<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04412148</url>
  </required_header>
  <id_info>
    <org_study_id>EgymSALT</org_study_id>
    <nct_id>NCT04412148</nct_id>
  </id_info>
  <brief_title>Modified SALT Score for Alopecia Areata</brief_title>
  <official_title>Modified SALT Score for Assessment of Alopecia Areata</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patchy Alopecia areata was treated by intralesional steroids for 3 months and was evaluated&#xD;
      by percentage of involvement, mSALT score and dermoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage involvement</measure>
    <time_frame>6months to 1 year</time_frame>
    <description>Degree of severity expressed as a percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Severity of Alopecia Tool (mSALT) score</measure>
    <time_frame>6 months to 1 year</time_frame>
    <description>New Score calculating severity (hair density) and area as a number minimum value is 0 and maximum value is 105 the higher the number of the score the worse the affection</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Alopecia Areata</condition>
  <arm_group>
    <arm_group_label>Intralesional Steroids</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone Acetonide</intervention_name>
    <description>intralesional injection of triamcinolone acetonide every 2 weeks for 6 sessions</description>
    <arm_group_label>Intralesional Steroids</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>saline</intervention_name>
    <description>intralesional injection of saline</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  localized scalp AA ( 2 patches and ≤50% scalp involvement , duration more than 6&#xD;
             months) • patients who did not receive any medication for at least 2 months before&#xD;
             starting the study and those who agreed to join the study and signed written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • pregnant, and lactating females&#xD;
&#xD;
               -  Alopecia totalis or universalis or ophiasis or cicatritial alopecia&#xD;
&#xD;
               -  Usage of systemic treatment of alopecia areata 2 months prior to the study.&#xD;
&#xD;
               -  Any scalp lesion within the treated area&#xD;
&#xD;
               -  Bleeding diathesis, severe anemia or platelet disorders&#xD;
&#xD;
               -  Medical conditions such as autoimmune diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rana Hilal, MD</last_name>
    <phone>1001488869</phone>
    <phone_ext>+20</phone_ext>
    <email>rana.hilal@kasralainy.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kasr El Ainy university hospital, Faulty of medicine,Cairo university</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rana Hilal, MD</last_name>
      <phone>1001488869</phone>
      <phone_ext>+20</phone_ext>
      <email>rana.hilal@kasralainy.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Rana F Hilal, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Triamcinolone diacetate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04412148
org study id: EgymSALT
nct id: NCT04412148
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Patchy Alopecia areata was treated by intralesional steroids for 3 months and was evaluated
      by percentage of involvement, mSALT score and dermoscopy.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Percentage involvement
time frame: 6months to 1 year
description: Degree of severity expressed as a percentage
measure: Modified Severity of Alopecia Tool (mSALT) score
time frame: 6 months to 1 year
description: New Score calculating severity (hair density) and area as a number minimum value is 0 and maximum value is 105 the higher the number of the score the worse the affection
arm group label: Intralesional Steroids
arm group type: Active Comparator
arm group label: Control
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Triamcinolone Acetonide
description: intralesional injection of triamcinolone acetonide every 2 weeks for 6 sessions
arm group label: Intralesional Steroids
intervention type: Other
intervention name: saline
description: intralesional injection of saline
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Rana Hilal, MD
phone: 1001488869
phone ext: +20
email: rana.hilal@kasralainy.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Rana F Hilal, MD
investigator title: Principal Investigator
mesh term: Alopecia
mesh term: Alopecia Areata
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Triamcinolone diacetate