Status:
COMPLETED
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris
Lead Sponsor:
LEO Pharma
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00248456
Start Date
October 1 2005
End Date
February 1 2006
Last Update
February 24 2025
Active Locations (1)
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1
Fudan University First Hospital, Dermatology Department
Shanghai, China, 200040