Skin Tests in Cat Allergic Patients With Cat Dander Sampl... | NCT02667379

Studies
Skin Tests in Cat Allergic Patients With Cat Dander Samples Obtained Before and After Vaccinating the Cat

NCT02667379

Sponsor

University of Zurich

Status

Completed

Last Update Posted

May 9, 2016Estimated

Enrollment

7Actual

Phase

Not Applicable

Conditions

Hypersensitivity

Interventions

Diagnostic skin testing

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Jan 20, 2016

First Submission Date that Met QC Criteria

Jan 25, 2016

First Posted Date

Jan 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2016

Last Update Posted Date

May 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnostic skin testing	Other	Diagnostic skin testing with cat dander samples on volar forearms.	Other: Diagnostic skin testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic skin testing	Other	14 Skin prick tests on each volar forearm with cat dander samples.	Diagnostic skin testing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wheal size of allergic skin reaction in mm² measured 15 minutes after application of test substance	The primary variable will be the wheal size area of the immediate phase reaction in mm² measured after 15 minutes. Determination of the concentration threshold at which no more skin reactivity can be observed.	15 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed Consent as documented by signature (Appendix Informed Consent Form)
Male or female between 18 years to 65 years
Confirmed cat allergy (positive skin prick test)

Exclusion Criteria:

Diseases or medications, influencing the skin tests or impairing the correct conduct and evaluation of the study
History of anaphylactic reaction
Pregnancy
Skin irritations in test area
Participation in another clinical trial within the last 30 days and during the present study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Kuendig, MD	University Hospital Zurich, Dept Dermatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Dept of Dermatology		Zurich	Canton of Zurich	8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided