<?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>IRCT20250124064503N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-03</date_registration>
      <primary_sponsor>Khawaja Muhammad Safdar Medical College/Allama Iqbal Memorial Teaching Hospital, Pakistan</primary_sponsor>
      <public_title>To Compare Efficacy and safety of Topical Dapsone 5% versus Topical Clindamycin 1% In Treatment of Mild to Moderate Acne Vulgaris</public_title>
      <acronym></acronym>
      <scientific_title>OUTCOME OF TOPICAL DAPSONE 5% VERSUS TOPICAL CLINDAMYCIN 1% IN TREATMENT OF MILD TO MODERATE ACNE VULGARIS</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>132</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81647</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A brief history of demographic information and written informed consent will be taken from each patient. Patients will be examined by dermatologists and will be graded. Patients will be randomly allocated using sealed opaque envelops bearing A= Clindamycin 1% gel group and B= Dapsone 5% gel group. Dapsone gel topically will be applied at bedtime on the lesions daily for 12 weeks. While clindamycin 1% gel treatment will be applied twice daily for 12 weeks. The outcome of both treatments will be assessed in 12 weeks of treatment .</study_design>
      <phase>3</phase>
      <hc_freetext>Acne Vulgaris.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Dapsone 5% Gel. Intervention 2: Intervention group 2: Clindamycin 1%.</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>Muhammad Bilal Iftikhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>bilaliftikhar28@gmail.com</address>
        <city>Sialkot</city>
        <country1>Pakistan</country1>
        <zip>51310</zip>
        <telephone>+92 48 3256011</telephone>
        <email>bilaliftikhar28@gmail.com</email>
        <affiliation>Khawaja Muhammad Safdar Medical College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Muhammad Bilal Iftikhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dermatology Department, Khawaja Muhammad Safdar Medical College, Sialkot</address>
        <city>Sialkot</city>
        <country1>Pakistan</country1>
        <zip>51310</zip>
        <telephone>+92 48 3256011</telephone>
        <email>bilaliftikhar28@gmail.com</email>
        <affiliation>Khawaja Muhammad Safdar Medical College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both Males and Females
18-60 Years of age
Mild to Moderate Acne Vulgaris as per Global Acne Grading Score</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant patients and Lactating mothers
Patients do not take any oral antibiotics for 4 weeks and topical antibiotics for 2 weeks
Patients have other facial conditions besides acne vulgaris (e.g.' ,rosacea)
Patients taking Glucocorticoids, Phenytoin, Isoniazid and Lithium
Patients with history of allergy with the study medication</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L70.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acne vulgaris</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 1: Dapsone 5% Gel</i_keyword>
      <i_keyword>Intervention group 2: Clindamycin 1%</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Primary Outcome will be the mean Global Acne Grading System Score in Dapsone 5% group and the Clindamycin 1% group at the end of 12 weeks treatment period. Timepoint: 12 weeks. Method of measurement: Global Acne Grading System Score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Other Variables like Irritation, Burning Sensation, Pruritis, Erythema and oily skin after use of the Topical Drugs. Timepoint: 12 weeks. Method of measurement: Question will be asked regarding  above mentioned side effects.</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>Khawaja Muhammad Safdar Medical College/Allama Iqbal Memorial Teaching Hospital, Pakistan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-31</approval_date>
        <contact_name>Research Ethics Committee, Khawaja Muhammad Safdar Medical College, Sialkot</contact_name>
        <contact_address>Khawaja Muhammad Safdar Medical College, Sialkot Sialkot Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
