PRUMEC
Research type
Research Study
Full title
Case-control mechanistic study of pruritus in adults with Dystrophic Epidermolysis Bullosa Pruriginosa (DEB-P)
IRAS ID
243002
Contact name
John McGrath
Contact email
Sponsor organisation
King's College London University
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Dystrophic epidermolysis bullosa (DEB) is a genetic condition which causes the skin to blister and tear at the slightest touch. This is caused by lack of collagen VII, the protein that ‘sticks’ the top (epidermis) and bottom layer (dermis) of the skin together. People with the ‘pruriginosa’ subtype (DEB-P) not only suffer from skin fragility, but also experience intense itching, and the scratching causes even more blistering.
At the moment we don’t really understand why the skin is itchy in DEB-P patients. The PRUMEC study aims to shed information about the mechanisms behind itch and what causes itch in DEB-P patients. We will do this by comparing blood and skin samples from these patients to samples from DEB patients who do not regularly experience itch, and samples from healthy volunteers.
Participants will be required to attend two appointments at Guy’s and St Thomas’ Hospitals. The initial screening appointment with the study doctor will involve taking medical history, physical examination, photographs of skin and questionnaires about itch and quality of life. A small blood sample of approximately 10 ml, about 2 teaspoons will be also be taken. After the screening visit participants will return for their second visit within 4 weeks. At this visit, blood samples (approximately 10 ml, about 2 teaspoons), and 3 skin biopsies of 4 mm each (total size smaller than a 5 pence coin) will be collected. For patients with DEB pruriginosa, there will be an extra 4ml of blood (a third of a teaspoon).
The study will recruit 10 to 30 patients with DEB-P, 10 to 30 patients with DEB-Non Pruriginosa and 10 to 30 as healthy controls.
REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/0957
Date of REC Opinion
16 Jul 2018
REC opinion
Further Information Favourable Opinion