<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200127046282N31</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-18</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of nanofat along with SVF and PRP in facial rejuvenation and dark circles around the eyes</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of nanofat along with Stromal vascular fraction (SVF) and Platelet Rich plasma (PRP) in facial rejuvenation and dark circles around the eyes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67652</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The patient and the doctor will have enough information about the treatment due to the sampling of fat tissue and blood. After transplantation and in the follow-up phase, all participants will be examined by a medical staff who is blinded to this study and group allocation. At this stage, this person does not know the type of intervention in each group. Therefore, the study will be single blind.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Condition 1: periorbital dark circles. Condition 2: Skin aging.</hc_freetext>
      <i_freetext>Intervention 1: Control group 1: In one session, patients are treated with 5 cc of nanofat injection (prepared at the research center clinic) in the whole face and under the eyes. Intervention 2: Control group 2: Patients are treated in one session by injecting 5 cc of nanofat (prepared in the research center clinic) and 2 cc of PRP (prepared in the research center laboratory) in the whole face and under the eyes. Intervention 3: Intervention group: In one session, patients were treated by injecting 5 cc of nanofat (prepared in the clinic of the research center), 1 cc of adipose tissue SVF (prepared in the clean room of the research center) and 1 cc of PRP (prepared in the laboratory of the research center) in They are placed on the whole face and under the eyes.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sona Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 4, Maryam Alley, South Kamraniyeh Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1937957511</zip>
        <telephone>+98 21 2665 7438</telephone>
        <email>sonazarebio@gmail.com</email>
        <affiliation>Skin and Stem cell Research Center of Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ali Nilforoushzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 4, Maryam Alley, South Kamraniyeh Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1937957511</zip>
        <telephone>+98 21 2665 7438</telephone>
        <email>nilforoosh@sina.tums.ac.ir</email>
        <affiliation>Skin and Stem cell Research Center of Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age from 18 to 65 years
Patient with periorbital dark circles
The patient has wrinkles</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Active infection on face
Pregnancy
Breastfeeding
History of cancer
structural dark circles or under eye loss of fat</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H02.71</hc_code>
      <hc_code>L90.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chloasma of eyelid and periocular area</hc_keyword>
      <hc_keyword>Atrophic disorder of skin, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group 1: In one session, patients are treated with 5 cc of nanofat injection (prepared at the research center clinic) in the whole face and under the eyes.</i_keyword>
      <i_keyword>Control group 2: Patients are treated in one session by injecting 5 cc of nanofat (prepared in the research center clinic) and 2 cc of PRP (prepared in the research center laboratory) in the whole face and under the eyes.</i_keyword>
      <i_keyword>Intervention group: In one session, patients were treated by injecting 5 cc of nanofat (prepared in the clinic of the research center), 1 cc of adipose tissue SVF (prepared in the clean room of the research center) and 1 cc of PRP (prepared in the laboratory of the research center) in They are placed on the whole face and under the eyes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Periorbital dark circles. Timepoint: Before, during the treatment and 3 months after intervention. Method of measurement: severity of under eye dark halos in comparison to the rest of the face, using Mexameter device.</prim_outcome>
      <prim_outcome>The amount of wrinkles. Timepoint: Before treatment and six months after intervention. Method of measurement: Visio face.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Satisfaction rate. Timepoint: After completing the intervention. Method of measurement: comparing the severity of periorbital dark circles, before and after treatment (score from 0 - 10).</sec_outcome>
      <sec_outcome>Inflammation. Timepoint: Half an hour after the end of the intervention. Method of measurement: Questionnaire and visit.</sec_outcome>
      <sec_outcome>Intensity of pain. Timepoint: At the time of the intervention. Method of measurement: Questionnaire and visit.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-09</approval_date>
        <contact_name>Research Ethics Committee of School of Medicine-Tehran University of Medical Sciences</contact_name>
        <contact_address>Room 604, 6th Floor, Tehran University of Medical Sciences Central Building, Qods St. intersection, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
