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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: calcipotriol hydrate [Daivonex]

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Belem, Brazil, 66087-670
  • Belo Horizonte, Brazil, 30150-221
  • Botucatu, Brazil, 18618-000
  • Brasilia, Brazil, 70840-901
  • Campinas, Brazil, 13060-803
  • Curitiba, Brazil, 8000001003
  • Rio de Janeiro, Brazil, 20020-020
  • Rio de Janeiro, Brazil, 22470-220
  • Salvador, Brazil, 41110-170
  • Sao Paulo, Brazil, 05403-900

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PASI reduction	Weeks 4 and 8

Secondary Outcome Measures

Outcome Measure	Time Frame
AEs.	Throughout study

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (ACTUAL): August 1, 2009
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: February 19, 2007
• First Submitted That Met QC Criteria: February 19, 2007
• First Posted (ESTIMATE): February 21, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Calcipotriene
• Other Study ID Numbers: ML19876