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

Tracking Information

First Received Date ^ICMJE

February 19, 2007

Last Updated Date

November 17, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

PASI (Psoriasis Area and Severity Index) reduction at treatment start-up and end of treatment (week 8); PASI 50 (difference in PASI value at treatment start-up and week 4);PASI reduction from week 4 to week 8.

Change History

Complete list of historical versions of study NCT00437619 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Adverse events

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

Drug: Calcipotriol hydrate [Daivonex]

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

August 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT ID ^ICMJE

NCT00437619

Responsible Party

Disclosures Group, Hoffmann-La Roche

Study ID Numbers ^ICMJE

ML19876

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP