Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris - Full Text View

Sponsor:	LEO Pharma
Information provided by:	LEO Pharma
ClinicalTrials.gov Identifier:	NCT00248456

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 IV

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:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Calcipotriene Bentelan Betamethasone Betamethasone dipropionate

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: State 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 February 12, 2012