<?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>IRCT20210524051384N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-14</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Triamcinolone and Verapamil injection on Keloid scars</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the combined effect of intralesional injection of Triamcinolone and Verapamil in the treatment of post-surgery Keloid scars</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58403</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, limited randomization will be used as a block randomization method to design patients into intervention and control groups. The latest allocation will prevent the direction from being detected in the blocks under consideration; the size of the blocks is considered random, with 2 or 4
It will use R software to generate random numbers using the Runif command.</study_design>
      <phase>3</phase>
      <hc_freetext>Surgical keloid lesion.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients which are candidate of receiving triamcinolone (without verapamil), Injections into scars with Insulin gauge syringe No. 24 without local anesthesia and intralesional injection of triamcinolone acetonide (Caspian khazar Triam Company) at a concentration of 40 mg / ml and a maximum dose of 2 mg per scar per session are performed. Intervention 2: Group receiving triamcinolone and verapamil (group 2) Scar injections with insulin gauge syringe number 24 without local anesthesia and intralesional injection of verapamil (myland verapamil) 2.5 mg / ml with a maximum dose of 2.5 mg and triamcinolone At a concentration of 40 mg / ml and a maximum dose of 2 mg per scar per session.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I haven't decided yet - the release schedule is still unknown</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ramin Hadadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velayat Hospital, Namjo St.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193713194</zip>
        <telephone>+98 13 3336 8540</telephone>
        <email>raminhadadi69@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Mohammadreza Mobayen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velayat Hospital, Namjo Street,</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193713191</zip>
        <telephone>+98 13 3336 8540</telephone>
        <email>Maziar.mobayen@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The Keloid scar should be at least 0.5 cm long and at most 10 cm
At least 3 months will be passed since their surgery
Patients are in the age range of 18 to 50 years
consent Informed</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Keloid scars with a duration of more than 12 months
Patients with infection or any other disease in the vicinity of the wound
Pregnant patients or those who plan to become pregnant in the near future
Breastfeeding women
Diabetic patients
Patients with high blood pressure or heart problems
People with chronic kidney disease or those who have had any abnormal changes in the CBC or liver tests
Patients taking steroids or verapamil for other conditions
Keloid scars of the head, face and neck</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L91.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypertrophic scar</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: patients which are candidate of receiving triamcinolone (without verapamil), Injections into scars with Insulin gauge syringe No. 24 without local anesthesia and intralesional injection of triamcinolone acetonide (Caspian khazar Triam Company) at a concentration of 40 mg / ml and a maximum dose of 2 mg per scar per session are performed.</i_keyword>
      <i_keyword>Group receiving triamcinolone and verapamil (group 2) Scar injections with insulin gauge syringe number 24 without local anesthesia and intralesional injection of verapamil (myland verapamil) 2.5 mg / ml with a maximum dose of 2.5 mg and triamcinolone At a concentration of 40 mg / ml and a maximum dose of 2 mg per scar per session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Length, Width, height of Keloid. Timepoint: Upon arrival and after each injection session until the lesion is completely flattened or up to 8 sessions. Method of measurement: Observer measurement by calibrated compass.</prim_outcome>
      <prim_outcome>Redness of the lesion. Timepoint: Upon arrival and after each injection session until the lesion is completely flattened or up to 8 sessions. Method of measurement: Based on the description of the Oscar method.</prim_outcome>
      <prim_outcome>Pigmentation. Timepoint: Upon arrival and after each injection session until the lesion is completely flattened or up to 8 sessions. Method of measurement: Based on the description of the Oscar method.</prim_outcome>
      <prim_outcome>Flexibility. Timepoint: Upon arrival and after each injection session until the lesion is completely flattened or up to 8 sessions. Method of measurement: Based on the description of the Oscar method.</prim_outcome>
      <prim_outcome>Severe itching. Timepoint: Upon arrival and after each injection session until the lesion is completely flattened or up to 8 sessions. Method of measurement: Based on the description of the Oscar method.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-11</approval_date>
        <contact_name>Ethics Committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>in front of 17 Shahrivar Hospital - St. - Shahid Siadati St. - Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
