<?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>IRCT20221222056891N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-13</date_registration>
      <primary_sponsor>Pak Emirates Military Hospital</primary_sponsor>
      <public_title>Permethrin and Ivermectin in the Scabies Treatment</public_title>
      <acronym></acronym>
      <scientific_title>Comparison Of Efficacy Of Single Application Topical 5% Permethrin Versus Single Dose Oral Ivermectin In The Treatment Of Scabies</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67571</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was conducted through sequentially numbered opaque envelopes generated from a random numbers table into two groups of 30 patients each. Each patient was assigned a number  at enrollment which defined a study assignment (Topical 5% Permethrin versus Oral Ivermectin).Method of randomization was simple and unit individual.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Scabies.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Permethrin Group(A): 30 patients fulfilling inclusion criteria were prescribed permethrin 5% cream. They were asked to apply the cream to whole body covering neck to toe. After application patient were to wear clothes. They were explained that the cream must remain in contact with the skin for at least 12 hours and not to take bath before 12 hours after application. Patients were asked to take bath after 12 hrs . If any other family member was having similar symptoms he was also prescribed same medication. Patients were evaluated at week 1,2 and 4 after the treatment for resolution of pruritus and scabietic lesions and development of any adverse effects. Intervention 2: Intervention group: Intervention group(B): 30 patients fulfilling inclusion criteria received oral ivermectin 200ug/kg( Tab Ivermite) single dose only and were evaluated at week 1,2 and 4 after the treatment for resolution of pruritus and scabietic lesions and development of any adverse effects.</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:
Deidentified Individual participant data like age, weight, duration of disease, gender, given drug and response to treatment will be shared. Efficacy with respect to duration of disease, gender, age and weight will also be provided.

When:
Data will be shared after the publication of the article likely by end of 2023.

To whom:
To the people associated with medical profession.

Conditions:
Documents would be used for educational purposes and will be shared by mail and will be entertained by primary researcher.

Where to obtain:
Data could be obtained from primary researcher as well as from Department of dermatology pak Emirates Military Hospital.

How to obtain:
Data could be obtained by mail and in person from hospital after approval from competent authority.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahir Rao</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Flat M, Block D10, CMT and SD Golra , Rawalpindi, Punjab Pakistan</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 7637382</telephone>
        <email>tahir_rao@yahoo.com</email>
        <affiliation>Pak Emirates Military Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahir Rao</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Flat M, Block D10, CMT and SD Golra , Rawalpindi, Punjab Pakistan</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 7637382</telephone>
        <email>tahir_rao@yahoo.com</email>
        <affiliation>Pak Emirates Military Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients above 5 years of age and more than 15 kg of weight
Both genders
Patients having scabies as per operational definition</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient treated with any scabicidal therapy in the last 01 month
Patients taking any topical or systemic antibiotic therapy in the week before entry into the study
H/o allergy to any of the study drugs
Immunologically-compromised  patients
Pregnancy in women
Crusted/Norwegian  scabies
H/o secondary bacterial infection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B86</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Scabies</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: Permethrin Group(A): 30 patients fulfilling inclusion criteria were prescribed permethrin 5% cream. They were asked to apply the cream to whole body covering neck to toe. After application patient were to wear clothes. They were explained that the cream must remain in contact with the skin for at least 12 hours and not to take bath before 12 hours after application. Patients were asked to take bath after 12 hrs . If any other family member was having similar symptoms he was also prescribed same medication. Patients were evaluated at week 1,2 and 4 after the treatment for resolution of pruritus and scabietic lesions and development of any adverse effects.</i_keyword>
      <i_keyword>Intervention group: Intervention group(B): 30 patients fulfilling inclusion criteria received oral ivermectin 200ug/kg( Tab Ivermite) single dose only and were evaluated at week 1,2 and 4 after the treatment for resolution of pruritus and scabietic lesions and development of any adverse effects.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pruritus. Timepoint: At the time of treatment and at 1st, 2nd and 4th week after intervention. Method of measurement: History for pruritus (relieved/not relieved).</prim_outcome>
      <prim_outcome>Scabietic Lesions (Burrows and Papules). Timepoint: At the time of treatment and at 1st, 2nd and 4th week after intervention. Method of measurement: Clinical Examination and Dermoscopy for scabietic lesions (present/not present).</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>Pak Emirates Military Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-08</approval_date>
        <contact_name>Ethical Committee Pak Emirates Military Hospital</contact_name>
        <contact_address>Peshawar road, rawalpindi saddar Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
