Psoriasis Vulgaris
Conditions
Brief summary
This study will evaluate the efficacy and safety of calcipotriol plus betamethasone dipropionate ointment compared with calcipotriol ointment in the treatment of patients with psoriasis vulgaris for a duration of 4 weeks. The study will focus on the percentage change of the psoriasis area and severity index (PASI) from baseline to the end of week 4.
Interventions
DRUGCalcipotriol plus betamethasone dipropionate ointment
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of psoriasis vulgaris in a stable condition * Extent of at least 10% of one or more body regions * Amenable to topical therapy with maximum of 100 g/week of investigational product
Exclusion criteria
* Patients with more than 30% of body surface area involved * Patients with facial psoriasis who need treatment * Patients who need treatment of scalp psoriasis with WHO group IV topical corticosteroids, tretinoin or topical vitamin D derivatives * Patients with unstable forms of psoriasis including guttate, erythrodermic, pustular, or arthritis psoriasis * Systemic treatment of psoriasis with corticosteroids or other therapy * Systemic antipsoriatic treatment (e.g. corticosteroids, immunosuppressive drugs, tretinoin, antibiotics, phototherapy or calcium agents) within 4 weeks prior to visit 1; or topical antipsoriatic treatment (e.g. keratolytics, topical corticosteroids, topical vitamin D derivatives, anthralin, crude coal tar, etc) within the previous 2 week period * Patients with planned exposure to phototherapy that may affect the psoriasis during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage change of PASI at the end of week 4 compared with baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of Dermatology Life Quality Index at the end of week 4 compared with baseline | — |
| Physician's Global Assessment at the end of week 4 | — |
| The change of PASI at the end of week 4 compared with baseline | — |
| The change of individual scores of redness, thickness, and scaliness at the end of week 4 on the target lesion compared with baseline | — |
| The change of overall lesion area percentage (scalp and face area excluded) at the end of week 4 compared with baseline | — |
| Patient's assessment by Visual Analogue Scale (VAS) at the end of week 4 | — |
Countries
China
Outcome results
None listed