<?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>IRCT2014030416837N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-04-21</date_registration>
      <primary_sponsor>Deputy of Research, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran</primary_sponsor>
      <public_title>Effects of permethrin on rosacea</public_title>
      <acronym></acronym>
      <scientific_title>Effects of permethrin 5% topical gel in comparison with placebo on Demodex density in rosacea patients: a double-blind, randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15620</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The study groups were simply randomized based on flipping a coin. The “heads” were supposed as “right, permethrin 5%; left, placebo” and the “tails” were assumed as “left, permethrin 5%; right, placebo”. Therefore, 40 half-faces were randomly divided into two equal groups for the permethrin 5% or placebo (20 half-faces in each group). For blinding, the permethrin 5% and placebo gels were filled in separate similar tubes labeled as “right” and “left”. Labeling and grouping were performed by a third party. The researcher and patients did not know the contents of the tubes. Each patient randomly applied the permethrin 5% gel on the clean skin of one side of the face and the placebo gel on the other side, twice daily for 12 weeks.</study_design>
      <phase>2</phase>
      <hc_freetext>Rosacea.</hc_freetext>
      <i_freetext>Intervention 1: Each patient randomly applied the permethrin 5% gel on the clean skin of one side of the face twice daily for 12 weeks. Intervention 2: Each patient randomly applied the placebo gel on the clean skin of one side of the face twice daily for 12 weeks.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Kosar Raoufinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19419</zip>
        <telephone>+98 21 2260 9043</telephone>
        <email>kosaraoofi@yahoo.com; kosaraoofi@gmail.com; mehdirj@aol.co.uk</email>
        <affiliation>Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Ir</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mehdi Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19419</zip>
        <telephone>+98 21 2260 9043</telephone>
        <email>mehdirj@aol.co.uk; kosaraoofi@yahoo.com; kosaraoofi@gmail.com</email>
        <affiliation>Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Ir</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Papulopustular rosacea patients; At least 5 mites per square centimeter in the facial biopsy samples of both left and right sides; At least 18 years old, regardless of gender; Exclusion criteria: Rosacea patients with less than 5 mites per square centimeter in the facial biopsy samples of one or both left and right sides; Patients with different types of skin cancers; Patients with severe skin infections; Patients with severe burnings; Sensitivity to permethrin; Pregnant women; Breastfeeding women</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>120 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L71</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rosacea</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Each patient randomly applied the permethrin 5% gel on the clean skin of one side of the face twice daily for 12 weeks.</i_keyword>
      <i_keyword>Each patient randomly applied the placebo gel on the clean skin of one side of the face twice daily for 12 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Density of Demodex mites per square centimeter of the facial surface on the left and right sides. Timepoint: Baseline and the 2nd, 5th, 8th, and 12th weeks after the initiation for both sides of the face. Method of measurement: Demodex densities per square centimeter of the facial surface on the left and right sides were determined by standard skin surface biopsy at the baseline and the 2nd, 5th, 8th, and 12th weeks after the initiation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Clinical presentations of rosacea patients including: transient erythema, nontransient erythema, papules and pustules, telangiectasia, burning or stinging, plaque, dry appearance, edema, ocular manifestations, and phymatous changes. Timepoint: Baseline and the 2nd, 5th, 8th, and 12th weeks after the initiation for both sides of the face. Method of measurement: The clinical presentations of both sides of the face were assessed by photography and the clinical criteria of the National Rosacea Society Scorecard at the baseline and the 2nd, 5th, 8th, and 12th weeks after the initiation.</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>Deputy of Research, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-03-13</approval_date>
        <contact_name>Ethics Committee of Medical Researches, Pharmaceutical Sciences Branch, Islamic Azad University, Teh</contact_name>
        <contact_address>Ethics Committee of Medical Researches, Pharmaceutical Sciences Branch, Islamic Azad University, PO Box 19419, Yasaman St, Yakhchal Ave, Qolhak Ave, Shariati Ave, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
