<?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>IRCT20211125053175N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-29</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating effectiveness of therapy with topical isoniazid in melasma</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Efficacy of topical isoniazid versus placebo in the treatment of patients with melasma in a randomized double-blind clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60359</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, a list of random numbers was created using Excel software that determined the patients in treatment groups. In this method, the presence of patients in groups was based on the inclusion in the study after obtaining informed consent. In this study, opaque sealed plates were used to conceal random allocation, so that it is not possible to guess the allocation of each patient to the treatment group until the envelope is opened, Blinding description: This is a double-blind study for patients and data analyzor . both drugs were kept in identical plastic containers,so the evaluating physician and patient didn't know about their containings.</study_design>
      <phase>2-3</phase>
      <hc_freetext>melasma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Isonicotinic acid hydrazide cream 10%. How to use: Topical use, once daily. Duration of treatment: 12 weeks. Manufacturing factory: Exir, Iran. Intervention 2: Control group: Intervention group: Cold cream. How to use: Topical use, every night. Duration of treatment: 12 weeks. Manufacturing factory:Gol daroo Pharmaceutical Factory.</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 because it is not necessary</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rezvan Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Highway, Afzalipour Hospital</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913911</zip>
        <telephone>+98 34 3132 8328</telephone>
        <email>rezvanamiri1358@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rezvan Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Highway, Afzalipour Hospital</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913911</zip>
        <telephone>+98 34 3132 8328</telephone>
        <email>rezvanamiri1358@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with minimum age 20 years old to maximum 60 years old
Patients with diagnosed melasma</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Other topical medication users  for melasma in the last four weeks
Kubner-positive diseases such as vitiligo
Lactation and pregnancy
Not consent to medical photography</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L81.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other melanin hyperpigmentation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Isonicotinic acid hydrazide cream 10%. How to use: Topical use, once daily. Duration of treatment: 12 weeks. Manufacturing factory: Exir, Iran.</i_keyword>
      <i_keyword>Control group: Intervention group: Cold cream. How to use: Topical use, every night. Duration of treatment: 12 weeks. Manufacturing factory:Gol daroo Pharmaceutical Factory.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Melanin content. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: According to Quantitative measurement of erythema and pigmentation of the patient's skin by Swiss made Dermocatch device.</prim_outcome>
      <prim_outcome>Efficacy. Timepoint: Percentage change in melanin content before intervention and ‍12 weeks after intervention. Method of measurement: Quantitative measurement of pigmentation of the patient's skin by Swiss made Dermocatch device.</prim_outcome>
      <prim_outcome>Erythema content. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: Using Quantitative measurement of erythema and pigmentation of the patient's skin by Swiss made Dermocatch device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Erythema. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: By physical examination and classification of the complications severity into mild, moderate and severe.</sec_outcome>
      <sec_outcome>Scaling. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: By physical examination and classification of the complications severity into mild, moderate and severe.</sec_outcome>
      <sec_outcome>Burning sensation. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: By physical examination and classification of the complications severity into mild, moderate and severe.</sec_outcome>
      <sec_outcome>Increased liver enzymes. Timepoint: At the begining of the study (before intervention) and 12 weeks after intervention. Method of measurement: Based on blood test findings.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-25</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical sciences</contact_name>
        <contact_address>Ebne Sina Ave,Tahmasb Abad Blvd. Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
