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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000962-47 | EudraCT Number |
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To explore the efficacy and safety of four BAY1003803 formulations by means of a within subject comparison in an open Psoriasis Plaque Test
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY1003803 0.1% lipophilic cream | Experimental | BAY1003803 0.1% lipophilic cream (on plaque and healthy skin) |
|
| BAY1003803 0.1% ointment | Experimental | BAY1003803 0.1% ointment (on plaque and healthy skin) |
|
| BAY1003803 0.01% lipophilic cream | Experimental | BAY1003803 0.01% lipophilic cream (on plaque and healthy skin) |
|
| BAY1003803 0.01% ointment | Experimental | BAY1003803 0.01% ointment (on plaque and healthy skin) |
|
| Clobetasol propionate | Active Comparator | Clobetasol propionate ointment 0.05 % (on plaque and healthy skin) |
|
| Betamethasone/calcipotriene | Active Comparator | Betamethasone/calcipotriene ointment 0.05 %/0.005% (on healthy skin) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1003803 | Drug | Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in infiltrate thickness from day 1 to day 29 measured by sonography using 22 MHz B mode ultrasound | Day 1 to 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamburg | Free and Hanseatic City of Hamburg | 20095 | Germany | |||
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| 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 |
|---|---|
| D002990 | Clobetasol |
| C517164 | betamethasone dipropionate, calcipotriol drug combination |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Clobetasol propionate | Drug | Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect |
|
| Betamethasone/calcipotriene | Drug | Simultaneous application of 10μl on healthy skin for 4 weeks and evaluation of pharmacodynamic effect |
|
| Schwerin |
| Mecklenburg-Vorpommern |
| 19055 |
| Germany |
| Bochum | North Rhine-Westphalia | 44803 | Germany |
| D011083 |
| Polycyclic Compounds |