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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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00437619
First received: February 19, 2007
Last updated: December 1, 2015
Last verified: December 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AEs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: February 19, 2007
Last Updated: December 1, 2015
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Calcitriol
Betamethasone-17,21-dipropionate
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
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on September 29, 2016