<?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>IRCT20140705018373N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-24</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effects and complications of classic and nanofat fat injections in reducing wrinkles</public_title>
      <acronym></acronym>
      <scientific_title>Effects and complications of classic and nanofat fat injections in reducing wrinkles, dimples and dark circles around the eyes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67049</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done using patient file numbers and using even or odd numbers. The criterion is the last digit of the number and the number zero will be considered even. Even numbers will be considered as intervention group and odd numbers as control group, Blinding description: The dermatologist evaluating the final effect of the intervention and possible complications as well as the person analyzing the data will be blinded to the type of intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Wrinkles around the eyes. Condition 2: Dimples around the eyes. Condition 3: Dark circles under the eyes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 20 cc of fat will be injected, 10 to 15 cc in the form of micrograft (2 to 3 cc for each eye) and 4 to 5 cc in the form of nanofat (1 to 2 cc for each eye). Intervention 2: Control group: 15 cc will be injected as a micrograft  (2 to 3 cc for each eye).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Study data is categorized and coded with no identifiable individuals.

When:
Access to study data after publication of the result is available in the journal.

To whom:
Anyone interested in using the data can access the study data.

Conditions:
Study data can be used for comparison with other results.

Where to obtain:
Refer to the study's scientific or public accountability person for data.

How to obtain:
The request will be sent by email to person responsible for scientific or public inquiries.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammadreza Ranjkesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina hospital, Azadi Ave.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5163639888</zip>
        <telephone>+98 41 3549 8236</telephone>
        <email>ranjkeshm@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohmmadreza Ranjkesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina hospital, Azadi Ave.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5163639888</zip>
        <telephone>+98 41 3549 8236</telephone>
        <email>ranjkeshm@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Visible darkness, dimples and wrinkles around the eyes
Failure to respond to topical treatments
Consent to participate in the study</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cardiovascular diseases
Coagulation diseases or use of anticoagulants
Puffiness around the eyes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L98</hc_code>
      <hc_code>L98</hc_code>
      <hc_code>L98</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of skin and subcutaneous tissue, not elsewhere classified</hc_keyword>
      <hc_keyword>Other disorders of skin and subcutaneous tissue, not elsewhere classified</hc_keyword>
      <hc_keyword>Other disorders of skin and subcutaneous tissue, not elsewhere classified</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: 20 cc of fat will be injected, 10 to 15 cc in the form of micrograft (2 to 3 cc for each eye) and 4 to 5 cc in the form of nanofat (1 to 2 cc for each eye).</i_keyword>
      <i_keyword>Control group: 15 cc will be injected as a micrograft  (2 to 3 cc for each eye).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of wrinkles around the eyes. Timepoint: First week, second week, third week and fourth week after injection. Method of measurement: Using the visual analog scale, poor: less than 25% recovery, moderate: between 26% and 50% recovery, good: between 51 and 75% recovery, excellent: between 76 and 90% recovery and perfect: between 91 and 100% recovery; will be evaluated.</prim_outcome>
      <prim_outcome>Severity of dimples around the eyes. Timepoint: First week, second week, third week and fourth week after injection. Method of measurement: Using the visual analog scale, poor: less than 25% recovery, moderate: between 26% and 50% recovery, good: between 51 and 75% recovery, excellent: between 76 and 90% recovery and perfect: between 91 and 100% recovery; will be evaluated.</prim_outcome>
      <prim_outcome>Severity of dark circles around the eyes. Timepoint: First week, second week, third week and fourth week after injection. Method of measurement: Using the visual analog scale, poor: less than 25% recovery, moderate: between 26% and 50% recovery, good: between 51 and 75% recovery, excellent: between 76 and 90% recovery and perfect: between 91 and 100% recovery; will be evaluated.</prim_outcome>
      <prim_outcome>Complications after injection. Timepoint: First week, second week, third week and fourth week after injection. Method of measurement: It is based on clinical examination and includes evaluation of allergy, hematoma, infection, numbness or change in sensation, and scar.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-21</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Sina hospital, between Hafez and Shahid-Montazeri square, Azadi street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
