MedDataX Logo

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

NCT ID: NCT00437619

Last Updated: 2015-12-02

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

calcipotriol hydrate [Daivonex]

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Belém, , Brazil

Site Status

Belo Horizonte, , Brazil

Site Status

Botucatu, , Brazil

Site Status

Brasília, , Brazil

Site Status

Campinas, , Brazil

Site Status

Curitiba, , Brazil

Site Status

Rio de Janeiro, , Brazil

Site Status

Rio de Janeiro, , Brazil

Site Status

Salvador, , Brazil

Site Status

São Paulo, , Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ML19876

Identifier Type: -

Identifier Source: org_study_id