A randomised controlled single-blind multi-centre study to investigate the induction of ALUminium contact allergy in children/adults receiving hyposensitisation therapy due to allergic disease
Completed
- Conditions
- AllergySkin and Connective Tissue Diseases
- Registration Number
- ISRCTN57796160
- Lead Sponsor
- Malmö University Hospital (Sweden)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
1. Children and adults who will start their hyposensitisation therapy during 2007 and 2008
2. Written informed consent
Exclusion Criteria
Experienced anaphylaxis during skin tests.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To estimate the proportion of children and adults who develop contact allergy to aluminium during the hyposensitisation therapy measured by patch testing<br>2. To compare the proportion of children and adults with positive patch test reactions to aluminum between groups, those with persistent nodules with or without itching and those without manifestations/symptoms<br><br>All patch testing will be performed in close connection with the injections, which means on the same day or the following days. The patch test reader will be blinded - he/she will not know which patient has already received the hyposensitisation therapy and which has not (and will be receiving).
- Secondary Outcome Measures
Name Time Method 1. To investigate the frequency of contact allergy in atopic children (contact allergy to aluminium and other sensitizers present in the European Patch Test Series)<br>2. To compare the contact allergy rated between atopic children and adults with and without atopic dermatitis (contact allergy to aluminium and other sensitisers present in the European Patch Test Series)<br>3. To make comparison between groups considering the following possible risk factors for developing persisting itching nodules with contact allergy to aluminium: <br>3.1. Doses <br>3.2. Sex <br>3.3. Age <br>3.4. Other medication/exposure