<?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>IRCT20230305057631N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-24</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Association of response to doxycycline and Azithromycin antibiotics therapy and  IL-4 gene ( SR8179190) polymorphism in patients with moderate acne vulgaris</public_title>
      <acronym></acronym>
      <scientific_title>Association of response to doxycycline and Azithromycin antibiotics therapy and  IL-4 gene ( SR8179190) polymorphism in patients with moderate acne vulgaris</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69056</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization, at first, the people who meet the criteria to enter the study will be selected to participate in the study based on their consent, and then the people will be divided into two intervention groups in the form of block allocation. In order to assign patients to two treatment groups, the Blocked Randomization method with blocks of four will be used. First, six possible states of blocks (BAAB, ABBA, BABA, BBAA, ABAB, AABB) are listed and a number from one to six is assigned to each block. Then, numbers between one and six are randomly selected using a table of random numbers, and then people are assigned to the azithromycin (A) and doxycycline (B) group based on the block corresponding to the selected number, and this work is done until completion. The sample size will continue.</study_design>
      <phase>2</phase>
      <hc_freetext>Acne vulgaris.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: At first, the patients were examined by a dermatologist and the severity of their acne was measured based on the Michelson acne score, and the patients were subjected to standard photography. Next, the patients are divided into two groups. The first group receives doxycycline 100 mg daily along with topical treatment (benzoyl peroxide and tretinoin). Intervention 2: Intervention group: At first, the patients were examined by a dermatologist and the severity of their acne was measured based on the Michelson acne score, and the patients were subjected to standard photography. Next, the patients are divided into two groups. The second group receives 250 mg of azithromycin every other day along with topical treatment (benzoyl peroxide and tretinoin).</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:
All the data will be provided to the researchers without names and specifications.

When:
After completing the research project and publishing the article

To whom:
All researchers

Conditions:
To conduct similar research, researchers can access the results of the project by referring to the research assistant of Gonabad University of Medical Sciences with a written consent letter from the research assistant.

Where to obtain:
Research assistant of Gonabad University

How to obtain:
Researchers can have access to the results of the project by referring to the vice president of research of Gonabad University of Medical Sciences with a written consent letter from the vice president of research.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamide Mohammadzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bohlool hospital, Parastar Blvd.</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>96917-97852</zip>
        <telephone>+98 51 5723 6832</telephone>
        <email>Mohammadzadeh.hamideh@yahoo.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamide Mohammadzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bohlool hospital, Parastar Blvd.</address>
        <city>gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>96917-97852</zip>
        <telephone>+98 51 5728 6832</telephone>
        <email>Mohammadzadeh.hamideh@yahoo.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Acne vulgaris with moderate severity according to the classification system (MAS score)
 Acne vulgaris with moderate severity according to vaishampayan classification system
 Age over 12 years</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to complete the treatment process by the patient
 Occurrence of unusual complications during treatment
 The patient's refusal to continue the treatment process</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: At first, the patients were examined by a dermatologist and the severity of their acne was measured based on the Michelson acne score, and the patients were subjected to standard photography. Next, the patients are divided into two groups. The first group receives doxycycline 100 mg daily along with topical treatment (benzoyl peroxide and tretinoin).</i_keyword>
      <i_keyword>Intervention group: At first, the patients were examined by a dermatologist and the severity of their acne was measured based on the Michelson acne score, and the patients were subjected to standard photography. Next, the patients are divided into two groups. The second group receives 250 mg of azithromycin every other day along with topical treatment (benzoyl peroxide and tretinoin).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Response to treatment. Timepoint: Before starting the treatment, after the end of the treatment. Method of measurement: MAS score.</prim_outcome>
      <prim_outcome>Satisfaction level. Timepoint: Before starting the treatment, after the end of the treatment. Method of measurement: check list.</prim_outcome>
      <prim_outcome>Recovery from the doctor's opinion. Timepoint: Before starting the treatment, after the end of the treatment. Method of measurement: Check list.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-24</approval_date>
        <contact_name>Gonabad University of Medical Sciences</contact_name>
        <contact_address>Gonabad University of Medical Sciences, near Asabi Road Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
