Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).
|Rhinitis, Allergic, Seasonal Conjunctivitis, Allergic||Other: Standardization of allergenic extract (Gly. domesticus)||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).|
- Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. [ Time Frame: 45 minutes per subject ]
|Study Start Date:||May 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Four concentrations of Glycyphagus domesticus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, was tested in every patient in duplicate on the volar surface of the forearm.
Other: Standardization of allergenic extract (Gly. domesticus)
Allergenic extract for cutaneous prick-test
The objective of this study is to determine the biologic activity of a Glycyphagus domesticus allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
The skin testing procedure, based on the Nordic Guidelines is the reference method for the biological calibration of in-House Reference Preparations (IHRP). The method is not intended for routine testing of allergen extracts. The use of this procedure is the basis for the definition of biological activity units: "the activity of an allergen extract is 10,000 Biological Units (BU) per ml (10 HEP per ml), when the extract provokes an specific skin reaction in the median sensitive patient with a wheal of the same size as a wheal provoked by a positive reference solution consisting of histamine 54.3 mmol/l (for example histamine dihydrochloride 10 mg/ml), when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are clinically allergic and cutaneously reactive to the allergen concerned".
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917488
|Clinica Dr. Lobatón|
|Cádiz, Cadiz, Spain, 11008|
|Principal Investigator:||Francisco Moreno, MD, PhD|