NCT02205593

Brief Summary

'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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

6.3 years

First QC Date

July 14, 2014

Last Update Submit

July 25, 2019

Conditions

PsoriasisAtopic Dermatitis/ Eczema

Keywords

psoriasisatopic dermatitiseczemapatient educationstress reductionquality of life

Outcome Measures

Primary Outcomes (5)

  • change in DLQI (Dermatology Life Quality Index) score [ ]

    DLQI is a questionnaire measuring Health related quality of life 10 questions

    baseline, 3 months, 6 months, 9 months

  • change in Skindex-29 score [ ]

    Questionnaire measuring Health related quality of life 29 questions

    baseline, 3 months, 6 months, 9 months

  • change in ShortForm 36 score [ ]

    Questionnaire measuring Health related quality of life

    baseline, 3 months, 6 months, 9 months

  • change in EQ 5D score [ ]

    Questionnaire measuring Health related quality of life

    baseline, 3 months, 6 months, 9 months

  • change in EQ VAS (EQ visual analogue scale) score [ ]

    Questionnaire measuring Health related quality of life

    baseline, 3 months, 6 months, 9 months

Secondary Outcomes (3)

  • change in EASI (eczema area and severity index) score [ ]

    baseline, 3 months, 6 months, 9 months

  • change in PASI (psoriasis area and severity index) [ ]

    baseline, 3 months, 6 months, 9 months

  • BDI (Beck Depression Inventory) score [ ]

    baseline, 3 months, 6 months, 9 months

Study Arms (2)

Control

PLACEBO COMPARATOR

patient group receiving regular follow-up visits (baseline, 3 months, 6 months, 9 months)

Behavioral: Control

Haut Tief patient education

ACTIVE COMPARATOR

patient group receives the educational program with regular follow-up visits (baseline, 3 months, 6 months, 9 months).

Behavioral: Control

Interventions

ControlBEHAVIORAL

Regular follow-up and treatment WITHOUT behavioural intervention

ControlHaut Tief patient education

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic psoriasis (disease for more than 3 months)
  • Chronic eczema (disease for more than 3) months)
  • Age ≥ 18 years
  • Oral and written informed consent

You may not qualify if:

  • systemic antiinflammatory therapy
  • treatment with other investigational products
  • other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
  • known or suspected non-compliance, drug or alcohol abuse,
  • inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject
  • participation in another study within the 30 days preceding and during the present study, (viii) previous enrollment into the current study,
  • enrolment of the investigator, his/her family members, employees and other dependent persons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Department of Dermatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

PsoriasisDermatitis, AtopicEczema

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Guenther Hofbauer, Prof MD

    University Hospital Zurich, Dept. of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 31, 2014

Study Start

July 1, 2012

Primary Completion

October 1, 2018

Study Completion

December 1, 2022

Last Updated

July 26, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)