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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00437619

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: Calcipotriol hydrate [Daivonex]	Phase IV

MedlinePlus related topics: Psoriasis

Drug Information available for: Calcipotriene Betamethasone Bentelan Betamethasone dipropionate Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:

Interventional

Study Design:

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

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:

198

Study Start Date:

February 2007

Estimated Study Completion Date:

April 2009

Arms	Assigned Interventions
1: Experimental	Drug: Calcipotriol hydrate [Daivonex] 50 micrograms/g bid for 4 weeks (weeks 5-8) in patients who have shown a >50% response to Daivobet from weeks 0-4.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437619

Locations

Brazil

SAO PAULO, Brazil, 05403-900

BRASILIA, Brazil, 70840-901

BELO HORIZONTE, Brazil, 30150-221

RIO DE JANEIRO, Brazil, 20020-020

CAMPINAS, Brazil, 13060-803

CURITIBA, Brazil, 8000001003

SALVADOR, Brazil, 40110-170

BELEM, Brazil, 66087-670

BOTUCATU, Brazil, 18618-000

RIO DE JANEIRO, Brazil, 22470-220

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:

Hoffmann-La Roche ( Clinical Trials, Study Director )

Study ID Numbers:

ML19876

First Received:

February 19, 2007

Last Updated:

December 2, 2008

ClinicalTrials.gov Identifier:

NCT00437619

Health Authority:

Brazil: National Health Surveillance Agency

Study placed in the following topic categories:

Calcipotriene
Naphazoline
Betamethasone-17,21-dipropionate
Oxymetazoline
Skin Diseases
Guaifenesin

Phenylephrine
Psoriasis
Betamethasone sodium phosphate
Phenylpropanolamine
Betamethasone
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 07, 2009