The objective of this study is to find out the relevance of adding isobornyl acrylate to the (meth) acrylate. Sub question: What is the relevant test concentration of isobornyl acrylate?
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are the results of the patch tests. These will be
scored following the guidelines of the International Contact Dermatitis
Research Group (ICDRG).The responses are qualified as -, +? , +, ++, +++ or IR
(irritation) response. The +, ++ and +++ will be translate in 1 and relevant
for our study, while -, +? and IR will be translated into 0 and will be
considered negative.
Besides the scores, we will also take pictures of the back.
Secondary outcome
n.a.
Background summary
The reason for this study is a 48 year old man who suffered of a
therapy-resistant hand eczema for nine months. He was working as a process
operator in a factory producing glass fibers. The patient was occupied with the
process of UV-painting of glass fibers, printing the glass fibers, covering it
with acrylate and cleaning the machines. His skin problems diminished
considerably during holidays and complaints returned as soon as he got back to
work at the factory. The patient was examined with the European Standard series
of the Epicutane allergy test (ECAT) and with ECAT (Meth) acrylate series.
Altough the patient did not react to the European Standard series, he responded
positively to many (meth) acrylates such as ethyl acrylate, butyl acrylate,
2-hydroxyethyl acrylate, 2-hydroxypropyl acrylate, 2-hydroxyethyl methacrylate,
2-hydroxypropyl methacrylate, triethylene glycol dimethacrylate, 1,6-hexanediol
diacrylate, diethyleneglycol diacrylate, triethylene glycol diacrylate.
However, these acrylates did not appear to be relevant for his complaints,
because these components did not occur in the substances with which our patient
was working with. After further analyzing his working area, isobornyl acrylate
appeared to be a component of the glass fiber coating, the Bufferlite and
UV-inkt. A new ECAT with isobornyl acrylate 0.1% showed a strong positive
allergic reaction.
Isobornyl acrylate is a substance which does not occur in the (meth)acyrlate
series. This patient and his positive reaction to isobornyl acrylate as well as
his positive responses to non-relevant acrylates create the base for this
study.
Cross reactions between acrylates have been known since 1977. Chung et all (1)
described this with search on guinea-pigs. A review from 2001 (2) described
that several hypotheses exist on cross responses depending on additive groups
of the monomeer and in vivo responses. However, this review doesn't mention
isobornyl acrylate. In today's literature little is known about isobornyl
acrylate. There are only four research groups which have specifically occupied
themselves with isobornyl acrylate. The studies which have been performed in
the past, rarely show an allergic response to isobornyl acrylate.
Kiec-Swierczynska et all (3) studied a group of 81 employees from a
video/television factory who were working with isobornyl acrylate 0.1%. None of
the employees showed a positive reaction to isobornyl acrylate. Aalto-Korte (4)
performed a few studies on isobornyl acrylate. In a retrospective research 49
patients were suspected of having a labour-related contact dermatitis, while
none of them reacted to isobornyl acrylate 0.1%. Busschots et al (5) found two
patients with a relevant contact allergy for isobornyl by using an insulin
pump.
Hypothesis: Patients who have tested positively for any of the substances in
the (meth) acrylate series in the past, can also have allergic reactions to
isobornyl acrylate. Patients who have reacted in the past to several acrylates
or to acrylates which are chemically more similair to the structure of
isobornyl acrylate are probably more likely to respond to isobornyl acrylate.
References:
1. Chung CW, Giles AL. Sensitization potentials of methyl, ethyl, and n-butly
methacrylates and mutual cross-sensitivity in guinea pigs. The journal of
investigative dermatology April 1977
2.Kanerva L. Cross-reactions of multifunctional methacrylates and acrylates.
Acta Odontol Scand 2001; 59:320-329. Oslo. ISSN 0001-6357.
3.Marta Kiec-Swierczynska, Beata Krecisz, Dominika Swierczynska-Machura, Joanna
Zaremba An epidemic of occupational contact dermatitis from an acrylic glue.
Contact Dermatitis. 2005 Mar;52(3):121-5.
4.Kristiina Aalto-Korte, Maj-Len Henriks-Eckerman, Outi Kuuliala, Riitta
Jolanki, Occupational methacrylate and acrylate allergy - cross-reactions and
possible screening allergens Contact Dermatitis. 2010 Dec;63(6):301-12. doi:
10.1111/j.1600-0536.2010.01760.x.
5.Busschots A M, Meuleman V, Poesen N, Dooms-Goossens A. Contact allergy to
components of glue in insulin pump infusion sets. Contact Dermatitis 1995: 33:
205-206.
Study objective
The objective of this study is to find out the relevance of adding isobornyl
acrylate to the (meth) acrylate.
Sub question: What is the relevant test concentration of isobornyl acrylate?
Study design
Participants to this study will undergo epicutane patchtesting according to the
protocol of the International Contact Dermatitis Research Group. The patchtest
exists of the (meth)acrylate series of the UMCG and a van der Bend Chamber
filled with isobornyl acrylate (IBA) in petrolatum in different concentrations.
IBA will be tested in concentrations varying from 0.3%, 0.1%, 0.03%, and 0.01%.
The patchtest will be applied onto the back and must stay in situ for 48 hours.
After 48 hours the patchtest will be removed and the first reading will be
performed. The patchtest will be read again after 72 hours. During the
readings we will use the guidelines of the International Contact Dermatitis
Research Group (ICDRG). The results will be graded as -, +? , +, ++, +++ or IR
(irritated) response. The results +, ++ and +++ are relevant for our study. We
will also take pictures of the participant's back.
References:
Contact Dermatitis 5th edition, Springer 2010, Jeanne Duus Johansen, Peter J.
Frosch, Jean-Pierre Lepoittevin
Fregert S. Publication of allergens. Contact Dermatitis 1985;12:123-124
Study burden and risks
The burden for the participants in this research will exist of the following:
- Before participation: exclusion of possible pregnancy, use of
immunosuppresive drugs and active skin disease on the back, which will be
followed by inspection of the back for exclusion of any active skin diseases by
menas of a questionnaire
- Four visits to the UMCG or house visits spread over one week. A visit lasts
15 minutes on average.
- The real burden exists of the application of the patch test on the back for
48 hours. The participant ought te keep the application site dry during one
week.
- Afterwards a second questionnaire will be used to manifest a possible
exposure to acrylates and isobornyl acrylate in particular.
Risks
- Irritation and itching on the site of the patchtest. To minimalizes these
risks hypoallergic bandages are used. Possible irritation or itching will
disappear spontaneously after removing the patcht test.
- Small risk of active sensibilization for isobornyl acrylate.
Hanzeplein 1
9713 GZ Groningen
NL
Hanzeplein 1
9713 GZ Groningen
NL
Listed location countries
Age
Inclusion criteria
- Adulthood
- Legal competence
- Epicutanous skin test in the UMCG between 01-01-2000 and 01-02-2012
- Positive reaction (at least +) for at least one acrylate
Exclusion criteria
- Legally incompetence
- Angry back in the past
- Active skin disease on the back
- Use of immunosuppresive drugs
- Pregnancy(wish)
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 | NL36823.042.11 |