A Study of Sequential Treatment With Daivobet (Betamethasone Dipropionate Plus Calcipotriol) and Daivonex (Calcipotriol) in Patients With Psoriasis.
- Registration Number
- NCT00437619
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 calcipotriol hydrate [Daivonex] -
- Primary Outcome Measures
Name Time Method PASI reduction Weeks 4 and 8
- Secondary Outcome Measures
Name Time Method AEs. Throughout study