<?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>IRCT20141209020250N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-19</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of DEMU La' farrerr Topical Cream Effect on Bruises Caused by Filler Injection</public_title>
      <acronym>DABCET-F</acronym>
      <scientific_title>Comparative Efficacy Evaluation of a Topical Cream (DEMUlcent ™) Containing Arnica and Rosemary Extracts with Placebo on Filler-Injected Patients Bruise: A randomized Double-blind Control Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70080</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In each of the two intervention groups, the participants are divided into randomized blocks based on the randomization process after confirming that they have the conditions to enter the project. Randomization in this way has been done with the help of 4 random blocks. Each of the houses is A or B, and when the patients go to the hospital, depending on the prepared envelopes, where the patient's number and the type of intervention A or B are marked on each envelope and the type of intervention A or B is marked inside the envelope, from the box containing product A Or it is given from the box containing product B.
In this study, 6 types of blocks for each block of 4 can be expected, with two placebo and two intervention volunteers in each group. Each block model is marked with a number from one to six, and for each block, a random number is taken from 1 to 6 with the help of Microsoft Excel, which determines the sequence of receiving cream and placebo for each person, and the total sequence . And the order of 20 blocks of this study is determined, Blinding description: Initially, patients are included in the process of research and are added to the plan if they wish. For more familiarity and assurance, an informed consent form is given to them. After entering the plan and seeing a bruise at the place of filler injection, in the first visit, they will be given an envelope containing the representative number of each person based on the appointment and the number that will be assigned to them. There is a sheet in each of these envelopes, some of which are sheet A and others are sheet B. Depending on which sheet the patient's envelope contains, a cream from box A or a cream from box B will be given from the two boxes available to the nurse of the plan.

A double-blind study means that all creams and boxes A or B are blinded for the research doctors of the plan, the executive director, the associate nurse, the patients, and all the hospital staff. Also, the formulation company delivers the intervention cream and placebo in the form of two separate boxes, and the labeling of which cream A contains intervention cream (demo) or placebo and B is done only by and with the knowledge of the plan's statistical consultant. And only he is aware of the grouping, but he does not participate or interfere in the process of implementing the plan. The method of randomization is based on the method that was explained.

All the creams with white tube and no explanation except that they are A or B. And in the process of formulating both, all facilities are used by the patient to match the color, smell, consistency, appearance and other tangible characteristics so that the type of cream available in each group A and B is not predictable.</study_design>
      <phase>3</phase>
      <hc_freetext>Bruising Caused by Nasolabial Filler Injection.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: DEMUlcent Cream Containing Arnica, Rosemary, Chamomile and...  Extracts La' farrerr in a white and unspecified Tube/Used for 14 days, Every 8 Hours at the Filler Injection Site and Around. Intervention 2: Control group: Placebo Cream Containing Other Ingredients Found in DEMUlcent La' farrerr Cream in a White and Unspecified Tube with the Same Smell and Viscosity/Used for 14 days, every 8 hours at the filler injection site and around of it.</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 Related information aren't published publicly, but will be available anytime.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Danial Mehrali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacy Faculty., Tehran University of Medical Sciences., 16 Azar St., Keshavarz Blvd., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 21 64120</telephone>
        <email>danielmehrali@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Narges Ghandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>District 12, vahdate eslami square, Razi hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1199663911</zip>
        <telephone>+98 21 5563 0553</telephone>
        <email>nghandi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals Receiving Nasolabial Filler Injection or Facial Botox at Razi Hospital (With Bruises Caused by Filler Injection in the Face Area)
Age between 18 and 65</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Possibility or Having Plan for Pregnancy in the Next 3 Months
Lactation
Taking Aspirin and Other Anticoagulant Medicines
Unwillingness to Participating in the Trial</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R23.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spontaneous ecchymoses (Petechiae). Excl: ecchymoses in fetus and newborn, purpura.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: DEMUlcent Cream Containing Arnica, Rosemary, Chamomile and...  Extracts La' farrerr in a white and unspecified Tube/Used for 14 days, Every 8 Hours at the Filler Injection Site and Around.</i_keyword>
      <i_keyword>Control group: Placebo Cream Containing Other Ingredients Found in DEMUlcent La' farrerr Cream in a White and Unspecified Tube with the Same Smell and Viscosity/Used for 14 days, every 8 hours at the filler injection site and around of it</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bruise Intensity by the Surface Area. Timepoint: Days 1, 2, 3, 4, 5, 7, 10 and 14. Method of measurement: Total bruised area measurement.</prim_outcome>
      <prim_outcome>The stage (age) of bruises. Timepoint: Days 1, 2, 3, 4, 5, 7, 10 and 14. Method of measurement: Spot Color by Colorimetric Scale NNDV No. 2.</prim_outcome>
      <prim_outcome>Bruise Control Time Period. Timepoint: Length of treatment period (14 days). Method of measurement: Clinical examination and review of images taken from the position.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain feeling in the spot. Timepoint: Days 1, 2, 3, 4, 5, 7, 10 and 14. Method of measurement: The numeric rating scale (NRS).</sec_outcome>
      <sec_outcome>Side Effects (Hypersensitivity or any other side effects not related to other treatments and medicines received by the patient). Timepoint: Length of treatment period (14 days). Method of measurement: Patient statements during examinations and other times.</sec_outcome>
      <sec_outcome>Volume of filler injected to the site by ml. Timepoint: Day 0 (Filler injection). Method of measurement: ml of filler injected.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>PergasTeb Ltd.</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>PergasTeb Ltd.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-06</approval_date>
        <contact_name>Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz Blvd., Corner of Qods St., Central Organization of Tehran University of Medical Sciences, 6th floor: Room 604 (Research and Technology Affairs Experts and Ethics Committee) Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
