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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00437619
First Posted: February 21, 2007
Last Update Posted: December 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • PASI reduction [ Time Frame: Weeks 4 and 8 ]

Secondary Outcome Measures:
  • AEs. [ Time Frame: Throughout study ]

Enrollment: 200
Study Start Date: February 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437619


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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00437619     History of Changes
Other Study ID Numbers: ML19876
First Submitted: February 19, 2007
First Posted: February 21, 2007
Last Update Posted: December 2, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Calcitriol
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents