Treatment and diagnosis of allergy to Artemisa vulgaris, Platanus acerifolia and Dermatophagoides farinae. MedDRA version: 14.1 Level: LLT Classification code 10036019 Term: Pollen allergy System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1 Level: LLT Classification code 10066092 Term: Acaridae allergy System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1 Level: PT Classification code 10048908 Term: Seasonal allergy System Organ Class: 10021428 -
Conditions
Interventions
Product Name: Extracto alergénico de polen de Artemisa vulgaris
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Artemisa vulgaris extracto de polen
Other descriptive name: Artemisa vulgar
Sponsors
Bial Industrial Farmacéutica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. History consistent with the allergen to be tested. 2. Subject monosensitized, or clinically relevant sensitization to allergen test only, or primary sensitization (maximum skin reactivity and IgE) to the allergen in question. 3. Wheal diameter to histamine 10 mg / ml ? 3 mm. 4. Age: 18-60 years. 5. Signed written informed consent. 6. Environment correlated with the allergen. 7. Women of childbearing age must submit a urine pregnancy test with negative result at the time of his entering the study Atopic subjects: wheal diameter =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Allergen-specific immunotheraphy in the last 5 years with Artemisa vulgaris and/or Platanus acerifolia and/or Dermatophagoides farinae. 2. Administration of medication that may interfere with the performance or results of testing (prick test). 3. Patients with clinical history of anaphylaxis 4. Patients with chronic urticaria 5. Patients with atopic dermatitis moderate to severe 6. Any medical condition that contraindicates the performance of skin testing by prick test. 7. Pregnant or lactating women. 8. Subjects who participated in another clinical trial 3 months before.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In-vivo determination of the biological activity of pollen extracts of Artemisa vulgaris, Platanus acerifoia and Dermatophagoides farinae.;Secondary Objective: In-vivo determination of the biological activity of pollen extracts of Artemisa vulgaris, Platanus acerifoia and Dermatophagoides farinae.;Primary end point(s): Planimetry: The size of the wheal was calculated by planimetry in Bial SA Pharmaceutical Industry and measured in units of mm2. The test is considered positive if the wheal diameter is 3mm, if the diameter is <3 mm the test is considered negative.;Timepoint(s) of evaluation of this end point: 15 minutes after prick test | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Spain
Contacts
Public ContactBegoña Soler López
E-C-BIO, S.L.
Outcome results
None listed