<?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>IRCT201101245678N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-07-02</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of two type corticosteroids  in Treatment of Oral Lichen Planus</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of  comparative evaluation of effect of Beclomethasone and Adcortyle in treatment of Oral Lichen Planus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-08-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>19</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6198</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Lichen planus.</hc_freetext>
      <i_freetext>Intervention 1: Adcortyle was used for treatment of control side. This paste is one of the  appropriate drug in treatment oral lichen planus, so used to compare with treatment effect of Bechlomethason spray in oral lichen planus lesions . Adcortyle contains triamcinolone 0.01% in a adhesive carrier          ( methyl cellulose). Dose of drug was 3 times a day.Patients first dried side of lesion then covered the lesion with paste and eat anything for one hour. Intervention 2: Intervention in this article is treatment of oral lichen planus lesions  with nasal spray Bechlomethasone dipropionate. Dose of drug was 50ugr/paff and used 4 times a day( 2 puff in each time) after meals and before sleep. Patient was demonstrated that spray must closed to lesion and sprayed 2 paff.</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>Nasrin Rafieian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>dental faculty, Shahid Fahmideh street, Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>081138677</zip>
        <telephone>+98 81 1835 4140</telephone>
        <email>rafieiann@yahoo.com,  abdolsamadi.umsha.ac.ir</email>
        <affiliation>Dental Faculty of Hamadam</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Rafieian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan Dental faculty, Shahid Fahmideh street, hamedan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>081138677</zip>
        <telephone>+98 218354250</telephone>
        <email>rafieiann@yahoo.com, abdolsamadi@umsha.ac.ir</email>
        <affiliation>"Hamadan Dental faculty"</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Criteria for inclusion: All patients had symptomatic bilateral erosive or ulcerative oral lichen planus  with similar intensity, Not used any systemic or topical corticosteroid, Written informed consent was obtained&#13;
Criteria for exclusion: Patients that were not cooperative , use of another topical or systemic  during the study</inclusion_criteria>
      <agemin>33 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the skin and subcutaneous tissue</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>Adcortyle was used for treatment of control side. This paste is one of the  appropriate drug in treatment oral lichen planus, so used to compare with treatment effect of Bechlomethason spray in oral lichen planus lesions . Adcortyle contains triamcinolone 0.01% in a adhesive carrier          ( methyl cellulose). Dose of drug was 3 times a day.Patients first dried side of lesion then covered the lesion with paste and eat anything for one hour.</i_keyword>
      <i_keyword>Intervention in this article is treatment of oral lichen planus lesions  with nasal spray Bechlomethasone dipropionate. Dose of drug was 50ugr/paff and used 4 times a day( 2 puff in each time) after meals and before sleep. Patient was demonstrated that spray must closed to lesion and sprayed 2 paff.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Scaling of lesion. Timepoint: 3-6-12 weeks. Method of measurement: REU.</prim_outcome>
      <prim_outcome>Pain. Timepoint: 3-6-12 weeks. Method of measurement: VAS (Visual Analuge Scaling).</prim_outcome>
      <prim_outcome>Raughness. Timepoint: 3-6-12 weeks. Method of measurement: VAS.</prim_outcome>
      <prim_outcome>Maximum diameter of lesion. Timepoint: 3-6-12 weeks. Method of measurement: periodental prob( millimeter).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Candidiasis, Mucosal atrophy. Timepoint: 3-6-12 weeks. Method of measurement: Clinical evaluation.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-03-03</approval_date>
        <contact_name>Ethic committi of "Shahid Beheshti dental faculty"</contact_name>
        <contact_address>Student BLV, Evin freeway, Tehran Tehtran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
