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TerminatedNCT01412528Updated Aug 9, 2011

Phase II Study to Standardize Allergen Extracts: Determination of Biological Activity in HEP Units

A Phase 2 interventional study of Allergen extracts in Allergy, sponsored by University of Zurich. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-08-09.

Sponsored by University of Zurich · Phase 2, Interventional, and Diagnostic

Why this study was terminated
Recruitment problems
Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Today a variety of diagnostic tools to detect allergenic agents are available such as skin tests, provocation tests and blood tests. Due to its high sensitivity and low costs the skin prick test is the most commonly used test to identify allergies in patients. By using this kind of skin test, up to 25 different agents can be tested in parallel, rendering the skin prick test a cheap, easy-to-handle and rapid diagnostic tool. However, as research proceeds, new tools appear with the intention to make future applications even more convenient -for both, the patient and the physician. For that purpose the development of the so called "Easyprick" Allergen Test System is under way, consisting of a foil that carries ready-to-use, allergen-soaked sponges which can easily be applied to the skin after pricking.

Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. In order to control variability and to achieve consistency and reproducibility for optimal safety and sensitivity/specificity, it is essential to standardize the amount of allergen used in prick tests. The present study aims to standardize eight allergen extracts by using this method. Standardized extracts will then be applied in the Easyprick Allergen Test System which will be evaluated and compared to the conventional prick test in a second study.

  • Trial with medicinal product
02

Conditions studied

  • Allergy

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03

In context

Hypersensitivity

1,925 studies on the registry are indexed under Hypersensitivity; 261 are open to participants now.

This study's planned enrollment of 160 is above the median of 58 across 1,391 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,048 studies on the registry; 131 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria:

  • 18-65 years old,
  • a positive clinical history for inhalant allergy to at least one of the allergens to be tested,
  • at least one positive prick test (mean wheal diameter = 3mm) when tested with already standardized extracts of the allergens under investigation.
  • a mean wheal size of = 7mm2 obtained in a prick test with histamine dihydrochloride (10mg/ml).
  • Written informed consent

Exclusion criteria: -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 an allergen preparation known to interfere with the allergens under investigation during the past two years,
  • skin lesions in the skin test areas
  • pregnancy or nursing,
  • treatment with prohibited concomitant medications (antihistamines, corticosteroids, anti-depressants, neuroleptics or specific immunotherapy)
  • alcohol or drug abuse,
  • impaired in understanding nature, meaning and the scope of the study or are incapable of giving written informed consent,
  • Participation in another clinical trial within the last 30 days.
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Other
    Eight different allergens will be standardized in this study

    Other: Allergen extracts

Interventions

  • OtherAllergen extracts
06

What researchers measure

Primary outcomes

  1. Wheal size

    15 minutes after skin prick test with a serial dilution of an allergen extracts, sizes of provoked wheals will be measured according to allergen standardization procedure.

07

Study locations

1 site
  • Clinical Trials Center
    Zurich, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01412528
First posted
Aug 9, 2011
Start date
Aug 2009
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Aug 9, 2011

Study contacts

01 Studienregister MasterAdmins
study director · UniversitaetsSpital Zuerich
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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