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

Primary Purpose

Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Diagnostic skin testing
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypersensitivity focused on measuring Cat, allergy, dander, Fel d 1, Felis domesticus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Zurich, Dept of Dermatology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Diagnostic skin testing

Arm Description

Diagnostic skin testing with cat dander samples on volar forearms.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 20, 2016
Last Updated
May 6, 2016
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02667379
Brief Title
Skin Tests in Cat Allergic Patients With Cat Dander Samples Obtained Before and After Vaccinating the Cat
Official Title
Evaluation of Skin Prick Tests in Cat Allergic Patients With Cat Dander Samples Obtained Before and After Vaccinating the Cat
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Determination of allergenicity of cat dander samples obtained before and after vaccinating the cat

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity
Keywords
Cat, allergy, dander, Fel d 1, Felis domesticus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic skin testing
Arm Type
Other
Arm Description
Diagnostic skin testing with cat dander samples on volar forearms.
Intervention Type
Other
Intervention Name(s)
Diagnostic skin testing
Intervention Description
14 Skin prick tests on each volar forearm with cat dander samples.
Primary Outcome Measure Information:
Title
Wheal size of allergic skin reaction in mm² measured 15 minutes after application of test substance
Description
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.
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kuendig, MD
Organizational Affiliation
University Hospital Zurich, Dept Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Dept of Dermatology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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