<?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>IRCT20190505043485N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-01</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of oral zinc therapy in Acne Vulgaris disease</public_title>
      <acronym></acronym>
      <scientific_title>Determination of the Effect of Oral zinc therapy on the Treatment of Acne vulgaris in Patients with Grade 2 and 3 Acne vulgaris</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39313</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Among the patients with Acne Vulgaris referred to the Khalij-e-Fars clinic of Bushehr, who are eligible for inclusion in the study, 100 patients are randomly selected and divided into Intervention and control groups by block method, each group Includes 50 patients.To do this, 50 sealed envelopes are used as envelopes A and 50 sealed envelopes as B envelopes. People who select envelope A fall into the control group and those who choose B envelope fall into the intervention group, Blinding description: Data will be analyzed by a statistician without knowing the type of patient treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Acne Vulgaris.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the intervention group in addition to the routine treatment of Acne Vulgaris (containing 1% topical Clindamycin gel and 1% topical Salicylic Acid gel) will receive  Zinc Sulfate tablets 60 mg daily orally as a therapeutic intervention for 3 months. Intervention 2: Control group: Patients in the control group received only routine Acne Vulgaris treatment without any extra work.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is It is not decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Doctor Marziyeh Afrouzandeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleqani Blvd</address>
        <city>Boushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7517933755</zip>
        <telephone>+98 77 3345 5490</telephone>
        <email>marzieh642004@yahoo.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor Marziyeh Afrouzandeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleqani Blvd</address>
        <city>Boushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7517933755</zip>
        <telephone>+98 77 3345 5390</telephone>
        <email>Marzieh642004@yahoo.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>2nd and 3rd grade of Acne Vulgaris patients depends on Pillsburg classification</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patients with Gastrointestinal disorder
The pregnant patients and breast feeding mothers
Using other topical and oral anti Acne drugs
Patients with Grade 1 and 4 Acne Vulgaris
Female patients with hormonal disorders
Patients with oral Isotretinoin in the last 3 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L70.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acne vulgaris</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>Intervention group: Patients in the intervention group in addition to the routine treatment of Acne Vulgaris (containing 1% topical Clindamycin gel and 1% topical Salicylic Acid gel) will receive  Zinc Sulfate tablets 60 mg daily orally as a therapeutic intervention for 3 months</i_keyword>
      <i_keyword>Control group: Patients in the control group received only routine Acne Vulgaris treatment without any extra work</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduce in  number of Acne. Timepoint: Evaluation the number of Acne in 14 days. Method of measurement: Observational.</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>Boushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-08</approval_date>
        <contact_name>Ethics committee of Boushehr University of Medical Sciences</contact_name>
        <contact_address>Salman Farsi st Boushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
