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

Psoriasis Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248456
• Other study ID #: EX 0501 CN
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2005
• Last updated: February 20, 2008
• Start date: October 2005
• Est. completion date: February 2006

Study information

• Verified date: February 2008
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Calcipotriol plus betamethasone dipropionate ointment

Locations

Country	Name	City	State
China	Fudan University First Hospital, Dermatology Department	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Secondary	The change of Dermatology Life Quality Index at the end of week 4 compared with baseline
Secondary	Physician's Global Assessment at the end of week 4
Secondary	Patient's assessment by Visual Analogue Scale (VAS) at the end of week 4
Secondary	The change of individual scores of redness, thickness, and scaliness at the end of week 4 on the target lesion compared with baseline
Secondary	The change of overall lesion area percentage (scalp and face area excluded) at the end of week 4 compared with baseline