To Determine the Minimum Amount of Artemisia Vulgaris Allergen Extract Producing a Positive Skin Reaction.
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|ClinicalTrials.gov Identifier: NCT01984541|
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : January 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Allergy to Pollen||Biological: Artemisia vulgaris||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biological Standardization of Artemisia Vulgaris Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP).|
|Study Start Date :||March 2014|
|Primary Completion Date :||June 2014|
|Study Completion Date :||September 2014|
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
- Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. [ Time Frame: 15-20 min after aplication ]
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): 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|