<?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>IRCT20111123008177N18</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-18</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Needling technique with topical Latanoprost in treatment of hypopigmented burn scars</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of needling technique with topical Latanoprost in treatment of hypopigmented burn scars in burn patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30737</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients in both groups (A) and (B) are treated in one limb and untreated in the other limb. Therefore, each intervention group will have a control group, Randomization description: Patients who have the inclusion criteria are enrolled in the study. Assigning the treatment type to either of the two same areas is done by simple randomization by software, Blinding description: To do blinding process, the placebo drops similar to those of Latanoprost are prepared and used simultaneously with the same dose. Patients who participate, main researchers of the study, dermatologist who perform the microneedling technique, the plastic surgeon examining the outcome of patient's scar before and after the intervention, and ultimately the person who is analyzing the data are blind to the study.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Hypopigmented scar.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Needling procedure is performed under local anesthesia on the hypopigmented or depigmated organs of the patient, measuring from 4 to 25 cm square. The German AMIEA MED microneedling is a DA-3.0-EN-MP type approved by CE Europe, ISO 13485, and the Ministry of Health. Then, a drop of latanoprost (0.005%, 50 μg / ml, Iran, Sina drug) is applied to the patient. The dose is one drop per 2 × 2 cm area twice daily for 24 weeks. Intervention 2: Intervention group 2: Needling procedure is performed under local anesthesia on the hypopigmented or depigmated organs of the patient, measuring from 4 to 25 cm square. Then placebo drops containing distilled water are used. The dose is one drop per 2 × 2 cm area twice daily for 24 weeks. Intervention 3: Control group: Symmetrical limb will be left untreated in each patient.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnoush Momeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Motahari Burn Hospital, Yasemi St., Vali-e-asr Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1196714353</zip>
        <telephone>+98 21 8888 4275</telephone>
        <email>mah_momeni@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Shafieyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Burn Research Center, Yasemi St., Vali-e-asr Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1196714353</zip>
        <telephone>+98 21 8888 4275</telephone>
        <email>sshafiiyan@yahoo.com</email>
        <affiliation>Iranian academic center for education culture and research</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 15-50 years.
In two symmetrical regions of the body (focusing on the organs) having hypopigmented scars.
Willing to cooperate and follow-up on treatment and complete the informed consent form.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are pregnant, are planning to become pregnant, or are breastfeeding.
Those who have had severe systemic diseases in the past 6 months.
Concomitant diseases (diabetes, connective tissue disease, chronic kidney disease, cardiovascular disease) and any type of disease that can cause immune system dysfunction and delay wound healing.
Immunosuppressant drugs and corticosteroids.
History of the use of depigmented or pigmented products on scars during the past 3 months.
Have a history of allergy or high sensitivity to the compounds used in the study.
Smoking and alcohol consumption.
Since the onset of a lesion leading to hypopigmented or depigmented scars, only 6 months have passed.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L81.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of diminished melanin formation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Needling procedure is performed under local anesthesia on the hypopigmented or depigmated organs of the patient, measuring from 4 to 25 cm square. The German AMIEA MED microneedling is a DA-3.0-EN-MP type approved by CE Europe, ISO 13485, and the Ministry of Health. Then, a drop of latanoprost (0.005%, 50 μg / ml, Iran, Sina drug) is applied to the patient. The dose is one drop per 2 × 2 cm area twice daily for 24 weeks.</i_keyword>
      <i_keyword>Intervention group 2: Needling procedure is performed under local anesthesia on the hypopigmented or depigmated organs of the patient, measuring from 4 to 25 cm square. Then placebo drops containing distilled water are used. The dose is one drop per 2 × 2 cm area twice daily for 24 weeks.</i_keyword>
      <i_keyword>Control group: Symmetrical limb will be left untreated in each patient.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Scar. Timepoint: Before intervention, 3 and 6 months after using the last dose of drops. Method of measurement: 0-4 scale (including resizing and colorimetric staining) and Vancouver Scar scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient satisfaction. Timepoint: Before intervention, 3 and 6 months after using the last dose of drops. Method of measurement: Visual Analog Scale.</sec_outcome>
      <sec_outcome>Cost. Timepoint: The end of the study. Method of measurement: Estimated cost of microneedling process and latanoprost drops.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-26</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Central building of Iran University of Medical Sciences, next to Milad Towe, Hemmat highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
