To Determine the Minimum Amount of Artemisia Vulgaris Allergen Extract Producing a Positive Skin Reaction.
|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|