Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris
Phase 4
Completed
- Conditions
- Psoriasis Vulgaris
- Registration Number
- NCT00248456
- Lead Sponsor
- LEO Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The percentage change of PASI at the end of week 4 compared with baseline
- Secondary Outcome Measures
Name Time Method The change of PASI at the end of week 4 compared with baseline 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 Patient's assessment by Visual Analogue Scale (VAS) at the end of week 4 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
Trial Locations
- Locations (1)
Fudan University First Hospital, Dermatology Department
🇨🇳Shanghai, China