Biological Standardization of Blomia Tropicalis Allergen Extract
|Allergy to Mites||Biological: Four different concentrations of Blomia tropicalis allergen extract, positive control and negative control||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Biological Standardization of Blomia Tropicalis Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units|
- Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. [ Time Frame: Test sites should be inspected and recorded 15-20 min after application ]
|Study Start Date:||April 2012|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Blomia tropicalis allergen extract (four concentrations: 5, 0.5, 0.05, 0.005 mg/ml)
Biological: Four different concentrations of Blomia tropicalis allergen extract, positive control and negative control
Four concentrations of Blomia tropicalis allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
Four concentrations of Blomia tropicalis 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: NCT01597752
|Complejo Hospitalario Universitario Insular Materno-Insular|
|Las Palmas de Gran Canarias, Canarias, Spain, 35016|
|Hospital Universitario de Gran Canaria Dr. Negrín|
|Las Palmas de Gran Canaria, Canarias, Spain, 35012|
|Study Chair:||María José Gómez||Laboratorios LETI, S.L.Unipersonal|