GRASS-UK
Research type
Research Study
Full title
The Global Registry of Alopecia Areata disease Severity and treatment Safety – United Kingdom
IRAS ID
332739
Contact name
Matthew Harries
Contact email
Sponsor organisation
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 those affected, impacting on quality of like, and resulting in increased rates of anxiety and depression.
Whilst several medical treatments are currently prescribed for AA there is considerable uncertainty regarding the most effective treatment options. Further, the treatment landscape for AA is changing, with new high-cost therapies (e.g., Janus kinase inhibitors) now becoming licensed for the treatment of this condition. Therefore, it is important to both patients and clinicians, and also the NHS, to know how these new, expensive drugs compare with existing therapies by capturing real-world data on treatment safety and effectiveness in the AA population (including children).
To do this an international collaboration termed the Global Registry of Alopecia areata disease Severity and treatment Safety (GRASS), of which GRASS-UK will be a member, have championed the concept of a global network of patient registries to meet this purpose.
GRASS-UK is a prospective, observational, multi-centre national clinical registry, which aims to determine the safety (pharmacovigilance) and effectiveness of treatments for AA. GRASS-UK will be part of international network of registries with harmonised datasets to generate high-quality, real-world data on existing and emerging therapies for AA. GRASS-UK will be hosted at the University of Manchester and governed by the British Association of Dermatologists.
The study will initially be piloted at 3 centres in England. Phase 1 expansion will be to centres with a specialist hair clinic and/or diphencyprone alopecia treatment service (34 in England / 4 in Scotland / 1 in NI / 1 in Wales) - these are the centres listed in question A72. After this, Phase 2 expansion will be to any dermatology centre in the UK.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
24/WM/0109
Date of REC Opinion
12 Jun 2024
REC opinion
Unfavourable Opinion