EUCTR2013-003892-36-ESActive, not recruitingPhase 1
Biological standardization of allergenic extracts of Platanus acerifolia, Salsola kali, Chenopodium album y Artemisia vulgaris . Open label. Multicenter. Phase II Study. - Biological standardization of allergenic extracts of Platanus acerifolia, Salsola kali, Chenopodium
INMUNAL SA0 sites100 target enrollmentStarted: April 14, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- 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
Exclusion Criteria
- •- Patients who had received previous immunotherapy within the previous
- •- 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)
Investigators
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