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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006600-37 | EudraCT Number | ||
| C3291022 | Other Identifier | Alias Study Number |
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The purpose of this study is to investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations with AN2728 in subjects with psoriasis vulgaris.
The study will be performed in 12 male subjects with stable psoriatic plaques. The study preparations and the comparator will be tested observer-blind. Treatments will be randomly assigned to the test fields. All subjects will receive all treatments, with intraindividual comparison of the treatments.
Altogether six test fields will be examined per subject (four active AN2728 creams of different concentrations: 2 %, 1 %, 0.3 %, 0.03 %, the active ingredient-free vehicle, and a marketed corticoid preparation). The test fields will be treated occlusively over a study period of 12 days. Topical application of approximately 200 uL of each assigned intervention is administered per treatment, for a total of 10 treatments over a 12-day treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AN2728 Cream, 2% |
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| 2 | Experimental | AN2728 Cream, 1% |
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| 3 | Experimental | AN2728 Cream, 0.3% |
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| 4 | Placebo Comparator | AN2728 Cream Vehicle |
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| 5 | Active Comparator | Betnesol®-V Creme (betamethasone 0.1 %) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AN2728 Cream, 2% | Drug |
| ||
| AN2728 Cream, 1% |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the active study preparations compared to the corresponding vehicle using differences in infiltrate thickness on study day 12. | Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in infiltrate thickness | Day 8 | |
| Sonographic measurements of infiltrate thickness | Day 8, Day 12 | |
| The AUC of the infiltrate thickness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioskin GmbH | Hamburg | 10117 | 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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| AN2728 Cream, 0.3% | Drug |
|
| AN2728 Cream Vehicle | Drug |
|
| Betnesol®-V Creme, 0.1% | Drug |
|
|
| Day 8, Day 12 |
| Clinical assessment scores for assessment of efficacy | Day 8, Day 12 |