Psoriasis Vulgaris
Conditions
Brief summary
Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with: 1. 4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8 weeks of calcipotriol cream 2. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate) ointment on weekends 3. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of vehicle of calcipotriol cream The objective is to compare the efficacy and safety of the different treatment regimens
Detailed description
A phase IV study of different treatment regimens of calcipotriol 50 mcg/g cream and combination (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) ointment following treatment with combination ointment in psoriasis vulgaris
Interventions
DRUGCalcipotriol, (calcipotriol + betamethasone)
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with psoriasis vulgaris of trunk and/or limbs
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of regimen (a) versus regimen (c) by % change in PASI at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of regimen (b) versus regimen (c) at week 12, safety of regimen (a) versus (c), safety of regimen (b) versus (c) | — |
Countries
Belgium, Canada, France, Germany, Netherlands, Spain, United Kingdom
Outcome results
None listed