<?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>IRCT20100314003566N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-02</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Benefits of Nd:YAG 1064 nm laser in the treatment of the face and lower limb telangiectasia</public_title>
      <acronym></acronym>
      <scientific_title>Determining the benefits and side effects of the Nd:YAG 1064 nm laser in order to achieve an effective pulse width with minimal side effects in the treatment of the face and lower limb telangiectasia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74056</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The degree of fluency, pulse width, and spot size utilized will be kept secret from patients.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Facial telangiectasia. Condition 2: Lower limb telangiectasia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Patients with facial telangiectasia treated with alexandrite laser with a wavelength of 1064 nm (Alexandrite ND: YAG, CA, USA) with fluence parameters of 140 and 150 J/cm2 with a pulse width of 20 milliseconds and a spot size of 3 mm will be squared. Before the treatment, anesthesia will be done with a thin layer of topical gel on the surface of the skin. Also, after laser treatment, sunscreen and repair cream will be used in all patients for at least 10 days. Intervention 2: Intervention group 2: Patients with lower limb telangiectasia treated with alexandrite laser with a wavelength of 1064 nm (Alexandrite ND: YAG, CA, USA) with fluence parameters of 160 and 180 J/cm2 with a pulse width of 20 milliseconds and a spot size of 5 mm will be squared. Before the treatment, anesthesia will be done with a thin layer of topical gel on the surface of the skin. Also, after laser treatment, sunscreen and repair cream will be used in all patients for at least 10 days.</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:
Study data is categorized and coded with no identifiable individuals.

When:
Access to study data after publication of the result is available in the journal.

To whom:
Anyone interested in using the data can access the study data.

Conditions:
Study data can be used for comparison with other results.

Where to obtain:
Refer to the study's scientific or public accountability person for data.

How to obtain:
The request will be sent by email to person responsible for scientific or public inquiries.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Hamide Azimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina hospital, Azadi avenue</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138663134</zip>
        <telephone>+98 41 1540 6612</telephone>
        <email>azimi@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hamide Azimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina hospital, Azadi avenue</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138663134</zip>
        <telephone>+98 41 1540 6612</telephone>
        <email>azimi@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with facial telangiectasia
Patients with telangiectasia of lower limbs
Consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant and lactating women
Patients with a history of coagulation disorders
Suffering from chronic systemic liver diseases
Patients with a history of hypertrophic scars and prone to keloid</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I78.0</hc_code>
      <hc_code>I78.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hereditary hemorrhagic telangiectasia</hc_keyword>
      <hc_keyword>Hereditary hemorrhagic telangiectasia</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>Intervention group 1: Patients with facial telangiectasia treated with alexandrite laser with a wavelength of 1064 nm (Alexandrite ND: YAG, CA, USA) with fluence parameters of 140 and 150 J/cm2 with a pulse width of 20 milliseconds and a spot size of 3 mm will be squared. Before the treatment, anesthesia will be done with a thin layer of topical gel on the surface of the skin. Also, after laser treatment, sunscreen and repair cream will be used in all patients for at least 10 days.</i_keyword>
      <i_keyword>Intervention group 2: Patients with lower limb telangiectasia treated with alexandrite laser with a wavelength of 1064 nm (Alexandrite ND: YAG, CA, USA) with fluence parameters of 160 and 180 J/cm2 with a pulse width of 20 milliseconds and a spot size of 5 mm will be squared. Before the treatment, anesthesia will be done with a thin layer of topical gel on the surface of the skin. Also, after laser treatment, sunscreen and repair cream will be used in all patients for at least 10 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Recovery rate of telangiectasia. Timepoint: Patients will be examined at baseline, 4 weeks after the first treatment, 4 weeks after the second treatment, and 4 weeks after the last evaluation. Method of measurement: Dermoscopy imaging.</prim_outcome>
      <prim_outcome>Patient satisfaction. Timepoint: Patients will be examined at baseline, 4 weeks after the first treatment, 4 weeks after the second treatment, and 4 weeks after the last evaluation. Method of measurement: Interview with patients.</prim_outcome>
      <prim_outcome>Side effects. Timepoint: Patients will be examined at baseline, 4 weeks after the first treatment, 4 weeks after the second treatment, and 4 weeks after the last evaluation. Method of measurement: Including wounds, scars, erythema, hyperpigmentation, hypopigmentation and blisters, which will be evaluated by a clinical examination by a dermatologist.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-20</approval_date>
        <contact_name>Ethics Committee Of Tabriz University Of Medical Sciences.</contact_name>
        <contact_address>Third Floor, Central Building of Number 2, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
