NCT02667379

Brief Summary

Determination of allergenicity of cat dander samples obtained before and after vaccinating the cat

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 9, 2016

Status Verified

May 1, 2016

Enrollment Period

3 months

First QC Date

January 20, 2016

Last Update Submit

May 6, 2016

Conditions

Hypersensitivity

Keywords

CatallergydanderFel d 1Felis domesticus

Outcome Measures

Primary Outcomes (1)

  • 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.

    15 minutes

Study Arms (1)

Diagnostic skin testing

OTHER

Diagnostic skin testing with cat dander samples on volar forearms.

Other: Diagnostic skin testing

Interventions

Diagnostic skin testingOTHER

14 Skin prick tests on each volar forearm with cat dander samples.

Diagnostic skin testing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Dept of Dermatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Thomas Kuendig, MD

    University Hospital Zurich, Dept Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 28, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 9, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)