<?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>IRCT2016110330682N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-07</date_registration>
      <primary_sponsor>Deputy of research of Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Study of the effect of phenol peeling blephroplasty for the periocular rejuvenation</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation and comparison of side effects and satisfaction of patient and physician in Micropunch Blepharopeeling versus blepharoplasty of the Upper Eyelids  for Periorbital Rejuvenation in patients who referred to Alzahra hospital in 2016</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24303</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Blepharochalasis.</hc_freetext>
      <i_freetext>Intervention 1: After cleaning the face and injecting the local anesthetic in the upper eyelid region in the blepharopeeling group, peeling is performed in all the periocular region using phenol 89% and a cotton applicator until a white layer is formed. With a pair of iris scissors then, depending on the patient's skin thickness , 5-20 scissors cuts , each 3-5 mm wide, are performed in a network model in the upper eyelid.the cuts are not sutured . they are however spontaneously epithelialized instead. Intervention 2: After injecting the local anesthetic in the blepharoplasty group, the cuts are suprtficially performed with surgery blade NO.15 through the epiderm of the skin which have previously been marked are taken off.&#13;
Hemostasis  is performed with a cauter and the fats are taken out and cauterized  and the wound is sutured.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Behzad Bafandeh</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></zip>
        <telephone>+98 31 3668 5555</telephone>
        <email>b.bafandeh@resident.mui.ac.irbehzad.bafandeh@gmail.combehzad_bafandeh@yahoo.com</email>
        <affiliation>Isfahan University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ali Asillian</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></zip>
        <telephone>+98 31 3620 2020</telephone>
        <email>asillian@med.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Science _ Skin disease and Leishmaniasis Research Center, Isfahan Univ</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age over 40 years; skin type :  Fitzpatrick I-III; skin thickness : thin to medium; periorbitally scattered wrinkles; upper eyelid medial or lateral mild- to- medium Ptosis and informed Satisfaction to participate in the study&#13;
Exclusion criteria: previous local treatment; patients dissatisfaction.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H02.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Blepharochalasis</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>After cleaning the face and injecting the local anesthetic in the upper eyelid region in the blepharopeeling group, peeling is performed in all the periocular region using phenol 89% and a cotton applicator until a white layer is formed. With a pair of iris scissors then, depending on the patient's skin thickness , 5-20 scissors cuts , each 3-5 mm wide, are performed in a network model in the upper eyelid.the cuts are not sutured . they are however spontaneously epithelialized instead.</i_keyword>
      <i_keyword>After injecting the local anesthetic in the blepharoplasty group, the cuts are suprtficially performed with surgery blade NO.15 through the epiderm of the skin which have previously been marked are taken off.&#13;
Hemostasis  is performed with a cauter and the fats are taken out and cauterized  and the wound is sutured.</i_keyword>
    </intervention_keyword>
    <primary_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 satisfaction for symmetry. Timepoint: two months after operation. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Rate of the physician's satisfaction with the upper eyelid flaccidity decrease. Timepoint: two months after operation. Method of measurement: observation.</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 general satisfaction. Timepoint: two months after operation. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Periorbital erythema. 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>
      <sec_outcome>Hypopigmentation. 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>
      <sec_outcome>Hyperpigmentation. 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>
      <sec_outcome>Scar. 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>
      <sec_outcome>Hematoma. 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>
      <sec_outcome>Granuloma. 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>
      <sec_outcome>Infection. 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>
      <sec_outcome>Dry eye syndrome. 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>
      <sec_outcome>Edema. 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>
      <sec_outcome>Bruising. 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>
      <sec_outcome>Loss of vision. 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>
      <sec_outcome>Diplopia. 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>
      <sec_outcome>Lagophtalmos. 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>
      <sec_outcome>Asymmetry. 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>
      <sec_outcome>Ptosis. 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>
      <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>Deputy of research of Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-04</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  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
