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

Phase 2

Terminated

• Conditions: Allergy
• Interventions: Other: Allergen extracts

• Registration Number: NCT01412528
• Lead Sponsor: University of Zurich

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-04-28
• Status Verified: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted QC: 2011-08-08
• Last Update Submitted: 2011-08-08
• Study First Posted: 2011-08-09
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eight different allergens will be standardized in this study	Allergen extracts	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Clinical Trials Center; 🇨🇭 Zurich, Switzerland