Status:
COMPLETED
Standardization of Chortoglyphus Arcuatus Allergenic Extract. Determination of Biological Activity in HEP Units
Lead Sponsor:
Laboratorios Leti, S.L.
Conditions:
Rhinitis, Allergic, Seasonal
Conjunctivitis, Allergic
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The main purpose of the trial is to prove the therapeutic value of the product and enable an effective and safe dosage schedule to be recommended
Detailed Description
The skin testing procedure, based on the Nordic Guidelines is the reference method for the biological calibration of in-House Reference Preparations (IHRP). The method is not intended for routine test...
Eligibility Criteria
Inclusion
- Voluntarily signed informed consent form by the patient
- Patients should live in a geographic zone where allergy caused by Chortoglyphus arcuatus is a relevant problem.
- Patients should not be excluded due to low or high sensitivity to the allergen, when they otherwise fulfil 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 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 \> 7 mm2 obtained in a prick test with histamine dihydrochloride 10 mg/ml.
- Age: 18-50 years.
- Both genders
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00718744
Start Date
June 1 2008
End Date
November 1 2008
Last Update
August 5 2010
Active Locations (1)
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1
Hospital "Xeral de Calde"
Calde, Lugo, Spain, 27004