<?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>IRCT20091012002581N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-21</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of topical ۵% Methimazole and 4 % Hydroquinone effect on melasma</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of topical Methimazole 5% versus topical Hydroquinone 4% on the improvement of melasma lesions</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66154</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>melasma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 5% topical methymazole cream that has been formulated in Tabriz University of Medical Sciencses Faculty of Pharmacy, is provided to the patients and they are asked to apply this cream to the right side of their cheek once a day. Patients are followed up at intervals of 4, 8, and 12 weeks, and their recovery rate, satisfaction, and Masi score are checked for them. Thyroid function tests are also requested again in the 8th week. The side effects and recovery rate will be checked based on the mentioned cases at the end of the 12th week. Intervention 2: Control group: 5% topical hydroquinone cream that has been formulated in Tabriz University of Medical Sciences Faculty of Pharmacy,is provided to the patients and they are asked to apply this cream to the right side of their cheek once a day. Patients are followed up at intervals of 4, 8, and 12 weeks, and their recovery rate, satisfaction, and Masi score are checked for them. Thyroid function tests are also requested again in the 8th week. The side effects and recovery rate will be checked based on the mentioned cases at the end of the 12th week.</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:
The data of the study are classified and coded so that the names of the people cannot be identified.

When:
Access starts from the beginning of data collection
November 1401

To whom:
For researchers in academic institutions

Conditions:
In order to use in other studies

Where to obtain:
To me, Hamida Harizchi Ghadim, all the ways of communication have been mentioned in the previous section
Priority through phone call , Email and then SMS
Shaghayegh Babapoor through phone call, SMS and E-mail

How to obtain:
After receiving the request via phone call or SMS and email, it will be sent within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Hamideh Herizchi- Ghadim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dermatology ward , Sina hospital,Azadi street, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614766</zip>
        <telephone>+98 41 1540 6612</telephone>
        <email>dr.herizchi@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr Hamideh Herizchi- Ghadim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dermatology ward, Sina hospital, Azadi street , Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614766</zip>
        <telephone>+98 41 1540 6612</telephone>
        <email>dr.herizchi@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age higher than 18 years and below 50 years
Informed consent participate in the  study
Presence of melanoma in both sides of cheeks</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of consent to participate in the study
Pregnancy or lactation
History of sensitivity to Tiamazoles
Thyroid dysfunction
History of using other topical drugs for melanoma in past 3 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L81.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chloasma</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 5% topical methymazole cream that has been formulated in Tabriz University of Medical Sciencses Faculty of Pharmacy, is provided to the patients and they are asked to apply this cream to the right side of their cheek once a day. Patients are followed up at intervals of 4, 8, and 12 weeks, and their recovery rate, satisfaction, and Masi score are checked for them. Thyroid function tests are also requested again in the 8th week. The side effects and recovery rate will be checked based on the mentioned cases at the end of the 12th week.</i_keyword>
      <i_keyword>Control group: 5% topical hydroquinone cream that has been formulated in Tabriz University of Medical Sciences Faculty of Pharmacy,is provided to the patients and they are asked to apply this cream to the right side of their cheek once a day. Patients are followed up at intervals of 4, 8, and 12 weeks, and their recovery rate, satisfaction, and Masi score are checked for them. Thyroid function tests are also requested again in the 8th week. The side effects and recovery rate will be checked based on the mentioned cases at the end of the 12th week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of melasma lesions. Timepoint: 1, 4, 8 and 12 months after treatment. Method of measurement: Clinical examination and comparison of photos and use of Hemi Masi score.</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>2022-11-22</approval_date>
        <contact_name>Vice Chancellor for research of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Research centre , 3th floor, Central building number 2,Tabriz University of Medical Sciences,Golgasht street ,Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
