Back to resultsA Study of Sequential Treatment With Daivobet (Betamethasone Dipropionate Plus Calcipotriol) and Daivonex (Calcipotriol) in Patients With Psoriasis.
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
calcipotriol hydrate [Daivonex]
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
PASI reduction
Secondary Outcome Measures
AEs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00437619
Brief Title
A Study of Sequential Treatment With Daivobet (Betamethasone Dipropionate Plus Calcipotriol) and Daivonex (Calcipotriol) in Patients With Psoriasis.
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 Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
calcipotriol hydrate [Daivonex]
Intervention Description
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 Outcome Measure Information:
Title
PASI reduction
Time Frame
Weeks 4 and 8
Secondary Outcome Measure Information:
Title
AEs.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Belem
ZIP/Postal Code
66087-670
Country
Brazil
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
City
Botucatu
ZIP/Postal Code
18618-000
Country
Brazil
City
Brasilia
ZIP/Postal Code
70840-901
Country
Brazil
City
Campinas
ZIP/Postal Code
13060-803
Country
Brazil
City
Curitiba
ZIP/Postal Code
8000001003
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
20020-020
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
22470-220
Country
Brazil
City
Salvador
ZIP/Postal Code
41110-170
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
A Study of Sequential Treatment With Daivobet (Betamethasone Dipropionate Plus Calcipotriol) and Daivonex (Calcipotriol) in Patients With Psoriasis.
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