The main objective of this study is to assess the in vivo efficacy of a skin protecting cream against skin irritation experimentally induced by sodium lauryl sulphate. Next, we aim to investigate whether the protective effect differs between…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the skin barrier and irritation response the following parameters
will be measured:
1. Transepidermal water loss (TEWL), pH and erythema
2. Levels of natural moisturizing factors (NMFs) (including
2-pyrrolidone-5-carboxylic acid, histidine and urocanic acid) and cytokines
(including IL-1α, IL-1β, Il-1RA, IL-8 and IL-10) in the stratum corneum
harvested by using adhesive tape
3. Skin morphology as assessed by using confocal laser scan microscopy
(Vivascope 1500, MAVIG, Germany)
4. Lipids (ceramides and free fatty acids) in the stratum corneum harvested by
using adhesive tape
Secondary outcome
not applicable
Background summary
The epidermal barrier function of the skin resides in the stratum corneum (SC).
Exposure to skin irritants like soaps, organic solvents and even water can
reduce the hydration status of the epidermis and cause changes in the
composition and organization of the SC lipids leading to xerotic skin and
inflammation. In addition to environmental influences, some skin diseases such
as atopic dermatitis are characterised by an intrinsically reduced skin
barrier. The recent identification of loss-of-function mutations in the gene
encoding for filaggrin protein (FLG) as a remarkably strong risk factor for AD
has been a major breakthrough, revealing that between 14% and 56% of AD cases
are carriers of at least one FLG mutation. Filaggrin is a key epidermal protein
that regulates several functions critical for the structure and composition of
the stratum corneum (SC). The well-established association between FLG
mutations and AD supports the hypothesis that an intrinsically impaired skin
barrier may be a primary step in the development of AD. Furthermore, we have
recently shown that carriers of FLG mutations have increased risk to develop
chronic irritant contact dermatitis, which is one of the most common
occupational diseases. Recently, several new barrier repair creams have been
put on the market aiming at restoration and protection of the skin barrier.,
however clinical efficacy data for these products are limited.
Study objective
The main objective of this study is to assess the in vivo efficacy of a skin
protecting cream against skin irritation experimentally induced by sodium
lauryl sulphate. Next, we aim to investigate whether the protective effect
differs between individuals with a healthy skin barrier and individuals with an
intrinsically impaired skin barrier caused by AD and/or FLG mutations.
Study design
Observational study
Study burden and risks
There are no health risks and only minor burden associated with participation
in this study. The outcome of this study (assessment of the efficacy of a
protective barrier cream) will contribute to prevention and improved treatment
of irritation-induced skin inflammation. This will be especially useful for
occupations with a high risk of contact eczema due to exposure to skin
irritants (e.g. hairdressing, nursing, metalworking).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1) age between 18 and 55 years,
2) Caucasian race of Western Europe origin
Exclusion criteria
1) dermatitis on mid-volar arms
2) systemic inflammation disease
3) skin disease other than AD
4) use of antihistaminics or inflammation suppressing medicines (e.g. corticosteroids, NSAIDs) or antibiotics one month prior to, and during the investigation.
5) sunbathing or using a tanning bed during 2 months prior to, and during 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
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In other registers
| Register | ID |
|---|---|
| CCMO | NL43221.018.13 |