<?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>IRCT20150923024147N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-04</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Excimer Laser in Alopecia Areata</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of 308-nm Xenon Chloride Excimer Laser on the Treatment of Patchy Alopecia Areata</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36911</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: One of the lesions that has the inclusion criteria is undergone the beam of excimer radiation by use of  permuted block randomization. And one of the other lesions is considered as a control for steroid injection, Blinding description: Two dermatologists evaluated the photographs and phototrichograms of three assessments of the baseline, after the last treatment session, and after one month of follow-up blindly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Alopecia Areata.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: another category of the lesions are treated with an excimer laser treatmentThe patient will visit the center for 12 sessions (once a week). In each session, the patient's lesion that was selected based on the initial blockage, is irradiated by the excimer laser beam .The laser start dose is 100 to 200 milijoule, depending on the skin type and increases by as much as 100 milijoule per square centimeter in each volume. In the event of complications such as laser-induced burns, the laser treatment of that session is discontinued and after the necessary steps and treatment with topical steroids in the next session, the dosage would be reduced by 100 mJ in the next session. Intervention 2: Control group: Patients' lesions are divided into two groups: one treatment group, corticosteroid injections (40 mg/ml triamcinolone acetonide diluted with lidocaine or distilled water) are treated monthly with 5 mg/ml in 3 sessions(once a month) for the patient.</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:
All patient information can be shared without naming and identifying them.

When:
Details of the data are immediately available after publishing the results.

To whom:
All researchers and health professionals working in academic, scientific and medical institutions.

Conditions:
The data is only shared for person whose purpose is to improve the therapeutic course of alopecia areata.
Any The type of statistical analysis can be done in order to  improve the treatment.

Where to obtain:
Tehran University of Medical Sciences
professor Maryam Daneshpazhooh
Dermatologist
Razi hospital, Wahdat-e-Islami Ave., Tehran, District 12
Phone number:
+98 912 130 6662
Email: maryamdanesh.pj@gmail.com

How to obtain:
Information is available immediately after verifying that the applicant's circumstances are met by the competent authorities.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nika Kianfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi hospital, Wahdat-e-Islami Ave., Tehran, District 12</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1199663911</zip>
        <telephone>+98 21 5561 8989</telephone>
        <email>Nika_kianfar@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Daneshpazhooh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi hospital, Wahdat-e-Islami Ave., Tehran, District 12</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1199663911</zip>
        <telephone>+98 21 5560 9951</telephone>
        <email>maryamdanesh.pj@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>clinical diagnosis of alopecia areata  by a dermatologist
Having at least 2 lesions or more (multiple-patchy) in the face or scalp
The size of the lesions is at least 2 cm in 2 cm
has not used a drug for the lesions, In the last 3 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having alopecia totalis or alopecia universalis or ophiasis
Pregnancy breast feeding
An underlying disease such as endocrine diseases or immonological disorders causes hair loss
If hair loss has a cause other than alopecia areata.
Taking a drug (systemically or topical) causes hair loss or hair regrowth in the last 3 months
Surgical treatment such as hair transplantation for the treatment of hair loss.
Any dermatological diseases such as skin cancer, infection which can cause hair loss
Photosensivity
If the patient becomes pregnant during the study
patients unwillingness to continue cooperation in the clinical trial
Progression of disease during the clinical trial</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alopecia areata</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: another category of the lesions are treated with an excimer laser treatmentThe patient will visit the center for 12 sessions (once a week). In each session, the patient's lesion that was selected based on the initial blockage, is irradiated by the excimer laser beam .The laser start dose is 100 to 200 milijoule, depending on the skin type and increases by as much as 100 milijoule per square centimeter in each volume. In the event of complications such as laser-induced burns, the laser treatment of that session is discontinued and after the necessary steps and treatment with topical steroids in the next session, the dosage would be reduced by 100 mJ in the next session</i_keyword>
      <i_keyword>Control group: Patients' lesions are divided into two groups: one treatment group, corticosteroid injections (40 mg/ml triamcinolone acetonide diluted with lidocaine or distilled water) are treated monthly with 5 mg/ml in 3 sessions(once a month) for the patient.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of hair regrowth. Timepoint: At at baseline, after the last treatment session (session 12); and after one month of follow-up, the percentage of hair regrowth is measured. Method of measurement: 1.By phototrichogram(fotofinder) device. 2.by Photographic evaluation by 2 other dermatologists 3.By general assessment of the patient.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-12</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>No. 1, Poorsina Ave., Ghods Ave., Enghelab Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
