Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Hoffmann-La Roche |
---|---|
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00437619 |
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 |
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 |
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.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML19876 |
Study First Received: | February 19, 2007 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00437619 |
Health Authority: | Brazil: National Health Surveillance Agency |
Calcipotriene Naphazoline Betamethasone-17,21-dipropionate Oxymetazoline Skin Diseases Guaifenesin |
Phenylephrine Psoriasis Betamethasone sodium phosphate Phenylpropanolamine Betamethasone Skin Diseases, Papulosquamous |
Anti-Inflammatory Agents Therapeutic Uses Dermatologic Agents Pharmacologic Actions |