<?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>IRCT201212303734N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-08-30</date_registration>
      <primary_sponsor>Barij Essence Herbal Medicine Research Center</primary_sponsor>
      <public_title>Efficacy of Anti-dry cream in  treatment of hand eczema</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating of Anti-dry cream vs Flucinolone acetonide 0/o25% cream in   treatment of hand eczema</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3847</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Hand eczema.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Anti dry® cream (contains Aleo vera essence, Geranium essence, Lavander essence, respectively, with ratio of 50:1:15 in vanishing cream), 1FTU (finger tip unit= 0.5g) for 10×10 cm2,  twice daily, for two weeks. Intervention 2: control group: fluocinolon acetonide cream 0.025%, twice daily, for two weeks.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>Abstract:&lt;br /&gt;&#13;
Introduction: Hand eczema is the most common dermatitis that affects hands. The annual prevalence of hand eczema has been reported to be between 7 and 12 percent. Due to the physical and psychological effects of hand eczema, failure of existing treatment methods and corticosteroids side effects the current study has been designed to assess the effect of anti-dry cream on treatment of hand eczema symptoms  and compare it with fluocinolone acetonide cream 0.025.&lt;br /&gt;&#13;
 Material and method: This study is a double-blind randomized clinical trial and has been conducted on hand eczema sufferers. Random allocation using the block method was assigned to two groups; anti-dry cream and fluocinolone acetonide cream 0.025.drug is applied for two weeks, twice daily, and in each time massaging cream gently into the position.Subjects were evaluated at the baseline and two weeks after treatment in terms of clinical symptoms and possible complications.&lt;br /&gt;&#13;
Findings:&lt;br /&gt;&#13;
In this study, 73 patients were studied out of which 16 were male and the rest were female. Distribution in terms of gender, age, education, occupation, duration of illness, frequency of disease occurrence, medications and personal and family medical history were similar in both groups.(p&gt;0.05)The results showed a decrease in score of disease  In anti dry group after treatment in  left and right hands, it was 3.94and 5.07 and for fluocinolone group it was 4.12 and 4 respectively. So there was no significant difference between two groups (p&gt;0.11)&lt;br /&gt;&#13;
Conclusions:&lt;br /&gt;&#13;
The results of this study indicate the therapeutic effects of anti- dry and fluocinolone cream. With regard to the lack of difference between the two groups, anti –dry cream can be used as an alternative treatment for hand eczema. &lt;br /&gt;&#13;
Keywords: Anti -dry, Fluocinolone acetonide, hand eczema&lt;br /&gt;&#13;
Introduction:&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
 &lt;br /&gt;&#13;
           </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>Rezvan Talaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dermatology department of Beheshti hospital, 5th kilometer of Ghotb  Ravandi Bulvard</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159/88141</zip>
        <telephone>+98 361555002126</telephone>
        <email>R_talaee2007@yahoo.com</email>
        <affiliation>Kashan university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rezvan Talaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dermatology department of Beheshti hospital, 5th Km of Ghotb Ravandi Bulvard</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159/88141</zip>
        <telephone>+98 361555002126</telephone>
        <email>R_Talaee2007@yahoo.com</email>
        <affiliation>Kashan university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Main inclusion criteria: age between 18-75y/o; patients should be eager to participate in trial; patients with hand eczema that is confirmed by dermatologist.&#13;
 Main exclusion criteria: pregnancy and lactation; application of topical drugs during previous two weeks; systemic therapies such as corticosteroids, immunosupressive drugs and antibiotics during the past 4 weeks; localized hand infection; history of  allergic reaction to the study medications.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>ICD-10: L3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ICD-10: Dermatitis unspecified Eczema NOS</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>Intervention group:  Anti dry® cream (contains Aleo vera essence, Geranium essence, Lavander essence, respectively, with ratio of 50:1:15 in vanishing cream), 1FTU (finger tip unit= 0.5g) for 10×10 cm2,  twice daily, for two weeks.</i_keyword>
      <i_keyword>control group: fluocinolon acetonide cream 0.025%, twice daily, for two weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change of signs and symptoms of hand eczema. Timepoint: The days of 0 and 14. Method of measurement: Questionnaire (contains of clinical signs and symptoms: erythema, scaling, lichenification/ hyperkeratosis, edema,vesicle, fissure, pruritus and pain).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects of drugs. Timepoint: 14 days after prescription of drug. Method of measurement: Change of pruritus, erythema and scaling, bullae.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Vice chancellor for research, Kashan University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Barij Essence Herbal Medicine Research Center</source_name>
      <source_name>Vice chancellor for research, Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-08-09</approval_date>
        <contact_name>Ethics committe of Kashan university of medical sciences</contact_name>
        <contact_address>5th kilometer of Ghotb Ravandi Bulvard Kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
