<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/NCT02999698</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-PSI-2016-71</org_study_id>
    <nct_id>NCT02999698</nct_id>
  </id_info>
  <brief_title>Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact</brief_title>
  <official_title>A Comparative Retrospective Study Between Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universitat Autonoma de Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the psychological impact of psoriasis or hidradenitis&#xD;
      suppurativa on patients, in order to compare both pathologies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dermatology Quality of Life Index (DLQI)</measure>
    <time_frame>1 day</time_frame>
    <description>The Dermatology Life Quality Index or DLQI, developed in 1994, was the first dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions in over 80 countries and is available in over 90 languages. Its use has been described in over 1000 publications including many multinational studies. The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>1 day</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>1 day</time_frame>
    <description>Perceived Stress Scale (PSS) was originally developed by Cohen (1983) and this scale is a self-report instrument that evaluates the level of stress perceived during the last month. The scale consists of 14 items with a response format of a five-point scale (0 = never, 1 = almost never, 2 = Every now and then, 3 = often, 4 = very often). The score obtained indicates that a higher score corresponds to a higher level of perceived stress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Holmes and Rahe stress scale</measure>
    <time_frame>1 day</time_frame>
    <description>The Holmes and Rahe stress scale is a list of 43 stressful life events that can contribute to illness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psoriasis Area Severity Index (PASI)</measure>
    <time_frame>1 day</time_frame>
    <description>The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static Physician's Global Assessment (sPGA)</measure>
    <time_frame>1 day</time_frame>
    <description>The PGA is a 5 point ordinal rating ranging from &quot;clear&quot; to &quot;very severe psoriasis&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hurley's staging system</measure>
    <time_frame>1 day</time_frame>
    <description>Hurley separated patients into three groups based largely on the presence and extent of cicatrization and sinuses. It has been used as a basis for clinical trials in the past and is a useful basis to approach therapy for patients. These three stages are based on Hurley's staging system, which is simple and relies on the subjective extent of the diseased tissue the patient has. Hurley's three stages of hidradenitis suppurativa.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA)</measure>
    <time_frame>1 day</time_frame>
    <description>The six-point Physician Global Assessment (PGA) ranges from clear to very severe. It is used in clinical trials to measure clinical improvement in inflammatory nodules, abscesses and draining fistulae</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Psoriasis</condition>
  <condition>Hidradenitis</condition>
  <arm_group>
    <arm_group_label>Psoriasis Group</arm_group_label>
    <description>Patients with psoriasis complete the questionnaires for psychological impact.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hidradenitis Suppurativa Group</arm_group_label>
    <description>Patients with hidradenitis suppurativa complete the questionnaires for psychological impact.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>Observational</description>
    <arm_group_label>Hidradenitis Suppurativa Group</arm_group_label>
    <arm_group_label>Psoriasis Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with hidradenitis suppurativa or psoriasis who have completed the&#xD;
        questionnaires for psychological impact in the Hospital de la Santa Creu and Sant Pau,&#xD;
        Barcelona.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women at least 18 years old at the time of selection.&#xD;
&#xD;
          -  Subjects diagnosed with psoriasis or hidradenitis suppurativa&#xD;
&#xD;
          -  Subjects who had completed the questionnaires for psychological impact.&#xD;
&#xD;
          -  Patients should be able to understand and communicate with the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects suffering from a serious concomitant illness.&#xD;
&#xD;
          -  Subjects with a mental illness.&#xD;
&#xD;
          -  Subjects who are performing psychiatric treatment.&#xD;
&#xD;
          -  Patients who have alcohol dependence or drug abuse.&#xD;
&#xD;
          -  Subjects that present legal incapacity or limited legal capacity.&#xD;
&#xD;
          -  Subjects presenting illiteracy or language barriers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esther Margarit de Miguel, Msc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antoni Font Guiteras, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universitat Autonoma de Barcelona</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Esther Margarit de Miguel, Msc</last_name>
    <phone>+34696617013</phone>
    <email>emargarit@santpau.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eva Vilarrasa Rull, Dr.</last_name>
    <phone>+34935537007</phone>
    <email>evilarrasa@santpau.cat</email>
  </overall_contact_backup>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriasis</keyword>
  <keyword>Hidradenitis</keyword>
  <keyword>Psychological impact</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Hidradenitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02999698
org study id: IIBSP-PSI-2016-71
nct id: NCT02999698
lead sponsor: 
collaborator: 
has dmc: No
The aim of this study is to evaluate the psychological impact of psoriasis or hidradenitis
      suppurativa on patients, in order to compare both pathologies.
time perspective: Retrospective
measure: Dermatology Quality of Life Index (DLQI)
time frame: 1 day
description: The Dermatology Life Quality Index or DLQI, developed in 1994, was the first dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions in over 80 countries and is available in over 90 languages. Its use has been described in over 1000 publications including many multinational studies. The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: 1 day
description: Hospital Anxiety and Depression Scale (HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression.
measure: Perceived Stress Scale (PSS)
time frame: 1 day
description: Perceived Stress Scale (PSS) was originally developed by Cohen (1983) and this scale is a self-report instrument that evaluates the level of stress perceived during the last month. The scale consists of 14 items with a response format of a five-point scale (0 = never, 1 = almost never, 2 = Every now and then, 3 = often, 4 = very often). The score obtained indicates that a higher score corresponds to a higher level of perceived stress.
measure: The Holmes and Rahe stress scale
time frame: 1 day
description: The Holmes and Rahe stress scale is a list of 43 stressful life events that can contribute to illness.
measure: Psoriasis Area Severity Index (PASI)
time frame: 1 day
description: The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area.
measure: Static Physician's Global Assessment (sPGA)
time frame: 1 day
description: The PGA is a 5 point ordinal rating ranging from "clear" to "very severe psoriasis".
measure: Hurley's staging system
time frame: 1 day
description: Hurley separated patients into three groups based largely on the presence and extent of cicatrization and sinuses. It has been used as a basis for clinical trials in the past and is a useful basis to approach therapy for patients. These three stages are based on Hurley's staging system, which is simple and relies on the subjective extent of the diseased tissue the patient has. Hurley's three stages of hidradenitis suppurativa.
measure: Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA)
time frame: 1 day
description: The six-point Physician Global Assessment (PGA) ranges from clear to very severe. It is used in clinical trials to measure clinical improvement in inflammatory nodules, abscesses and draining fistulae
arm group label: Psoriasis Group
description: Patients with psoriasis complete the questionnaires for psychological impact.
arm group label: Hidradenitis Suppurativa Group
description: Patients with hidradenitis suppurativa complete the questionnaires for psychological impact.
intervention type: Other
intervention name: Observational
description: Observational
arm group label: Hidradenitis Suppurativa Group
arm group label: Psoriasis Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Esther Margarit de Miguel, Msc
role: Principal Investigator
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
last name: Antoni Font Guiteras, PhD
role: Study Director
affiliation: Universitat Autonoma de Barcelona
last name: Esther Margarit de Miguel, Msc
phone: +34696617013
email: emargarit@santpau.cat
last name: Eva Vilarrasa Rull, Dr.
phone: +34935537007
email: evilarrasa@santpau.cat
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Hidradenitis
sharing ipd: No