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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
  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:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

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 May 19, 2013