<?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>IRCT20200127046282N32</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-13</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of conditioned medium with IPL laser compared to extracellular vesicles with IPL laser in the treatment of rosacea</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of conditioning medium derived from Wharton's jelly tissue along with IPL laser Compared with Wharton jelly tissue-derived extracellular vesicles conditioned with IPL laser In the treatment of rosacea</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67650</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple randomization, randomization unit: individual, randomization tool: random number table, total sample size of 30 patients with a history of rosacea in three groups, clinical trial phase: 1-2, Blinding description: Since the appearance of both products are completely similar in terms of color, smell and appearance, patients and doctors do not know about the intervention and control groups, and the study will be considered double-blind.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Rosacea.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After performing the IPL laser, the patients are subjected to the local spray of 5 cc human Wharton's jelly mesenchymal stem cell conditioned medium (Produced by Zist Sakht Bianyan Pars Company - Iran), 3 times with an interval of 1 month. Intervention 2: Intervention group: After performing IPL laser, patients are subjected to local spray of 5 cc extracellular vesicles conditioned medium of human mesenchymal stem cells of Wharton's jelly (Produced by Zist Sakht Bianyan Pars Company - Iran), 3 times with an interval of 1 month. Intervention 3: Control group: Patients treated with IPL laser are subjected to a local spray of 5 cc of normal saline, 3 times with an interval of 1 month.</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 -</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sona Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 4, Maryam Alley, South Kamraniyeh Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1937957511</zip>
        <telephone>+98 21 2665 7438</telephone>
        <email>sonazarebio@gmail.com</email>
        <affiliation>Skin and Stem cell Research Center of Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ali Nilforoushzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 4, Maryam Alley, South Kamraniyeh Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1937957511</zip>
        <telephone>+98 21 2665 7438</telephone>
        <email>nilforoosh@sina.tums.ac.ir</email>
        <affiliation>Skin and Stem cell Research Center of Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Suffering from rosacea
Not receiving other treatments in the last three months
Eligible men and women from 18 to 60 years
with severe erythema rosacea based on a patient self-assessment (PSA) score of 4 (severe) and a physician evaluation of erythema (CEA) score of 3 or more
have the ability to enter the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>causing severe drug side effects
Those who had more than 5 inflammatory lesions on the face (pointy acne or purulent acne)
Specific forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pastilosis of the chin)
They had other facial dermatitis similar to rosacea (such as perioral dermatitis), dimadisidosis, keratinization, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasian.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L71</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rosacea</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After performing the IPL laser, the patients are subjected to the local spray of 5 cc human Wharton's jelly mesenchymal stem cell conditioned medium (Produced by Zist Sakht Bianyan Pars Company - Iran), 3 times with an interval of 1 month.</i_keyword>
      <i_keyword>Intervention group: After performing IPL laser, patients are subjected to local spray of 5 cc extracellular vesicles conditioned medium of human mesenchymal stem cells of Wharton's jelly (Produced by Zist Sakht Bianyan Pars Company - Iran), 3 times with an interval of 1 month.</i_keyword>
      <i_keyword>Control group: Patients treated with IPL laser are subjected to a local spray of 5 cc of normal saline, 3 times with an interval of 1 month.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of rosacea lesions based on physician assessment (CEA). Timepoint: Before treatment and 4 and 8 weeks after. Method of measurement: Physical examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of rosacea lesions based on patient self-assessment (PSA). Timepoint: Before treatment and 4 and 8 weeks after. Method of measurement: Questionnaire PSA (patient's self-assessment) (evaluating the severity of erythema and redness from the patient's perspective).</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-10</approval_date>
        <contact_name>Research Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences, Keshavarz blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
