GRASS-UK
Research type
Research Study
Full title
The Global Register of Alopecia Areata disease Severity and treatment Safety – United Kingdom
IRAS ID
346841
Contact name
Matthew Harries
Contact email
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
037/R/20, British Skin Foundation; AUK2022_006, Alopecia UK
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
Alopecia areata (AA) is a common autoimmune hair loss condition that results in patchy to complete scalp and body hair loss, estimated to affect 400,000 people in the UK. Hair loss can have a significant emotional impact on both the person affected as well as their wider family, lowering quality of life, and resulting in increased rates of anxiety and depression. We currently do not know what the most effective and safe treatment options for AA are or how new small-molecule and biologic treatments that are under development (and now being introduced into the NHS) compare with conventional AA treatments or how well these new therapies work in the real-world and over a longer timeframe.
GRASS-UK is a prospective national disease register designed to determine the short- and long-term safety and effectiveness of conventional AA treatments compared with new small-molecule and biologic drugs, as they are introduced.
GRASS-UK is open to children and adults of any age with moderate to severe alopecia areata undergoing NHS care.
The study will initially be piloted at 3 centres in England. Phase 1 expansion will be to centres with specialist hair clinics with further expansion to any NHS dermatology centre in the UK who are willing to recruit to this study.
This is a long-term observational study of people with AA undergoing standard NHS care. This is a 5-year study, with participants seen every 6 months for 3 years, then annual for 2 years, with visits performed at the same time as their planned dermatology clinic appointments. Routine clinical data will be collected, including disease severity, response to treatment and treatment-related side effects. Participants will also be asked to complete questionnaires and undergo procedures to collect height and weight measurements at each timepoint.
REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0809
Date of REC Opinion
5 Nov 2024
REC opinion
Favourable Opinion