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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00012745
Date of registration:	06/10/2017
Prospective Registration:	Yes
Primary sponsor:	Skåne University Hospital, Malmö Department of Dermatology
Public title:	The Psychosocial Burden of Skin Disease: Stigmatization and body image. An international multicenter study
Scientific title:	The Psychosocial Burden of Skin Disease: Stigmatization and body image. An international multicenter study - STIGDERM
Date of first enrolment:	15/10/2017
Target sample size:	8250
Recruitment status:	Pending
URL:	http://drks.de/search/en/trial/DRKS00012745
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: screening
Phase:

Countries of recruitment
Austria	Denmark	France	Germany	Hungary	Italy	Macedonia	Netherlands
Norway	Poland	Portugal	Russia	Spain	Sweden	Turkey	United Kingdom

Contacts

Name:	Florence Dalgard
Address:	Jan Waldenstrom gata 18 21428 Malmö Sweden
Telephone:	004640337552
Email:	florikje@gmail.com
Affiliation:	Department of Dermatology, Skåne University Hospital Malmö

Name:	Jörg Kupfer
Address:	Klinikstr. 29 35392 Gießen Germany
Telephone:	06419945684
Email:	joerg.p.kupfer@psycho.med.uni-giessen.de
Affiliation:	Institut für Medizinische Psychologie, Fachbereich Humanmedizin der Justus-Liebig Universität Gießen

Key inclusion & exclusion criteria

Inclusion criteria: Patients at dermatological out-patient clinics competent to read and write the language of the questionnaire. Controls competent to read and write the language of the questionnaire.
Exclusion criteria: controls: people with a skin condition under treatment

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

skin disease

Intervention(s)

Group 1:
Patients with dermatological disease

Clinical assessment: diagnosis, if available further diagnosis; evaluation of each condition as “mild”, “moderate” or “severe”; presence of other treated co-morbidities (cardio-vascular disease, chronic respiratory disease, diabetes, rheumatologic disease, other diseases); whether signs of depression, anxiety and feelings of dysmorphic concern are present in the patient.

Self-reported measures
Information on (questionnaire): Socio demographic background, employment status, weight/height, itch: presence and characteristics, suicidal ideation: presence and frequency, severity of condition (“mild”, “moderate”, “severe”), age of onset of skin disease, localization of the disease
The Patient Health Questionnaire PHQ-2: a validated questionnaire to assess depression
The General Anxiety Disorder Assessment GAD-2: a validated instrument to assess anxiety
Self-reported Health State: EQ5D-VAS
Perceived Stigmatisation Questionnaire PSQ to assess perceived stigmatization
Dysmorphic Concern Questionnaire DCQ to assess body image concern
Perceived Stress Scale PSS: 10 items assessing stress.

Group 2:
Control group without dermatological disease

Self-reported measures
Information on (questionnaire): Socio demographic background, employment status, weight/height, itch: presence and characteristics, suicidal ideation: presence and frequency, comorbidities under treatment
The Patient Health Questionnaire PHQ-2: a validated questionnaire to assess depression
The General Anxiety Disorder Assessment GAD-2: a validated instrument to assess anxiety
Self-reported Health State: EQ5D-VAS
Perceived Stigmatisation Questionnaire PSQ to assess perceived stigmatization
Dysmorphic Concern Questionnaire DCQ to assess body image concern
Perc

Primary Outcome(s)

Feelings of stigmatization (Perceived Stigmatisation Questionnaire PSQ, cross-sectional study, one-time measurement)

Secondary Outcome(s)

Body dysmorphic disease (Dysmorphic Concern Questionnaire DCQ, cross-sectional study, one-time measurement)

Secondary ID(s)

U1111-1199-2270

Source(s) of Monetary Support

Institut für Medizinische Psychologie, Fachbereich Humanmedizin der Justus-Liebig Universität Gießen

Skåne University Hospital, MalmöDepartment of Dermatology

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 17/07/2017
Contact:

ethik.kommission@pharma.med.uni-giessen.de

Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen

+49-641-9942470

ethik.kommission@pharma.med.uni-giessen.de

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00012745#studyResults

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