<?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>IRCT20181216042009N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-20</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of peeling with phenol to rejuvenate the lower eyelids</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation and comparison of side effects and satisfaction of patient and physician in minimally invasive inferior phenol blepharopeeling versus blepharoplasty without peeling for rejuvenation of lower lids</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36053</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed in a simple way. Based on the random number tables, the patients are divided into two groups, Blinding description: The person responsible for evaluation of treatment results in predetermined time sequence will score patients without knowing the treatment modality.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fat herniation of lower eyelids.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After cleaning the face and injecting the local anesthetic in the lower eyelid region in the blepharopeeling group, peeling is performed in lower periocular region using phenol 89% and a cotton applicator until a white layer is formed. The skin and underlying muscle were incised superficially using bisturi no 15, and then underlying fat tissue excised using finger pressure, bishop forceps and curve forceps. Following excision of adequate fat tissue, remained stalk was burned using cautery. This process was performed for all marked fat pads Then, a simple suture of ethilon 5.0 is used to close the gap. Intervention 2: Control group: After injecting the local anesthetic in the blepharoplasty group, the skin and underlying muscle were incised superficially using bisturi no 15, and then underlying fat tissue excised using finger pressure, bishop forceps and curve forceps. Following excision of adequate fat tissue, remained stalk was burned using cautery. This process was performed for all marked fat pads Then, a simple suture with ethilon 5.0 is used to close the gap.</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 .</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahboobeh Talakoob</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Izadi alley ,Tohid Ave , Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8173783581</zip>
        <telephone>+98 31 3628 4700</telephone>
        <email>Mahboobeh.talakoob@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Asilian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of dermatology, Al Zahra Hospital , Soffeh Blvd</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 1668 5555</telephone>
        <email>asillian@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Skin type of 1-3 based on Fitz Patrick criteria
presentation of herniation under eyelid located fatty tissue
Absence of tear trough deformity
over 40 years of age
patients' willingness for participation the study</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who presented any history of previous local treatment
history of psychological diseases
severe aging related changes in the inferior eyelid</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After cleaning the face and injecting the local anesthetic in the lower eyelid region in the blepharopeeling group, peeling is performed in lower periocular region using phenol 89% and a cotton applicator until a white layer is formed. The skin and underlying muscle were incised superficially using bisturi no 15, and then underlying fat tissue excised using finger pressure, bishop forceps and curve forceps. Following excision of adequate fat tissue, remained stalk was burned using cautery. This process was performed for all marked fat pads Then, a simple suture of ethilon 5.0 is used to close the gap.</i_keyword>
      <i_keyword>Control group: After injecting the local anesthetic in the blepharoplasty group, the skin and underlying muscle were incised superficially using bisturi no 15, and then underlying fat tissue excised using finger pressure, bishop forceps and curve forceps. Following excision of adequate fat tissue, remained stalk was burned using cautery. This process was performed for all marked fat pads Then, a simple suture with ethilon 5.0 is used to close the gap.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rate of the patient's satisfaction for decrease fat herniation of lower lids. Timepoint: Two months after operation. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Rate of the patient's satisfaction for symmetry. Timepoint: Two months after operation. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Rate of the patient's satisfaction for esthetics. Timepoint: Two months after operation. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Rate of the patient's satisfaction for eyelid prolapse. Timepoint: Two months after operation. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Rate of the patient's general satisfaction. Timepoint: Two months after operation. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Rate of the physician's satisfaction with the lower eyelid flaccidity decrease. Timepoint: Two months after operation. Method of measurement: Observation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Periorbital erythema. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Hypopigmentation. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Hyperpigmentation. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Scar. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Hematoma. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Granuloma. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Infection. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Dry eye syndrome. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Edema. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Bruising. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Loss of vision. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Diplopia. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Lagophtalmos. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Asymmetry. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Ptosis. Timepoint: Daily up to one week and then 2 weeks and 2 months after operation. Method of measurement: Visit, history and physical examination.</sec_outcome>
      <sec_outcome>Pain. Timepoint: Daily up to one week and then 2 weeks and 2 months after treatment start. Method of measurement: Visit, history and physical examination.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-29</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
