<?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>IRCT20150529022468N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-30</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of tranexamic acid versus Kligman’s application in the treatment of macular amyloidosis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of efficacy and safety of intra lesional tranexamic acid injection versus topical Kligman’s formula application in the treatment of macular amyloidosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40458</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To select patients randomly, 40 pieces of paper will be numbered from 1 to 40. For each patient one of the papers will be taken in random order. If the number is paired, the patient will be in the tranexamic acid group, and if the number is Odd in the Kligman group, Blinding description: Patients will be evaluated by a physician. This physician will be blind to the grouping of patients. In addition, the data analyzer will be blind to the grouping of patients.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Macular amyloidosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: tranexamic acid. Six sessions of treatment every two weeks are given by the physician as an intra lesional tranexamic acid. Each session, 0.1 cc of 4 mg / ml tranexamic acid will be injected interdermally with a 30-G needle and at a distance of 1 cm to an area of 10*10 cm which covers the entire lesion area. Intervention 2: Intervention group: Kligman (with  hydroquinone 4.0%, tretinoin 0.05%, fluocinolone acetonide 0.01%, vit c 500mg formula). Apply a tip of finger topical Kligman on a dry and clean skin each night for 12 weeks and do not rinse at least 4 hours after 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All of information without name

When:
1 years after publish

To whom:
Researchers

Conditions:
All of patients information without their name

Where to obtain:
Study researcher: Mohammadreza Ghasemi

How to obtain:
sending email to the researcher: ghassemi.mr@iums.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadreza Ghassemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrate Rasoule Akram Hospital, Niayesh St,Satarkhan Av, Tehran, IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 6650 2040</telephone>
        <email>ghassemi.mr@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadreza Ghassemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrate Rasoule Akram Hospital, Niayesh St,Satarkhan Av, Tehran, IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 6435 2528</telephone>
        <email>ghassemi.mr@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 18 to 50 years
Suffering from macular amyloidosis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant or lactating women
History of cardiovascular disease
Keloid patients
Patients taking anticoagulants
Any allergy to the study drugs
History of bleeding disorder
Topical treatment three months before entering the study
No consent to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E85.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other 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: tranexamic acid. Six sessions of treatment every two weeks are given by the physician as an intra lesional tranexamic acid. Each session, 0.1 cc of 4 mg / ml tranexamic acid will be injected interdermally with a 30-G needle and at a distance of 1 cm to an area of 10*10 cm which covers the entire lesion area.</i_keyword>
      <i_keyword>Intervention group: Kligman (with  hydroquinone 4.0%, tretinoin 0.05%, fluocinolone acetonide 0.01%, vit c 500mg formula). Apply a tip of finger topical Kligman on a dry and clean skin each night for 12 weeks and do not rinse at least 4 hours after application.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Skin darkness. Timepoint: 4, 8 and 12 weeks after start and 3 months after finishing the treatment. Method of measurement: The Visioface device, the third physician's opinion, and the patient's opinion.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Drug side effects. Timepoint: 4, 8 and 12 weeks after start and 3 months after finishing the treatment. Method of measurement: Check list.</sec_outcome>
      <sec_outcome>Onset of therapeutic effect. Timepoint: 4, 8 and 12 weeks after start and 3 months after finishing the treatment. Method of measurement: The Visioface device, the third physician's opinion, and the patient's opinion. The doctor's and patient opinion will be announced through the following options: 1. No response (no amelioration) 2. poor response (amelioration less than 25%) 3. average response (amelioration from 25% to 50%) 4. good response (amelioration from 50% to 75%) 5. very good response (amelioration by more than 75%).</sec_outcome>
      <sec_outcome>Continuity of drug effect. Timepoint: 4, 8 and 12 weeks after start and 3 months after finishing the treatment. Method of measurement: The Visioface device, the third physician's opinion, and the patient's opinion. The doctor's and patient opinion will be announced through the following options: 1. No response: no amelioration 2. poor response: amelioration less than 25% 3. average response: amelioration from 25% to 50% 4. good response: amelioration from 50% to 75% 5. very good response: amelioration by more than 75%.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-02</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
