- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03901443
Survey on Itch in Outpatients of a University Clinic
April 4, 2019 updated by: University Hospital, Basel, Switzerland
This study is to investigate the pruriception (i.e. the perception of the character and intensity of itch), the impact of itch on quality of life, the response to itch and the subjective efficacy and preferences of the different treatment options among patients with different skin diseases.
Better insights into these aspects might help to optimize itch treatment in clinical Settings.
Study Overview
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Basel, Switzerland, 4031
- Department of Dermatology, University Hospital Basel
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All outpatients of the dermatologic university clinic suffering from itch are eligible to participate in the study (from December 2015 until the end of April 2016).
Description
Inclusion Criteria:
- outpatients suffering from itch
Exclusion Criteria:
- outpatients (suffering from itch) not willing or able to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
itch intensity
Time Frame: single time point assessment at baseline
|
Questions regarding itch perception (NRS 0-10; 0 = no itch, 10 = worst imaginable itch) experienced at the moment, within the last 7 days, within the last month
|
single time point assessment at baseline
|
|
itch perception
Time Frame: single time point assessment at baseline
|
Questions regarding situations in which the itch is especially bad (multiple choice options regarding day time, daily situations, season); objective assessment in which respondents are asked to select answers from the choices offered as a list
|
single time point assessment at baseline
|
|
impact of itch on quality of life
Time Frame: single time point assessment at baseline
|
Questions regarding strength of impact of itch on quality of life (NRS 0-10; 0 = no impact, 10 = extreme)
|
single time point assessment at baseline
|
|
quality of sleep
Time Frame: single time point assessment at baseline
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Questions regarding sleep disturbance by itch (Does itch disturb the patient's sleep and/or sleep of other persons?
(yes/no))
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single time point assessment at baseline
|
|
days missing at work
Time Frame: single time point assessment at baseline
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Approximate number of days missing at work due to itch within last 6 months
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single time point assessment at baseline
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helpfulness of common itch therapies
Time Frame: single time point assessment at baseline
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Questions regarding helpfulness of common itch therapies (NRS 0-10; 0 = no reduction in itch, 10 = complete reduction of itch; additionally free text options to indicate specific creams, tablets or alternative medicine) |
single time point assessment at baseline
|
|
preferred treatment options
Time Frame: single time point assessment at baseline
|
Questions regarding preferred treatment options (NRS 0- 10; 0 = unimportant, 10 = most important; including additional free text option)
|
single time point assessment at baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 9, 2015
Primary Completion (Actual)
April 30, 2016
Study Completion (Actual)
April 30, 2016
Study Registration Dates
First Submitted
April 1, 2019
First Submitted That Met QC Criteria
April 2, 2019
First Posted (Actual)
April 3, 2019
Study Record Updates
Last Update Posted (Actual)
April 8, 2019
Last Update Submitted That Met QC Criteria
April 4, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBE 15/114, sp15Mueller3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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