To Determine the Minimum Amount of Artemisia Vulgaris Allergen Extract Producing a Positive Skin Reaction.
The objective of this study is to determine the biological activity of Artemisia vulgaris allergen extract in histamine equivalent units (HEP) units, in order to be used as in-house reference preparation (IHRP).
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Biological Standardization of Artemisia Vulgaris Allergen Extract to Determine the 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: 15-20 min after aplication ] [ Designated as safety issue: No ]
|Study Start Date:||March 2014|
|Study Completion Date:||September 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Artemisia vulgaris allergen extract(four concentrations 10, 1, 0,1 y 0,01 mg/ml) Positive Control Negative Control
Biological: Artemisia vulgaris
Four concentrations of Artemisia vulgaris allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
Other Name: Four different concentrations of Artemisia vulgaris allergen extract, positive control and negative control
This is an open, unblinded and non-randomized biological assay. Tehe study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
Four concentrations of Artemisia vulgaris 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01984541
|Hospital de La Agencia Valenciana de Salud Vega Baja|
|Orihuela, Alicante, Spain, 03314|
|Hospital Clinic de Barcelona|
|Barcelona, Spain, 08036|
|Study Chair:||Lena Erbiti||Laboratorios Leti, S.L.U|