Trial Information

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

Status: No longer recruiting

Protocol Number: ML19876

Sponsor: Produtos Roche Químicos e Farmacêuticos S.A.

Company Division: Pharmaceutical

Official Scientific Title: An open label study to evaluate the clinical response to sequential treatment with Daivobet and Daivonex in patients with mild to moderate psoriasis

Brief Summary: 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. Target sample size is 198.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

Condition: Psoriasis

Intervention Type: Drug

Intervention Name: Calcipotriol hydrate [Daivonex]

Primary Outcome: 1. PASI reduction Time frame: Weeks 4 and 8

Key Secondary Outcomes: 1. AEs. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: February, 2007

Trial Registration Date: 02/19/2007

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: September 2, 2008 at 2:13:22 PM