<?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>IRCT20230415057912N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-07</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>efficacy and safety of oral pioglitazone in treatment of lichen planopilaris</public_title>
      <acronym></acronym>
      <scientific_title>efficacy and safety of adding oral pioglitazone to standard treatment in lichen planopilaris</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69880</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: By random allocation software, they are divided into two treatment groups with methotrexate and methotrexate and pioglitazone, and patients are selected by a simple random table, Blinding description: The patient and the main executive of the plan, those who check the outcome, know that there are two treatment groups, but the assistant of the main executive knows who is in which group.</study_design>
      <phase>3</phase>
      <hc_freetext>Lichen planopilaris.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Methotrexate group with pioglitazone, test dose of MTX is given in the amount of 15 mg by injection. 1 week later, CBC, liver enzymes and kidney function will be checked. If the tests are normal, the dose of 15 mg weekly systemically along with oral pioglitazone 15 mg daily is started for the patient.The minimum duration of treatment and follow-up is 6 months, and follow-up is done in months 0, 2, 4, and 6. Intervention 2: Control group: Methotrexate group, the test dose of MTX is given in the amount of 15 mg by injection. 1 week later, CBC, liver enzymes and kidney function will be checked. If the tests are normal, a weekly dose of 15 mg is started for the patient. The minimum duration of treatment and follow-up is 6 months, and follow-up is done in months 0, 2, 4, and 6.</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 A decision will be made after the project is finished.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fereshteh Sherafat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.67,Joshaghani Ave.,Hakim nezami street.,Esfahan town</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8164654933</zip>
        <telephone>+98 910 205 0355</telephone>
        <email>dr.fereshteh69@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fereshteh Sherafat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.67,Joshaghani Ave.,Hakim nezami street.,Esfahan town</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8164654933</zip>
        <telephone>+98 910 205 0355</telephone>
        <email>dr.fereshteh69@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>a disease that is resistant to treatment. It means that the treatment has been ineffective for at least 6 months.
Newly diagnosed patients who have not yet received treatment.
Patients who have been treated before and whose disease is still active.
Patients who, for any reason, have discontinued any previous medication 1 month before entering the study and have not used any other medication at the time of the study.
Patients between 18 and 50 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy or breastfeeding
wbc&lt;3000
platelet&lt;100000
hemoglobin&lt;9
Liver enzymes that are too normal for reference and active liver disease
Positive tests for viral hepatitis
Heart failure
Type 1 diabetes
Allergy to pioglitazone and methotrexate
Bladder cancer
Tissue edema</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L66.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lichen planopilaris</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Methotrexate group with pioglitazone, test dose of MTX is given in the amount of 15 mg by injection. 1 week later, CBC, liver enzymes and kidney function will be checked. If the tests are normal, the dose of 15 mg weekly systemically along with oral pioglitazone 15 mg daily is started for the patient.The minimum duration of treatment and follow-up is 6 months, and follow-up is done in months 0, 2, 4, and 6.</i_keyword>
      <i_keyword>Control group: Methotrexate group, the test dose of MTX is given in the amount of 15 mg by injection. 1 week later, CBC, liver enzymes and kidney function will be checked. If the tests are normal, a weekly dose of 15 mg is started for the patient. The minimum duration of treatment and follow-up is 6 months, and follow-up is done in months 0, 2, 4, and 6.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lichen Planopilaris Activity Index. Timepoint: Months 0, 2, 4, and 6 after starting the drug. Method of measurement: Handyscope dermatoskope (FotoFinder System GmbH, Bad Brinbach, Germany.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-14</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Science</contact_name>
        <contact_address>NO13, between 6 and 8 Vatan alley, East  Haft Dast St ,Isfahan town ISFAHAN Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
