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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002447-17 | EudraCT Number |
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This study is being conducted to evaluate the safety of topical BOS-475 compared to topically applied comparator formulations and vehicle.
This is a three-center, randomized, placebo- and comparator-controlled, double-blind for the Investigational Medicinal Products (IMPs), observer-blind for the controls, intraindividual comparison of all 6 treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOS-475 0.5% | Experimental | Daily application of BOS-475 0.5% |
|
| BOS-475 1% | Experimental | Daily application of BOS-475 1% |
|
| BOS-475 2% | Experimental | Daily application of BOS-475 2% |
|
| Active ingredient-free vehicle cream | Placebo Comparator | Daily application of vehicle cream |
|
| Daivonex cream | Active Comparator | Daily application of Daivonex cream (calcipotriol 0.005%) |
|
| Betnesol-V cream (betamethasone 0.1%) | Active Comparator | Daily application of Betnesol-V cream (betamethasone 0.1%) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOS-475 | Drug | topical cream |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events (TEAEs) | up to Day 19 | |
| Number of treatment-emergent application site reactions | up to Day 19 | |
| Change from Baseline in systolic and diastolic blood pressure | Baseline; up to Day 19 | |
| Change from Baseline in pulse | Baseline; up to Day 19 | |
| Change from Baseline in respiration | Baseline; up to Day 19 | |
| Change from Baseline in body temperature | Baseline; up to Day 19 | |
| Number of participants with clinically significant physical examination findings | up to Day 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in psoriatic infiltrate thickness on Day 19 (assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-megahertz (MHz) sonography) | Baseline; Day 19 | |
| Change from Baseline in psoriatic infiltrate thickness on Days 8 and 15 (assessed by measurement of the thickness of the EPB of the inflammatory infiltrate using 22-MHz sonography) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaobing Qian, MD, PhD | Boston Pharmaceuticals, Vice President, Clinical Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemeinschaftspraxis Dr. med. Johannes Niesmann und Dr. med. Nick Othlinghaus Hauszentrum im Jahrhunderthaus - Zentrum für klinische Studien | Bochum | Germany |
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| Active ingredient-free vehicle cream |
| Drug |
topical cream |
|
| Daivonex cream (calcipotriol 0.005%) | Drug | topical cream |
|
| Betnesol-V cream (betamethasone 0.1%) | Drug | topical cream |
|
| Baseline; Days 8 and 15 |
| Area under the curve (AUC) of change from Baseline in thickness of the EPB of the inflammatory infiltrate | Baseline; Day 19 |
| Change from Baseline in the test fields compared to the surrounding plaque skin, as an evaluation of the antipsoriatic efficacy by clinical assessment, using a 5-point score | -1 = worsened; 0 = unchanged (no effect); 1 = slight improvement; 2 = clear improvement but not completely healed; 3 = completely healed. | Baseline; Days 1, 8, 15, and 19 (End of Trial) |
| bioskin GmbH | Hamburg | Germany |
| Klinische Forschung Schwerin GmbH | Schwerin | Germany |