Allergy to Platanus acerifolia MedDRA version: 15.0 Level: LLT Classification code 10036019 Term: Pollen allergy System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: Extracto alergénico nativo de Platanus acerifolia.
Product Code: 6022
Pharmaceutical Form: Solution for skin-prick test
INN or Proposed INN: Extracto alergénico nativo de Platanus acerif
Sponsors
Laboratorios Leti, S.L.Unipersonal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested due to a high degree of cross-reactivity (for example: other species of Platanus: Platanus orientalis, Platanus occidentalis). -Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1 of the protocol -Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants or IMAOs, beta-blockers, chronic use of corticosteroids or use of oral or parenteral corticosteroids in repeated and intermittent patterns (10 mg/daily of 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the concentration of Platanus acerifolia allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.;Secondary Objective: In this study there are no secondary objectives;Primary end point(s): Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.;Timepoint(s) of evaluation of this end point: The primary endpoint will be determined after the last patient last visit(end of study). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No secondary endpoints in this study;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Spain
Contacts
Public ContactDepartamento Médico
Laboratorios Leti, S.L.U
Outcome results
None listed