Determine the protective effects of sunscreens against UV-radiation by measuring biomarkers in the stratum corneum.
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, immunological factors (chemokines,
cytokines, MMP (metalloproteinases)), and angiogenesis factors in the the
stratum corneum.
Secondary outcome
n.a.
Background summary
Non-melanoma skin cancer (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. In our previous work, we determined various
biomarkers of DNA damage and immune response to monitor the effects of UVR, in
the stratum corneum. In this follow-up study we will use the previously
determined biomarkers to measure the protective effect of sunscreens in vivo.
Study objective
Determine the protective effects of sunscreens against UV-radiation by
measuring biomarkers in the stratum corneum.
Study design
Intervention study in healthy volunteers (single-center). Exposure to
UV-radiation and two sunscreens. Part of the back skin (2 x 30 cm2) protected
with sunscreen, will be exposed to an UVR-dose of 150 mJ/cm2. Another part of
the back skin (4 x 30 cm2) will be exposed to an UVR-dose of 7.5, 15, 30 and 60
mJ/cm2, unprotected.
Intervention
Broad-band UV exposure of the unprotected back skin of the volunteers at
UV-dose of 7.5, 15, 30 and 60 mJ/cm2. The sunscreen protected (SPF 50+) skin
will be exposed at a UVR-dose of 150 mJ/cm2. 5 times weekly during 1 week.
Samples of the stratum corneum will be collected on day 1, 3, 5 and 6. The
collection of the stratum corneum will be carried out using adhesive tapes.
This procedure is not invasive and painless.
Study burden and risks
Besides mild redness of the skin after first exposures no other effects are
expected. The UVR-doses used in the present study, are similar to those in
large numbers of studies researching the sun protection factor (SPF) of
sunscreens.
The used sunscreens are commercially available.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Male and female individuals between 18 and 65 years.
Fitzpatrick skin types II or III.
Free of any dermatological or systemic disorder which would interfere with the
results, at the discretion of the investigator.
Individual who has read, understood and signed an informed consent document
relating to the specific study to which he/she is subscribing.
Individuals with no known abnormal response to sunlight (e.g. polymorphic
eruption) or (ingredients of) sunscreens.
Willingness to actively participate in the study and come to the scheduled
visits
Willingness to discontinue the use of detergents (e.g. soaps) and cosmetics
products (e.g. creams, moisturizers) in the treatment area throughout the
course of the study
Willingness to avoid any exposure of the test area to artificial or natural
ultraviolet light throughout the course of the study
Exclusion criteria
Taking medication which in the opinion of the investigator would mask or
interfere with the results.
With chronic skin allergies.
With suntan of sunburn
Breastfeeding
Pregnancy or intention to become pregnant over the duration of the study
Participation in, or being in the waiting period for another study
Individual with moles, tattoos, scars, irritated skin, hairs, etc. at the test
area that could influence the investigation.
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 | NL70109.018.19 |