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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: calcipotriol hydrate [Daivonex] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Belem 66087-670, Brazil

Belo Horizonte 30150-221, Brazil

Botucatu 18618-000, Brazil

Brasilia 70840-901, Brazil

Campinas 13060-803, Brazil

Curitiba 8000001003, Brazil

Rio de Janeiro 20020-020, Brazil

Rio de Janeiro 22470-220, Brazil

Salvador 41110-170, Brazil

Sao Paulo 05403-900, Brazil

Additional Information

Starting date: February 2007
Last updated: August 17, 2015

Page last updated: August 23, 2015

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