LEO 90100 twice weekly maintenance regimen for psoriasis vulgaris
Research type
Research Study
Full title
A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis vulgaris. A 12 month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm, parallel group trial.
IRAS ID
208172
Contact name
Richard Warren
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2016-000556-95
Clinicaltrials.gov Identifier
DERM 30731, CCRN
Duration of Study in the UK
2 years, 1 months, 0 days
Research summary
Psoriasis is an inflammatory skin disease that affects 2-3% of the population worldwide. Most patients have plaque
psoriasis on the scalp, elbows and knees. Lesions can be painful and itchy causing emotional and physical
discomfort.
Psoriasis is a life-long disease for most patients, the majority of patients present with mild to moderate disease
which can be treated with topical treatment. Often when treatment is discontinued the lesions will reappear. There is
a need for a safe and effective long-term treatment plan in order to treat and prevent recurrence.
This trial will assess the safety and efficacy of a topical product (active drug) containing calcipotriol 50mcg/g and
betamethasone 0.5mg/g as a dipropionate (currently marketed in the UK as Enstilar®).
This study will be conducted in adults, with a diagnosis of psoriasis vulgaris for more than 6 months. The psoriasis
should cover 2-30% of their body surface area, excluding the scalp.
Eligible patients will enter an open label phase for 4 weeks where all subjects will apply active drug daily to the
affected lesions. Subjects, not responding to this treatment will leave the trial after the open label 4 weeks. Subjects
who respond to the active drug will continue into the 52 week maintenance period and will be randomised into either
of the two arms; one receiving active drug the other receiving placebo. Subjects will apply the randomised treatment
twice weekly to their lesions and attend study visits every 4 weeks throughout the trial. In the event of a relapse the
subject will make an appointment with their trial doctor. If the subjects meet the criteria for relapse they will begin
therapy with active drug daily for 4 weeks. Subjects will complete questionnaires and monitor their psoriasis
symptoms throughout the study. This trial will be conducted both at GP practices and Hospitals.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
16/WM/0478
Date of REC Opinion
3 Jan 2017
REC opinion
Further Information Favourable Opinion