Condition category
Skin and Connective Tissue Diseases
Date applied
25/09/2007
Date assigned
08/02/2008
Last edited
20/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.hand.mas.lu.se

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes