To explore skin adaptation after repeated sub-erythemal UV-dose and individual factors that might underlie this process.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Minimal erythemal dose-levels (MED)
Secondary outcome
changes in thickness of stratum corneum (SC) and epidermal thickness, SC levels
of immunological markers and urocanic acid isomers, levels of 25(OH)D3 in serum
Background summary
Skin adaptation after UV-exposure is an important field of research. In
general, skin adaptation and underlying mechanisms are largely unknown, while
this knowledge is of interest for development of prevention strategies in the
workplace, the general population and for skin therapy. For several immune
mediated skin diseases, suberythemal UV-therapy by means of a home-installed
UV-device has proven to be a safe, effective and patient-friendly approach.
(21) The role of individual characteristics such as skin phototype and SC
thickness on the changes in the skin barrier, inflammatory- and immune response
induced by repeated suberythemal UV exposure is scarce.
Study objective
To explore skin adaptation after repeated sub-erythemal UV-dose and individual
factors that might underlie this process.
Study design
Experimental exposure study in healthy volunteers (a single-center)
Intervention
Broad-spectrum UV-irradiation with repeated use of a home-installed UV-device
(the Sunshower medical) of the back skin at suberythemal dose, three times
every week during 10 minutes (0,8 SED per time)
Study burden and risks
UV-source which resembles sunlight will be installed at homes of volunteers.
Subjects will visit the research site (AMC, Department of Dermatology) six
times: intake visit, after 1,5 and 3 months. The day after every consultation,
the participants will be evaluated on erythema after application of the MED
device. At each visit, samples of the stratum corneum will be collected, and
stratum corneum thickness will be measured with non-invasive Optical Coherence
Tomography. At the first and last consultation, blood samples will be
collected. Minimal erythemal dose (MED) will be measured after every
consultation. The day after every consultation, participants are asked to come
back to the research unit to determine erythema.There is no direct benefit for
the patient.
Collection of the stratum corneum will be performed by using adhesive tapes (12
consecutive tapes from one skin site), which is a minimally invasive procedure,
and has often been applied in own studies and elsewhere. The epidermal
thickness is measured with Optical Coherence Tomography (OCT). This is a
non-invasive optical imaging technique that uses low-power infrared laser
light. MED will be measured with a MED measurement device. Blood serum is
collected to measure 25(OH)D3 levels. Each visit will take approximately 45
minutes.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Individuals between 18 and 35 years.
- Fitzpatrick skin types II, III, IV or VI
- 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 relating to the specific study to which they are subscribing.
Exclusion criteria
- Individuals taking medication which in the opinion of the investigator would
mask or interfere with the results.
- Individuals with chronic skin allergie
- Individuals with suntan or sunburn.
- Individuals with abnormal reactions to the sun.
- Individuals who use oral supplementation of vitamin D
- Subjects who used sun beds or were extensively exposed to UVR in the previous
30 days (e.g. during holidays), or are planning on doing so during the study
- Subjects who consumed alcohol 1 day prior to MED assessment
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 | NL82865.018.22 |