<?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>IRCT20190911044742N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-19</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of oral methotrexate and oral prednisolone in Lichen planopilaris</public_title>
      <acronym></acronym>
      <scientific_title>Comparative efficacy study of oral  methotrexate and oral prednisolone versus oral methotrexate in Lichen planopilaris patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42185</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual randomization, using random number table
Each patient will be assigned a number from 01 to 28. Then we randomly choose a spot on the random digit table. we use the first 2 digits of the numbers on the chart (since we have a population of 28 patients) and document the first 14 numbers that are less than 29. Patients with these numbers are allocated to control group. Patients with the next 14 numbers collected from the chart, are allocated to recive methotrexate and prednisolone. Patients are not aware of group allocation, Blinding description: Patients receive different drugs but they are not aware of their intervention group.
An investigator who examines patients and records data is not aware of patients' interventional group.</study_design>
      <phase>3</phase>
      <hc_freetext>Lichen planopilaris.</hc_freetext>
      <i_freetext>Intervention 1: Control group:  Methotrexate 15 mg per week (2.5 mg tablets 6 number). Intervention 2: Intervention group: Methotrexate 15 mg per week and pulse prednisolone 200 mg per week (50 mg tablets 4 number).</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There isn't any more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farifteh Esfahanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3th level,Aftab apartment bulding,Navid dead end,Yaghob jan alley,Nazar street,Esfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8175785994</zip>
        <telephone>+98 31 3627 9010</telephone>
        <email>farifteh_165@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farifteh Esfahanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3th level,Aftab apartment bulding,Navid dead end,Yaghob jan alley,Nazar street,Esfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8175785994</zip>
        <telephone>+98 31 3627 9010</telephone>
        <email>farifteh_165@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Scalp involvement more than 10% ( New cases and resistant to topical therapy cases)
Localized scalp involvement (less than 10%) resistant to systemic and topical therapy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and lactation
Hemoglobin &lt; 9 mg/ dl
Leukocyte &lt; 4000
Platelet &lt; 100000
Liver enzymes higher than 2 fold normal range
Positive hepatitis viral test
Diabetes
Hypothyroidism and hyperthyroidism
Severe hypertension
Heart failure
Active infection
Nephropathy
Peptic ulcer</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>Control group:  Methotrexate 15 mg per week (2.5 mg tablets 6 number)</i_keyword>
      <i_keyword>Intervention group: Methotrexate 15 mg per week and pulse prednisolone 200 mg per week (50 mg tablets 4 number)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pruritis. Timepoint: Baseline and at  2,4,6 months. Method of measurement: Asking patient   ( Negative  = 0 ,  + / - = 1 ,  + = 2 , ++  +++ = 3).</prim_outcome>
      <prim_outcome>Pain. Timepoint: Baseline and at  2,4,6 months. Method of measurement: Asking patient   ( Negative  = 0 ,  + / - = 1 ,  + = 2 , ++  +++ = 3).</prim_outcome>
      <prim_outcome>Soreness. Timepoint: Baseline and at  2,4,6 months. Method of measurement: Asking patient   ( Negative  = 0 ,  + / - = 1 ,  + = 2 , ++  +++ = 3).</prim_outcome>
      <prim_outcome>Erythema. Timepoint: Baseline and at  2,4,6 months. Method of measurement: Examining patient   ( Negative  = 0 ,  + / - = 1 ,  + = 2 , ++  +++ = 3).</prim_outcome>
      <prim_outcome>Peri follicular erythema. Timepoint: Baseline and at  2,4,6 months. Method of measurement: Examining patient   ( Negative  = 0 ,  + / - = 1 ,  + = 2 , ++  +++ = 3).</prim_outcome>
      <prim_outcome>Peri follicular scale. Timepoint: Baseline and at  2,4,6 months. Method of measurement: Examining patient   ( Negative  = 0 ,  + / - = 1 ,  + = 2 , ++  +++ = 3).</prim_outcome>
      <prim_outcome>Spreading. Timepoint: Baseline and at  2,4,6 months. Method of measurement: Examining patient   ( No Spreading = 0  Indeterminate = 1  Presence of Spreading = 2).</prim_outcome>
      <prim_outcome>Anagen pull test. Timepoint: Baseline and at  2,4,6 months. Method of measurement: Examining patient: No Anagen Hairs = 0 Presence of Anagen Hairs = 1.</prim_outcome>
      <prim_outcome>7-point scale bases on pre treatment and post treatment photography. Timepoint: Base line and at 6 months. Method of measurement: scoring based on pretreatment and post treatment photographs: (Greatly decreased = -3Moderately decreased = -2Slightly decreased = -1No change = 0Slightly increased = +1Moderately increased = +2Greatly increased = +3Don’t know = Technical issues with the photographs did not for accurate evaluation).</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>2019-08-28</approval_date>
        <contact_name>Ethics committee of Isfahan Univesity of Medical sciences</contact_name>
        <contact_address>3th level,Aftab apartment bulding,Navid dead end,Yaghob jan alley,Nazar street,Esfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
