Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris

Condition(s) targeted: Psoriasis Vulgaris

Intervention: Calcipotriol plus betamethasone dipropionate ointment (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: LEO Pharma

Official(s) and/or principal investigator(s):
Zheng Zhi Zhong, Professor, Principal Investigator, Affiliation: Fudan University First Hospital, Dermatology Department

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: The percentage change of PASI at the end of week 4 compared with baseline

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Fudan University First Hospital, Dermatology Department, Shanghai 200040, China

Starting date: October 2005
Last updated: February 20, 2008