<?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>IRCT20220322054341N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-22</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of svf in periorbital rejuvenation</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of stromal vascular fraction gel (svf+non cross-linked hyaluronic acid)on the periorbital rejuvenation and comparig it with svf injection alone</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86768</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Blinding description: The injection of stromal vascular fraction (SVF), stromal vascular fraction (SVF)and normal saline was done with syringes of the same shape, the contents of which are not known, and the patient does not know which treatment group he is in. Also, the doctor evaluating the results and the statistician are blinded to the treatment group of the patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>periorbital aging/wrinkles/hyperpigmentation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention Group 1: Injection of 2 cc stromal vascular fraction (SVF) cells extracted from abdominal fat  into one side of the periocular area. Fat harvesting involves 40 cc abdominal fat aspiration, followed by centrifugation at 1200g for 3 minutes, nanofat separation with physical filters, and a second centrifugation at 2000g for 3 minutes to isolate the SVF layer. Injection is intradermal, at 1 cm intervals, in a single session. Intervention 2: .Intervention Group 2: Injection of a combination of 1 cc SVF (prepared as above) and 1 cc non-crosslinked hyaluronic acid gel (Luxiva) into the contralateral periocular area. The mixture is injected intradermally at 1 cm intervals, in a single session.Both interventions are randomly assigned to either the left or right side. Patients and evaluators (two dermatologists) are blinded to the type of injection on each side (double-blind.</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 نامشخص</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Roohaninasab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No., 21st Street, Next to Shafagh Park, Seyed Jamaleddin Asadabadi Street, Tehran, Iran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>143933111</zip>
        <telephone>+98 21 8871 7272</telephone>
        <email>rohaninasab.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoomeh Roohaninasab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No., 21st Street, Next to Shafagh Park, Seyed Jamaleddin Asadabadi Street, Tehran, Iran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1433933111</zip>
        <telephone>+98 21 8871 7272</telephone>
        <email>rohaninasab.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>participants aged 20 to 65 years presenting with age-related periorbital changes (including dark circles, periorbital wrinkles, decreased skin firmness, and under-eye laxity), who provide informed consent and are able to attend follow-up visits, will be included in the study.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Active inflammation or herpetic infection at the procedure site, collagen vascular diseases, or warts
use of corticosteroids, immunosuppressive, anticoagulant, or antiplatelet medications
platelet function disorders or thrombocytopenia
pregnancy or lactation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L81.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other melanin hyperpigmentation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention Group 1: Injection of 2 cc stromal vascular fraction (SVF) cells extracted from abdominal fat  into one side of the periocular area. Fat harvesting involves 40 cc abdominal fat aspiration, followed by centrifugation at 1200g for 3 minutes, nanofat separation with physical filters, and a second centrifugation at 2000g for 3 minutes to isolate the SVF layer. Injection is intradermal, at 1 cm intervals, in a single session.</i_keyword>
      <i_keyword>.Intervention Group 2: Injection of a combination of 1 cc SVF (prepared as above) and 1 cc non-crosslinked hyaluronic acid gel (Luxiva) into the contralateral periocular area. The mixture is injected intradermally at 1 cm intervals, in a single session.Both interventions are randomly assigned to either the left or right side. Patients and evaluators (two dermatologists) are blinded to the type of injection on each side (double-blind</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pigmentation (color of the lesion). Timepoint: 1 and 3 months after the treatment. Method of measurement: Skin analysis using the VisioFace system/Patient satisfaction (Patient Global Assessment Score/Physician satisfaction (Physician Global Assessment Score.</prim_outcome>
      <prim_outcome>Wrinkle. Timepoint: 1 and 3 months after the treatment. Method of measurement: Skin analysis using the VisioFace system/Patient satisfaction (Patient Global Assessment Score/Physician satisfaction (Physician Global Assessment Score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complications. Timepoint: 1 and 3 months after the treatment. Method of measurement: Using a checklist containing treatment complications including pain, erythema and edema.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-20</approval_date>
        <contact_name>Research Ethics Committee of School of Medicine, Iran University of medical sciences</contact_name>
        <contact_address>School of medicine, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
