ItchNCT03901443
Survey on Itch in Outpatients of a University Clinic
An observational study of Itch, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Itch
- What is being tested?
- Survey on itch
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Dec 2015to 30 Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- outpatients suffering from itch
Who cannot join
- outpatients (suffering from itch) not willing or able to participate
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Dermatology, University Hospital Basel
Basel, 4031
About this study
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.
- Conditions
- Itch
- Being tested
- Survey on itch
- Keywords
- itchy skin diseases, itch treatments, pruriception
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey on itchOther
self-administered patient questionnaire regarding the different aspects of itch
What is being measured
The primary outcome is the main question the study is designed to answer.
itch intensity
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
Measured: single time point assessment at baseline
itch perception
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
Measured: single time point assessment at baseline
impact of itch on quality of life
Questions regarding strength of impact of itch on quality of life (NRS 0-10; 0 = no impact, 10 = extreme)
Measured: single time point assessment at baseline
quality of sleep
Questions regarding sleep disturbance by itch (Does itch disturb the patient's sleep and/or sleep of other persons? (yes/no))
Measured: single time point assessment at baseline
days missing at work
Approximate number of days missing at work due to itch within last 6 months
Measured: single time point assessment at baseline
helpfulness of common itch therapies
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)
Measured: single time point assessment at baseline
preferred treatment options
Questions regarding preferred treatment options (NRS 0- 10; 0 = unimportant, 10 = most important; including additional free text option)
Measured: single time point assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start9 Dec 2015
- Primary completion30 Apr 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ItchStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Müller, Dr. med, Principal investigator, Department of Dermatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901443
- Sponsor's protocol ID
- UBE 15/114, sp15Mueller3
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on Itch in Outpatients of a University Clinic
- ClinicalTrials.gov ID
- NCT03901443
- Acronym / sponsor ID
- UBE 15/114, sp15Mueller3
- Conditions
- Itch
- Keywords
- itchy skin diseases, itch treatments, pruriception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 9 Dec 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- outpatients suffering from itch
Key exclusion criteria (1 listed)
- outpatients (suffering from itch) not willing or able to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey on itchself-administered patient questionnaire regarding the different aspects of itch | Other | – |
Primary outcome
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
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
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)
quality of sleep
Time frame: single time point assessment at baseline
Questions regarding sleep disturbance by itch (Does itch disturb the patient's sleep and/or sleep of other persons? (yes/no))
days missing at work
Time frame: single time point assessment at baseline
Approximate number of days missing at work due to itch within last 6 months
helpfulness of common itch therapies
Time frame: single time point assessment at baseline
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
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Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)
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Novel Strategies for Reducing Burn Scar Itch
Burn Scar, Itch Scarring
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Müller, Dr. med principal investigator
Department of Dermatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Itch, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
itch intensity (time frame: single time point assessment at baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.