<?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>IRCT20140212016557N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-07</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of skin graft with and without phototherapy in the treatment of acral vitiligo</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the additive effect of topical psoralen with ultraviolet A (PUVA) phototherapy after suction blister epidermal grafting surgery in patients with acral vitiligo</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58631</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants were randomized using permuted block randomization (size of each block: 4), in individual units, using random allocation software. The output of software is a table that determines the right or left side undergoes phototherapy, Blinding description: Due to the different treatment methods in two sides, the participants cannot be blinded. Principle investigator, and care provider physician are also aware of the the side undergoing phototherapy. But, outcome assessors are not aware of the side undergoing phototherapy in each patient.</study_design>
      <phase>3</phase>
      <hc_freetext>Vitiligo.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Suction blister epidermal grafting surgery with topical psoralen with ultraviolet A (PUVA) phototherapy in one side hand or foot (Twice weekly for 6 months). Intervention 2: Control group: Suction blister epidermal grafting surgery without topical psoralen with ultraviolet A (PUVA) phototherapy in one side hand or foot.</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 Possibility of loss of confidentiality</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirhossein Heydarnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz University of Medical Sciences, Zand St., Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134844119</zip>
        <telephone>+98 712125239</telephone>
        <email>amirhosseinheydarnejad@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mozhdeh Sepaskhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz University of Medical Sciences, Zand St., Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134844119</zip>
        <telephone>+98 712125239</telephone>
        <email>sepaskhah@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Acral vitiligo
18 years of age and higher
Bilateral lesions
Stable vitiligo in the past 6 months
Ability to refer for phototherapy
Minimum size of 1*1 cm
Maximum size of 3*3 cm</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of keloid
Treatment for vitiligo in the past one month
Poor wound healing
Consumption of anticoagulant drugs
Consumption of immunosuppresant drugs
Pregnancy
Lactation</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 - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Suction blister epidermal grafting surgery with topical psoralen with ultraviolet A (PUVA) phototherapy in one side hand or foot (Twice weekly for 6 months)</i_keyword>
      <i_keyword>Control group: Suction blister epidermal grafting surgery without topical psoralen with ultraviolet A (PUVA) phototherapy in one side hand or foot</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reversal of normal skin pigment. Timepoint: Months 1, 2, 4, and 6. Method of measurement: Reverse Vitiligo Area Severity Index (VASI), which measures the percentage of pigment reversal.</prim_outcome>
      <prim_outcome>Vitiligo Extent Score for a Target Area (VESTA). Timepoint: Months 1, 2, 4, and 6. Method of measurement: A formula that considers fully repigmented area, remaining area, and perifollicular repigmentation in the remaining area.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Time of pigment reversal. Timepoint: Months 1, 2, 4, and 6. Method of measurement: Measurement of the numbers of weeks to achieve 50% pigment reversal.</sec_outcome>
      <sec_outcome>Color match. Timepoint: Months 1, 2, 4, and 6. Method of measurement: Difference of the lesion color with surrounding normal skin color measured by colorimetric device.</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: At the beginning and end of treatment. Method of measurement: Vitiligo Quality of Life index (VitiQoL).</sec_outcome>
      <sec_outcome>Patient satisfaction. Timepoint: At the  end of treatment. Method of measurement: Three questions with answers from 0 to 10.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-19</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz University of Medical Sciences, Zand St., Shiraz. Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
