Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bioskin GmbH | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The current most important topical treatments for psoriasis are vitamin D3 analogues and/or corticosteroids. The possibility of another effective treatment for psoriasis could be based on the immunosuppressive efficacy of selective blockers of a lymphocyte potassium channel.
The aim of the clinical trial is to evaluate the safety, tolerability and anti-psoriatic efficacy of topical SPS4251 formulations in comparison to placebo and to a marketed topical Vitamin-D analogue ointment in a psoriasis plaque test.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psoriasis Plaque Test | Experimental | SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPS4251 Ointment | Drug | Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate | Up to Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of anti-psoriatic efficacy by clinical assessment | Up to day 12 | |
| Number of subjects with Adverse Events | Up to day 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioskin | Berlin | Germany | ||||
| Bioskin |
Not provided
| ID | Term |
|---|---|
| C055085 | calcipotriene |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments) |
|
| Daivonex® ointment | Drug | Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments). |
|
|
| Hamburg |
| Germany |