To design an industry-sponsored surveillance study incorporating both additional and existing materials that has the possibility of identifying trends in the incidence of skin contact allergy.
ID
Source
Brief title
Condition
- Administration site reactions
- Allergic conditions
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The results of the epicutaneous patch tests for the different concentrations of
the fragrance materials according to the guidelines of the International
Contact Dermatitis Research Group (ICDRG)
Secondary outcome
• Gain familiarisation with the additional materials
• Test quality procedures designed to address intra- and inter centre variations
• Test the CRF (Case Report Form: See Annex VI) and its administration
Background summary
Fragrance-induced skin contact allergy has been identified as being of high
concern. The IDEA project is designed to provide a broadly agreed and
transparent framework for assessing fragrance sensitizers globally. A key issue
for successful monitoring in trends has been that testing has relied on a set
of patch test substances, i.e., Fragrance Mix 1 and Fragrance Mix 2 (FM 1 and
FM 2) that have remained essentially unchanged for over 35 and 15 years
respectively with no additional materials being added. There are number of
materials of varying potency which hitherto have not been tested on a
systematic basis, which are in use in product types with high consumer
exposure.
Study objective
To design an industry-sponsored surveillance study incorporating both
additional and existing materials that has the possibility of identifying
trends in the incidence of skin contact allergy.
Study design
Study design:
Observational, non-invasive pilot study with the application of additional
epicutaneous patch test series on the back. Without the use of medicinal
product, non-blinded and non- randomized.
Duration:
The duration for an individual participant is one week during which there will
be three visits of variable time durations. The visits are already scheduled
because of scheduled diagnostic work-up.
Visit 1, day 0:
A short interview will be held to reconfirm basic information about the subject
and to check the inclusion and exclusion criteria. Informed consent will be
signed. This visit also includes the preparation of material, the application
of the patch test on the back. This visit will take about 30 minutes. The
actual patch test needs to be in situ for 48 hours.
Visit 2, day 3, 72 hours after application:
The visit will take about 15 minutes and includes reading and photographing of
the (possible) skin reactions at the sites of application.
Visit 3, day 7, 168 hours after application:
This visit includes the final reading and photographing of the (possible) skin
reaction at the sites of applications and will take about 15 minutes.
Study burden and risks
It is important to note that included subjects are already scheduled for
routine diagnostic patch test investigation because of dermatitis. Therefore,
subject do not have to schedule additional visits for study participation. For
the routine diagnostic patch test investigation three visits will be planned.
The first visit will take approximately 30 minutes and the remaining visits
will take 15 minutes each. At first visit, after inclusion, subjects will be
asked to answer questions concerning medical history and concomitant
medication. Subjects are at risk for developing an allergic skin reaction on
the test sites. This skin reaction is self-limiting in nature, but can be
treated with a local corticosteroid cream if the reaction is inconvenient.
Rue de la Fontaine 15
Geneve 1204
CH
Rue de la Fontaine 15
Geneve 1204
CH
Listed location countries
Age
Inclusion criteria
- Adulthood (>=18 years); 4 weeks before the day of application of the patch test
- Legal competence
Exclusion criteria
- Patients who have had topical steroids applied to their back less than 7 days
before the application of the patch test.
- Active skin disease or skin anomalies on the back
- Immunosuppressive medication (e.g. oral cortosteroïds, methotrexate,
cyclosporine)
during or in the previous 4 weeks of the study;
- pregnancy or breastfeeding
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73107.042.20 |