<?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>IRCT20210208050292N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-02</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of oral N-acetil cystein Vs oral Pentoxyphilline in patients with Lichen planopillaris</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy, safety, satisfaction and tolerability of oral N-acetil cystein Vs oral Pentoxyphilline in patients with Lichen planopillaris: A randomized controled clinical trial; assessor and analysted blinder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55256</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method will be used to perform the randomization process. The patients will be divided into three groups using Cards or envelop shuffling method, Blinding description: All assessments and analyzes will be performed by blind people other than the main researchers.</study_design>
      <phase>3</phase>
      <hc_freetext>Lichen planopilaris.</hc_freetext>
      <i_freetext>Intervention group:The intervention groups in addition to the control treatment will be treated with pentoxifylline 400 mg twice daily and N-acetylcysteine ​​600 mg twice daily, respectively. LPPAI in each group at the beginning of the study, two months later and 4 months after the start of treatment and changes from baseline to the end of the study between all three groups were analyzed and evaluated. Response to treatment will be achieved if we have a 25 to 85% reduction in the LPPAI system.The control group will receive 0.05% topical clobetasol solution each night with at least 30 drops to the alopecia area..</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Ahmadi Kahjoogh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>10th Alley, Niayesh Ave, 16th West Ave, Sahand Town</address>
        <city>Maragheh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5518937747</zip>
        <telephone>+98 41 3741 7015</telephone>
        <email>hossein.ak31@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Ahmadi Kahjoogh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>10th Alley, Niayesh Ave, 16th West Ave, Sahand Town</address>
        <city>Maragheh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5518937747</zip>
        <telephone>+98 41 3741 7015</telephone>
        <email>hossein.ak31@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent
Do not have serious internal disease.
Aged between 15-70
No history of serious gastrointestinal problems.
There is no accompanying disease on the treatment site
The initial general Lab data of the patient do not show a serious problem</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:The intervention groups in addition to the control treatment will be treated with pentoxifylline 400 mg twice daily and N-acetylcysteine ​​600 mg twice daily, respectively. LPPAI in each group at the beginning of the study, two months later and 4 months after the start of treatment and changes from baseline to the end of the study between all three groups were analyzed and evaluated. Response to treatment will be achieved if we have a 25 to 85% reduction in the LPPAI system.The control group will receive 0.05% topical clobetasol solution each night with at least 30 drops to the alopecia area.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>To facilitate statistical comparison of the study results, the lichen planopilaris activity index scoring system (LPPAI) introduced by Chiang in 2010 will be used. In this system, 8 signs and symptoms of the disease are scored, including Itching, burning, pain, erythema, pre-follicular erythema, pre-follicular scale, anagen pull test and disease spreading.each criteria will be scored from 0 to 3:Thus, 0:lack of sign/symptom, 1:the mild sign/symptom,  2:the moderate sign/symptom and 3:the severe sign/symptom. In agagen pull test, zero score shows the result is negative and it is positive when the score is one. In spreading score, zero score shows no spreading, 1:moderate spreading and 2: sever spreading. The total score according to the following formula will be 0 to 10: LPPAI (0 to 10) = (itching + burning + pain) / 3 + (scalp erythema + pre-follicular erythema + pre-follicular shell) / 3 + 2.5 (anagen pull test)+1/5(spreading/ 2).The tolerability of the treatment will be measured by asking the patients (yes / no) and the satisfaction of the treatment will be evaluated by a Likert scoring. Patients will be asked about the possible side effects of the drugs used in each appointment session (basic visit, second and fourth month). Timepoint: At the beginning of the study (before the intervention), 2 and 4 months after the intervention. Method of measurement: Lichen planopilaris activity index score: A questionnaire for assessing the severity of lichen planoplaris disease, which was developed and reported in 2010 by Chiang. Complications: Patient response based on Likert scale. Tolerance: Patient response based on Likert scale. Satisfaction: Patient response based on Likert scale.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-18</approval_date>
        <contact_name>Ethics committee of Iran university of medical sciences</contact_name>
        <contact_address>10th Alley, Niayesh Ave, 16th West Ave, Sahand Town Maragheh East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
