6、9 months after treatment for further follow-up.Before and after the treatment, the&#xD;
      striae distensae will be assessed subjectively by satisfaction assessment, and objectively by&#xD;
      ultrasound and immunohistochemical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2019</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immunohistochemical analysis</measure>
    <time_frame>Change from baseline at 15 months.</time_frame>
    <description>The tissue extracted will be taken for immunohistochemical analysis to observe the amount of elastic fiber and collagen fiber,etc. More collagen fiber generated better outcome of the treatments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ultrasound</measure>
    <time_frame>Change from baseline dermal thickness at 3,6,9,12,15 months of the treatments.</time_frame>
    <description>The striae distensae will be assessed by ultrasound in order to observe the change of dermal thickness of striae after the application of nanofat or microfat grafting with PRP injection. if the treatments worked, the dermal thickness will be increased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasound</measure>
    <time_frame>Change from baseline width of striae at 3,6,9,12,15 months of the treatments.</time_frame>
    <description>The striae distensae will be assessed by ultrasound in order to observe the change of width of striae after the application of nanofat or microfat grafting with PRP injection. Smaller the width better the results.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Satisfaction assessments of participants: questionnaire</measure>
    <time_frame>At 15th month.</time_frame>
    <description>The participants will fill in a questionnaire about the efficacy of the treatments. Participants will choose one of the following answers 'satisfied, unchanged, not satisfied' as feedback.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Treatments of Striae Distensae</condition>
  <arm_group>
    <arm_group_label>Nanofat grafting and PRP injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Striae diatensae will be treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microfat grafting and PRP injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Striae diatensae will be treated by microfat grafting once every three months for 2 times combined with PRP injection once a month for 6 times.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Nanofat grafting</intervention_name>
    <description>Nanofat grafting will be applied once every three months for 2 times.</description>
    <arm_group_label>Nanofat grafting and PRP injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Microfat grafting</intervention_name>
    <description>Microfat grafting will be applied once every three months for 2 times.</description>
    <arm_group_label>Microfat grafting and PRP injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Platelet-rich plasma (PRP) Injection</intervention_name>
    <description>PRP Injection will be applied once a month for 6 times.</description>
    <arm_group_label>Microfat grafting and PRP injection</arm_group_label>
    <arm_group_label>Nanofat grafting and PRP injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The striae distensae&#xD;
&#xD;
          -  Age ≤ 35 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Skin allergy&#xD;
&#xD;
          -  Cicatricial diathesis&#xD;
&#xD;
          -  Skin inflammation or wound&#xD;
&#xD;
          -  Platelet dysfunction syndrome&#xD;
&#xD;
          -  Take anticoagulant drugs&#xD;
&#xD;
          -  Acute or chronic infection&#xD;
&#xD;
          -  Chronic liver disease&#xD;
&#xD;
          -  Active vitiligo, psoriasis, systemic lupus erythematosus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li Ling Xiao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Jinan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pik Nga Cheung, MD</last_name>
    <phone>+8613631394662</phone>
    <email>cheungpiknga@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Jinan University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>500011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pik Nga Cheung, MD</last_name>
      <phone>+8613631394662</phone>
      <email>cheungpiknga@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Watson RE, Parry EJ, Humphries JD, Jones CJ, Polson DW, Kielty CM, Griffiths CE. Fibrillin microfibrils are reduced in skin exhibiting striae distensae. Br J Dermatol. 1998 Jun;138(6):931-7. doi: 10.1046/j.1365-2133.1998.02257.x.</citation>
    <PMID>9747352</PMID>
  </reference>
  <reference>
    <citation>Cho C, Cho E, Kim N, Shin J, Woo S, Lee J, Lee J, Lee E, Ha J. Biophysical properties of striae rubra and striae alba in human skin: Comparison with normal skin. Skin Res Technol. 2019 May;25(3):283-288. doi: 10.1111/srt.12645. Epub 2018 Oct 22.</citation>
    <PMID>30345576</PMID>
  </reference>
  <reference>
    <citation>Forbat E, Al-Niaimi F. Treatment of striae distensae: An evidence-based approach. J Cosmet Laser Ther. 2019;21(1):49-57. doi: 10.1080/14764172.2017.1418515. Epub 2018 Feb 16.</citation>
    <PMID>29451986</PMID>
  </reference>
  <reference>
    <citation>Hague A, Bayat A. Therapeutic targets in the management of striae distensae: A systematic review. J Am Acad Dermatol. 2017 Sep;77(3):559-568.e18. doi: 10.1016/j.jaad.2017.02.048. Epub 2017 May 24.</citation>
    <PMID>28551068</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital of Jinan University</investigator_affiliation>
    <investigator_full_name>Li-Ling Xiao</investigator_full_name>
    <investigator_title>Associate Chief of Department of Plastic Surgery</investigator_title>
  </responsible_party>
  <keyword>Striae Distensae</keyword>
  <keyword>Platelet-Rich Plasma (PRP)</keyword>
  <keyword>Nanofat Graft</keyword>
  <keyword>Microfat Graft</keyword>
  <keyword>Combination Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Striae Distensae</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 16, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03807986/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03807986
org study id: Xiao FirstJinanU
nct id: NCT03807986
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Striae distensae is caused by the fracture and damage of the elastic fibers and collagen
      fibers, which is still a difficulty to overcome. Based on the studies demonstrated that
      platelet-rich plasma(PRP) has positive effect on superficial scar, and nanofat and microfat
      are effective in treating atrophic scar. So in this clinical trial, the investigators are
      going to treat striae distensae by using two combination therapies. One is nanofat grafting
      and PRP injection synergy, and the other one is treated by microfat grafting with PRP
      injection.
The participants were randomly assigned into two groups. Group A is treated by nanofat
      grafting once every three months for 2 times combined with PRP injection once a month for 6
      times. Group B will be treated by microfat grafting onceevery three months for 2 times
      combined with PRP injection once a month for 6 times. The participants were asked to come
      back 1、3、6、9 months after treatment for further follow-up.Before and after the treatment, the
      striae distensae will be assessed subjectively by satisfaction assessment, and objectively by
      ultrasound and immunohistochemical analysis.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Immunohistochemical analysis
time frame: Change from baseline at 15 months.
description: The tissue extracted will be taken for immunohistochemical analysis to observe the amount of elastic fiber and collagen fiber,etc. More collagen fiber generated better outcome of the treatments.
measure: Ultrasound
time frame: Change from baseline dermal thickness at 3,6,9,12,15 months of the treatments.
description: The striae distensae will be assessed by ultrasound in order to observe the change of dermal thickness of striae after the application of nanofat or microfat grafting with PRP injection. if the treatments worked, the dermal thickness will be increased.
measure: Ultrasound
time frame: Change from baseline width of striae at 3,6,9,12,15 months of the treatments.
description: The striae distensae will be assessed by ultrasound in order to observe the change of width of striae after the application of nanofat or microfat grafting with PRP injection. Smaller the width better the results.
measure: Satisfaction assessments of participants: questionnaire
time frame: At 15th month.
description: The participants will fill in a questionnaire about the efficacy of the treatments. Participants will choose one of the following answers 'satisfied, unchanged, not satisfied' as feedback.
arm group label: Nanofat grafting and PRP injection
arm group type: Experimental
description: Striae diatensae will be treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times.
arm group label: Microfat grafting and PRP injection
arm group type: Experimental
description: Striae diatensae will be treated by microfat grafting once every three months for 2 times combined with PRP injection once a month for 6 times.
intervention type: Procedure
intervention name: Nanofat grafting
description: Nanofat grafting will be applied once every three months for 2 times.
arm group label: Nanofat grafting and PRP injection
intervention type: Procedure
intervention name: Microfat grafting
description: Microfat grafting will be applied once every three months for 2 times.
arm group label: Microfat grafting and PRP injection
intervention type: Procedure
intervention name: Platelet-rich plasma (PRP) Injection
description: PRP Injection will be applied once a month for 6 times.
arm group label: Microfat grafting and PRP injection
arm group label: Nanofat grafting and PRP injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Li Ling Xiao, MD
role: Principal Investigator
affiliation: First Affiliated Hospital of Jinan University
last name: Pik Nga Cheung, MD
phone: +8613631394662
email: cheungpiknga@126.com
facility: 
status: Recruiting
contact: 
country: China
citation: Watson RE, Parry EJ, Humphries JD, Jones CJ, Polson DW, Kielty CM, Griffiths CE. Fibrillin microfibrils are reduced in skin exhibiting striae distensae. Br J Dermatol. 1998 Jun;138(6):931-7. doi: 10.1046/j.1365-2133.1998.02257.x.
PMID: 9747352
citation: Cho C, Cho E, Kim N, Shin J, Woo S, Lee J, Lee J, Lee E, Ha J. Biophysical properties of striae rubra and striae alba in human skin: Comparison with normal skin. Skin Res Technol. 2019 May;25(3):283-288. doi: 10.1111/srt.12645. Epub 2018 Oct 22.
PMID: 30345576
citation: Forbat E, Al-Niaimi F. Treatment of striae distensae: An evidence-based approach. J Cosmet Laser Ther. 2019;21(1):49-57. doi: 10.1080/14764172.2017.1418515. Epub 2018 Feb 16.
PMID: 29451986
citation: Hague A, Bayat A. Therapeutic targets in the management of striae distensae: A systematic review. J Am Acad Dermatol. 2017 Sep;77(3):559-568.e18. doi: 10.1016/j.jaad.2017.02.048. Epub 2017 May 24.
PMID: 28551068
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital of Jinan University
investigator full name: Li-Ling Xiao
investigator title: Associate Chief of Department of Plastic Surgery
mesh term: Striae Distensae
sharing ipd: No
provided document: 