The objective of this study is to determine the biologic activity of a Blomia tropicalis
allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house
reference preparation (IHRP).
Biological: Four different concentrations of Blomia tropicalis allergen extract, positive control and negative control
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Full eligibility criteria for NCT01597752
Ages eligible for Study
18 Years to 50 Years
Genders eligible for Study
Accepts Healthy Volunteers
A documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to Blomia tropicalis.
Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
Subject can be male or female of any race and ethnic group.
Age > 18 years and < 50 years at the study inclusion day.
Positive skin prick test with a standardized commercially available preparation of Blomia tropicalis allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study
A positive test for specific IgE to Blomia tropicalis(CAP-RAST ≥ 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
Allergic symptoms during the season of Blomia tropicalis.
Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm.
Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., mites group extracts).
Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1
Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (> 10 mg/day of prednisone or equivalent).
Dermographism affecting the skin area at the test site at either study visit.
Atopic dermatitis affecting the skin area at the test site at either study visit.
Urticaria affecting the skin area at the test site at either study visit.
Participation in another clinical trial within the last month.
Subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension,...)
Las Palmas de Gran Canarias, Canarias, Spain, 35016
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Canarias, Spain, 35012
View full eligibility
Tris trial is registered with FDA with number: NCT01597752. The sponsor of the trial is Laboratorios Leti, S.L. and it is looking for 20 volunteers for the current phase.
Official trial title: Biological Standardization of Blomia Tropicalis Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units
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