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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Calcipotriene; Calcitriol

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.