Clinical trial NCT00248456: Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris
Official title: A Randomised, Double-blind, Active-controlled, Parallel, Multi-center Study to Investigate the Efficacy and Safety of Daivobet® Ointment in Patients With Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2005-11-04
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The percentage change of PASI at the end of week 4 compared with baseline
Secondary outcomes:
measure: The change of PASI at the end of week 4 compared with baseline
measure: The change of Dermatology Life Quality Index at the end of week 4 compared with baseline
measure: Physician's Global Assessment at the end of week 4
measure: Patient's assessment by Visual Analogue Scale (VAS) at the end of week 4
measure: The change of individual scores of redness, thickness, and scaliness at the end of week 4 on the target lesion compared with baseline
measure: The change of overall lesion area percentage (scalp and face area excluded) at the end of week 4 compared with baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University First Hospital, Dermatology Department
Study officials:
affiliation: Fudan University First Hospital, Dermatology Department
name: Zheng Zhi Zhong, Professor
role: PRINCIPAL_INVESTIGATOR
References: