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
  Purpose

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.


Condition Intervention Phase
Psoriasis Vulgaris
Drug: Calcipotriol plus betamethasone dipropionate ointment
Phase 4

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

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

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

Estimated Enrollment: 320
Study Start Date: October 2005
Estimated Study Completion Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248456

Locations
China
Fudan University First Hospital, Dermatology Department
Shanghai, China, 200040
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Zheng Zhi Zhong, Professor Fudan University First Hospital, Dermatology Department
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00248456     History of Changes
Other Study ID Numbers: EX 0501 CN
Study First Received: November 3, 2005
Last Updated: February 20, 2008
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Calcipotriene
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on April 15, 2014