A Pilot Study for the Determination of Allergenicity of Cat Dander Samples Obtained by Different Methods

April 9, 2014 updated by: Thomas Kuendig

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

  • Switzerland
      • Zurich, Switzerland, 8091
        • Clinical Trials Center, University Hospital and University Zurich

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,
  • 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.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Cat fur scratch test
Other: Cat fur scratch test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary variable will be the wheal size area of the immediate phase reaction in mm²
Time Frame: measured after 15 minutes
measured after 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Kuendig

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, 2014

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (ESTIMATE)

January 30, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 10, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • ZU-Scratch-Cat-001

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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