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Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract

Allergic Rhinitis Clinical Trial

Official title:
Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract to Determine the Biological Activity in HEP Units.

Clinical Trial Summary

The objective of this study is to determine the biologic activity of a Dermatophagoides pteronyssinus allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

Clinical Trial Description

This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

Three concentrations of Dermatophagoides pteronyssinus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01821716
Study type Interventional
Source Laboratorios Leti, S.L.
Contact
Status Completed
Phase Phase 2
Start date March 2013
Completion date January 2014
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