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”

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 Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• PASI reduction
  • Time Frame: Weeks 4 and 8
    Safety Issue?: No

Secondary Measures

• AEs.
  • Time Frame: Throughout study
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche, +1 973 235 5000  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00437619

Study ID Number: ML19876

ClinicalTrials.gov Identifier: NCT00437619

Health Authority: Brazil: National Health Surveillance Agency