In vivo characterization of allergen extracts - 2
Completed
- Conditions
- allergieallergic reactions
- Registration Number
- NL-OMON35402
- Lead Sponsor
- HAL Allergenen Lab
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
1. Subjects who give a positive reaction on the skin prick test (sum of erythema diameters ><= 40 mm) with the extract of interest
2. Subjects with a skin colour from which erythema can be readily distinguished
3. Age between 18 and 65 years
4. Subjects shall give a written informed consent
Exclusion Criteria
1. Treatment with immunotherapy (IT) of the involved allergen during the last 5 years
2. The use of oral and/or local antihistamines in the last 4 days
3. The use of oral corticosteroids or mast cell stabilizers in the last 48 hours
4. Pregnancy
5. Lack of cooperation or severe psychological disorders
6. Negative control in the SPT sum of wheal diameters > 5 mm
7. Positive control in the SPT sum of erythema diameters * 30 mm
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The test parameter is the sum of diameters of the erythema 20 minutes after<br /><br>intracutanous injection of the allergen extract dilution. The sum is determined<br /><br>by the sum of the longest diameter of the redness and the mid-point diameter<br /><br>perpendicular to the longest diameter. From the main study parameter the<br /><br>biological alergy units of the extract will be calculated.</p><br>
- Secondary Outcome Measures
Name Time Method <p>No secondary parameters will be determined.</p><br>