Back to resultsEfficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Calcipotriol plus betamethasone dipropionate ointment
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris
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
Sites / Locations
- Fudan University First Hospital, Dermatology Department
Outcomes
Primary Outcome Measures
The percentage change of PASI at the end of week 4 compared with baseline
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00248456
Brief Title
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
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
LEO Pharma
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
320 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Calcipotriol plus betamethasone dipropionate ointment
Primary Outcome Measure Information:
Title
The percentage change of PASI at the end of week 4 compared with baseline
Secondary Outcome Measure Information:
Title
The change of PASI at the end of week 4 compared with baseline
Title
The change of Dermatology Life Quality Index at the end of week 4 compared with baseline
Title
Physician's Global Assessment at the end of week 4
Title
Patient's assessment by Visual Analogue Scale (VAS) at the end of week 4
Title
The change of individual scores of redness, thickness, and scaliness at the end of week 4 on the target lesion compared with baseline
Title
The change of overall lesion area percentage (scalp and face area excluded) at the end of week 4 compared with baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zheng Zhi Zhong, Professor
Organizational Affiliation
Fudan University First Hospital, Dermatology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University First Hospital, Dermatology Department
City
Shanghai
ZIP/Postal Code
200040
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris
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