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Evaluate the effects of topical C-82 in a psoriasis plaque test.
The primary objective of this trial is to evaluate antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate using 20 MHz sonography. To gain additional information about possible efficacy the change of the test fields compared to untreated plaque will be clinically assessed by visual scoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMP 1 | Experimental | C-82 Topical Gel, 1% |
|
| IMP 2 | Placebo Comparator | C-82 Topical Gel, placebo |
|
| IMP 3 | Active Comparator | Daivonex cream |
|
| IMP 4 | Active Comparator | Diprosis gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-82 Topical Gel, Placebo | Drug | placebo |
| |
| C-82 Topical Gel, 1% |
| Measure | Description | Time Frame |
|---|---|---|
| antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate | day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| antipsoriatic efficacy compared to control by clinical assessment using a 5-point score. | Day 8 & Day 12 | |
| number of subjects with adverse events | daily through Day 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Theis, MD | Klinische Forschung Schwerin GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schwerin | 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 |
|---|---|
| C055085 | calcipotriene |
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
active |
|
| Daivonex cream | Drug | comparator |
|
|
| Diprosis gel | Drug | comparator |
|
|
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |