Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).
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|ClinicalTrials.gov Identifier: NCT00917488|
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : June 20, 2011
|Condition or disease||Intervention/treatment||Phase|
|Rhinitis, Allergic, Seasonal Conjunctivitis, Allergic||Other: Standardization of allergenic extract (Gly. domesticus)||Phase 2|
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".
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||July 2010|
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
- Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. [ Time Frame: 45 minutes per subject ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917488
|Clinica Dr. Lobatón|
|Cádiz, Cadiz, Spain, 11008|
|Principal Investigator:||Francisco Moreno, MD, PhD|