Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Survey on Itch in Outpatients of a University Clinic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03901443
Recruitment Status : Completed
First Posted : April 3, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. Better insights into these aspects might help to optimize itch treatment in clinical Settings.

Condition or disease Intervention/treatment
Itch Other: Survey on itch

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Survey on Itch in Outpatients of a University Clinic
Actual Study Start Date : December 9, 2015
Actual Primary Completion Date : April 30, 2016
Actual Study Completion Date : April 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Other: Survey on itch
    self-administered patient questionnaire regarding the different aspects of itch

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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))

  5. 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

  6. 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)


  7. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  • outpatients suffering from itch

Exclusion Criteria:

  • outpatients (suffering from itch) not willing or able to participate
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901443


Locations
Layout table for location information
Switzerland
Department of Dermatology, University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Layout table for investigator information
Principal Investigator: Simon Müller, Dr. med Department of Dermatology, University Hospital Basel
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03901443    
Other Study ID Numbers: UBE 15/114, sp15Mueller3
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
itchy skin diseases
itch treatments
pruriception
Additional relevant MeSH terms:
Layout table for MeSH terms
Pruritus
Skin Diseases
Skin Manifestations