<?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>IRCT20220806055626N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-08</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the Effect of Three Different Type of Treatment in Patients Being Treated for Vitiligo Lesions: 1. Microneedling, 2. Microneedling with Topical Fluocinolone and 3. Microneedling with 5-FU</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the Effect of Three Different Type of Treatment in Patients Being Treated for Vitiligo Lesions: 1. Microneedling, 2. Microneedling with Topical Fluocinolone and 3. Microneedling with 5-FU</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65609</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Vitiligo.</hc_freetext>
      <i_freetext>Intervention 1: Control group: The combination of microneedling and fluocinolone; In this group, dermapen cartridge 36 (Dr.Pen brand) microneedling with a thickness of 1.5 mm is performed once a week until Pinpoint Bleeding occurs, and after that the patient uses fluocinolone 0.025% cream twice a day. Intervention 2: Intervention group: Microneedling; In this group, microneedling is performed only once a week. Before performing the process of all three patches, the lesion site is numbed for 20 minutes after sterilizing with 70% alcohol using lidocaine cream. Intervention 3: Intervention group: Combination of microneedling and topical fluorouracil;  In this group, microneedling is performed once a week, and immediately after microneedling, 5% FU cream is applied on the surface of the lesion as a thick layer, then the lesion is covered with a closed dressing for 24 hours. After opening the dressing, the desired area is washed and cleaned. Also, the patient uses 5-FU cream topically on the lesion once a day. The duration of treatment for each person is three months, during which the patient undergoes microneedling 12 times with 5-FU cream.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasrin Kheirkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dermatology Dep, Emam Khomeini Hospital, Azadegan Ave.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673166</zip>
        <telephone>+98 61 3311 3938</telephone>
        <email>kheirkhah.n@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Kheirkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dermatology Dep, Emam Khomeini Hospital, Azadegan Ave.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673166</zip>
        <telephone>+98 61 3311 3938</telephone>
        <email>kheirkhah.n@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with stable vitiligo without new lesions in the previous six months who have read and signed the consent form</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant Women
Lactating Mothers
Facial lesions, genitalia and wrinkled areas
Active koebner phenomenon
Having coagulation diseases
Patients with active infection
Patient with high risk of keloid and previous history of keloid
Presence of sensitivity to the study drugs</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 - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: The combination of microneedling and fluocinolone; In this group, dermapen cartridge 36 (Dr.Pen brand) microneedling with a thickness of 1.5 mm is performed once a week until Pinpoint Bleeding occurs, and after that the patient uses fluocinolone 0.025% cream twice a day.</i_keyword>
      <i_keyword>Intervention group: Microneedling; In this group, microneedling is performed only once a week. Before performing the process of all three patches, the lesion site is numbed for 20 minutes after sterilizing with 70% alcohol using lidocaine cream.</i_keyword>
      <i_keyword>Intervention group: Combination of microneedling and topical fluorouracil;  In this group, microneedling is performed once a week, and immediately after microneedling, 5% FU cream is applied on the surface of the lesion as a thick layer, then the lesion is covered with a closed dressing for 24 hours. After opening the dressing, the desired area is washed and cleaned. Also, the patient uses 5-FU cream topically on the lesion once a day. The duration of treatment for each person is three months, during which the patient undergoes microneedling 12 times with 5-FU cream.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vitiligo lesions repigmentation. Timepoint: At the beginning of the study; After starting the study every week for three months; Three and six months after completing the study. Method of measurement: The amount of change in the area of the lesion after treatment by examining the photos in color analysis software.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>G-score. Timepoint: After the beginning of repigmentation every week, every month after the end of the study for up to six months. Method of measurement: Color analysis software.</sec_outcome>
      <sec_outcome>Repigmentation start time. Timepoint: After starting to study, every week. Method of measurement: Observing the color change through photo analysis.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-17</approval_date>
        <contact_name>Ethics committee of Golestan Hospital</contact_name>
        <contact_address>Golestan Hospital, Golestan Ave., Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
