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: April 7, 2014
Last verified: April 2014
  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
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
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

No publications provided

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: April 7, 2014
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Calcipotriene
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on April 16, 2014