Biological standardization for allergenic extracts in patients with hipersensibility to extracts. MedDRA version: 14.1 Level: HLGT Classification code 10001708 Term: Allergic conditions System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: Dermatophagoides farinae
Product Code: DF
Pharmaceutical Form: Concentrate and solvent for cutaneous solution
INN or Proposed INN: Dermatophagoides farinae
Other descriptive name: DERMAT
Sponsors
Instituto de Inmunología y Alergia INMUNAL S.A..U.
Eligibility
Sex/Gender
All
Inclusion criteria
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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The biological characterization of allergen extracts.;Secondary Objective: - To determine the specificity of extracts in patients with hipersensibility. - 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 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Spain
Contacts
Public ContactIsabel Conde
Instituto de Inmunología y Alergia INMUNAL S.A..U.
Outcome results
None listed