<?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>IRCT20210206050270N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-21</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of suction blister and micro punch grafting methods in the treatment of patients with stable vitiligo</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of suction blister and micro punch grafting methods in the treatment of patients with stable vitiligo</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>31</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54166</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In each patient, 2 vitiligo patches are selected in similar parts of the body or in symmetrical parts of the body. Then one of the patches is called A and the other B is called by the third person not involved in the study without the patient and the reader.
The patch for each intervention will be selected using the online software Random.org so that the two letters A and B are entered in the software, then the letter that the software shows in the first row will indicate the patch that The suction blister on it and the second letter displayed will indicate the patch on which the micro punch grafting will be performed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Vitiligo.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Punch graft 1) Sterilize the graft site 2) The site will be anesthetized with topical lidocaine.3) Harvesting 100-200 2 mm punches in one or more stages 4) Graft implantation with 1.5 punch at the lesion site 5) Dressing the graft site with Vaseline gas 6) Remove the dressing a week later. Intervention 2: Intervention group: suction blister 1) Blisters on healthy areas of the skin that cover areas of the body2) Sterilize the graft site3) The site will be anesthetized with topical lidocaine.4) A vesicle is then formed at the donor site using the device described by Gupta et al.5) At this stage, the vitiligo patch is prepared and the dermis is removed on it by a dermabrator at an average speed of 15,000 rpm until the bleeding spots related to the papillary dermis appear. The blister created is then placed on a glass slide separated by special scissors and carefully placed on the patch.6) The lesion is then bandaged.7) Remove the dressing a week later.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefe Samimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.186, Farhang Complex, 6th Ave, Shafagh Blv,</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>685311654</zip>
        <telephone>+98 31 3782 0132</telephone>
        <email>atsamimi71@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefe Samimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.186, Farhang Complex, 6th Ave, Shafagh Blv,</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8565121654</zip>
        <telephone>+98 31 3782 0132</telephone>
        <email>atsamimi71@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with persistent vitiligo are resistant to medical treatment, ie they have not had a new lesion in the past year and their previous lesions have not become larger.
Patients should be between 13 and 65 years old
Patients must give informed consent
Patients should be willing to cooperate during the study and follow-up period.</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with immunodeficiency
atients with bleeding disorders
Patients being treated for other illnesses</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vitiligo</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Punch graft 1) Sterilize the graft site 2) The site will be anesthetized with topical lidocaine.3) Harvesting 100-200 2 mm punches in one or more stages 4) Graft implantation with 1.5 punch at the lesion site 5) Dressing the graft site with Vaseline gas 6) Remove the dressing a week later</i_keyword>
      <i_keyword>Intervention group: suction blister 1) Blisters on healthy areas of the skin that cover areas of the body2) Sterilize the graft site3) The site will be anesthetized with topical lidocaine.4) A vesicle is then formed at the donor site using the device described by Gupta et al.5) At this stage, the vitiligo patch is prepared and the dermis is removed on it by a dermabrator at an average speed of 15,000 rpm until the bleeding spots related to the papillary dermis appear. The blister created is then placed on a glass slide separated by special scissors and carefully placed on the patch.6) The lesion is then bandaged.7) Remove the dressing a week later</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Having Complaints. Timepoint: 2 and 4 months after treatment. Method of measurement: questionnaire- visual analog scale (VAS).</prim_outcome>
      <prim_outcome>Improvement Score. Timepoint: 2 and 4 months after treatment. Method of measurement: questionnaire-visual analog scale (VAS).</prim_outcome>
      <prim_outcome>Satisfaction Score. Timepoint: 2 and 4 months after treatment. Method of measurement: questionnaire -visual analog scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Esfahan University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice Chancellor for Research, Isfahan University of Medical Sciences</source_name>
      <source_name>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-03</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>No. 186, Farhang Complex, 6th Ave., Farhang Blvd. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
