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

ISRCTN	ISRCTN57796160
DOI	https://doi.org/10.1186/ISRCTN57796160
Protocol serial number	N/A
Sponsor	Malmö University Hospital (Sweden)
Funder	Department of Occupational and Environmental Dermatology, Malmö University Hospital, Malmö (Sweden)

Submission date: 25/09/2007
Registration date: 08/02/2008
Last edited: 20/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Magnus Bruze
Scientific

Department of Occupational and Environmental Dermatology
Malmö University Hospital
Malmö
205 02
Sweden

Phone	+46 40 336516
Email	magnus.bruze@med.lu.se

Study information

Primary study design	Interventional
Study design	Randomised, controlled, single-blind, multi-centre study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	ALU study
Study objectives	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(s)	Approval received from the local ethics committee (Regionala Etikprövningsnämnden i Lund, Avd 2) (ref: Dnr 277/2007)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	01/03/2009

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	500
Key inclusion criteria	1. Children and adults who will start their hyposensitisation therapy during 2007 and 2008 2. Written informed consent
Key exclusion criteria	Experienced anaphylaxis during skin tests.
Date of first enrolment	27/08/2007
Date of final enrolment	01/03/2009

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Occupational and Environmental Dermatology

Malmö
205 02
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes