<?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>IRCT20210130050179N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-27</date_registration>
      <primary_sponsor>Vera Rahesh Pharmed Pharmaceutical Company</primary_sponsor>
      <public_title>Evaluating the safety and efficiency of the combined use of mask and hair spray with the iDR brand in repairing and improving the appearance of damaged hair</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the safety and efficiency of the combined use of mask and hair spray with the iDR brand, a product of Vera Rahesh Pharmed Company in repairing and improving the appearance of damaged hair compared to placebo.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>14</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74460</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 14 people are assigned to one of AB, BA sequences using block randomization, Blinding description: The physician and expert evaluating the results and the participants are unaware of the type of products offered in each cycle. Blinding the participants will be such that both products will be packed in the same containers, that are distinguished from each other only by code number on the packaging. In order to blind the outcome assessor, the randomization list will be provided to a third person and the allocation of formulations to each of the participants will be done after receiving the random code.</study_design>
      <phase>2-3</phase>
      <hc_freetext>hair damage.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Using iDR brand hair spray and mask after bathing for two weeks, at least 4 times. Depending on length and volume of the hair, one to three milliliters of the product should be used on the hair. After 5 minutes, use two puffs of iDR hair mask on the hair and avoid washing it. Intervention 2: Control group: Using spray with the same packaging as the original product containing normal saline after bathing for two weeks, at least 4 times. Depending on length and volume of the hair, one to three milliliters of hair mask with mask base composition, without active ingredients on the hair and avoid washing 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>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>Taraneh Yazdanparast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416613675</zip>
        <telephone>+98 21 8897 2220</telephone>
        <email>drtaraneh@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Firooz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416613675</zip>
        <telephone>+98 21 8897 7921</telephone>
        <email>firozali@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>female aged 18-55 years.
Good general health
People with damaged hair naturally or after using hair color, including tangles, frizz, frizz, dullness.
Voluntary participation and sign the written informed consent.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>People with known allergies to mask or spray ingredients
Active acute or chronic scalp disease such as psoriasis, lichen planus, etc.
Having any type of malignancy
Scalp surgeries
Pregnancy and breastfeeding
Change in shampoo used or supplements taken such as zinc and vitamin C during the study.
Using 2 in 1 shampoo containing softener, hair ointment, hair gel or tuft during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L67</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hair color and hair shaft abnormalities</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: Using iDR brand hair spray and mask after bathing for two weeks, at least 4 times. Depending on length and volume of the hair, one to three milliliters of the product should be used on the hair. After 5 minutes, use two puffs of iDR hair mask on the hair and avoid washing it.</i_keyword>
      <i_keyword>Control group: Using spray with the same packaging as the original product containing normal saline after bathing for two weeks, at least 4 times. Depending on length and volume of the hair, one to three milliliters of hair mask with mask base composition, without active ingredients on the hair and avoid washing it.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hair shine. Timepoint: Before intervention, 30 minutes and two weeks after use. Method of measurement: By Glossymeter probe from the device Multi Probe Adapter (MPA).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Number of people in improved or better condition. Timepoint: Before intervention, 30 minutes and two weeks after use. Method of measurement: Based on GAIS criteria: 0 = worse than baseline pretreatment appearance, 1 = no change, 2 = improved, 3 = much improved, 4 = excellent improvement.</sec_outcome>
      <sec_outcome>The level of satisfaction of consumers in general and also separately for each of the parameters of hair softness, hair manageability, easy to comb and maintaining shine. Timepoint: Before intervention, 30 minutes and two weeks after use. Method of measurement: based on not at all satisfied (-2), not satisfied (-1), not having a particular opinion (0), almost satisfied (1), very satisfied (2).</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>Vera Rahesh Pharmed Pharmaceutical Company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-12</approval_date>
        <contact_name>Ethics committee of The Institute of Pharmaceutical Sciences of Tehran University of Medical Science</contact_name>
        <contact_address>Unit 1-219, 2nd floor,The Institute of Pharmaceutical Sciences, Faculty of Pharmacy,16 Azar Avenue Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
