HypersensitivityNCT02667379
Skin Tests in Cat Allergic Patients With Cat Dander Samples Obtained Before and After Vaccinating the Cat
A study testing Diagnostic skin testing in people with Hypersensitivity, run by University of Zurich at 1 site in Switzerland.
Trial summary
Determination of allergenicity of cat dander samples obtained before and after vaccinating the cat Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- Diagnostic skin testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2016to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Dept of Dermatology
Zurich, Canton of Zurich, 8091
About this study
Official title: 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
- Conditions
- Hypersensitivity
- Being tested
- Diagnostic skin testing
- Keywords
- Cat, allergy, dander, Fel d 1, Felis domesticus
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic skin testingOther
14 Skin prick tests on each volar forearm with cat dander samples.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic skin testing | Other | Diagnostic skin testing with cat dander samples on volar forearms. Receives: Other: Diagnostic skin testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Kuendig, MD, Principal investigator, University Hospital Zurich, Dept Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667379
- Sponsor's protocol ID
- ZU-HypoCat-001
- Status last verified
- May 2016
- First submitted
- 20 Jan 2016
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Skin Prick Tests in Cat Allergic Patients With Cat Dander Samples Obtained Before and After Vaccinating the Cat
- ClinicalTrials.gov ID
- NCT02667379
- Acronym / sponsor ID
- ZU-HypoCat-001
- Conditions
- Hypersensitivity
- Keywords
- Cat, allergy, dander, Fel d 1, Felis domesticus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determination of allergenicity of cat dander samples obtained before and after vaccinating the cat
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic skin testing | Other | Other: Diagnostic skin testingDiagnostic skin testing with cat dander samples on volar forearms. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic skin testing14 Skin prick tests on each volar forearm with cat dander samples. | Other | Diagnostic skin testing |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kuendig, MD principal investigator
University Hospital Zurich, Dept Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic skin testing in people with Hypersensitivity, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wheal size of allergic skin reaction in mm² measured 15 minutes after application of test substance (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.