Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04280315 |
| Other study ID # |
SkinBarrier_30092019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 18, 2020 |
| Est. completion date |
June 14, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Copenhagen University Hospital at Herlev |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study is a case-control study comparing the skin barrier between 50 T1D patients with
healthy controls in 3 age-strata including both pediatric and adult patients.
Description:
The skin is a crucial barrier against external allergens and irritants. Therefore the
function of the skin barrier is central regarding evolvement of eczema. In patients with type
1 diabetes (T1D) using insulin pumps and/or glucose sensor, eczema is unfortunately a
frequent reaction. The skin consists of three layers: epidermis, dermis and subcutaneous fat,
whereas epidermis is most determining regarding skin barrier. Epidermis can further be
subdivided, where stratum corneum (SC) is the outer part, which means most regarding
vulnerability towards external allergens.
The function of the skin barrier can be investigated by non-invasive methods using
transepidermal water loss (TEWL), which shows the water vapour flux from the skin. Besides SC
can be determined using the tape strip method, where few SC cells are peeled off and thereby
can be analyzed with mass-spectrometry. Natural moisturizing factors (NMF) is though one of
the very important functionalities of the SC, which are determined by the amount of
2-pyrrolidone-5-carboxylic acid (PCA). Besides, the lipid distribution, presence of
antimicrobial peptide and cytokine response give as well important information regarding the
skin barrier.
Dermatological manifestations of T1D are quite frequent and have been shown to be related to
glycemic control, placing dermatological manifestations as a precursor of other microvascular
complications11. There is a lack of studies regarding skin barrier function in patients with
T1D, and especially in a pediatric study population. Therefore, this case-control study will
be conducted investigating skin barrier function in pediatric patients with T1D compared to
healthy controls in order to both meet this lack of knowledge, but as well to improve the
prevention of skin problems to devices used in T1D-treatment.
The examination program of just one visit per participant consists of:
- TEWL-measure at forearm and buttock
- Buccal swab regarding filaggrin gene status
- Microbiological swab from the skin at forearm and buttock
- 2X11 tape strips from the skin at foream and buttock to be analyzed for NMF, Lipid,
Cytokines, Antimicrobial peptide and Dermal Topographical Index as well as protein
content using SquameScan
- Measure of skin PH, hydration and sebum content at forearm and buttock
- Capillary Blood Glucose
- Survey regarding atopic and dermatological symptoms
