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Clinical Trial Summary

Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. Many factors such as the variability, differences in extraction process and subsequent handling of allergens can affect the final composition, potency, and stability of allergen preparations. Genetic diversity of affected people adds another level of complexity. 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. Therefore, the system for biological standardization mainly used in Europe still is the biological calibration of in-House Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT) value. The aim of this procedure is to estimate the biological activity of allergen extracts. The activity of an allergen extract is defined as 1 SPT per ml, when the extract provokes a specific skin reaction with a wheal of the same size as a wheal provoked by reference histamine at a concentration of 10 mg/ml, when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are sensitized to the allergen concerned.

The present study aims to standardize the allergen extracts of Artemisia vulgaris, Platanus acerifolia, Dermatophagoides farinae by using this method.


Clinical Trial Description

The present study aims to standardize the allergen extracts of Artemisa vulgaris, Platanus acerifolia and Dermatophagoides farinae by using this method. Standardized extracts will then be used for diagnostics and treatment of allergies as mentioned above. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02474836
Study type Interventional
Source Roxall Medicina España S.A
Contact
Status Completed
Phase Phase 2
Start date November 2012
Completion date September 2013

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