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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT No. 2008-002795-96 |
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This study will determine the efficacy of topical BFH772 in psoriasis patients and the safety after multiple dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BFH772 cream 1% | Experimental |
| |
| Placebo to BFH772 cream 1% | Placebo Comparator |
| |
| BFH772 ointment 1% | Experimental |
| |
| Placebo to BFH772 ointment | Placebo Comparator |
| |
| calcipotriol/betamethasone ointment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BFH772 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Plaque PASI score | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Local tolerability | Time Frame: baseline (predose Day 1) and 1h, 3h, 6h after the morning dose, then before each application (morning and evening) until the morning application on Day 5 and then at each visit before the morning application, and at study completion | |
| Measure: BFH772 concentration in plasma |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Berlin | Germany |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| C055085 | calcipotriene |
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| BFH772 | Drug |
|
| Placebo | Drug |
|
| calcipotriol/betamethasone | Drug |
|
| Day 1: Pre-dose; 4h post dose. |
| Measure: BFH772 concentration in skin | Week 4 |
| D009140 | Musculoskeletal Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |