Cat Dander AllergyNCT02050412
A Pilot Study for the Determination of Allergenicity of Cat Dander Samples Obtained by Different Methods
A study testing Cat fur scratch test in people with Cat Dander Allergy, run by Thomas Kuendig at 1 site in Switzerland.
Trial summary
Measurement of skin reactivity of cat dander samples obtained by different methods. Subjects will be assessed for the study by of a conventional skin prick test with a positive (histamine), a positive (standardized cat dander extract) and a negative allergen control (a diluent) if they fulfil all other in- and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cat Dander Allergy
- What is being tested?
- Cat fur scratch test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Apr 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Male or female between 18 years to 65 years
- A positive clinical history with inhalant allergy presumably due to cat allergen.
- Positive screening prick test (mean wheal diameter ≥ 3 mm) when tested with already standardized cat allergen extract.
- Positive screening prick test (wheal diameter ≥ 3mm) to Histamine dihydrochloride 10mg/ml.
Who cannot join
- Impaired in understanding the nature, meaning and scope of the study or incapable of giving written informed consent,
- Participation in another clinical trial within the last 30 days and during the present study,
- Pregnant or lactating women,
- Positive skin reaction in the screening prick test to negative control,
- Currently suffering from allergy symptoms,
- History of systemic reactions to allergens,
Show all 11Show fewer
- Severe diseases influencing the results of the present study by discretion of the investigator,
- Immunotherapy with the allergen preparation during the past two years,
- Skin lesions and excessive hair-growth in the skin test areas,
- Treatment with prohibited concomitant medications according to section 9.3 (protocol) with the exception of medications with local effects which will not influence the results of the skin tests,
- Alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinical Trials Center, University Hospital and University Zurich
Zurich, Canton of Zurich, 8091
About this study
Measurement of skin reactivity of cat dander samples obtained by different methods.
Subjects will be assessed for the study by of a conventional skin prick test with a positive (histamine), a positive (standardized cat dander extract) and a negative allergen control (a diluent) if they fulfil all other in- and exclusion criteria, too.
Read more
A screening prick test will be performed in order to confirm positivity (cat dander allergy).
A scratch test will be performed in participants after a positive screening prick test, in order to measure skin reactivity to cat dander, originating of three different body areas of the cat. For this purpose, a small amount of cat fur in solution with distilled water will be placed onto the volar aspect of both forearms after the skin has been scratched with a scratch lancet. The distilled water in which the cat hair was solved before will serve as negative control.
This procedure will be repeated with fur of the three different areas of the cat, always using triplicates (nine samples per cat).
From each of the 20 cats, nine samples will be tested on 20 subjects (one cat/subject).
- Conditions
- Cat Dander Allergy
- Being tested
- Cat fur scratch test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cat fur scratch testOther
| Study group | Role | What they receive |
|---|---|---|
| Cat fur scratch test | Other | Not described Receives: Other: Cat fur scratch test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary variable will be the wheal size area of the immediate phase reaction in mm²
Measured: measured after 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cat Dander AllergyStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Kuendig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Kuendig, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050412
- Sponsor's protocol ID
- ZU-Scratch-Cat-001
- Status last verified
- Apr 2014
- First submitted
- 28 Jan 2014
- Last updated
- 10 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the Determination of Allergenicity of Cat Dander Samples Obtained by Different Methods
- ClinicalTrials.gov ID
- NCT02050412
- Acronym / sponsor ID
- ZU-Scratch-Cat-001
- Conditions
- Cat Dander Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Thomas KuendigUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Jan 2014 (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.
Measurement of skin reactivity of cat dander samples obtained by different methods.
Subjects will be assessed for the study by of a conventional skin prick test with a positive (histamine), a positive (standardized cat dander extract) and a negative allergen control (a diluent) if they fulfil all other in- and exclusion criteria, too.
A screening prick test will be performed in order to confirm positivity (cat dander allergy).
A scratch test will be performed in participants after a positive screening prick test, in order to measure skin reactivity to cat dander, originating of three different body areas of the cat. For this purpose, a small amount of cat fur in solution with distilled water will be placed onto the volar aspect of both forearms after the skin has been scratched with a scratch lancet. The distilled water in which the cat hair was solved before will serve as negative control.
This procedure will be repeated with fur of the three different areas of the cat, always using triplicates (nine samples per cat).
From each of the 20 cats, nine samples will be tested on 20 subjects (one cat/subject).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cat fur scratch test | Other | Other: Cat fur scratch test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- Male or female between 18 years to 65 years
- A positive clinical history with inhalant allergy presumably due to cat allergen.
- Positive screening prick test (mean wheal diameter ≥ 3 mm) when tested with already standardized cat allergen extract.
- Positive screening prick test (wheal diameter ≥ 3mm) to Histamine dihydrochloride 10mg/ml.
Key exclusion criteria (11 listed)
- Impaired in understanding the nature, meaning and scope of the study or incapable of giving written informed consent,
- Participation in another clinical trial within the last 30 days and during the present study,
- Pregnant or lactating women,
- Positive skin reaction in the screening prick test to negative control,
- Currently suffering from allergy symptoms,
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 |
|---|---|---|
| Cat fur scratch test | Other | Cat fur scratch test |
Primary outcome
The primary variable will be the wheal size area of the immediate phase reaction in mm²
Time frame: measured after 15 minutes
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 10 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cat fur scratch test in people with Cat Dander Allergy, run by Thomas Kuendig 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 5 inclusion and 11 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 10 Apr 2014. 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?
The primary variable will be the wheal size area of the immediate phase reaction in mm² (time frame: measured after 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 10 Apr 2014.