A Study of Sequential Treatment With Daivobet (Betamethasone Dipropionate Plus Calcipotriol) and Daivonex (Calcipotriol) in Patients With Psoriasis. - Tabular View

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Descriptive Information Fields

Brief Title ^†

A Study of Sequential Treatment With Daivobet (Betamethasone Dipropionate Plus Calcipotriol) and Daivonex (Calcipotriol) in Patients With Psoriasis.

Official Title ^†

An Open Label Study to Evaluate the Clinical Response to Sequential Treatment With Daivobet and Daivonex in Patients With Mild to Moderate Psoriasis

Brief Summary

This single arm study will evaluate the efficacy and safety of sequential treatment with Diavobet (betamethasone propionate 0.5mg/g plus calcipotriol hydrate 50 micrograms/g) once daily for 4 weeks followed by Daivonex (calcipotriol hydrate 50 micrograms/g) twice daily for 4 weeks, in the control of signs and symptoms in patients with mild to moderate psoriasis. Only patients showing a >50% response to Daivobet will progress to the Daivonex maintenance phase. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

PASI reduction [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

AEs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Condition ^†

Psoriasis

Intervention ^†

Drug: Calcipotriol hydrate [Daivonex]

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

198

Start Date ^†

February 2007

Completion Date

April 2009

Eligibility Criteria ^†

Inclusion Criteria:

adult patients >=18 years of age;
clinical diagnosis of psoriasis vulgaris;
PASI score 1-12 in >=1 body area.

Exclusion Criteria:

clinical presentation of erythrodermic pustular psoriasis, expressed in plates and localized lesions on face and/or scalp;
viral, fungal or bacterial skin infections;
use of any topical treatment for psoriasis within previous 15 days;
use of any systemic therapy and phototherapy for psoriasis within previous 30 days.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Brazil

Administrative Information Fields

NCT ID ^†

NCT00437619

Organization ID

ML19876

Secondary IDs ^††

Study Sponsor ^†

Hoffmann-La Roche

Collaborators ^††

Investigators ^†

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

December 2008

First Received Date ^†

February 19, 2007

Last Updated Date

December 2, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.