PRO-SCALP Study
Research type
Research Study
Full title
An international, prospective, observational cohort study to assess patient treatment satisfaction, patient-reported outcomes, effectiveness, and safety of a fixed-dose combination of Calcipotriene/Betamethasone Dipropionate PAD cream in the treatment of mild-to-moderate plaque psoriasis of the scalp in adults (PRO-SCALP).
IRAS ID
326834
Contact name
Martin S Wade
Contact email
Sponsor organisation
Almirall, S.A.
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This is an international, prospective, observational, multicentre study to assess the satisfaction of adult patients with mild-to-moderate plaque psoriasis of the scalp with a fixed-dose combination of CAL/BDP PAD cream (Wynzora®) under real-life conditions. The main objective of this study is to assess the patient satisfaction with CAL/BDP PAD cream in a real-life setting.
A total of 300 patients with mild-to-moderate plaque psoriasis of the scalp will be included from three countries: Germany, Spain, and the United Kingdom (UK). Sites will be hospitals or outpatient offices where patients with mild-to-moderate plaque psoriasis of the scalp are usually managed. The participating physicians will be dermatologists or general practitioners with extended roles (specialised in dermatology).
In this study, CAL/BDP PAD cream will be prescribed according to Summary of Product Characteristics (SmPC). CAL/BDP PAD cream prescription to a patient will not be decided in advance by the study protocol but will be done within current clinical practice, thus the prescription of CAL/BDP PAD cream will be clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures will be applied to the patients. Data collection (using surveys) will begin when the clinician consents and recruits study eligible patients at respective sites. Each patient will be observed during two study visits that are part of usual: baseline visit, and end of study visit (EOS visit; at 8 + 4 weeks), or until the time of CAL/BDP PAD cream treatment discontinuation, whichever occurs earlier. In one site in the UK (in the lead center within UK), an additional patient visit will be observed at approximately 4 weeks from baseline. Patients and clinicians will complete patient-specific survey during study visits. Only de-identified information will be recorded study surveys, depicting patient health status and treatment outcomes.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0474
Date of REC Opinion
5 Jul 2023
REC opinion
Further Information Favourable Opinion