SCRIPTOR - Non-interventional Retrospective Chart Review in GPP
Research type
Research Study
Full title
A non-interventional, international, multicentre study to characterise the clinical characteristics, disease burden, and unmet medical needs of Generalized Pustular Psoriasis (GPP) patients
IRAS ID
314707
Contact name
Christopher Griffiths
Contact email
Sponsor organisation
Boehringer Ingelheim
Clinicaltrials.gov Identifier
DERM 52824, NIHR CRN
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
This is an non-interventional, retrospective chart review study sponsered by Boehringer Ingelheim. The study will extract data from existing medical records across 5 UK sites and will include up to 50 patients diagnosed with Generalised pustular psoriasis (GPP).
GPP is a rare chronic, relapsing systemic inflammation of the skin and other organs. The disease presents as repeated flares of widespread sterile pustules, causing significant suffering or disability and may be life threatening in severe cases. GPP affects both children and adults, and women and men are affected equally, and the occurrence is thought to be higher in Asian than Caucasian populations.
Most cases of GPP have no identifiable cause, however, risk factors that are thought to have a role in its origin include: a positive family history of psoriasis, stress, corticosteroid use, steroid withdrawal, upper respiratory tract infections, and pregnancy.
GPP is a challenging disease to manage and the treatment approach involves topical and systemic therapies. The management approach is largely based on the treatment guidelines of plaque psoriasis. Treatments include oral retinoids, methotrexate, cyclosporine, topical corticosteroids, and topical therapy.
Limited data are available on the burden of disease, the clinical characteristics, general management of the disease, treatment patterns, and the long-term real-world outcomes. No gold standard therapy has yet been identified, and none of the available treatments are curative.
This non-interventional, retrospective chart review study aims to address these gaps and evaluate the care situation of GPP patients.
REC name
Wales REC 7
REC reference
22/WA/0266
Date of REC Opinion
11 Oct 2022
REC opinion
Further Information Favourable Opinion