<?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>IRCT20170818035762N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-30</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>betamethasone valerate on post-cryotherapy</public_title>
      <acronym></acronym>
      <scientific_title>The effects of topical betamethasone valerate on post-cryotherapy inflammation in cutaneous wart treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46964</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: we use medicine on one limb and use 
placebo. on another limb. 
executor of plan and Patient don't know which limb take the medicine.</study_design>
      <phase>2-3</phase>
      <hc_freetext>skin wart.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In our study, patients with skin warts in two different organs were included. The first intervention group was given one of the organs with betamethasone valrate after cryotherapy. Intervention 2: Control group: Control group: In our study, patients enter the study who have skin warts in two different organs. In the second intervention group, we used placebo on an organ that did not use betamethasone valrate.</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:
Only part of the data, such as information about the main outcome or the like, can be shared

When:
Start the access period 6 months after printing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Researchers working in academic and scientific institutions

Where to obtain:
Email to: A.kazeminejad@mazums.ac.ir

How to obtain:
After communicating with the email if available, data and results will be available

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Armaghan Kazeminezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mazandaran University of Medical Sciences ,Sari , Mazandaran</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۸۱۵۷۳۳۹۷۱</zip>
        <telephone>+98 11 4221 8021</telephone>
        <email>a.kazeminejad@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.ArMarghan Kazeminejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815733971</zip>
        <telephone>+98 11 3304 4001</telephone>
        <email>A.kazeminejad@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with skin wart who are diagnosed by a dermatologist clinically or pathologically and have cryotherapy indications.
Patients over 2 years of age
They have a conscious consent to enter the study
the maximum number of warts is up to 20</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnant and lactating women
People treated with systemic medications that interfere with wound healing or immuno suppressive drugs
Patients who have contraindications for cryotherapy
Patients who have used topical medications other than emollients in the past month
People who are allergic to betamethasone or topical steroids
Patients with wound healing disorders such as diabetes
Distributed and resistant warts that need further treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B07</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Viral warts</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: In our study, patients with skin warts in two different organs were included. The first intervention group was given one of the organs with betamethasone valrate after cryotherapy.</i_keyword>
      <i_keyword>Control group: Control group: In our study, patients enter the study who have skin warts in two different organs. In the second intervention group, we used placebo on an organ that did not use betamethasone valrate</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tolerance of pain to cryotherapy treatment. Timepoint: Day 1,7 and 14. Method of measurement: Vas scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Illness severity. Timepoint: At the beginning of the study. Method of measurement: Based on the number of warts.</sec_outcome>
      <sec_outcome>Duration of illness. Timepoint: At the beginning of the study. Method of measurement: Number of days before starting treatment.</sec_outcome>
      <sec_outcome>Eritrea. Timepoint: The second, eighth and fifteenth day after starting treatment. Method of measurement: Based on the examination.</sec_outcome>
      <sec_outcome>Blisters. Timepoint: The second, eighth and fifteenth day after starting treatment. Method of measurement: Based on the examination.</sec_outcome>
      <sec_outcome>Scar. Timepoint: The second, eighth and fifteenth day after starting treatment. Method of measurement: Based on the examination.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-16</approval_date>
        <contact_name>Ethics committee of mazandaran University of Medical Sciences</contact_name>
        <contact_address>Central Headquarters of Mazandaran University of Medical Sciences,at the beginning of Valiasr Highway,Joibar Three Ways,Imam Square, Sari sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
