No registrations found.
ID
Source
Brief title
Health condition
Atopic Eczema, skin barrier, stratum corneum
Intervention
Outcome measures
Primary outcome
The lipid compostion of the stratum corneum. The lameller and lateral lipid organization.
Secondary outcome
Barrier function as Trans epidermal water loss (TEWL).
Barrier recovery monitored as TEWL over time. Here the % of barrier recovery will be
calculated using the TEWL before and after disruption as 100% and 0% of barrier
recovery, respectively.
Background summary
Information not provided by researcher.
Study objective
The study investigates if how the skin recovers after barrier disruption by tape-stripping and what the effects the application of a formulation is on this process. Lipophilic formulations are commonly used in the treatment of atopic eczema, yet, how these formulations exert there effect is unknown. In this study the effects of the formulation on the barrier function measured as trans epidermal water loss and the lipid composition and organization of the other most layer of the skin: the stratum corneum, are investigated. It is hypothesized that the formulation will affect the lipid composition of the stratum corneum and this changes towards a composition with better barrier properties thereby improve the skin barrier.
Study design
The trans epidermal water loss will be monitored at day 0, 1, 2, 3, 7, and 16 after barrier disruption. The lipid composition is measured by acquiring stratum corneum material at day 16 by tape stripping. Tape strips are extracted and analyzed using liquid chromatography and mass spectrometry. The lateral organization is studied at day 16 using attenuated total reflectance Fourier-transform infrared spectroscopy. The lamellar organization is studied using small angle x-ray diffraction of biopsy obtained at day 16.
Intervention
Treatment with a venix caseosa based formulation
[default]
The Netherlands
[default]
The Netherlands
Inclusion criteria
- Age between 18-40
- Caucasian
Exclusion criteria
- Abundant hair presence on the ventral forearms;
- Unnatural abnormalities on one of their ventral forearms (e.g. skin lesions, tattoos);
- Subjects using any systemic drug therapy (e.g. cholesterol-lowering drugs, insulin
related drugs, steroids and immunosuppressants);
- Chronically inflammatory disease;
- Dermatological disorders or a history of dermatological disorders;
- History of drug abuse;
- Pregnancy;
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7003 |
| NTR-old | NTR7193 |
| CCMO | NL51870.058.14 |
| OMON | NL-OMON43983 |