Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-004690-10 | EudraCT Number |
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
This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic patients to better understand the skin penetration of topically applied BCT194.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCT194 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCT194 | Drug | Topically applied BCT194 cream (0.5%) |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in Maximum dermal interstitial concentration of BCT194 | Interstitial fluid will be collected and concentrations of BCT194 determined determined on Day 1 and Day 8 at several timepoints | Day 1 and day 8 |
| Area under the curve interstitial concentrations of BCT194 | Interstitial fluid will be collected and concentrations of BCT194 determined on Day 1 and Day 8 at several timepoints | day 1 and day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of locally produced tumor necrosis factor-alpha (TNF-alpha) | Interstitial fluid will be collected and concentrations of Tumor Necrosis Factor alpha determined determined on Day 1 and Day 8 at several timepoints | day 1 and day 8 |
| Change in plaque PASI scores of psoriasis lesions |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Graz | Austria |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Treatment areas will be assessed clinically at baseline and Day 8 |
| day 1 and day 8 |
| BCT194 concentrations in skin biopsies | Biopsies of lesional and nonlesional skin will be collected 4 hours post dose on Day 1 and Day 8 for measurement of BCT194 concentration. | day 1 and day 8 |
| Change in Local tolerability score | Local tolerability assessed using a validated score (0-4) for each treatment area Safety Issue: Treatment sites will be visually assessed for visible reaction to the treatment. | Pre-dose, Day 1, Day 2, Day 3, Day 5, Day 8, Day 9 and Day 13 |