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

Roche

Status and phase: Completed; Phase 4

Conditions: Psoriasis

Treatments: Drug: calcipotriol hydrate [Daivonex]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00437619

ML19876

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

1

Experimental group

Treatment:

Drug: calcipotriol hydrate [Daivonex]