<?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>IRCT20221016056203N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-19</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>studying the effect of botox on hormonal female hair loss</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the results of using botulinum toxin by different doses in women suffering from androgenic alopecia .</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>63</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66404</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized assignment of individuals to treatment and controls groups.
simple with sealed envelopes containing the material , Blinding description: Double blinded
The patient receives the injection substance (intervention or control group) in sealed envelopes that are coded. Coding is done by one of the collaborators of the project and the evaluator and the patient are blinded.</study_design>
      <phase>2-3</phase>
      <hc_freetext>androgenetic alopecia.</hc_freetext>
      <i_freetext>Intervention 1: Control group: using minoxidil solution 5% with normal saline injection. Intervention 2: Intervention group: using minoxidil 5% solution with the injection of 100 units botulinum toxin (Masport). Intervention 3: Intervention group: using minoxidil 5% solution with the injection of 200 units botulinum toxin (Masport).</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Individual information about the disease will be confidential and will be shared in general about the effect of the treatment on all patients</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hawraa Taleb</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 82 , Behzad sedakat intersection ,Zhiyan Panah street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1111111111</zip>
        <telephone>+98 922 231 3954</telephone>
        <email>hawraa-taleb@outlook.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Safoura Shakoei  Nejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 82 , Behzad sedakat intersection ,Zhiyan Panah street .</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111111111</zip>
        <telephone>+98 922 231 3954</telephone>
        <email>hawraa-taleb@outlook.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with grade 2/4/3 based on SINCLAIR SCALE for disease severity
having the ability for regular visits
Not receiving previous treatment in the last three months
age between 18-55
not having contraindication for minoxidil 5% and botulinum toxin</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having needle phobia
Having alopecia areata and another hair diseases(LPP)
Having neuromuscular disease
Previous use of corticosteroids or immunosuppressive drugrs in the last 3 months
Having localized infection
Having internal systemic and skin disease or localized dermatosis.
Patients with a history of bleeding diseases or under treatment with anticoagulants
Previous family or personal history of keloid
Having koebner phenomenon
Having symptoms of hyperandrogenism and in need for systemic drugs
pregnancy and lactation
Another treatments in less than 3 months.</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: using minoxidil solution 5% with normal saline injection</i_keyword>
      <i_keyword>Intervention group: using minoxidil 5% solution with the injection of 100 units botulinum toxin (Masport)</i_keyword>
      <i_keyword>Intervention group: using minoxidil 5% solution with the injection of 200 units botulinum toxin (Masport).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hair volume and density in qualitative and quantitative way. Timepoint: 3 and 6 months after starting treatment. Method of measurement: photography - photo finder - dermoscopy -self assessment.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Masoondarou pharmaceutical Company MDPC</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
      <source_name>Masoondarou pharmaceutical Company MDPC</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-22</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>No 82 , Behzad sedakat intersection ,Zhiyan Panah street . Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
