A randomized controlled single blind multicenter study to investigate the induction of aluminium contact allergy in children/adults receiving hyposensitisation therapy due to allergic disease. Children and adults will answer questionnaires and be tested epicutaneously to detect aluminium hypersensitivity and possible risk factors associated with the development of contact allergy to aluminium due to hyposensitisation therapy

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003000-35-SE

Enrollment

500

Registered

2007-06-07

Start date

2007-07-09

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

The development of contact allergy to aluminium during hyposensitization therapy.

Interventions

Trade Name: Alutard SQ Product Name: Alutard SQ Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Informed written consent given by adult participants, children more than 15 years of age and parent/guardian. Children and adults who will start there hyposensitisation therapy during 2007 and 2008 at 22 hospital clinics in Sweden. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Experienced anaphylaxis during skin tests.

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objectives; •To estimate the proportions of children and adults who develop contact allergy to aluminium during the hyposensitization therapy. •To compare the proportions of children and adults with a positive patch test to aluminium between groups, those with late local reactions, characterized as an by itching subcutaneous nodules and those without manifestations symptoms in three parallel groups. ;Primary end point(s): A positive patch test to aluminium Development of an itching nodule and the proportion of individuals that develop itching nodules in the group with a positive patch test to aluminium in comparison with those who develop an itching nodule with a negative patch test to aluminium. ;Secondary Objective: Secondary objectives; •To investigate the frequency of contact allergy in atopic children and adults with allergic rhinitis and/or asthma •To compare the contact allergy rates between atopic children and adults with and without atopic dermatitis •To make comparison between groups considering the following possible risk factors for developing persisting itching nodules with contact allergy to aluminium. - Number of received doses/injections of hyposensitization extracts - Sex - Age - Other medication ( e.g. antacids) - Use of deodorants, antiperspirants - Work or hobby which involves exposure to aluminium	—

Measure

Time frame

Main Objective: Main objectives; •To estimate the proportions of children and adults who develop contact allergy to aluminium during the hyposensitization therapy. •To compare the proportions of children and adults with a positive patch test to aluminium between groups, those with late local reactions, characterized as an by itching subcutaneous nodules and those without manifestations symptoms in three parallel groups. ;Primary end point(s): A positive patch test to aluminium Development of an itching nodule and the proportion of individuals that develop itching nodules in the group with a positive patch test to aluminium in comparison with those who develop an itching nodule with a negative patch test to aluminium. ;Secondary Objective: Secondary objectives; •To investigate the frequency of contact allergy in atopic children and adults with allergic rhinitis and/or asthma •To compare the contact allergy rates between atopic children and adults with and without atopic dermatitis •To make comparison between groups considering the following possible risk factors for developing persisting itching nodules with contact allergy to aluminium. - Number of received doses/injections of hyposensitization extracts - Sex - Age - Other medication ( e.g. antacids) - Use of deodorants, antiperspirants - Work or hobby which involves exposure to aluminium

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Countries

Sweden

Outcome results

None listed

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