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

NCT ID: NCT00248456

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Calcipotriol plus betamethasone dipropionate ointment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Principal Investigators

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Zheng Zhi Zhong, Professor

Role: PRINCIPAL_INVESTIGATOR

Fudan University First Hospital, Dermatology Department

Locations

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Fudan University First Hospital, Dermatology Department

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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EX 0501 CN

Identifier Type: -

Identifier Source: org_study_id

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