To test the feasibility of an intended large scale fragrance-allergy prevalence study in the population of the north of the Netherlands and to make a more reliable estimate of the prevalence in the population for poweranalysis of the intended largeā¦
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Oversenstivenessreaction of the skin and presence of NAT-1 en NAT-2 (fast en
slow acetylators) in the blood.
Secondary outcome
n.v.t.
Background summary
Fragrances or perfumes are part of cosmetics according to a European
definition. They are constantly present in our environment and in products
which we daily use, like soap, lotions and shampoos. Therefore its not
surprising that fragance is becoming more prevalent as a form of
contactdermatitis. Contactdermatitis is an infection which leads to a red skin,
itch, and swelling of the skin which can cause severe limitations in daily
living. The symptoms appear mostly in the face, the eylids, neck, arm-pits and
groins.
Study objective
To test the feasibility of an intended large scale fragrance-allergy prevalence
study in the population of the north of the Netherlands and to make a more
reliable estimate of the prevalence in the population for poweranalysis of the
intended large scale study.
Study design
A questionnaire has been developed by the EDEN group and was tested for
reliability in a prepilot-study. The questionnaire can approximately define
whether a person has had an allergic reaction of the skin which can be ascribed
to cosmetics and/or fragrances. Persons with a positive outcome on the
questionnaire (cases), which means that they are possibly allergic to
cosmetics/fragrances will be asked (cases) to cooperate on a patch-test
procedure to validate the questionnaire and to define the algorithm and to a
blood test to define the over-senstiviness for hair cosmetics. The same will be
asked to a at random selected number of persons with a negative outcome
(controls).
Study burden and risks
The time-estimate for completing the questionnaire is at most twenty minutes.
Cooperation in the patch-test procedure contains the following. The patch-test
will be fixed on the respondents back for two days. The respondent will be
hindered by the patch-test if the patch-test is abundantly contacted with
water. Showering therefore has to be done with a hand shower. The patchtest
will be removed after two days, and the day after (day three) it has to be read
at the out-patient department of the UMCG. Removal of the patch-test will be
done by the same person who filled out the questionnaire in a place which is
choosen by the respondent. Five milliliters of blood will be taken at the
moment the respondent comes to the out-patient clinic and if positive
permission is given beforehand.
9713AV
9713AV Groningen
Nederland
9713AV
9713AV Groningen
Nederland
Listed location countries
Age
Inclusion criteria
age 18-75 years old, Dutch speaking, able to gibve informed consent
Exclusion criteria
not known with an active skin disorder
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 | NL13475.042.06 |