<?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>IRCT2017032530808N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-24</date_registration>
      <primary_sponsor>Vice chancellor for research, Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>The effects of Laser and Microneedling combined with phototherapy for treating vitiligo in resistant of hair skin</public_title>
      <acronym></acronym>
      <scientific_title>Assay of the CO2 fractional laser and micro needling plus hair follicle transplantation in the treatment of refractory and stable vitiligo.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24364</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Vitiligo.</hc_freetext>
      <i_freetext>Comparable vitiliginous lesions were selected from both sides of the body. On Day 0, heavily pigmented follicular grafts were harvested from the scalp by follicular unit extraction and transplanted in a 1-cm grid pattern throughout the selected lesions. At Day 30±4 and Day 60±4, left-sided lesions received single treatments with fractional CO2 laser, MX-7000 (10,600 nm, 100 MJ pulse energy and 200 spots/cm3 in static mode) (Daeshin Enterprise Corporation, Seoul, Korea). Right-sided lesions received 1.5-2 mm needle length-assisted microneedling until pinpoint bleeding was achieved. On Day 30±4 and Day 60±4, silver sulfadiazine ointment was applied to treated skin, twice daily, for 5 days without occlusion.On Day 41±2, right and left-sided lesional skin received NBUVB phototherapy (dermalight 1,000/1,000 L, 800 W, Power supply: 230 V/50 Hz; Dr. Honle medizinitechnik, GmbH, Germany) three times a week until Day 60±4; phototherapy was restarted on day 71±2. The phototherapeutic dose was increased by 15% at each treatment interval and was completed by Day 100±4 (for a total of 12 weeks of treatment). Clobetasol 45% solution was applied twice daily throughout the phototherapy phase of the study.The diameter of repigmentation around each graft was measured with appropriately calibrated calipers at baseline, Day 30±4, Day 60±4 and Day 100±4..</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>Navid Kalani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran Jahrom</address>
        <city>jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 7157414846199</telephone>
        <email>navidkalani@ymail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Feily</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran Jahrom</address>
        <city>jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 5423 4665</telephone>
        <email>dr.feily@yahoo.com</email>
        <affiliation>Jahrom university of mwdical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria included:All patients were dermatologically diagnosed with refractory, palmar-plantar vitiligo&#13;
exclusion criteria included:hypersensitivity to laser and hair transplantation materials</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Comparable vitiliginous lesions were selected from both sides of the body. On Day 0, heavily pigmented follicular grafts were harvested from the scalp by follicular unit extraction and transplanted in a 1-cm grid pattern throughout the selected lesions. At Day 30±4 and Day 60±4, left-sided lesions received single treatments with fractional CO2 laser, MX-7000 (10,600 nm, 100 MJ pulse energy and 200 spots/cm3 in static mode) (Daeshin Enterprise Corporation, Seoul, Korea). Right-sided lesions received 1.5-2 mm needle length-assisted microneedling until pinpoint bleeding was achieved. On Day 30±4 and Day 60±4, silver sulfadiazine ointment was applied to treated skin, twice daily, for 5 days without occlusion.On Day 41±2, right and left-sided lesional skin received NBUVB phototherapy (dermalight 1,000/1,000 L, 800 W, Power supply: 230 V/50 Hz; Dr. Honle medizinitechnik, GmbH, Germany) three times a week until Day 60±4; phototherapy was restarted on day 71±2. The phototherapeutic dose was increased by 15% at each treatment interval and was completed by Day 100±4 (for a total of 12 weeks of treatment). Clobetasol 45% solution was applied twice daily throughout the phototherapy phase of the study.The diameter of repigmentation around each graft was measured with appropriately calibrated calipers at baseline, Day 30±4, Day 60±4 and Day 100±4.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Scale of pigmentation improvement of lesion( scale of repigmentation). Timepoint: in Three month ,each month once after intervention. Method of measurement: The scale of repigmentation (increase the amount of pigment in vitiligo patches) will be classified based on percentage of improvement in 4 grades. The ratings are: Scale 0: no repigmentation- Scale 1: Returning pigmentation between 0% to 25% which is mild pigmentation- Scale 2: The return of pigmentation 25% and 50% which is average- Scale 3: Good pigmentation which is between 50% to 75%- Scale 4: the return of pigmentation between 75% and 100% which is considered excellent. Measurements are performed by a physician through examination under a Wood's lamp and photography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complications due to interventions. Timepoint: 1 week, 4 week, 2 months, 4 months and 6 months after start of treatment. Method of measurement: Every kind of local or generalized complication due to intervention which according to the confirm of dermatologist should be recorded in the questionnaire. These complications are usually redness and irritation at the site of intervention.</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>Vice chancellor for research, Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-09</approval_date>
        <contact_name>Ethics committee of jahrom University of Medical Sciences</contact_name>
        <contact_address>Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran Jahrom  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
