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

Overview

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.

Full Title of Study: “An Open Label Study to Evaluate the Clinical Response to Sequential Treatment With Daivobet and Daivonex in Patients With Mild to Moderate Psoriasis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2009

Interventions

  • 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

  • Experimental: 1

Clinical Trial Outcome Measures

Primary Measures

  • PASI reduction
    • Time Frame: Weeks 4 and 8

Secondary Measures

  • AEs.
    • Time Frame: Throughout study

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Hoffmann-La Roche

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