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

This study has been completed.
Sponsor:
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00248456
First received: November 3, 2005
Last updated: February 20, 2008
Last verified: February 2008
History of Changes

November 3, 2005
February 20, 2008
October 2005
Not Provided
The percentage change of PASI at the end of week 4 compared with baseline
Same as current
Complete list of historical versions of study NCT00248456 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
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Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Psoriasis Vulgaris
Drug: Calcipotriol plus betamethasone dipropionate ointment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
February 2006
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00248456
EX 0501 CN
Not Provided
Not Provided
LEO Pharma
Not Provided
Principal Investigator: Zheng Zhi Zhong, Professor Fudan University First Hospital, Dermatology Department
LEO Pharma
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP