<?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>IRCT20230103057039N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-06</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Evaluation of the efficacy of laser and plasma in the treatment of freckles</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the plasma effect with and without alexandrite laser in the treatment of freckles in patients referred to the clinics affiliated with Tehran Medical Sciences Azad University in 2022-2023</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67838</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The evaluation of the results of the interventions is done by a dermatologist and this study is blinded by her.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with  freckles.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: A group of 30 patients with fitzpatrick skin type 1 to 4 who had no history of using topical lightening drugs from 8 weeks before treatment, without sexual restriction, over 16 years old, will be treated with plasma single pass. The amount of skin pigmentation in two stages before and after treatment is determined. The response to treatment will be complete loss of lesions (recovery above 80%). Intervention 2: Second group of intervention:  A group of 30 patients with fitzpatrick skin type 1 to 4 who had no history of using topical lightening drugs from 8 weeks before treatment, without sexual restriction ,over 16 years old will be treated with plasma single pass with a single pass laser shot with a wavelength of 755 nm with a wavelength of 5 mm and Pulse duration of 0.5 milisecond with Fluence = 20 J/cm2 for skin type 3 and 4 /Fluence = 24 J/cm2 for skin type 1 and 2 in single pass. The amount of skin pigmentation in two stages before and after treatment is determined. The response to treatment will be complete loss of lesions (recovery above 80%).</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 NO more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahin Fathi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2,Arash street, Park Ave, Hamila Blvd, Punak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1469696006</zip>
        <telephone>+98 21 4613 8218</telephone>
        <email>mahin.pt86@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Fathi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.7, Arash street, Park Ave,Hamila Blv,Punak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1469696006</zip>
        <telephone>+98 21 4613 8218</telephone>
        <email>mahin.pt86@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having freckles
Skin types 1 to 4 on the Fitzpatrich scale
Patient over 16 years old</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking skin lightening drugs 8 weeks before treatment
Fitzpatrick scale type 5 skin
People who are directly exposed to UV light
People under 16 years old</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L81.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Freckles</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: A group of 30 patients with fitzpatrick skin type 1 to 4 who had no history of using topical lightening drugs from 8 weeks before treatment, without sexual restriction, over 16 years old, will be treated with plasma single pass. The amount of skin pigmentation in two stages before and after treatment is determined. The response to treatment will be complete loss of lesions (recovery above 80%).</i_keyword>
      <i_keyword>Second group of intervention:  A group of 30 patients with fitzpatrick skin type 1 to 4 who had no history of using topical lightening drugs from 8 weeks before treatment, without sexual restriction ,over 16 years old will be treated with plasma single pass with a single pass laser shot with a wavelength of 755 nm with a wavelength of 5 mm and Pulse duration of 0.5 milisecond with Fluence = 20 J/cm2 for skin type 3 and 4 /Fluence = 24 J/cm2 for skin type 1 and 2 in single pass. The amount of skin pigmentation in two stages before and after treatment is determined. The response to treatment will be complete loss of lesions (recovery above 80%).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Degree of pigmentation. Timepoint: Before and after the intervention. Method of measurement: Based on the reduction of pigmentation: Weak, Medium, Excellent.</prim_outcome>
      <prim_outcome>Side effects. Timepoint: A month after the treatment is finished. Method of measurement: Ask the patient.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-26</approval_date>
        <contact_name>Ethics Committee in Research Faculty of Medicine,Tehran Islamic Azad University of Medical Sciences</contact_name>
        <contact_address>Headquarters Building of Islamic Azad University of Medical Sciences Tehran,Corner of Ice Flower Street,Ayeneh Boulevard, Dr. Shariati Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
