<?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>IRCT20170608034390N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-14</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating three different regimes of permethrin in head lice treatment</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effectiveness of topical permethrin with three different methods for treating head lice</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40471</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done using the block randomization method. To do this, 10 blocks of 9 people were prepared in the Sealed Envelope online software (www.sealedenvelope.com) and 30 patients were placed in each group. Due to the fact that the patient's family must be treated in case of infestation, other family members will also be in the allocation group of the main patient.
More Details: To create this list, we consider the number of block sizes as 9 and the list length as 90, in the treatment groups section, we enter three groups: Group A, Group B and Group C, in which case the software generats,10 blocks with 9 options. Out of a total of 90 codes, 30 will be Group A, 30 will be Group B, as well as 30 in Group C, Blinding description: The expert who examines the response to the interventions and the statistical analyzer is blinded.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Head lice.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Received permethrin shampoo that stays on the head for 10 minutes according to the instructions. Intervention 2: Intervention group: Received permethrin shampoo that stays on the head for one hour according to the instructions. Intervention 3: Intervention group: Received permethrin cream rinse that stays on the head for 10 minutes according to the instructions.</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:
the whole potential data is unpublished after being unidentifiable.

When:
start the access period 6 month after pricing the result

To whom:
researchers working in academic and industrial institutions.

Conditions:
it can be used to carry out research work.

Where to obtain:
Dr Hadi Esmaily, faculty of pharmacy, shahid beheshti university of medical science

How to obtain:
sending request is available.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hadi Esmaily</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Pharmaceutical Faculty, Vali Ars AVe</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1991953381</zip>
        <telephone>+98 211579064</telephone>
        <email>Esmaily_hadi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hadi Esmaily</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Pharmaceutical Faculty, Vali Ars AVe</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1991953381</zip>
        <telephone>+98 21 8820 0118</telephone>
        <email>esmaily_hadi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with head lice infestation
Up than 6 years old</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of allergy or side effects with permethrin shampoo or permethrin cream
Pregnant Women
Lactating Women
History of Asthma
History of hypersensitivity reaction to permethrin
History of seizure
Active wounds in scalp</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B85.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pediculosis due to Pediculus humanus capitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Received permethrin shampoo that stays on the head for 10 minutes according to the instructions.</i_keyword>
      <i_keyword>Intervention group: Received permethrin shampoo that stays on the head for one hour according to the instructions.</i_keyword>
      <i_keyword>Intervention group: Received permethrin cream rinse that stays on the head for 10 minutes according to the instructions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Presence of live lice (both adult and nymph) using the. Timepoint: First week, Second week, third week. Method of measurement: Dry combing method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Time to eradication. Timepoint: First week, Second week, Third week. Method of measurement: Time (Date).</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-15</approval_date>
        <contact_name>National ethics ommittee for biomedical research</contact_name>
        <contact_address>Central Department of Ministerial of Health and Medical Education, Sima Iran St, between South Falamak and Zarafshan St, Shark Gharb Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
