Primary Objective: to explore whether UVB exposure leads to detectable changes of the biomarkers of the skin barrier, immune response and DNA-damage in urine and stratum corneum Secondary Objective(s): to explore the profile of biomarkers in…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The levels of urocanic acid isomers, MMP, cytokines and DNA-photoproducts
measured in the stratum corneum and/or urine at different time points during a
3-weeks study
Secondary outcome
The levels of urocanic acid isomers, MMP, cytokines and DNA-photoproducts at
different stratum corneum depths (i.e. 1st to 12th collected tape from the same
skin site)
Background summary
Non-melanoma skin cancers (NMSC; synonym: keratinocyte skin cancers ) is a
growing health problem in occupations associated with high doses of solar
ultraviolet radiation (UVR). In several EU countries NMSC are recognized as an
occupational disease. Various prevention strategies including application of
sunscreens, administrative policies or education have recently been developed.
Efficacy of these interventions has insufficiently been evaluated, partly due
to the lack of relevant outcomes. Various biomarkers of DNA damage and immune
response have been proposed to monitor the effects of UVR, however so far they
have been determined in blood or skin biopsy. Development of non-invasive
biomarkers e.g. in urine or in the stratum corneum would therefore be of great
value.
Study objective
Primary Objective: to explore whether UVB exposure leads to detectable changes
of the biomarkers of the skin barrier, immune response and DNA-damage in urine
and stratum corneum
Secondary Objective(s): to explore the profile of biomarkers in relation to the
depth of the stratum corneum
Study design
Explorative study in healthy volunteers (a single-center)
Intervention
Broad-band UV exposure of the back skin of the volunteers at sub-erythemal dose
of 20-30 mJ/cm2, 3 times weekly during 3 weeks. Before each UV-irradiation
samples urine and stratum corneum will be collected. The collection of the
stratum corneum will be carried out by using adhesive tapes. This procedure is
not invasive and painless.
Study burden and risks
Besides slight redness of the skin after first exposures no other effects are
expected
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Male individuals between 18 and 65 years.
* Fitzpatrick skin types II or III.
* Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the investigator.
* Individuals who have read, understood and signed an informed consent document relat-ing to the specific study to which they are subscribing.
* Individuals with no known abnormal response to sunlight (e.g. polymorphic eruption).
Exclusion criteria
* Individuals taking medication which in the opinion of the investigator would mask or in-terfere with the results.
* Individuals with chronic skin allergies.
* Individuals with abnormal reaction to the sun.
* Subjects who used sun beds in the previous 30 days.
Design
Recruitment
Medical products/devices used
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 | NL68855.018.19 |