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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary:

• The percentage change of PASI at the end of week 4 compared with baseline

Secondary:

• 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

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

Lead Sponsor: LEO Pharma

Fudan University First Hospital, Dermatology Department

Shanghai  200040 China

Overall Clinical Trial Officials and Contacts

Zheng Zhi Zhong, Professor Principal Investigator Fudan University First Hospital, Dermatology Department  

Information obtained from ClinicalTrials.gov on July 23, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00248456

Study ID Number: EX 0501 CN

ClinicalTrials.gov Identifier: NCT00248456

Health Authority: China: State Food and Drug Administration