<?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>IRCT2015012520802N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-15</date_registration>
      <primary_sponsor>Vice chancellor for research,Islamic Azad University Pharmaceutical Branch of Tehran</primary_sponsor>
      <public_title>Herbal extract solution in treatment of seborrheic dermatitis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of  the effect and safety of herbal extracts anti dandruff formulation comparing with clotrimazole lotion in patients with seborrheic dermatitis referring to the clinic of center for research and training in skin diseases and leprosy during the year 1394</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18393</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Seborrheic Dermatitis.</hc_freetext>
      <i_freetext>Intervention 1: Volunteers in the intervention group use the anti dandruff lotion with herbal extracts twice a day for 4 weeks,1 cc per consumption topical on their scalp. Intervention 2: Volunteers in the control group use clotrimazole lotion 1 cc twice daily for 4 weeks, topically on their scalp.</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 Hamid Reza Ahmadi Ashtiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmaceutical Sciences Branch of Islamic Azad University, Yakhchal St, Shariati Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2264 0051</telephone>
        <email>ahmadi@iaups.ac.ir</email>
        <affiliation>Pharmaceutical Sciences Branch of Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Hamid Reza Ahmadi Ashtiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmaceutical Sciences Branch of Islamic Azad University, Yakhchal St, Shariati Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2248 0233</telephone>
        <email>ahmadi@iaups.ac.ir</email>
        <affiliation>Pharmaceutical Sciences Branch of Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
male patients; healthy general condition;  clinically diagnosed seborrheic dermatitis;  20-30 years old;  consent form signed by patients.&#13;
Exclusion criteria: &#13;
use of topical steroids during 2 weeks ago; use of topical retinoids during 2 weeks ago; use of topical antifungals during 2 weeks ago; use oftopical anti-inflammatory druds during 2 weeks ago; use of topical antibiotics and any other topical treatments for seborrheic dermatitis like anti-dandruff shampoo and coal tar during 2 weeks ago; use of systemic anti-fungals during the last month;  use of systemic steroids during the last month; use of systemic antibiotic during the last month; use of systemic anti-inflammatory drugs and immunomodulator drugs during the last month; use oral retinoid during last 6 months; history of hypersensitivity  to  azoles or herbal compound of our solution; comorbidities(AIDS,Parkinson,diabetes,…); skin disease like psoriasis, acne, …</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L21.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other seborrhoeic dermatitis</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>Volunteers in the intervention group use the anti dandruff lotion with herbal extracts twice a day for 4 weeks,1 cc per consumption topical on their scalp</i_keyword>
      <i_keyword>Volunteers in the control group use clotrimazole lotion 1 cc twice daily for 4 weeks, topically on their scalp</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Scalp sebum. Timepoint: Beginning of the study, 2 weeks and 4 weeks after starting the treatment. Method of measurement: Sebometer.</prim_outcome>
      <prim_outcome>Scalp PH. Timepoint: Beginning of the study, 2 weeks and 4 weeks after starting the treatment. Method of measurement: PH meter.</prim_outcome>
      <prim_outcome>Dandruff. Timepoint: Beginning of the study, 2 weeks and 4 weeks after starting the treatment. Method of measurement: Pixel.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Erythema and itching. Timepoint: Begining of the study,2 weeks and 4 weeks after treatment. Method of measurement: Clinical examination, Questionnaire.</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>Vice chancellor for research,Islamic Azad University Pharmaceutical Branch of Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-04-18</approval_date>
        <contact_name>Ethics Committee of centre for research and training in skin disease and leprosy</contact_name>
        <contact_address>415,Taleghani st Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
