<?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>IRCT20241015063373N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-08</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Lavender Essential Oil Formulation on Hair loss</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the Effectiveness of Nanostructured Lipid Carriers Containing Lavender Essential Oil Compared to 2% Minoxidil for Androgenic Hair loss; Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79732</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Androgenic Alopecia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the Intervention Group, Lipid Nanostructure Formulation Containing Lavender Essential Oil will be used. In order to prepare Lipid Nanostructures, a High-speed Homogenization Method is used using a Homogenizer. The Formulation of Lipid Nanostructures Containing Lavender Essential Oil is made in the Laboratory of the Tabriz Faculty of Pharmacy. To prepare this Formulation, 400 mg of Lavender Essential oil as a Liquid Phase, 600 mg of Precirol as a Solid Phase, and 250 mg of Ploxamer as a Surfactant are used. (The Steps of Producing Lipid Nanostructures are briefly written.) Lavender essential Oil contains Compounds that cause the Expression of Factors that Increase Hair Growth and Hair Density. The Intervention Period is 24 weeks, in which 2% Minoxidil Manufactured by Pak Darou Company is used on One Side and a Formulation of Lipid Nanostructures Containing Lavender Essential Oil is used on the Other side at Two Symmetrical Points on the Head. The Desired Formulation will be applied One Night a week in an Amount of 1 cc in a Pre-determined Area of ​​1 cm in Diameter. The necessary Photographs will be taken by Dermatoscope at times Zero, 12 weeks and 24 weeks after the Start, and the Images will be analyzed by the Doctor. Intervention 2: Control group: In the Control group, 2% Minoxidil, a Product of Pak Darou Company, will be used Once daily. 2% minoxidil will be applied once every Night in an Amount of 1 cc in a Pre-determined Area of ​​1 cm in Diameter. The Intervention Period is 24 weeks, and Imaging is performed at times Zero, 12 weeks, and 24 weeks after the Start of the 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>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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Farshidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz faculty of Pharmacy, Attar Neyshabouri Ave., Golgasht Blvd.,</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5184836533</zip>
        <telephone>+98 41 3288 1744</telephone>
        <email>farshidimahsa8@gmal.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahsa Farshidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz faculty of Pharmacy, Attar neyshabouri Ave., Golgasht Blvd.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5184836533</zip>
        <telephone>+98 41 3288 1744</telephone>
        <email>Farshidimahsa8@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male Sex
Progressive Symptoms of Hair loss in the Frontotemporal Area</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Any Manifestation of Skin Disease in the Study Area
Allergy or Hypersensitivity Reaction to Medicinal Products or Components of the Study Product
History of Skin Cancer
Acute or Chronic Disease that could Interfere with the Study
Use of Topical or Systemic Medications or Cosmetic Products that could Interfere with the Study</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 - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the Intervention Group, Lipid Nanostructure Formulation Containing Lavender Essential Oil will be used. In order to prepare Lipid Nanostructures, a High-speed Homogenization Method is used using a Homogenizer. The Formulation of Lipid Nanostructures Containing Lavender Essential Oil is made in the Laboratory of the Tabriz Faculty of Pharmacy. To prepare this Formulation, 400 mg of Lavender Essential oil as a Liquid Phase, 600 mg of Precirol as a Solid Phase, and 250 mg of Ploxamer as a Surfactant are used. (The Steps of Producing Lipid Nanostructures are briefly written.) Lavender essential Oil contains Compounds that cause the Expression of Factors that Increase Hair Growth and Hair Density. The Intervention Period is 24 weeks, in which 2% Minoxidil Manufactured by Pak Darou Company is used on One Side and a Formulation of Lipid Nanostructures Containing Lavender Essential Oil is used on the Other side at Two Symmetrical Points on the Head. The Desired Formulation will be applied One Night a week in an Amount of 1 cc in a Pre-determined Area of ​​1 cm in Diameter. The necessary Photographs will be taken by Dermatoscope at times Zero, 12 weeks and 24 weeks after the Start, and the Images will be analyzed by the Doctor.</i_keyword>
      <i_keyword>Control group: In the Control group, 2% Minoxidil, a Product of Pak Darou Company, will be used Once daily. 2% minoxidil will be applied once every Night in an Amount of 1 cc in a Pre-determined Area of ​​1 cm in Diameter. The Intervention Period is 24 weeks, and Imaging is performed at times Zero, 12 weeks, and 24 weeks after the Start of the Intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage Change in Hair Density per unit of Specified Scalp Area. Timepoint: Before the Start of the Intervention, 12 Weeks after the Start of the Intervention, immediately after the End of the Intervention (24 weeks). Method of measurement: Dermatoscope Device, Yinama Model, Made in China.</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>2024-09-29</approval_date>
        <contact_name>Ethics Committee of Faculty of Pharmacy-Tabriz University of Medical Sciences</contact_name>
        <contact_address>Medical Sciences Research Committee of Tabriz, Attar neyshabouri Ave., Golgasht Blvd. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
