Psoriasis
Conditions
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.
Interventions
DRUGcalcipotriol 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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PASI reduction | Weeks 4 and 8 |
Secondary
| Measure | Time frame |
|---|---|
| AEs. | Throughout study |
Countries
Brazil
Outcome results
None listed