<?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>IRCT2014122420426N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-04-09</date_registration>
      <primary_sponsor>Vice Chancellor foer research of Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Osmidrosis treatment with percutaneous ethanol injection</public_title>
      <acronym></acronym>
      <scientific_title>Clinical effect of percutaneous ethanol injection in the treatment of osmidrosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18116</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>1</phase>
      <hc_freetext>Osmidrosis.</hc_freetext>
      <i_freetext>Intervention 1: 30 Patients ranged in age from 12 to 35 years in case group  were treated with percutaneous ethanol injection well. The injection procedure was carried out in an outpatient basis. Patients were placed in a supine position&#13;
with their arms abducted about 100 degrees to&#13;
expose the axilla. Marks were made around the&#13;
location of the axillary hair-bearing area, where the apocrine glands are located. When we first started&#13;
using the technique, grid-pattern markings were used&#13;
to reduce the chances of uneven distribution of the&#13;
ethanol. Intervention 2: 30 Patients ranged in age from 12 to 35 year in  control  group as placebo were treated with percutaneous saline injection well. The injection procedure was carried out in an outpatientbasis. Patients were placed in a supine positionwith their arms abducted about 100 degrees toexpose the axilla. Marks were made around thelocation of the axillary hair-bearing area, where the apocrine glands are located. When we first startedusing the technique, grid-pattern markings were usedto reduce the chances of uneven distribution of thesaline.</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>Dr. Masoom Shahbazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Dermatology, Al-Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences .</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3626 9683</telephone>
        <email>masoom_shahbazi@med.mui.ac.ir</email>
        <affiliation>Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ali  Asilian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Dermatology, Al-Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences .</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3665 5555</telephone>
        <email>asilian@med.mui.ac.ir</email>
        <affiliation>Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: having the complaint osmidrosis; age between 12-35 years old; both genders; willingness for participation in the study and signing the consent form. Exclusion criteria: pregnant or breast-feeding women; active infection at the axilla.</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L75</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Apocrine sweat disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>30 Patients ranged in age from 12 to 35 years in case group  were treated with percutaneous ethanol injection well. The injection procedure was carried out in an outpatient basis. Patients were placed in a supine position&#13;
with their arms abducted about 100 degrees to&#13;
expose the axilla. Marks were made around the&#13;
location of the axillary hair-bearing area, where the apocrine glands are located. When we first started&#13;
using the technique, grid-pattern markings were used&#13;
to reduce the chances of uneven distribution of the&#13;
ethanol.</i_keyword>
      <i_keyword>30 Patients ranged in age from 12 to 35 year in  control  group as placebo were treated with percutaneous saline injection well. The injection procedure was carried out in an outpatientbasis. Patients were placed in a supine positionwith their arms abducted about 100 degrees toexpose the axilla. Marks were made around thelocation of the axillary hair-bearing area, where the apocrine glands are located. When we first startedusing the technique, grid-pattern markings were usedto reduce the chances of uneven distribution of thesaline.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Osmidrosis. Timepoint: after ten months of injection. Method of measurement: starch-iodine test , visual analog scale(VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patients satisfaction. Timepoint: At base line – at the end of the study. Method of measurement: visual analog scale (VAS).</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>Vice Chancellor foer research of Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-04-16</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jarib Avenue , Isfahan Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
