<?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>IRCT20191023045213N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-19</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Finasteride solution on male hair loss</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of topical solution of Finasteride 0/2% versus topical solution of Minoxidil 5% in the treatment of Androgenic Alopecia in men, A Randomized, Double-Blind, Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43253</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, there will be two types of dark bottles, one named A and the other B. In one type of bottle 25 ml of Finasteride 0/2% topical solution and in the second type 25 ml of Minoxidil 5% topical solution are poured. The patients were randomly divided into two groups of 100 each and In the first stage, they are subjected to a Pull test, which is an important test to determine the active sites of Alopecia and In it 60-70 pieces of patient hair are grabbed and pulled hairs are counted and If the number of plucked hairs is more than 6-7, the test is positive and the area of ​​the head is considered as the active site for Alopecia and its subsequent monthly examination. In subsequent monthly examinations, those points on the head will be tested for loss. Then, one group is given bottle A and the other group is given bottle B. The patient should apply 15 drops of these solutions on his head every 12 hours and at the end of each month, go to the clinic for a checkup. In the monthly examination, patients also undergo a pull test and the number of hairs plucked in the test is recorded, until the end of the sixth month, which is the end of treatment. If the patient runs out of medicine during this time, he will receive a bottle with the same name as the first bottle, and if he forgets to use his medication on time, he should use his medication immediately after being reminded, but if there is a gap of more than a week between taking the drug the patient will be excluded from the study.
Patients under study should not use any other drugs (traditional and industrial) during these six months, either topically or systemically as they will be excluded if the study is used, If used, they will be excluded from the study, Blinding description: During this study, a dermatologist as the head of the research group in the clinic, after explaining the working method for patients and possible problems during the research period for patients, if he volunteers, he puts them in the study. In order to start treatment, they enter group A or B as one of the volunteer patients. After assigning the checklist to each patient (according to the entered group), the patient receives bottles containing the treatment solution (A or B) from the head of the clinic according to his checklist.
During this process, neither the specialist physician nor the clinic manager nor the patient don't knows the contents of the therapeutic bottle and which group of bottles are Finasteride or Minoxidil.
Therapeutic bottles are made by a pharmacologist in the university laboratory and poured into bottles and then transported to the clinic of the study.
The pharmacologist is the only person who knows the contents of the bottles and during the study and analysis of the data has nothing to do with the dermatologist and the head of clinic and the analyzer and patients.
After the end of sampling and the end of the 6-month treatment period, by analyzing the data, the analyzer presents the information in the form of an initial grouping, and at the end of the analysis, the nature of the bottles will be determined by a pharmacologist.</study_design>
      <phase>3</phase>
      <hc_freetext>Androgenic Alopecia.</hc_freetext>
      <i_freetext>Intervention 1: Control group: After receiving a topical solution of Minoxidil and taking the drug every 12 hours 15 mg, they are included in the study and examined monthly. Intervention 2: Intervention group: After receiving a topical solution of Finasteride and taking it according to Minoxidil, they are included in the study and examined monthly.</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 data is potentially shareable after unidentified individuals.

When:
Access started from 1401

To whom:
Researchers working in academic and scientific institutions.

Conditions:
If the purpose of access is to investigate possible bugs in the study.

Where to obtain:
Amir Sadrinia
Email address:
sadriamir73@gmail.com

How to obtain:
As soon as the email is sent to the mentioned address, the information will be sent with the confirmation of the purpose.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Rostami Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Sq</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5615731567</zip>
        <telephone>+98 45 3373 3081</telephone>
        <email>drrostami@yahoo.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Rostami Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah Ave</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5618985991</zip>
        <telephone>+98 45 3353 4790</telephone>
        <email>drrostami@yahoo.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Volunteer to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L64</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Androgenic alopecia</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>Control group: After receiving a topical solution of Minoxidil and taking the drug every 12 hours 15 mg, they are included in the study and examined monthly.</i_keyword>
      <i_keyword>Intervention group: After receiving a topical solution of Finasteride and taking it according to Minoxidil, they are included in the study and examined monthly</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pull test score. Timepoint: Monthly. Method of measurement: Physical exam.</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>Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-01</approval_date>
        <contact_name>Ethics committee of Ardebil University of Medical Sciences</contact_name>
        <contact_address>Daneshgah Ave Ardebil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
