<?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>IRCT20120524009844N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-13</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Therapeutic effects and complications of hydrogen peroxide solution in genital warts</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of therapeutic effects and complications of 40% topical hydrogen peroxide solution with cryotherapy in genital wart lesions</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68639</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization will be carried out on an individual basis by RandList software. The selection of patients will be based on sealed envelopes that be  written A and B inside them. 40 envelopes will be prepared in two groups. After entering the clinic and before the visit, patients will receive the envelope from the secretary and hand it over to the physician.</study_design>
      <phase>3</phase>
      <hc_freetext>Genital wart.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: In each patient, after examining the warts and relative matching according to the size and location, local 40% hydrogen peroxide solution will be used on one or two genital wart lesions in the intervention group. this solution will be used on the lesion to cover the entire surface of the lesion And then it will be kept for 20 seconds with rotating movements and pressure on the lesion. In each session, this cycle will be repeated 4 times, which will be 80 seconds in total. This intervention will be done at the beginning of the study and will be repeated in the third and sixth weeks if there is no improvement.For their other lesions, only standard genital wart treatment (cryotherapy) will be used.in the visit 8 weeks later, the patients will be evaluated only in terms of The effects of treatment, efficiency and side effects of receiving the drug have been checked and they will not receive intervention. Intervention 2: Control group: The Control group will be treated with liquid nitrogen cryotherapy, using spray 1-2 cm away from the lesion for 20-30 seconds, depending on the size of the wart to create a white halo around the wart as much as 1 mm. Cryotherapy (for the control group) will be performed in the first visit, the visit 3 weeks later and the visit 6 weeks later, and each time the patients will be examined in terms of the effects of the treatment, efficiency and side effects of the treatment, and in the visit 8 weeks later, the patients will be evaluated only in terms of The effects of treatment, efficiency and side effects of receiving the drug have been checked and they will not receive intervention.</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:
Study data is categorized and coded with no identifiable individuals.

When:
Access to study data after publication of the result is available in the journal.

To whom:
Anyone interested in using the data can access the study data.

Conditions:
Study data can be used for comparison with other results.

Where to obtain:
Refer to the study's scientific or public accountability person for data.

How to obtain:
The request will be sent by email to person responsible for scientific or public inquiries.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mehdi Amirnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Hospital, Azadi Street, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>516369888</zip>
        <telephone>+98 41 3549 8236</telephone>
        <email>mehamir46@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mehdi Amirnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Hospital, Azadi Street, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>516369888</zip>
        <telephone>+98 41 3549 8236</telephone>
        <email>mehamir46@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having at least 1 genital wart
Satisfaction with the study
Age above 18 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant and beast feeder women
Patients who are afraid to use treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B07.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other viral warts</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: In each patient, after examining the warts and relative matching according to the size and location, local 40% hydrogen peroxide solution will be used on one or two genital wart lesions in the intervention group. this solution will be used on the lesion to cover the entire surface of the lesion And then it will be kept for 20 seconds with rotating movements and pressure on the lesion. In each session, this cycle will be repeated 4 times, which will be 80 seconds in total. This intervention will be done at the beginning of the study and will be repeated in the third and sixth weeks if there is no improvement.For their other lesions, only standard genital wart treatment (cryotherapy) will be used.in the visit 8 weeks later, the patients will be evaluated only in terms of The effects of treatment, efficiency and side effects of receiving the drug have been checked and they will not receive intervention.</i_keyword>
      <i_keyword>Control group: The Control group will be treated with liquid nitrogen cryotherapy, using spray 1-2 cm away from the lesion for 20-30 seconds, depending on the size of the wart to create a white halo around the wart as much as 1 mm. Cryotherapy (for the control group) will be performed in the first visit, the visit 3 weeks later and the visit 6 weeks later, and each time the patients will be examined in terms of the effects of the treatment, efficiency and side effects of the treatment, and in the visit 8 weeks later, the patients will be evaluated only in terms of The effects of treatment, efficiency and side effects of receiving the drug have been checked and they will not receive intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Diameter of warts. Timepoint: Weeks 0,3,6 and 8 after treatment. Method of measurement: Clinical examination and Measure by ruler.</prim_outcome>
      <prim_outcome>Height of warts. Timepoint: Weeks 0,3,6 and 8 after treatment. Method of measurement: Clinical examination and measurement with caliper.</prim_outcome>
      <prim_outcome>Probable side effects. Timepoint: Weeks 0,3,6 and 8 after treatment. Method of measurement: Observation.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-06</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Sina Hospital, Azadi street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
