Biological Standardization of Chenopodium Album Allergen Extract
- Conditions
- Allergy to Chenopodium Album
- Registration Number
- NCT01675349
- Lead Sponsor
- Laboratorios Leti, S.L.
- Brief Summary
The objective of this study is to determine the biologic activity of a Chenopodium album allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
- Detailed Description
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 Chenopodium album 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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 > and =18 years and < and =60 years at the study inclusion day.
- Positive skin prick test with a standardized commercially available preparation of chenopodium album allergen extract.
- A positive test for specific IgE to chenopodium album (CAP-RAST major or equal to 2).
- Allergic symptoms during the pollen season of Chenopodium album.
- Medical history positive allergy inhalation (rhinitis and /or rhinoconjunctivitis and/or asthma) from Chenopodium album.
-
Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested.
-
Use of drugs that may interfere with the skin reactions (e.g., antihistamines).
-
Treatment with any of the following medications: tricyclic or tetracyclic
o IMAOs antidepressants,b-blockers or chronic use of corticosteroids or oral or use of corticoids both via oral or parenteral, in repeated patterns and intermittent (> 10 mg/día de prednisone or equivalent).
-
Women who are pregnant or period of breastfeeding and women with a pregnancy test positive during the visit 2, prior to the prick test.
-
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.
-
Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies.
-
Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases, endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases.
-
Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial.
-
Patients with diseases or conditions that limit the use of adrenaline (heart disease, severe hypertension, ..)
-
Severe psychiatric, psychological or neurological disorders
-
Abuse of alcohol, drugs or medicines in the previous year.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. 15-20 min after application
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Hospital General de Elche
🇪🇸Alicante, Spain
Centro Médico Adeslas
🇪🇸Córdoba, Spain
Hospital General de Elche🇪🇸Alicante, Spain