Global Healthcare Study on Atopic Dermatitis (GHSAD)
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Julia-Tatjana Maul, Prof. Dr. med.
- Phone Number: +41 76 441 51 09
- Email: julia-tatjana.maul@usz.ch
Study Contact Backup
- Name: Johannes Didaskalu
- Email: johannes.didaskalu@usz.ch
Study Locations
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-
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Zurich, Switzerland
- Recruiting
- University of Zurich
-
Contact:
- Julia-Tatjana Maul, Prof. Dr. med.
- Phone Number: +41 76 441 51 09
- Email: julia-tatjana.maul@usz.ch
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Signed General Consent Form, or equivalent document
- Confirmed diagnosis of Atopic Dermatitis
Exclusion Criteria:
- Inability to provide informed consent.
- Datasets with ambiguous or unclear diagnosis.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
|
Global Healthcare Study on Atopic Dermatitis
Patients with Atopic Dermatitis
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eczema Area and Severity Index (EASI)
Time Frame: Baseline and follow-up visits every 6-12 months for up to 5 years.
|
Clinician-assessed measure of atopic dermatitis severity based on extent and severity of eczema signs; total score ranges from 0 to 72, with higher scores indicating more severe disease.
|
Baseline and follow-up visits every 6-12 months for up to 5 years.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dermatology Life Quality Index (DLQI)
Time Frame: Baseline and follow-up visits every 6-12 months for up to 5 years.
|
Patient-reported measure of dermatology-specific quality of life; total score ranges from 0 to 30, with higher scores indicating greater impairment.
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Baseline and follow-up visits every 6-12 months for up to 5 years.
|
|
SCORing Atopic Dermatitis (SCORAD)
Time Frame: Baseline and follow-up visits every 6-12 months for up to 5 years.
|
Clinician-assessed measure of atopic dermatitis severity incorporating extent, intensity, and subjective symptoms; total score ranges from 0 to 103, with higher scores indicating more severe disease.
|
Baseline and follow-up visits every 6-12 months for up to 5 years.
|
|
Patient-Oriented Eczema Measure (POEM)
Time Frame: Baseline and follow-up visits every 6-12 months for up to 5 years.
|
Patient-reported measure of atopic dermatitis symptoms and disease burden; total score ranges from 0 to 28, with higher scores indicating more severe disease.
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Baseline and follow-up visits every 6-12 months for up to 5 years.
|
|
Peak Pruritus Numerical Rating Scale (PP-NRS)
Time Frame: Baseline and follow-up visits every 6-12 months for up to 5 years.
|
Patient-reported assessment of peak itch severity on a numerical rating scale from 0 (no itch) to 10 (worst imaginable itch).
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Baseline and follow-up visits every 6-12 months for up to 5 years.
|
|
Physician Global Assessment (PGA)
Time Frame: Baseline and follow-up visits every 6-12 months for up to 5 years.
|
Clinician-assessed global measure of atopic dermatitis severity on a scale from 0 (clear) to 4 (severe).
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Baseline and follow-up visits every 6-12 months for up to 5 years.
|
|
Body Surface Area (BSA)
Time Frame: Baseline and follow-up visits every 6-12 months for up to 5 years.
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Percentage of total body surface area affected by atopic dermatitis, ranging from 0% to 100%.
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Baseline and follow-up visits every 6-12 months for up to 5 years.
|
|
Patient-reported Numerical Rating Scale (NRS) for atopic dermatitis severity
Time Frame: Baseline and follow-up visits every 6-12 months for up to 5 years.
|
Patient-reported assessment of overall atopic dermatitis severity on a numerical rating scale from 0 (no disease) to 10 (most severe disease imaginable).
|
Baseline and follow-up visits every 6-12 months for up to 5 years.
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Julia-Tatjana Maul, Prof. Dr. med., University of Zurich
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2024-01704-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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