Standardization of Latex allergenic extract. Determination of biological activity in HEP units
- Conditions
- The objective of the study is to know the biologic activity of the Latex reference extract (IHRP) in HEP units. The HEP value will be the reference of every other diagnostic or treatment preparations.
- Registration Number
- EUCTR2005-001880-68-DE
- Lead Sponsor
- ETI Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
·Patients should live in an environment where allergy caused by Latex is a relevant problem.
·Patients should not be excluded due to low or high sensitivity to the allergen, when they otherwise fulfill the inclusion criteria.
·A positive case history with inhalant allergy related to exposure to the allergen to be tested.
·A positive prick test (mean wheal diameter ³ 3 mm) when tested with a standardized extract prepared from the allergen source in question and/or a positive test for specific IgE.
·A mean wheal diameter ³ 7 mm2 obtained in a prick test with histamine dihydrochloride 10 mg/ml.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
·Immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested.
·Use of drugs that may interfere with the skin reactions.
·Pregnancy, dermographism, atopic dermatitis (locally at the test site), urticaria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Open, unblinded and non-randomized biological assay. In each patient four ten- fold concentrations of allergen should be tested in duplicate starting with the lowest concentration with histamine as reference solution. Should the patient develop a skin reaction > 2 fold histamine reaction during test procedure a higher concentrated test solution will not be applied;Secondary Objective: No secondary endpoints will be measured;Primary end point(s): Wheal size area (mm2) of the immediate phase reaction
- Secondary Outcome Measures
Name Time Method