Effect of inflammation on the stratum corneum lipid biosynthesis in the skin barrier of atopic eczema patients

Effect of inflammation on the stratum corneum lipid biosynthesis in the skin barrier of atopic eczema patients - SC lipids and inflammation in AE (EISBA)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42915

Enrollment

Registered

2016-09-12

Start date

2016-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis neurodermitis

Interventions

atopic eczema

inflammation

lipid biosynthesis

stratum corneum

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: (page 13 research protocol) - Aged between 18 and 40 years; - Caucasian.

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
- The skin pH, measured by skin pH-meter - Local and total SCORAD, and EASI (both questionnaires)	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)