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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Belo Horizonte, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

calcipotriol hydrate [Daivonex]

Drug

50 micrograms/g bid for 4 weeks (weeks 5-8) in patients who have shown a >50% response to Daivobet from weeks 0-4.

Primary outcomes

PASI reduction

Time frame: Weeks 4 and 8

Secondary outcomes

AEs.

Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Feb 21, 2007
Registry last updated: Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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