<?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>IRCT20210823052264N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-15</date_registration>
      <primary_sponsor>Combined Military Hospital Quetta</primary_sponsor>
      <public_title>Efficacy of itraconazole in the prevention of recurrence of Pityriasis Versicolor</public_title>
      <acronym>pityriasis versicolor PV</acronym>
      <scientific_title>Efficacy of itraconazole in the prevention of recurrence of Pityriasis Versicolor</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>144</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78952</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: All participants will receive initial treatment with itraconazole (Cap Itraconazole 100mg twice daily for 7 DAYS).Following successful initial treatment after 1 week, cured participants will be randomly assigned by lottery method to either the itraconazole group (Group A) or the placebo group (Group B).Group A will receive Cap Itraconazole 200mg twice a day in a month for 4 consecutive months and Group B will receive placebo. Participants will be assessed with scheduled follow-up visits on monthly intervals for 4 months and then after further 2 months to see sustained response. The date of any recurrence and details of the lesions or any adverse events will also be documented during follow-up visits, Blinding description: Double blinded study (participant and data analyser are blinded).</study_design>
      <phase>3</phase>
      <hc_freetext>Pityriasis Versicolor.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A will receive Cap Itraconazole 200mg twice a day in a month for 4 consecutive month. Ferozsons laboratory (cap icon 100mg). Intervention 2: Control group: Group B will receive placebo once a day in a month for 4 consecutive month.Martin dow multibionata (multivitamin cap) used as placebo.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zara Babar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>CMH Quetta</address>
        <city>Quetta</city>
        <country1>Pakistan</country1>
        <zip>08762</zip>
        <telephone>+92 331 4005972</telephone>
        <email>zara.babar@yahoo.com</email>
        <affiliation>Combined Military Hospital Quetta</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zara Babar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>CMH Quetta</address>
        <city>Quetta</city>
        <country1>Pakistan</country1>
        <zip>08762</zip>
        <telephone>+92 331 4005972</telephone>
        <email>zara.babar@yahoo.com</email>
        <affiliation>Combined Military Hospital Quetta</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmed diagnosis of pityriasis versicolor based on clinical examination supported by Wood's lamp examination
Not taken antifungal medication in previous 1 month
Ability to adhere to treatment and follow-up visits</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Known hypersensitivity to itraconazole or other triazole antifungals
Liver disease or abnormal liver function tests
Pregnancy or nursing mother
Concurrent use of medications known to interact with itraconazole
Active antifungal infections other than  pityriasis versicolor
Immunodeficiency or immunosuppressive therapy
Any other medical condition deemed a safety risk by the investigator</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B36.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pityriasis versicolor</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: Group A will receive Cap Itraconazole 200mg twice a day in a month for 4 consecutive month. Ferozsons laboratory (cap icon 100mg)</i_keyword>
      <i_keyword>Control group: Group B will receive placebo once a day in a month for 4 consecutive month.Martin dow multibionata (multivitamin cap) used as placebo</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Skin lesions consistent with pityriasis versicolor. Timepoint: before start of study then 1 week, 1,2,3,4 and 6 months after treatment. Method of measurement: clinical examination and woods lamp examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Any side effects during itraconazole treament. Timepoint: 1 week, 1,2,3,4 and 6 months after treatment. Method of measurement: interviewing with the patients and clinical examination.</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>Combined Military Hospital Quetta</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-08-21</approval_date>
        <contact_name>Institutional ethical review board (IERB) certificate - CMH Quetta</contact_name>
        <contact_address>cmh quetta quetta balochistan Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
