<?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>IRCT20260806070555N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-18</date_registration>
      <primary_sponsor>Lady Reading Hospital /MTI</primary_sponsor>
      <public_title>oral melatonin in Melasma</public_title>
      <acronym>efficacy of oral melatonin in melasma</acronym>
      <scientific_title>Efficacy of oral melatonin vs oral tranexemic acid in the treatment of melasma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92376</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible participants will be recruited through non-probability consecutive sampling. After enrollment, participants will be randomly allocated in a 1:1 ratio to either the oral melatonin group or the oral tranexamic acid group using a simple lottery method. Sequentially numbered opaque sealed envelopes containing group assignments will be prepared before recruitment. Each participant will draw one envelope, and the assignment inside will determine the treatment group. Randomization will be performed at the individual participant level. Allocation concealment will be maintained until the envelope is opened at the time of assignment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Epidermal Melasma : Its characterized by hyperpigmented macules and patches on face due to excess melanin accumulation in the skin. It can be confirmed by woods lamp examination where the pigmentation becomes accentuated..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants will receive oral melatonin 3 mg once daily at bedtime for 12 weeks, along with standard sun protection measures and broad-spectrum sunscreen. Intervention 2: Control group: Participants will receive oral tranexamic acid 250 mg twice daily for 12 weeks, along with standard sun protection measures and broad-spectrum sunscreen.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Sadia Hameed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dermatology unit, lady Reading hospital /MTI, Peshawar, KPK, Pakistan</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 331 5175185</telephone>
        <email>sadia.hameed@lrh.edu.pk</email>
        <affiliation>Lady Reading Hospital /MTI</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sadia Hameed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dermatology unit, lady Reading hospital /MTI, Peshawar, KPK, Pakistan</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 331 5175185</telephone>
        <email>sadia.hameed@lrh.edu.pk</email>
        <affiliation>Lady Reading Hospital /MTI</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1.	 Patients of 18-50 years age diagnosed with melasma.
Three clinical patterns associated with melasma i.e centrofacial, malar and mandibular will be examined
Both genders</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and lactation
Patients  with autoimmune disorders,bleeding disorders ,diabetes,history of thromboembolic events and  renal impairment
Patients with a history of hypersensitivity to oral tranexamic acid or melatonin
Use of topical treatments eg topical hydroquinone, whitening agents, topical retinoids, and topical steroids on the affected area within 4 weeks prior to enrollment.</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: Participants will receive oral melatonin 3 mg once daily at bedtime for 12 weeks, along with standard sun protection measures and broad-spectrum sunscreen.</i_keyword>
      <i_keyword>Control group: Participants will receive oral tranexamic acid 250 mg twice daily for 12 weeks, along with standard sun protection measures and broad-spectrum sunscreen.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in Melasma Area and Severity Index (MASI) score from baseline to 12 weeks after intervention. Timepoint: before intervention and at 6 and 12 weeks after intervention. Method of measurement: Modified MASI score ( Melasma Area severity index).</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>Lady Reading Hospital /MTI</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-08-06</approval_date>
        <contact_name>Ethics Committee of Lady Reading Hospital /MTI(Institutional Review Board ,IRB)</contact_name>
        <contact_address>Room no 5 (Research Cell), 4th Floor, Med Surge block, lady Reading hospital /MTI, Peshawar, KPK, Pakistan Peshawar Khyber Pakhtunkhwa Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
