<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/NCT04472715</url>
  </required_header>
  <id_info>
    <org_study_id>00007555</org_study_id>
    <nct_id>NCT04472715</nct_id>
  </id_info>
  <brief_title>Hair Transplantation in Cicatricial Alopecia</brief_title>
  <official_title>EVALUATION OF THE EFFICACY OF FOLLICULAR UNIT EXTRACTION VERSUS FOLLICULAR UNIT EXTRACTION WITH PLATELETS RICH PLASMA IN TREATMENT OF CICATRICAL ALOPECIA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria 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>
      follicular unit extraction as a method of hair transplantation in cicatricial alopecia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include 20 patients with cicatrical alopecia.Patients will be randomly&#xD;
      assigned into two groups:Group (A):include ten patients will undergo (FUE) alone.&#xD;
&#xD;
      Group (B): include ten patients will undergo(FUE) and (PRP).3-Surgical technique:&#xD;
&#xD;
        -  Preoperative Investigations including complete blood count, coagulation profile and&#xD;
           hepatitis viral markers.&#xD;
&#xD;
           1-Group(A): will undergo (FUE)&#xD;
&#xD;
        -  Washing the scalp with antiseptic shampoo before the procedure.&#xD;
&#xD;
        -  Tumuscentanaesthesia:The donor area is anesthetized with a lidocaine 1% solution diluted&#xD;
           with 20 cc saline in addition to adrenaline.&#xD;
&#xD;
        -  Creation of micropunches(0.7-1 mm) using micromotor.&#xD;
&#xD;
        -  After removal of the punch,the follicular unit is extracted with Jweler's forceps.&#xD;
&#xD;
        -  Extracted grafts are then placed on chilled saline gauze for maximum four hours until&#xD;
           ready for transplantation.&#xD;
&#xD;
        -  The recipient area is prepared with rectangular scalpel blades 1mm or hypodermic blades&#xD;
           0.9 mm.&#xD;
&#xD;
        -  Implantation using fine tipped jweler's forceps.&#xD;
&#xD;
        -  Finally, receptor and donor areas will be softly cleansed with saline and crepe bandage&#xD;
           is applied.&#xD;
&#xD;
           2-Group (B): FUE+PRP&#xD;
&#xD;
        -  The same procedure will be done but grafts will be placed in Prp solution.&#xD;
&#xD;
        -  Prp session one week before transplantation then monthly for 3 monthes after (FUE).&#xD;
&#xD;
        -  Preparation of PRP&#xD;
&#xD;
        -  10 cc blood will be aspirated in test tube contained a modified solution of&#xD;
           anticoagulant,called acid-citrate-dextrose type (ACDA), in which the physiological pH&#xD;
           will reached to preserve the platelet integrity.&#xD;
&#xD;
        -  The first spin of whole blood sample will be at 2500 rpm for 4 minutes&#xD;
&#xD;
        -  The second spin at 4000 for 20 minutes for obtained plasma.&#xD;
&#xD;
        -  Platelets are separated as a pellet at the bottom of the tube from platelet-poor plasma&#xD;
           (PPP) above. The platelet-rich pellet is resuspended in remaining amount of plasma. The&#xD;
           resulting suspension is used as PRP.&#xD;
&#xD;
        -  Prp is injected in the recipient area. 4-Follow up:&#xD;
&#xD;
        -  Follow up clinically by digital photographs and trichoscopy 1 week after operation,&#xD;
           after 3 months and after 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2020</start_date>
  <completion_date type="Actual">December 5, 2020</completion_date>
  <primary_completion_date type="Actual">December 5, 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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hair regrowth</measure>
    <time_frame>6 months</time_frame>
    <description>transplanted hair develop int new hair growth in bald area</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hair Transplantation</condition>
  <condition>Cicatricial Alopecia</condition>
  <arm_group>
    <arm_group_label>follicular unit extraction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>extraction of hair follicle unit from donar area and tranplant it into recepient bald area</description>
  </arm_group>
  <arm_group>
    <arm_group_label>foolicular unit extraction and platelet rich plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the same procedure mentioned above coupled with session of platelet rich plasma before and after transplantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>follicular unit extarcation and platelet rich plasma</intervention_name>
    <description>hair transplantation procedure</description>
    <arm_group_label>follicular unit extraction</arm_group_label>
    <arm_group_label>foolicular unit extraction and platelet rich plasma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Patients with unacceptable visible scarring alopecia.&#xD;
&#xD;
               -  Adequate donor area.&#xD;
&#xD;
               -  patient free of signs of disease activity evidenced by trichoscopy.&#xD;
&#xD;
               -  Patients having inadequate laxity for a strip excision (too tight skin).&#xD;
&#xD;
               -  When previous scars of strip surgeries make further strips impossible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Inadequate donor area.&#xD;
&#xD;
               -  Signs of active disease or infection.&#xD;
&#xD;
               -  Patient who is not willing for long sessions for several hours or multiple&#xD;
                  sessions as needed due to the slowness of the process&#xD;
&#xD;
               -  Contraindications for surgical procedure as bleeding tendency.&#xD;
&#xD;
               -  Contraindications for PRP as (cardiovascular, autoimmune disorders, hematological&#xD;
                  disorders and neoplasms).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <zip>21521</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 23, 2021</last_update_submitted>
  <last_update_submitted_qc>July 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>marwa eldeeb</investigator_full_name>
    <investigator_title>Lecturer of dermatology</investigator_title>
  </responsible_party>
  <keyword>hair loss, follicuular unit extraction, platelet rich plasma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</mesh_term>
  </condition_browse>
  <!-- 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/NCT04472715
org study id: 00007555
nct id: NCT04472715
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
follicular unit extraction as a method of hair transplantation in cicatricial alopecia
The study will include 20 patients with cicatrical alopecia.Patients will be randomly
      assigned into two groups:Group (A):include ten patients will undergo (FUE) alone.

      Group (B): include ten patients will undergo(FUE) and (PRP).3-Surgical technique:

        -  Preoperative Investigations including complete blood count, coagulation profile and
           hepatitis viral markers.

           1-Group(A): will undergo (FUE)

        -  Washing the scalp with antiseptic shampoo before the procedure.

        -  Tumuscentanaesthesia:The donor area is anesthetized with a lidocaine 1% solution diluted
           with 20 cc saline in addition to adrenaline.

        -  Creation of micropunches(0.7-1 mm) using micromotor.

        -  After removal of the punch,the follicular unit is extracted with Jweler's forceps.

        -  Extracted grafts are then placed on chilled saline gauze for maximum four hours until
           ready for transplantation.

        -  The recipient area is prepared with rectangular scalpel blades 1mm or hypodermic blades
           0.9 mm.

        -  Implantation using fine tipped jweler's forceps.

        -  Finally, receptor and donor areas will be softly cleansed with saline and crepe bandage
           is applied.

           2-Group (B): FUE+PRP

        -  The same procedure will be done but grafts will be placed in Prp solution.

        -  Prp session one week before transplantation then monthly for 3 monthes after (FUE).

        -  Preparation of PRP

        -  10 cc blood will be aspirated in test tube contained a modified solution of
           anticoagulant,called acid-citrate-dextrose type (ACDA), in which the physiological pH
           will reached to preserve the platelet integrity.

        -  The first spin of whole blood sample will be at 2500 rpm for 4 minutes

        -  The second spin at 4000 for 20 minutes for obtained plasma.

        -  Platelets are separated as a pellet at the bottom of the tube from platelet-poor plasma
           (PPP) above. The platelet-rich pellet is resuspended in remaining amount of plasma. The
           resulting suspension is used as PRP.

        -  Prp is injected in the recipient area. 4-Follow up:

        -  Follow up clinically by digital photographs and trichoscopy 1 week after operation,
           after 3 months and after 6 months.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: hair regrowth
time frame: 6 months
description: transplanted hair develop int new hair growth in bald area
arm group label: follicular unit extraction
arm group type: Experimental
description: extraction of hair follicle unit from donar area and tranplant it into recepient bald area
arm group label: foolicular unit extraction and platelet rich plasma
arm group type: Experimental
description: the same procedure mentioned above coupled with session of platelet rich plasma before and after transplantation
intervention type: Procedure
intervention name: follicular unit extarcation and platelet rich plasma
description: hair transplantation procedure
arm group label: follicular unit extraction
arm group label: foolicular unit extraction and platelet rich plasma
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: marwa eldeeb
investigator title: Lecturer of dermatology
mesh term: Alopecia
mesh term: Alopecia Areata