<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/NCT04415034</url>
  </required_header>
  <id_info>
    <org_study_id>0920/UN2.F1/ETIK/2018</org_study_id>
    <nct_id>NCT04415034</nct_id>
  </id_info>
  <brief_title>Scalp Pruritus Measurement Using Visual Analog Scale and 5-d Itch Scale in Children With Pediculosis Capitis</brief_title>
  <official_title>Scalp Pruritus Measurement Using Visual Analog Scale and 5-d Itch Scale in Children With Pediculosis Capitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indonesia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pediculosis capitis is a parasitic infestation that can cause scalp pruritus and quality of&#xD;
      life disturbances. There are two objective measurement for pruritus, visual analog scale&#xD;
      (VAS) and 5-D itch scale, which can assess the severity of the scalp pruritus and the latter&#xD;
      can also asses the quality of life affected by pruritus. Even though VAS can not be used to&#xD;
      evaluate the impact of pruritus on quality of life, it is very easy to use while 5-D itch&#xD;
      scale is complex and not child-friendly.&#xD;
&#xD;
      The aim of this study is to determine the relationship between two different pruritus scales&#xD;
      and to establish validity of pruritus VAS scale in evaluating quality of life in children&#xD;
      with pediculosis capitis. We compare two pruritus scale on students with pediculosis of two&#xD;
      boarding school in Bogor, West Java, Indonesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study used cross sectional design study.&#xD;
&#xD;
      Subjects with eligible criteria were included and informed consent from the parents or legal&#xD;
      guardian were obtained.&#xD;
&#xD;
      The diagnosis of pediculosis capitis was made based on the findings of eggs, larva, or an&#xD;
      adult parasite on the scalp or in the hair of the students. All subjects were asked for both&#xD;
      VAS and 5-D itch scale.The VAS is categorized into five groups based on the point, as&#xD;
      follows: 0 for no pruritus, &lt;3 for mild pruritus, ≥ 3 - &lt;7 for moderate pruritus, ≥ 7 - &lt;9&#xD;
      for severe pruritus, and ≥ 9 for very severe pruritus. The 5-D itch scale consists of five&#xD;
      parameters: duration, degree, direction, disability (sleep, leisure/social activities,&#xD;
      housework/errands, work/school), and distribution of the pruritus with points ranging from&#xD;
      one to five.&#xD;
&#xD;
      Data were recorded for statistical analysis, a chi-square test was used to determine the&#xD;
      relationship between two categorical variables. The correlation coefficient between the VAS&#xD;
      and 5-D itch scale was calculated using Spearman's rank correlation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pruritus severity (1)</measure>
    <time_frame>Baseline, during examination</time_frame>
    <description>Pruritus severity evaluated by visual analog scale (VAS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pruritus severity (2)</measure>
    <time_frame>Baseline, during examination</time_frame>
    <description>Pruritus severity evaluated by 5-D itch scale</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">357</enrollment>
  <condition>Pediculus Capitis</condition>
  <condition>Pruritus</condition>
  <arm_group>
    <arm_group_label>Pediculosis capitis</arm_group_label>
    <description>Subjects with pediculosis capitis based on the findings of eggs, larva, or an adult parasite on the scalp or in the hair</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>VAS and 5-D itch pruritus assessment</intervention_name>
    <description>All subjects were evaluated for presence of pruritus using VAS and 5-D itch scale</description>
    <arm_group_label>Pediculosis capitis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with pediculosis capitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students studying in Junior high school at Boarding School in Bogor with medium length&#xD;
             hair who were clinically diagnosed with pediculosis capitis&#xD;
&#xD;
          -  Willingness to participate as a research subject (to be interviewed and undergo&#xD;
             physical examination), and after being explained the details of the study, granted the&#xD;
             headmaster permission to sign consent in their name (informed assent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chemical treatment of PC within 10 days before the trial&#xD;
&#xD;
          -  History of permethrin hypersensitivity&#xD;
&#xD;
          -  Unwillingness to participate as a research subject&#xD;
&#xD;
          -  Mild-to-severe secondary infection&#xD;
&#xD;
          -  Long or short hair&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female students</gender_description>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra Widaty, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pesantren Al Hidayah Cibinong</name>
      <address>
        <city>Bogor</city>
        <state>Jawa Barat</state>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 30, 2020</last_update_submitted>
  <last_update_submitted_qc>May 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>Dr. dr. Sandra Widaty, SpKK (K)</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Pediculosis capitis</keyword>
  <keyword>Scalp pruritus</keyword>
  <keyword>VAS scale</keyword>
  <keyword>5-D itch scale</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lice Infestations</mesh_term>
    <mesh_term>Pruritus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04415034
org study id: 0920/UN2.F1/ETIK/2018
nct id: NCT04415034
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pediculosis capitis is a parasitic infestation that can cause scalp pruritus and quality of
      life disturbances. There are two objective measurement for pruritus, visual analog scale
      (VAS) and 5-D itch scale, which can assess the severity of the scalp pruritus and the latter
      can also asses the quality of life affected by pruritus. Even though VAS can not be used to
      evaluate the impact of pruritus on quality of life, it is very easy to use while 5-D itch
      scale is complex and not child-friendly.

      The aim of this study is to determine the relationship between two different pruritus scales
      and to establish validity of pruritus VAS scale in evaluating quality of life in children
      with pediculosis capitis. We compare two pruritus scale on students with pediculosis of two
      boarding school in Bogor, West Java, Indonesia.
This study used cross sectional design study.

      Subjects with eligible criteria were included and informed consent from the parents or legal
      guardian were obtained.

      The diagnosis of pediculosis capitis was made based on the findings of eggs, larva, or an
      adult parasite on the scalp or in the hair of the students. All subjects were asked for both
      VAS and 5-D itch scale.The VAS is categorized into five groups based on the point, as
      follows: 0 for no pruritus, <3 for mild pruritus, ≥ 3 - <7 for moderate pruritus, ≥ 7 - <9
      for severe pruritus, and ≥ 9 for very severe pruritus. The 5-D itch scale consists of five
      parameters: duration, degree, direction, disability (sleep, leisure/social activities,
      housework/errands, work/school), and distribution of the pruritus with points ranging from
      one to five.

      Data were recorded for statistical analysis, a chi-square test was used to determine the
      relationship between two categorical variables. The correlation coefficient between the VAS
      and 5-D itch scale was calculated using Spearman's rank correlation
observational model: Other
time perspective: Cross-Sectional
measure: Pruritus severity (1)
time frame: Baseline, during examination
description: Pruritus severity evaluated by visual analog scale (VAS)
measure: Pruritus severity (2)
time frame: Baseline, during examination
description: Pruritus severity evaluated by 5-D itch scale
arm group label: Pediculosis capitis
description: Subjects with pediculosis capitis based on the findings of eggs, larva, or an adult parasite on the scalp or in the hair
intervention type: Other
intervention name: VAS and 5-D itch pruritus assessment
description: All subjects were evaluated for presence of pruritus using VAS and 5-D itch scale
arm group label: Pediculosis capitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Female students
minimum age: 11 Years
maximum age: 18 Years
healthy volunteers: No
last name: Sandra Widaty, MD, PhD
role: Principal Investigator
affiliation: Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia
facility: 
country: Indonesia
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: Dr. dr. Sandra Widaty, SpKK (K)
investigator title: Principal investigator
mesh term: Lice Infestations
mesh term: Pruritus
sharing ipd: Undecided