Determine the relationship between stratum corneum lipids (and their enzymes) and inflammatory markers in patients with AE. This is achieved by measuring:i) The SC lipid matrix and bound lipids, focussing on ceramides and its biosynthesis (i.e. the…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To achieve our main objective of the study (Determine the relationship between
stratum corneum lipids (and their enzymes) and inflammatory markers in patients
with AE), analysis focuses on:
- Stratum corneum lipids
The SC lipid composition and SC bound lipids, focusing on ceramides and
analysed by LC/MS
- Local inflammatory markers and stratum corneum lipid enzymes
By means of two biopsies (per skin site), both local inflammation markers as
well as the protein expression and enzyme activity of key SC lipid biosynthesis
enzymes (e.g. GBA and aSMase) are analysed in situ by fluorescence microscopy
- Systemic inflammation markers
By means of a venepuncture, blood serum is obtained and levels of inflammatory
markers are determined
- Skin barrier function
We analyze TEWL, as it is a common parameter that reflects the stratum corneum
barrier function.
Secondary outcome
- The skin pH, measured by skin pH-meter
- Local and total SCORAD, and EASI (both questionnaires)
Background summary
De horny layer of the skin (stratum corneum) consists of dead skin cells
surrounded by a lipid matrix. These lipids form a barrier: 1) it prevents
excessive water loss (dehydration) from inside-out; 2) it prevents the
penetration of exogenous compounds. In a previous study (p09.171), we
demonstrated that patients with atopic eczema have a reduced skin barrier as a
result of changes in the composition of the stratum corneum. Therefore, the
skin of atopic eczema patients cannot maintain a normal water hydration level.
In addition, it is expected that compounds (like irritants and allergens) can
penetrate the skin more easily and cause an inflammatory response. This
inflammation leads to red, dry and itchy skin. The previous study concluded
that the level of changes in the skin barrier are strongly correlated to the
altered stratum corneum lipids. At that time, we reported that future research
should focus on 1) the cause of these changes in stratum corneum lipids (thus
the enzymatic biosynthesis of the lipids); and 2) the role of inflammatory
components for these changes in stratum corneum lipids.
This is exactly what the new study addresses.
Study objective
Determine the relationship between stratum corneum lipids (and their enzymes)
and inflammatory markers in patients with AE. This is achieved by measuring:
i) The SC lipid matrix and bound lipids, focussing on ceramides and its
biosynthesis (i.e. the expression and activity of enzymes related to the SC
lipids).
ii) Local and systemic inflammatory markers.
ii) Transepidermal water loss (TEWL) levels: a common parameter reflecting SC
barrier function.
Study design
Etiological case-control study that examines the relationship between SC lipids
(and their enzymes) and inflammatory markers in patients with atopic eczema.
Study burden and risks
The potential risk is minimal, and the obtained outcomes will lead to novel
knowledge on atopic eczema. To relate the outcomes to the diseased state
(atopic eczema) It is therefore necessary that we have to include AE patients
as well as a control group
Einsteinweg 55
Leiden 2333CC
NL
Einsteinweg 55
Leiden 2333CC
NL
Listed location countries
Age
Inclusion criteria
(page 13 research protocol)
- Aged between 18 and 40 years;
- Caucasian.
Exclusion criteria
(page 14 research protocol)
- Aged under 18 or over 40;
- Non-Caucasian;
- Abundant hair presence on the ventral forearms;
- Unnatural abnormalities on one of their ventral forearms (e.g. skin lesions, tattoos);
- Using any systemic drug therapy (e.g. cholesterol-lowering drugs, insulin related drugs, steroids and immunosuppressants);
- Who received phototherapy in the past 2 years
- Pregnancy
Additional exclusion criteria for healthy subjects:
- No chronically inflammatory disease;
- Use of dermatological products (e.g. creams) on their ventral forearms on a daily basis.
- Dermatological disorders or a history of dermatological disorders
Additional exclusion criteria for AE patients:
- The absence of both lesional and non-lesional skin sites on their ventral forearms at day 0 of the study.
- The use of corticosteroids class IV or higher. Patients with corticosteroids class I-III need to give informed consent about changing their medication to a standardized regimen (see protocol page 11-13).
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 | NL57958.058.16 |