<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/NCT02205593</url>
  </required_header>
  <id_info>
    <org_study_id>Haut-Tief</org_study_id>
    <nct_id>NCT02205593</nct_id>
  </id_info>
  <brief_title>Haut-Tief Patient Education on Psoriasis and Eczema</brief_title>
  <official_title>A Prospective, Randomized, Controlled Study of the Impact of Education and Stress-reduction Techniques on Psoriasis and Eczema.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      'Haut-Tief' (Skin Deep) is an educational, stress reducing program for patients with&#xD;
      psoriasis or atopic dermatitis. A range of support activities will be offered in order to&#xD;
      learn effective self-management strategies and attitude to one's chronic skin disease and&#xD;
      consequently improving quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The educational program consists of 2-hours of educational (dermatology, specialized nurse,&#xD;
      psychologist) and stress-reduction sessions (yoga, meditation, physiotherapy) twice a week&#xD;
      during 9 weeks.&#xD;
&#xD;
      A multidisciplinary team of trainers is involved. Primary endpoint is the general and skin&#xD;
      dependent quality of life measured by questionnaires. HRQoL (Health-Related Quality of Life)&#xD;
      is measured at baseline, after 3 months, 6 months and 9 months follow up. Patients are&#xD;
      recruited from the out-patient clinic at the Department of Dermatology of the University&#xD;
      Hospital Zurich. Patients are randomized in an intervention and control group. Intervention&#xD;
      group receives the education program additionally to follow-up visits whereas the control&#xD;
      group receives follow-up visits. Several runs are planned.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Actual">October 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in DLQI (Dermatology Life Quality Index) score [ ]</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months</time_frame>
    <description>DLQI is a questionnaire measuring Health related quality of life 10 questions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in Skindex-29 score [ ]</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months</time_frame>
    <description>Questionnaire measuring Health related quality of life 29 questions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in ShortForm 36 score [ ]</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months</time_frame>
    <description>Questionnaire measuring Health related quality of life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in EQ 5D score [ ]</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months</time_frame>
    <description>Questionnaire measuring Health related quality of life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in EQ VAS (EQ visual analogue scale) score [ ]</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months</time_frame>
    <description>Questionnaire measuring Health related quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in EASI (eczema area and severity index) score [ ]</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months</time_frame>
    <description>clinical score for atopic dermatitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in PASI (psoriasis area and severity index) [ ]</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months</time_frame>
    <description>clinical score for psoriasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDI (Beck Depression Inventory) score [ ]</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Psoriasis</condition>
  <condition>Atopic Dermatitis/ Eczema</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patient group receiving regular follow-up visits (baseline, 3 months, 6 months, 9 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Haut Tief patient education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patient group receives the educational program with regular follow-up visits (baseline, 3 months, 6 months, 9 months).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Regular follow-up and treatment WITHOUT behavioural intervention</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Haut Tief patient education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic psoriasis (disease for more than 3 months)&#xD;
&#xD;
          -  Chronic eczema (disease for more than 3) months)&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Oral and written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic antiinflammatory therapy&#xD;
&#xD;
          -  treatment with other investigational products&#xD;
&#xD;
          -  other clinically significant concomitant disease states (e.g., renal failure, hepatic&#xD;
             dysfunction, cardiovascular disease, etc),&#xD;
&#xD;
          -  known or suspected non-compliance, drug or alcohol abuse,&#xD;
&#xD;
          -  inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia or confusional state of the subject&#xD;
&#xD;
          -  participation in another study within the 30 days preceding and during the present&#xD;
             study, (viii) previous enrollment into the current study,&#xD;
&#xD;
          -  enrolment of the investigator, his/her family members, employees and other dependent&#xD;
             persons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guenther Hofbauer, Prof MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Dept. of Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Department of Dermatology</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>July 25, 2019</last_update_submitted>
  <last_update_submitted_qc>July 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>psoriasis</keyword>
  <keyword>atopic dermatitis</keyword>
  <keyword>eczema</keyword>
  <keyword>patient education</keyword>
  <keyword>stress reduction</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</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/NCT02205593
org study id: Haut-Tief
nct id: NCT02205593
lead sponsor: 
has dmc: No
'Haut-Tief' (Skin Deep) is an educational, stress reducing program for patients with
      psoriasis or atopic dermatitis. A range of support activities will be offered in order to
      learn effective self-management strategies and attitude to one's chronic skin disease and
      consequently improving quality of life.
The educational program consists of 2-hours of educational (dermatology, specialized nurse,
      psychologist) and stress-reduction sessions (yoga, meditation, physiotherapy) twice a week
      during 9 weeks.

      A multidisciplinary team of trainers is involved. Primary endpoint is the general and skin
      dependent quality of life measured by questionnaires. HRQoL (Health-Related Quality of Life)
      is measured at baseline, after 3 months, 6 months and 9 months follow up. Patients are
      recruited from the out-patient clinic at the Department of Dermatology of the University
      Hospital Zurich. Patients are randomized in an intervention and control group. Intervention
      group receives the education program additionally to follow-up visits whereas the control
      group receives follow-up visits. Several runs are planned.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: change in DLQI (Dermatology Life Quality Index) score [ ]
time frame: baseline, 3 months, 6 months, 9 months
description: DLQI is a questionnaire measuring Health related quality of life 10 questions
measure: change in Skindex-29 score [ ]
time frame: baseline, 3 months, 6 months, 9 months
description: Questionnaire measuring Health related quality of life 29 questions
measure: change in ShortForm 36 score [ ]
time frame: baseline, 3 months, 6 months, 9 months
description: Questionnaire measuring Health related quality of life
measure: change in EQ 5D score [ ]
time frame: baseline, 3 months, 6 months, 9 months
description: Questionnaire measuring Health related quality of life
measure: change in EQ VAS (EQ visual analogue scale) score [ ]
time frame: baseline, 3 months, 6 months, 9 months
description: Questionnaire measuring Health related quality of life
measure: change in EASI (eczema area and severity index) score [ ]
time frame: baseline, 3 months, 6 months, 9 months
description: clinical score for atopic dermatitis
measure: change in PASI (psoriasis area and severity index) [ ]
time frame: baseline, 3 months, 6 months, 9 months
description: clinical score for psoriasis
measure: BDI (Beck Depression Inventory) score [ ]
time frame: baseline, 3 months, 6 months, 9 months
arm group label: Control
arm group type: Placebo Comparator
description: patient group receiving regular follow-up visits (baseline, 3 months, 6 months, 9 months)
arm group label: Haut Tief patient education
arm group type: Active Comparator
description: patient group receives the educational program with regular follow-up visits (baseline, 3 months, 6 months, 9 months).
intervention type: Behavioral
intervention name: Control
description: Regular follow-up and treatment WITHOUT behavioural intervention
arm group label: Control
arm group label: Haut Tief patient education
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Guenther Hofbauer, Prof MD
role: Principal Investigator
affiliation: University Hospital Zurich, Dept. of Dermatology
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Psoriasis
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No