Allergy to Cupressus arizonica MedDRA version: 17.1 Level: LLT Classification code 10036019 Term: Pollen allergy System Organ Class: 100000004870
Conditions
Interventions
Product Name: Extracto alergénico nativo de Cupressus arizonica
Pharmaceutical Form: Solution for skin-prick test
INN or Proposed INN: Extracto alergénico de Cupressus arizonica
Current Sponsor code:
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 subject. Subject can be male or female of any race and ethinic group. Age ? 18 years and ? 60 years ata the study inclusión day. Positive clinical history of inhalatory allergy to Cupressus arizonica. A positive prick test with a standarices commercially Cupressus arizonica allergen extract. A positive prick test with positive control of histamine 10 mg/ml. A positive test for specific IgE to Cupressus arizonica. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=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 extract Cupressus arizonca or other allergen extract tan may interfere with the allergene to be tested. Use of drugs that may interfere before and after with the skin reactions. Treatment with certain drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary obcjetive is to assess the concentration of Cupressus arizonica allergen extract that elictis a wheal size equivalent to that of 10 mg/ml histamine dyhidrochloride solution.;Secondary Objective: No secundary objectives;Primary end point(s): The wheal size área (mm2) which is produced on the skin after application of Cupressus arizonica allergen extract at various concentrations, along with the wheal área induced by the positive control and the negative by Skin prick Test technique.;Timepoint(s) of evaluation of this end point: The primary endpoint will be determined after the last pratient las visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No secondary end point;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Spain
Contacts
Public ContactCountry Study Manager
LABORATORIOS LETI, S.L.Unipersonal
Outcome results
None listed