<?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>IRCT20220306054206N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-26</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of Triamcinolone topical cream with sulfur cream in hand eczema</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Triamcinolone 0.1% topical cream with sulfur 2% cream in the treatment of patients with hand eczema</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66955</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Since each patient uses two types of creams, and since the patient's right-handedness or left-handedness may affect the severity of each hand's eczema, it is up to the patient to choose the type of cream to use for each hand. so that randomization is done in this way and the intervention of the executive is removed from this process, Blinding description: To create triple blinding of the study, under sterile conditions, creams are poured into tubes without a printed brand, and the cream is named by the company as numbers 1 and 2, and until the completion of the study, the patient and the project manager and the data analyst are of the type The received cream is not aware so that the study is triple blinded.</study_design>
      <phase>3</phase>
      <hc_freetext>eczema.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group uses triamcinolone cream 0.01% from Iran Daru factory twice a day for one month on the hands, and then the use is stopped and follow-up is carried out for the next month. Intervention 2: The second intervention group uses 2% sulfur cream made by A2Z company locally 2 times a day in the hands and then stops using the cream and is followed up for the next month.</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 data is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the publication of the results

To whom:
It will be available only to researchers working in academic and scientific institutions

Conditions:
If they have documentation of conducting research in this field, the documentation will be provided

Where to obtain:
To receive the data/document from the email address of the main author

How to obtain:
Documents will be provided within a maximum of one month from the time of sending the requester's email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Mohammadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazar Jarib St., University of Medical Sciences and Health Care Services</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>parisa14m@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Asilian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazar Jarib St., University of Medical Sciences and Health Care Services</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>asilian@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients who have hand eczema and
patients have not been treated in the last month.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>There are patients who are taking another medicine
Patients who do not have the possibility to refer for the necessary follow-up
Patients who have other accompanying skin disease in the hand area other than eczema</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L20.82</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Flexural eczema</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>The first intervention group uses triamcinolone cream 0.01% from Iran Daru factory twice a day for one month on the hands, and then the use is stopped and follow-up is carried out for the next month.</i_keyword>
      <i_keyword>The second intervention group uses 2% sulfur cream made by A2Z company locally 2 times a day in the hands and then stops using the cream and is followed up for the next month.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Itching score. Timepoint: 4 weeks after treatment and 4 weeks after follow-up. Method of measurement: Itching is given a score from 1 to 10, and for each individual cream before treatment, after 4 weeks of treatment, and after 4 weeks of follow-up, patients' itching is scored in order to check the therapeutic effect of the drugs used.</prim_outcome>
      <prim_outcome>Dryness score. Timepoint: 4 weeks after treatment and 4 weeks after follow-up. Method of measurement: Dryness is given a score from 1 to 10, and for each individual cream before treatment, after 4 weeks of treatment and after 4 weeks of follow-up, patients' dryness is scored in order to check the therapeutic effect of the drugs used.</prim_outcome>
      <prim_outcome>Burning score. Timepoint: 4 weeks after treatment and 4 weeks after follow-up. Method of measurement: Burning is given a score from 1 to 10, and for each individual cream before treatment, after 4 weeks of treatment and after 4 weeks of follow-up, patients' burning is scored to check the therapeutic effect of the drugs used.</prim_outcome>
      <prim_outcome>Erythema score. Timepoint: 4 weeks after treatment and 4 weeks after follow-up. Method of measurement: Erythema is given a score from 1 to 10, and for each individual cream before treatment, after 4 weeks of treatment and after 4 weeks of follow-up, patients' erythema is scored to check the therapeutic effect of the drugs used.</prim_outcome>
      <prim_outcome>Satisfaction with treatment. Timepoint: 4 weeks after treatment and 4 weeks after follow-up. Method of measurement: To evaluate patients' satisfaction with treatment, Vas Score is recorded.</prim_outcome>
      <prim_outcome>Eczema severity. Timepoint: Before the start of treatment, the end of 4 weeks of treatment and the end of 4 weeks of follow-up. Method of measurement: Hand eczema severity index (HECSI) score is used for patients.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-14</approval_date>
        <contact_name>Ethical Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hazar Jarib Street, Isfahan University of Medical Sciences and Health Services isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
