biological potency of the cat epithelial allergenic extracts

Conditions: Cat Allergy (Disorder)

Summary: the primary objective of this clinical trial is to quantify the loss of in vivo biological potency of a depigmented polymerized (dpp) allergenic cat epithelial extract versus the native allergenic extract (n).

this is an open-label, non-randomized phase ii clinical trial. three different concentrations of three different cat epithelial allergenic extracts, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride and a glycerated phenol saline solution, respectively, will be tested in every subject on the volar surface of the forearm.

Eligibility criteria:
inclusion criteria: a subject will be eligible for inclusion in the study only if all of the following criteria are met: * the subject (and/or legal representative, where applicable) has given written, signed and dated informed consent. * subjects of either sex and of any race or ethnic group. * age \> 18 years and \< 60 years on the day of inclusion in the study. * positive clinical history of allergy to cat epithelia (i.e., rhinitis, conjunctivitis, rhinoconjunctivitis, asthma, urticaria, etc. ). * a positive prick-test (mean diameter of papule ≥ 3 mm or area of papule ≥ 7 mm2) with a commercial extract of cat epithelium. the results of the prick-test will be valid if they were obtained in the year prior to inclusion of the subject in the study. * a positive specific ige test (\> 0.70 ku/l) for cat epithelium. the results of the ige test will be valid if they were obtained in the year prior to inclusion of the subject in the study. exclusion criteria: a subject will not be eligible for inclusion in the study if any of the following criteria are met: * immunotherapy in the last 5 years involving allergens known to be able to interfere with the test allergen (e.g., cat extract). * use of drugs that can interfere with the skin response before and during the study (e.g., antihistamines), within the intervals established in section 9.1 and appendix 1. * treatment with any of the following medicines: tricyclic or tetracyclic antidepressants or maois (monoamine oxidase inhibitors), beta-blockers or chronic use of oral corticosteroids or use of corticosteroids via either the oral or the parenteral route in repeated and intermittent dosing regimens (\> 10 mg/day of prednisone or equivalent). * pregnant or nursing women and women with a positive pregnancy test in visit 2. * dermographism affecting the skin of the test site, in either of the two visits to the study centre. * atopic dermatitis affecting the skin of the test site, in either of the two visits to the study centre. * urticaria affecting the skin of the test site, in either of the two visits to the study centre. * clinically relevant immune system diseases (both autoimmune disorders and immune deficiencies). (hashimoto's thyroiditis with hypothyroidism well controlled through thyroid hormone therapy does not necessarily represent a contraindication. graves' disease (hyperthyroidism) would be an exclusion criterion due to the potential risk in the event adrenaline must be used.) * serious uncontrolled diseases that may increase the safety risk of the subjects participating in the study, including but not limited to the following: heart failure, serious or uncontrolled respiratory diseases, endocrine disorders, clinically relevant liver or kidney diseases, or haematological disorders. * patents with diseases or conditions that limit adrenaline use (coronary disease, severe arterial hypertension, etc.). * serious psychiatric, psychological or neurological problems. * medication, alcohol or illegal drug abuse in the last year. * participation in any other clinical trial during the 30 days (or 5 times the biological half-life of the investigational product - whichever is longest) prior to inclusion of the subject in this study.

Keywords: immunotherapy subcutaneous immunotherapy skin prick test dose response prick test