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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcipotriol hydrate [Daivonex] | Drug | 50 micrograms/g bid for 4 weeks (weeks 5-8) in patients who have shown a >50% response to Daivobet from weeks 0-4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PASI reduction | Weeks 4 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| AEs. | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belém | 66087-670 | Brazil | ||||
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| Belo Horizonte |
| 30150-221 |
| Brazil |
| Botucatu | 18618-000 | Brazil |
| Brasília | 70840-901 | Brazil |
| Campinas | 13060-803 | Brazil |
| Curitiba | 8000001003 | Brazil |
| Rio de Janeiro | 20020-020 | Brazil |
| Rio de Janeiro | 22470-220 | Brazil |
| Salvador | 41110-170 | Brazil |
| São Paulo | 05403-900 | Brazil |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C055085 | calcipotriene |
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