This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic patients to better understand the skin penetration of topically applied BCT194.
Study Type
INTERVENTIONAL
Allocation
NA
Enrollment
12
Topically applied BCT194 cream (0.5%)
Novartis Investigative Site
Graz, Austria
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
Time frame: 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
Time frame: day 1 and day 8
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
Time frame: day 1 and day 8
Change in plaque PASI scores of psoriasis lesions
Treatment areas will be assessed clinically at baseline and Day 8
Time frame: 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.
Time frame: 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.
Time frame: Pre-dose, Day 1, Day 2, Day 3, Day 5, Day 8, Day 9 and Day 13
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