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
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
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
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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