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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
35
3 different cat epithelium allergenic extracts at 3 different concentrations, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
Fundación Jimenez Diaz
Madrid, Madrid / Madrid, Spain
Hospital El Tomillar - Area Hospitalaria de Valme
Dos Hermanas, Sevilla, Sevilla / Andalucia, Spain
Wheal size area (mm2)elicited on the skin after the dose-response prick-test
Wheal size area (mm2)elicited on the skin after the dose-response prick-test, in duplicate, of the native and depigmented polymerized cat epithelial allergenic extracts, together with the area of the wheals induced by the positive and negative controls.
Time frame: Test sites should be inspected and recorded 15-20 min after application
Wheal size area (mm2)elicited on the skin after the dose-response prick-test
Wheal size area (mm2)elicited on the skin after the dose-response prick-test, in duplicate, of the native and depigmented cat epithelial allergenic extracts, together with the area of the wheals induced by the positive and negative controls.
Time frame: Test sites should be inspected and recorded 15-20 min after application
Wheal siza area (mm2)elicited on the skin after the dose-response prick-test
Wheal siza area (mm2)elicited on the skin after the dose-response prick-test, in duplicate, of the depigmented and depigmented polymerized cat epithelial allergenic extracts, together with the area of the wheals induced by the positive and negative controls.
Time frame: Test sites should be inspected and recorded 15-20 min after application
Determine the HEP dose of the native (N) cat epithelial allergenic extract
Calculation will be made of the 10 HEP dose of the native (N) cat epithelial allergenic extract.
Time frame: Wheals will be elicited in visit 2. CRFs will be retrieved, measured in-house and filed back in the site before study closure (maximum 3 months after being elicited).
Loss of in vitro potency of the cat epithelial allergenic extracts
To quantify the loss of in vitro potency of cat epithelial allergenic extracts, based on specific IgE and IgG inhibition studies.
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Time frame: Blood will be collected in visit 2. Serum samples will be analyze once every sample is received. The samples will be analyzed at most 12 months after received