Biological standardization of allergenic extracts of Platanus acerifolia, Salsola kali, Chenopodium album y Artemisia vulgaris
- Conditions
- Biological standardization for allergenic extracts in patients withhipersensibility to extracts.MedDRA version: 18.0Level: HLGTClassification code 10001708Term: Allergic conditionsSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2013-003892-36-ES
- Lead Sponsor
- INMUNAL SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
- Informed consent signed and dated by the patient/witness.
- Patients living in an area where the allergen is considered as a relevant
health problem.
- Medical history supporting the allergy to the allergen.
- Positive diagnosis to the allergen
- Specific IgE positive for any of the allergens
- Age range between 18 and 64 years old for both genders
-Negative pregnancy test for fertile women
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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Patients who had received previous immunotherapy within the previous
2 years
- Patients who had received within the previous 15 day sany intake of
drugs able to interfere in the Skin Prick test (e.g. anti histaminic, topic
corticoids, blockers or tryciclic antidepresives).
- Pregnant women or breast feeding
- Patients who has received systemic corticoids (dose greater than 30 mg
prednisone/day) for longer than a week.
- Patients with cutaneous reactions which can modify the response (e.g.
Dermographism, dermatitis, severe asthma, hipersensibility to phenol or
any of the components of the prick test)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The biological characterization of allergen extracts.;Secondary Objective: - To determine the specificity of extracts in patients with hipersensibility.<br>- To determine the optimal dose of the allergen extract on skin test.;Primary end point(s): Cutaneous reaction to the extract;Timepoint(s) of evaluation of this end point: 30 min.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable