The primary objective of this study is to evaluate whether the recovery of the skin barrier after acute perturbation by repetitive application of adhesive tape (*tape stripping*) is accelerated following irradiation with visible light. The secondary…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the recovery of the skin barrier after tape
stripping, measured with transepidermal water loss (marker of skin barrier
status), and the clearance of inflammation after histamine iontophoresis,
measured with a* value (marker of skin redness). Both measurements are
non-invasive. Tape stripping and histamine iontophoresis will be performed
twice on the same volunteer, on two consecutive weeks. On one occasion
stimulation is followed by irradiation, in the other no irradiation is
performed serving as control.
Secondary outcome
Not applicable
Background summary
Recent studies have demonstrated the presence of photoreceptors in the skin and
suggest that visible (blue and red) light has biological effects in the skin,
including decrease of inflammation, decrease of epidermal proliferation and
enhancement of skin barrier repair. In this study we address the potential of
red and blue light in fastening the recovery of skin homeostasis after
experimentally-induced skin barrier disruption and inflammation. Light-based
treatments/products could be developed starting from the outcomes of this study
to diminish adverse skin reactions of people with sensitive skin.
Study objective
The primary objective of this study is to evaluate whether the recovery of the
skin barrier after acute perturbation by repetitive application of adhesive
tape (*tape stripping*) is accelerated following irradiation with visible
light. The secondary objective of this study is to evaluate whether the
clearance of inflammation following application of histamine via iontophoresis
is accelerated following irradiation with visible light. Four different
irradiation settings will be employed and the primary and secondary objectives
will be evaluated within each irradiation setting.
Study design
This is an observational case-control pilot study, where volunteers serve as
their own internal control, performed at the dermatology department of Radboud
University Medical Center
Study burden and risks
This study does not lead to any short term benefit for the volunteers, as
clearly expressed in the information provided. On the long term, volunteers may
benefit of better products/treatments created starting from the insights into
the effects of visible light on skin homeostasis gained within this study. The
study is performed on six visits spanned over two consecutive weeks. The study
procedures are the same for each week: on the first visit, stimulation with
tape stripping and histamine iontophoresis is performed on the volar forearm
and skin reactions are evaluated up to 1 hour after stimulation. These are also
evaluated later in the week, at 24 hours and 72 hours. The only difference is
that, in one of the two weeks, stimulation is followed by irradiation with
visible light. Total study duration for each volunteer is five hours.
Stimulation may result in transient skin discomfort, itch and redness and last
up to a few hours (histamine) and days (tape stripping). From our point of
view, the short follow-up time, the minimally invasive stimulations and the
non-invasive readouts make participation to the study acceptable.
High Tech Campus 34
Eindhoven 5656 AE
NL
High Tech Campus 34
Eindhoven 5656 AE
NL
Listed location countries
Age
Inclusion criteria
1. skin type I, II or III (Fitzpatrick scale);
2. 18 - 40 years old;
3. willing to give written informed consent
Exclusion criteria
1. diagnosis of histamine hypersensitivity;
2. presence of cardiac pacemakers or other implanted electric devices;
3. pregnancy or lactation;
4. atopic predisposition (i.e. allergy, atopic/contact dermatitis, hay fever, asthma);
5. any current (skin) disease including conditions causing photosensitivity;
6. predisposition to respond allergic;
7. use of immunosuppressive drugs;
8. use of antihistamines drugs;
9. use of medication for hypertension with airway constricting activity;
10. use of medication with photosensitizing effects;
11. skin type IV, V, VI (Fitzpatrick scale);
12. excessive sun exposure or tanning less than 2 weeks before the beginning of the study.
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL56421.091.16 |
| OMON | NL-OMON20423 |