Allergy to Mites Clinical Trial
Official title:
Biological Standardization of Blomia Tropicalis Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units
The objective of this study is to determine the biologic activity of a Blomia tropicalis allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
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.
Four concentrations of Blomia tropicalis 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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic