The main objective is to evaluate the cytokine response to tape stripping in vivo, dynamically and non-invasively by means of patches..The secondary objectives are (i) to correlate the cytokine response with transepidermal water loss (TEWL), a well-…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study eindpoints are the levels of cytokines at baseline and at
different time points following acute disruption of the skin barrier by means
of tape stripping.
Secondary outcome
Not applicable
Background summary
Cytokines are signalling molecules involved in the process of cutaneous
irritation. Tape stripping is a minimally invasive model of acute skin barrier
disruption which mimics mechanical cutaneous irritation. Being able to measure,
in vivo and non-invasively, cytokines release following tape stripping would
bring further insights into the inflammatory mechanisms triggered by skin
barrier disruption, as well as insights into the repairing mechanisms of the
skin barrier. Knowledge of such insights could be applied, for example, in the
development/improvement of products/treatments dedicated to the lessening of
skin irritation following skin-material interaction (e.g. during shaving or
sport).
Study objective
The main objective is to evaluate the cytokine response to tape stripping in
vivo, dynamically and non-invasively by means of patches..
The secondary objectives are (i) to correlate the cytokine response with
transepidermal water loss (TEWL), a well-known marker of the status of the skin
barrier, measured non-invasively; and (ii) to study the effect (if any) of the
repetitive application of the patches on the evaluation of the cytokine
response.
Study design
This is a descriptive and exploratory pilot study.
Study burden and risks
Participation in the study does not lead to any short term benefit for the
volunteers. They are informed of this before giving informed consent. On the
long term, volunteers may benefit of better products/treatments created or
optimized starting from the insights into the cutaneous irritation following
mechanical stimulation (e.g. shavers) gained within this and future studies.
Volunteers need to visit the research site (dermatology department of
Radboudumc) three times. On the first visit, tape stripping is performed on
four sites of the volar forearm and evaluation (cytokine and transepidermal
water loss measurement) is performed at two time points post tape stripping.
The first visit lasts 1 hour and 10 minutes. The second and third visits take
place 24 and 72 hours after the first visit. During these visits, each
30-minutes long, the skin on which tape stripping was performed is evaluated
(cytokine and transepidermal water loss measurement).
The acute disruption of the skin barrier with tape stripping may result in
transient skin discomfort. From our point of view, the short follow-up time,
the minimally invasive stimulation (tape stripping) and the non-invasive
evaluation of cytokines and transepidermal water loss make participation to the
study acceptable.
Rene Descartesdreef 1
Nijmegen 6500HB
NL
Rene Descartesdreef 1
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
Age between 18 and 65 years;
Must be willing to give a written informed consent;
Must have skin type II or III (Fitzpatrick scale)
Exclusion criteria
Pregnancy or lactation;
Atopic predisposition (i.e. history of allergic rhinitis or allergic conjunctivitis, atopic or contact dermatitis, hay fever, asthma);
Any skin disease, including possible lesions found during screening;
Skin types I, IV, V, VI;
Use of immunosuppressive drugs (NSAIDs, biological, topical or systemic corticosteroids)
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 | NL54094.091.15 |