<?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>IRCT20200119046187N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-11</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Laser in lichen planus</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the efficacy of the Er-Cr-YSGG laser before topical corticosteroid therapy in treatment of Oral lichen planus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45120</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For treatment, symmetrical two focal lesions in the mouth are randomly divided into two groups. Accidental lesions are divided into two groups by permuted random block method as block 4, Blinding description: 1. The efficacy of laser is performed by a person other than the collector of the lesion information.
2. The person who is collecting the lesions information does not know in
3. For treatment, symmetrical two focal lesions in the mouth are randomly divided into two groups. Accidental lesions are divided into two groups by permuted random block method as block 4.
4. To blind the patient, a placebo laser is used on the opposite side.</study_design>
      <phase>3</phase>
      <hc_freetext>Oral lichen planus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Before starting drug treatment, this group is under laser radiation (Er.Cr.YSGG) with the specifications of the American Waterlase device (with 2780 nm parameters, energy: J / cm3 1.75, non-contact pattern, very long pulse, water: 70%, 80%: air, tip MZ 8, distance 1 mm, time 350 microseconds and this radiation is repeated 8 times in each session of visit in 8 consecutive weeks and at the same time using topical treatment Triamcinolone None ointment is applied for a maximum of 8 weeks, so that the entire surface of the lesion is covered by the above ointment three times a day after meals. Intervention 2: Control group: Topical treatments are treated with Trimcinolone NN ointment for a maximum of 8 weeks. In such a way that the whole surface of the lesion is smeared with the above ointment three times a day after eating and by the applicator.To blind the patient, a placebo laser is used on the opposite side.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
There are currently plans to release the data.

When:
There are currently plans to release the data.

To whom:
There are currently plans to release the data.

Conditions:
There are currently plans to release the data.

Where to obtain:
There are currently plans to release the data.

How to obtain:
There are currently plans to release the data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamidreza khalighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Oral Medicine, Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin, Shahid Chamran Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2990 2302</telephone>
        <email>dr.hkh92@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gelareh Forouzani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Oral Medicine, Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin, Shahid Chamran Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19839369411</zip>
        <telephone>+98 21 2266 5704</telephone>
        <email>glareh.forouzani@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Lichen planus Patients with symmetrical two focal parts
Patient satisfaction and cooperation</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Recurrence history
Mucocutaneous involvement
Take effective medications over the past month
The history of the cancer in the head and neck
History of proliferative diseases
History of thyroid disease
Pregnancy
Keratotic lichen planus</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lichen planus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Before starting drug treatment, this group is under laser radiation (Er.Cr.YSGG) with the specifications of the American Waterlase device (with 2780 nm parameters, energy: J / cm3 1.75, non-contact pattern, very long pulse, water: 70%, 80%: air, tip MZ 8, distance 1 mm, time 350 microseconds and this radiation is repeated 8 times in each session of visit in 8 consecutive weeks and at the same time using topical treatment Triamcinolone None ointment is applied for a maximum of 8 weeks, so that the entire surface of the lesion is covered by the above ointment three times a day after meals.</i_keyword>
      <i_keyword>Control group: Topical treatments are treated with Trimcinolone NN ointment for a maximum of 8 weeks. In such a way that the whole surface of the lesion is smeared with the above ointment three times a day after eating and by the applicator.To blind the patient, a placebo laser is used on the opposite side.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oral lichen planus lesions recovery time:time to reach score 1 or zero according to Thongprasom sign scoring  in weeks 1 to 8. According to Thongprasom sign scoring in oral lichen planus lesion the score is from zero to five. Zero score: no wounds - Natural mucus, score 1: mild white steria , score 2: white steria with atrophic and erythematous areas (less than 1 cm square), score 3: white steria with atrophic and erythematous areas (more than 1 cm square), score 4: White steria with ulcerative (less than 1 cm square), score 5: White steria with ulcerative (more than 1 cm square). Timepoint: In each session before treatment, 8 times in 8 consecutive weeks. Method of measurement: By collis and clinical observation.</prim_outcome>
      <prim_outcome>The severity of the lesion is based on Thongprasom sign scoring (categories 0 to 5). Timepoint: In each session before treatment, 8 times in 8 consecutive weeks. Method of measurement: By the collis and clinical observation in each session before the start of treatment in mm / cm (categories 0 to 5).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Burning intensity: Verbal Analog scale (score 0 to 10):The patient's severity of discomfort from the burning for each lesion is measured separately by the analog scale verbal criteria, so that the number zero is considered as non-irritating and the number ten is considered as the highest possible burn and the patient is asked to number In this interval, select as the intensity of the burn. Timepoint: In each session before treatment, 8 times in 8 consecutive weeks. Method of measurement: By determining the number by patients in each session before starting treatment.</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>Shahid beheshti University of medical science, dental school</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-08</approval_date>
        <contact_name>Ethics committee of Shahid beheshti University of Medical Sciences</contact_name>
        <contact_address>Department of Oral Medicine, Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin, Shahid Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
