A Study of Sequential Treatment With Daivobet (Betamethasone Dipropionate Plus Calcipotriol) and Daivonex (Calcipotriol) in Patients With Psoriasis.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: Calcipotriol hydrate [Daivonex] (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
Overall contact:
Please reference Study ID Number: RLI_ML19876, Phone: 973-235-5000
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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: PASI reduction
Secondary outcome: AEs.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Please reference Study ID Number: RLI_ML19876, Phone: 973-235-5000
SAO PAULO 05403-900, Brazil; Recruiting
BRASILIA 70840-901, Brazil; Recruiting
BELO HORIZONTE 30150-221, Brazil; Recruiting
RIO DE JANEIRO 20020-020, Brazil; Recruiting
CAMPINAS 13060-803, Brazil; Recruiting
RIO DE JANEIRO 22470-220, Brazil; Recruiting
SALVADOR 40110-170, Brazil; Recruiting
BELEM 66087-670, Brazil; Recruiting
BOTUCATU 18618-000, Brazil; Recruiting
CURITIBA 8000001003, Brazil; Recruiting
Additional Information
Starting date: February 2007
Ending date: September 2008
Last updated: July 16, 2008
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