Contact information
Type
Scientific
Primary contact
Prof Magnus Bruze
ORCID ID
Contact details
Department of Occupational and Environmental Dermatology
Malmö University Hospital
Malmö
205 02
Sweden
+46 40 336516
magnus.bruze@med.lu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
ALU study
Study hypothesis
The development of persisting itching nodules at the injection site after desensitisation therapy with aluminium precipitated antigen extract has been described in several reports, and also after vaccination with aluminium adsorbed vaccines.
The overriding aim of the planned study is to investigate the proportion of children and adults who develop contact allergy to aluminium during hyposensitisation therapy and if development of allergy to aluminium is linked to a persistent itching subcutaneous nodule.
Ethics approval
Approval received from the local ethics committee (Regionala Etikprövningsnämnden i Lund, Avd 2) (ref: Dnr 277/2007)
Study design
Randomised, controlled, single-blind, multi-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Allergy
Intervention
Intervention arm: Hyposensitisation therapy with aluminium precipitated antigen extract, used subcutaneously. The duration of hyposensitisation therapy varies between patients, as each patient receives a different course of treatment, depending on his/her condition.
Control arm: No treatment
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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).
Secondary outcome measures
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
Overall trial start date
27/08/2007
Overall trial end date
01/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children and adults who will start their hyposensitisation therapy during 2007 and 2008
2. Written informed consent
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
500
Participant exclusion criteria
Experienced anaphylaxis during skin tests.
Recruitment start date
27/08/2007
Recruitment end date
01/03/2009
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Occupational and Environmental Dermatology
Malmö
205 02
Sweden
Sponsor information
Organisation
Malmö University Hospital (Sweden)
Sponsor details
Department of Occupational and Environmental Dermatology
Malmö
205 02
Sweden
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Department of Occupational and Environmental Dermatology, Malmö University Hospital, Malmö (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list