<?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>IRCT20160514027888N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-26</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of plasma spark with argon plasma and shower on face and neck skin rejuvenation</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of plasma spark with argon plasma and shower on face and neck skin rejuvenation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68741</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: 40 cases divided into 4 groups (10 processing with plasma spark, 10 processing with spark and argon jet, 10 processing with spark and shower, 10 processing with 2 different spark modes) based on the random list provided by the statistical analyst (list based on blocks  randomly provided) will be processed.  Placing the clients in different groups and creating a random sequence was done by Random Allocation Software 2.0 for 4 groups and 40 samples.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Wrinkles and sagging skin.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Processing only with dot mode of the Plasma Spark device. Intervention 2: Intervention group: Processing with the dot mode of the plasma spark device along with the argon plasma jet. Intervention 3: Intervention group: Processing with the dot mode of the plasma spark device along with the plasma shower. Intervention 4: Intervention group: Simultaneous processing with two point and spray mode of the spark plasma device.</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:
At the end of the project, the achievements and performance of the Spark device alone and also together with other devices and methods will be published.

When:
The access period starts 6 months after the results are published

To whom:
It will be available only to researchers working in academic and scientific institutions

Conditions:
To refer to achievements and referencing

Where to obtain:
Mohammadreza Khani +989122531497 m_khani@sbu.ac.ir

How to obtain:
3 months

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadreza Khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University, Daneshjo Blvd., Evin, Shahid Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 2990 4017</telephone>
        <email>m_khani@sbu.ac.ir</email>
        <affiliation>Laser and Plasma Research Institute/ Shahid Beheshti University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadreza Khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University, Daneshjo Blvd., Evin, Shahid Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 2990 4017</telephone>
        <email>m_khani@sbu.ac.ir</email>
        <affiliation>Laser and Plasma Research Institute/ Shahid Beheshti University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having wrinkles and sagging skin in the desired areas</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence of active infection
history of skin cancer in the treatment area
history of keloid formation
history of hereditary or acquired connective tissue diseases
history of coagulation disorders
use of drugs involved in coagulation
having metal implants
use of Retin A drug
pregnancy or breastfeeding
people with skin color group V, VI
clients with an artificial heart pacemaker
patients who underwent cosmetic procedures around the eyes such as laser and photodynamic therapy, blepharoplasty, rhytidectomy and subcutaneous filler injections in the last 12 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L98</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of skin and subcutaneous tissue, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Processing only with dot mode of the Plasma Spark device</i_keyword>
      <i_keyword>Intervention group: Processing with the dot mode of the plasma spark device along with the argon plasma jet</i_keyword>
      <i_keyword>Intervention group: Processing with the dot mode of the plasma spark device along with the plasma shower</i_keyword>
      <i_keyword>Intervention group: Simultaneous processing with two point and spray mode of the spark plasma device</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes of collagen in the skin. Timepoint: Before starting the processes and weeks 2, 4, 6 and 10 after the processing. Method of measurement: Skin ultrasound device.</prim_outcome>
      <prim_outcome>Skin elasticity. Timepoint: Before starting the processes and weeks 2, 4, 6 and 10 after the processing. Method of measurement: MPA9 multifunctional device.</prim_outcome>
      <prim_outcome>Water evaporated from the skin surface. Timepoint: Before starting the processes and weeks 2, 4, 6 and 10 after the processing. Method of measurement: MPA9 multifunctional device.</prim_outcome>
      <prim_outcome>Skin melanin changes. Timepoint: Before starting the processes and weeks 2, 4, 6 and 10 after the processing. Method of measurement: MPA9 multifunctional device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Shahid Beheshti University</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Research Deputy ofTehran University of Medical Sciences</source_name>
      <source_name>Shahid Beheshti University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-19</approval_date>
        <contact_name>Faculty of Medicine - Tehran University of Medical Sciences (Research Ethics Committee)</contact_name>
        <contact_address>Laser and Plasma Research Institute,Shahid Beheshti University,Shahid Shahriari Square,Evin,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
