NCT03901443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

April 1, 2019

Last Update Submit

April 4, 2019

Conditions

Keywords

itchy skin diseasesitch treatmentspruriception

Outcome Measures

Primary Outcomes (7)

  • 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

    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

    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)

    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))

    single time point assessment at baseline

  • days missing at work

    Approximate number of days missing at work due to itch within last 6 months

    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)

    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)

    single time point assessment at baseline

Interventions

self-administered patient questionnaire regarding the different aspects of itch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • outpatients suffering from itch

You may not qualify if:

  • outpatients (suffering from itch) not willing or able to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Simon Müller, Dr. med

    Department of Dermatology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 3, 2019

Study Start

December 9, 2015

Primary Completion

April 30, 2016

Study Completion

April 30, 2016

Last Updated

April 8, 2019

Record last verified: 2019-04

Locations