- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02667379
Skin Tests in Cat Allergic Patients With Cat Dander Samples Obtained Before and After Vaccinating the Cat
May 6, 2016 updated by: University of Zurich
Evaluation of Skin Prick Tests in Cat Allergic Patients With Cat Dander Samples Obtained Before and After Vaccinating the Cat
Determination of allergenicity of cat dander samples obtained before and after vaccinating the cat
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Dept of Dermatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Diagnostic skin testing
Diagnostic skin testing with cat dander samples on volar forearms.
|
14 Skin prick tests on each volar forearm with cat dander samples.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wheal size of allergic skin reaction in mm² measured 15 minutes after application of test substance
Time Frame: 15 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Kuendig, MD, University Hospital Zurich, Dept Dermatology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
January 20, 2016
First Submitted That Met QC Criteria
January 25, 2016
First Posted (Estimate)
January 28, 2016
Study Record Updates
Last Update Posted (Estimate)
May 9, 2016
Last Update Submitted That Met QC Criteria
May 6, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZU-HypoCat-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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