The PSO-ABLE trial
Research type
Research Study
Full title
LEO 90100 aerosol foam compared to calcipotriol plus betamethasone dipropionate gel in subjects with psoriasis vulgaris
IRAS ID
148568
Contact name
Christopher Griffiths
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2013-004686-14
ISRCTN Number
N/A
Research summary
Psoriasis is a common skin condition where patches or “plaques” develop which are thick, red and scaly and the psoriasis patients often suffer from itch. There are several treatments available which reduce the signs and symptoms of psoriasis. This trial is looking at a new treatment to be applied to the skin (a topical treatment) which is an aerosol foam (LEO 90100 aerosol foam), meaning it is sprayed onto the skin. This trial will look at this new treatment and how well it treats psoriasis compared with another existing topical treatment for psoriasis, a calcipotriol betamethasone dipropionate (BDP) gel. Both LEO 90100 aerosol foam and the calcipotriol BDP gel contain the same therapeutic ingredients – calcipotriol and betamethasone dipropionate, but patients may also receive a “vehicle only” treatment (a placebo treatment containing no therapeutic ingredients), which could be either the aerosol foam vehicle or the gel vehicle. The patients will be assigned to a treatment by chance. Neither the doctor nor the patient will know which treatment they are receiving, although the patient will know whether they are receiving an aerosol foam or a gel. The patients will apply the trial medication once daily for up to 12 weeks. Patients will be seen at NHS hospitals or GP surgeries within the UK. They will be able to participate if they have at least mild psoriasis and if they meet specific inclusion and exclusion criteria. Patients will participate in the trial for 12–18 weeks and will have 8-10 visits during this time when the safety of the patient and the condition of the psoriasis will be assessed.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/0132
Date of REC Opinion
29 May 2014
REC opinion
Further Information Favourable Opinion