<?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>IRCT201111266959N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-01-11</date_registration>
      <primary_sponsor>Skin research center of Shahid Beheshti  university of medical sciences</primary_sponsor>
      <public_title>The evaluation of efficacy of topical use of Nigella cream (Nigella sativa oil-extract) in chonic hand eczema</public_title>
      <acronym></acronym>
      <scientific_title>The evaluation of efficacy of topical use of Nigella cream (Nigella sativa oil-extract) in  comparison with topical use of 0.1% Betamethasone and Eucerin on the clinical severity and quality of life in patients with chonic hand eczema reffering to Loghman-e-Hakim and Shohada-e-Tajrish hospitals during the year 1388-1389</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7417</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>hand eczema.</hc_freetext>
      <i_freetext>Intervention 1: The nigella cream with eucerin base is made by a valid pharmacology company. For blinding the participants but not investigators, all three creams( Nigella, Betamethasone, eucerin as placebo)  will be prepared in the identical tubes which only labeled A, B, and C with no other information. Intervention  group Participants will apply maximally one gram of study drugs topically on eczematous lesions twice a day for a period of four weeks; the amount of applied creams is estimated by Finger Tip Unit (FTU). Intervention 2: We use Eucerin as a creamy base for the nigella oil  so  we use eucerin as a placebo.  The  Eucerin cream  will be  prepared in tubes with the same  weight and appearance to nigella cream tubes  and randomly will be administered for the patients. In this  group the eucerin cream is applied twice daily for 4 weeks in amount of a finger tip units and the maximum dose is 1 gr per each application. Intervention 3: We use Eucerin as a creamy base for the nigella oil so we use eucerin as a base for betamethasone cream too. The  betamethasone cream will be prepared in tubes with the same weight and appearance to nigella and placebo cream tubes and randomly will be administered for the patients. In this group the betamethasone cream is applied twice daily for 4 weeks in amount of a finger tip units and the maximum dose is 1 gr per each application.</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>Behrooz Barikbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohada e Tajrish hospital, Tajrish Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2274 1507</telephone>
        <email>b_barikbin@sbmu.ac.ir</email>
        <affiliation>Skin research center  of Shahid Beheshti  university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behrooz Barikbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohada e Tajrish hospital, Tajrish Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2274 1507</telephone>
        <email>b_barikbin@sbmu.ac.ir</email>
        <affiliation>skin research center of Shahid Beheshti  university  of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion  criteria:&#13;
  - age between 18-60 y/o&#13;
  - patients should be eager to participate in trial&#13;
  -patients should have chronic hand eczema that is confirmed by two dermatologist&#13;
   separetely&#13;
     Exclusion criteria:&#13;
  -pregnancy and lactation&#13;
  -application of topical drugs during previous two weeks&#13;
  -usage of systemic therapies such as corticosteroids and immunosupressive drugs and antibiotics during the past 4 weeks&#13;
  - localized hand infection&#13;
  -history of  hand contact dermatitis due to topical drugs including herbal remedies</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L30.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dermatitis, unspecified      Eczema NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The nigella cream with eucerin base is made by a valid pharmacology company. For blinding the participants but not investigators, all three creams( Nigella, Betamethasone, eucerin as placebo)  will be prepared in the identical tubes which only labeled A, B, and C with no other information. Intervention  group Participants will apply maximally one gram of study drugs topically on eczematous lesions twice a day for a period of four weeks; the amount of applied creams is estimated by Finger Tip Unit (FTU).</i_keyword>
      <i_keyword>We use Eucerin as a creamy base for the nigella oil  so  we use eucerin as a placebo.  The  Eucerin cream  will be  prepared in tubes with the same  weight and appearance to nigella cream tubes  and randomly will be administered for the patients. In this  group the eucerin cream is applied twice daily for 4 weeks in amount of a finger tip units and the maximum dose is 1 gr per each application.</i_keyword>
      <i_keyword>We use Eucerin as a creamy base for the nigella oil so we use eucerin as a base for betamethasone cream too. The  betamethasone cream will be prepared in tubes with the same weight and appearance to nigella and placebo cream tubes and randomly will be administered for the patients. In this group the betamethasone cream is applied twice daily for 4 weeks in amount of a finger tip units and the maximum dose is 1 gr per each application.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: 2 weeks. Method of measurement: Dermatology Life Quality Index (DLQI).</prim_outcome>
      <prim_outcome>Resolution of severity and intensity of lesions. Timepoint: 2 weeks. Method of measurement: Hand Eczema Severity Index (HECSI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Irritant or allergic contact dermatitis. Timepoint: 4 weeks. Method of measurement: physician assessment.</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>Skin research center of Shahid Beheshti  university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-12-29</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti  university of medical sciences</contact_name>
        <contact_address>Shahid beheshti medical university, Velenjak Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
