<?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>IRCT2013111015364N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-06-25</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahid Sadoghi Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparative effect treatment of Ficus Carica Latex cream vs. Podophyllin in treatment of Genital Warts</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effect treatment of Ficus Carica Latex cream vs. Podophyllin in treatment of Genital Warts</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14645</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Genital Wart.</hc_freetext>
      <i_freetext>Intervention 1: The intervention in case group is by Ficus Carica latex cream. This cream pharmaceutical processes using latex of Figs and pharmaceutical base creams and Vaseline with varying proportions of each material is produced. Cream is made of 20%  Fig latex. Term use of this cream will be at least 2 weeks and a maximum of 8 weeks. Cream 3- 4 times daily by the patients themselves and by the swab is placed on warts. Intervention 2: Control group using standard methods of genital warts treatment is called Podophyllin. Podophyllin 20% in this study is used in the cream forms. Treatment in this group will be at least two weeks and a maximum of 8 weeks. Cream once a week by an programs expert is placed on the warts and be patient to wait for a few minutes on the bed  and get up out of bed and put on clothes.</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>Sepideh Mahdavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4 Floor, 114 Number, Elahi street( 216East street), Fourth Sguare Tehran Pars, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7706 1380</telephone>
        <email>sepideh.mahdavi@ssu.ac.ir; s.mahdavi88@gmail.com</email>
        <affiliation>Health College, Shahid Sadoghi University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sepideh Mahdavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4 Floor, 114 Number, Elahi street( 216East street), Fourth Sguare Tehran Pars, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7706 1380</telephone>
        <email>sepideh.mahdavi@ssu.ac.ir; s.mahdavi88@gmail.com</email>
        <affiliation>Health College, Shahid Sadoghi University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Patients with genital warts disease who have been approved by the gynecologist and oncologist. Total area of ​​warts is not greater than 10 cm ², wart area is external genital warts and anal, Gender women, patients none of the treatments had to be received in 3 month ago, Less than a year having passed from patient to patient. There is no active genital herpes lesions. No skin erythema and inflammation&#13;
Exclusion Criteria: Occurrence of any serious skin condition that usually does not respond to allergy medications, HIV infection</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A63.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anogenital (venereal) warts</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>The intervention in case group is by Ficus Carica latex cream. This cream pharmaceutical processes using latex of Figs and pharmaceutical base creams and Vaseline with varying proportions of each material is produced. Cream is made of 20%  Fig latex. Term use of this cream will be at least 2 weeks and a maximum of 8 weeks. Cream 3- 4 times daily by the patients themselves and by the swab is placed on warts</i_keyword>
      <i_keyword>Control group using standard methods of genital warts treatment is called Podophyllin. Podophyllin 20% in this study is used in the cream forms. Treatment in this group will be at least two weeks and a maximum of 8 weeks. Cream once a week by an programs expert is placed on the warts and be patient to wait for a few minutes on the bed  and get up out of bed and put on clothes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comparative effect treatment of Ficus Carica Latex cream and Podophyllin in treatment of Genital Warts. Timepoint: Before intervention, One month after the intervention, 8 week after the intervention, one months after the end of intervention. Method of measurement: Number and total area of warts and warts in the beginning and during the treatment, Visit and use Photography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Determine and Compare side effect  of Ficus Carica Latex cream vs. Podophyllin in treatment of Genital Warts. Timepoint: One month after the intervention- After the intervention. Method of measurement: A visual examination by a gynecologist- A patient questionnaire complications include itching, burning, pain, and inflammation.</sec_outcome>
      <sec_outcome>Determine and compare the recurrence rate of genital warts after one months after completion of treatment in both treatment groups. Timepoint: One months after the intervention. Method of measurement: Photo taken from the baseline and end of treatment. Counting the number of warts- Warts area Comparison.</sec_outcome>
      <sec_outcome>Determine and compare patient satisfaction with treatment compared with Ficus Carica cream vs  Podophyllin. Timepoint: After treatment. Method of measurement: Questionnaire including questions of overall satisfaction, satisfaction with treatment site, and overall satisfaction with the group treated with 5 benchmark score.</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, Shahid Sadoghi Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-07-29</approval_date>
        <contact_name>Ethics Committee Shahid Sadoghi University of Medical Science</contact_name>
        <contact_address>Health College, Shahid Sadoghi University of Medical Science, Daneshjo Bolvar, Emam Hosein Square, Yazd Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
