<?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>IRCT20181114041658N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-24</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparing  dimethyl sulfoxide solution versus topical tretinoin in  cutaneous amyloidosis</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the efficacy of 50% dimethyl sulfoxide solution versus topical tretinoin 0.5% cream in patients with cutaneous amyloidosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35313</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We use simple randomization by the random number table in order to generate random sequence. To this end, a biostatistician employs the random allocation software and after obtaining the reading trend, the first number will assign to the right side and the second number will assign to the left side. The odd number and even number represent the intervention and control sides, respectively. Therefore, dimethyl sulfoxide and tretinoin will be assigned for each side (right or left). Then, allocation concealment will be done using SNOSE method and numbered, sealed and opaque envelopes by a medical doctorate candidate will be sequenced and will be delivered to the principal dermatologist. In time of enrolling the participants to the study who is fulfilled the inclusion criteria, evaluated by the dermatologist, two consecutive envelops will be open and the allocated sides will be obtained. Each patient will serve as his/her own control; by doing so, the problem of confounding factor will be avoided.  Also, for concealment, we will use similar containers in shape and color, Blinding description: Although the treatments were allocated randomly, the patients were aware of the treatments (dimethyl sulfoxide solution and tretinoin cream can be distinguished). They instructed by a blinded dermatologist (Researchers  will be blinded  to  the  allocation  until  the  end  of  study.  To  conceal  group  allocation,  we  use  similar containers in shape and color) to apply treatments daily in the first four weeks and every other day later on. Notably, tubes are identical and based on list and number on tubes, will be assigned to each side in every patient. Also, the baseline outcomes will record. Patients reattended and further colorimetery, itching scoring, and photography were then undertaken at the end of 4th, 12th, and 18th week follow ups with the dermatologist unaware of the treatments’ side which the volunteer had been randomized. َAdditionally, dermatologist will record the outcomes as well. Data analysis will be done by an epidemiologist who is unaware of treatments.</study_design>
      <phase>3</phase>
      <hc_freetext>Primary localized cutaneous amyloidosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group receives topical dimethyl sulfoxide (DMSO) 50% solution (formulized and prepared at the School of Pharmacy, Shiraz University of Medical Sciences) on the assigned side daily for 4 weeks and every other day to the 20th week. After cleansing the target lesion with water and soap, topical DMSO 50% solusion applies by a spigot. Intervention 2: Control group uses tretinoin 0.5% (Iran Daroo, Tehran, Iran) on the assigned side daily for 4 weeks and every other day to the 20th week.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Najmeh Ahramyianpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Setad Sque., Zand Blvd., Shiraz.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7176913861</zip>
        <telephone>+98 71 3235 1087</telephone>
        <email>najmeh.pour@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Saki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Setad Sque., Zand Blvd., Shiraz.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134846114</zip>
        <telephone>+98 71 3235 1087</telephone>
        <email>nasrinsa85@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with clinical and pathological diagnosis of lichen and macular amyloidosis in trunk and lower limbs
bilateral amyloidosis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>using other topical drugs in last four weeks
sensitivity to retinoids
hepatic disorders
breast feeding
pregnancy
no consent for photography</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E85.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Organ-limited amyloidosis</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 receives topical dimethyl sulfoxide (DMSO) 50% solution (formulized and prepared at the School of Pharmacy, Shiraz University of Medical Sciences) on the assigned side daily for 4 weeks and every other day to the 20th week. After cleansing the target lesion with water and soap, topical DMSO 50% solusion applies by a spigot.</i_keyword>
      <i_keyword>Control group uses tretinoin 0.5% (Iran Daroo, Tehran, Iran) on the assigned side daily for 4 weeks and every other day to the 20th week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Melanin. Timepoint: baseline and at the end of 4th, 12th, and 18th week of 20-week treatment period. Method of measurement: colorimetery (dermocatch).</prim_outcome>
      <prim_outcome>Itching. Timepoint: baseline and at the end of 4th, 12th, and 18th week of 20-week treatment period. Method of measurement: itching scoring (0-10).</prim_outcome>
      <prim_outcome>Erythema. Timepoint: baseline and at the end of 4th, 12th, and 18th week of 20-week treatment period. Method of measurement: colorimetery (dermocatch).</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-17</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Local Ethics Committee, Shiraz University of Medical Sciences,  Setad Squ., Zand Blvd., Shiraz. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
