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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57796160
Enrollment
500
Registered
2008-02-08
Start date
2007-08-27
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy Skin and Connective Tissue Diseases Allergy

Interventions

Intervention arm: Hyposensitisation therapy with aluminium precipitated antigen extract, used subcutaneously. The duration of hyposensitisation therapy varies between patients, as each patient receive

Sponsors

Malmö University Hospital (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children and adults who will start their hyposensitisation therapy during 2007 and 2008 2. Written informed consent

Exclusion criteria

Exclusion criteria: Experienced anaphylaxis during skin tests.

Design outcomes

Secondary

MeasureTime frame
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) 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) 3. To make comparison between groups considering the following possible risk factors for developing persisting itching nodules with contact allergy to aluminium: 3.1. Doses 3.2. Sex 3.3. Age 3.4. Other medication/exposure

Primary

MeasureTime frame
1. To estimate the proportion of children and adults who develop contact allergy to aluminium during the hyposensitisation therapy measured by patch testing 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 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).

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026