Study of the Safety, Tolerability and Efficacy of BCT194 in Healthy Volunteers and Patients With Psoriasis.
The purpose of this study is to assess the local tolerability of a single topical administration of BCT194 in healthy volunteers and, potentially, to evaluate the safety, tolerability, and efficacy of a multiple topical administrations in patients with psoriasis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multicenter, Double-Blind, Placebo Controlled Exploratory Study to Evaluate the Safety, Tolerability and Pharmacodynamics of a Single Administration of BCT194 in Healthy Volunteers and Multiple Administrations in Patients With Psoriasis.|
- Safety & tolerability
- Efficacy as assessed by plaque Psoriasis Area and Severity Index (PASI) scoring at 4 weeks
- Potential of absorption of topical BCT194 into the systemic circulation and to determine skin exposure
- Cellular changes in psoriasis skin by immunohistology at day 8
- Changes in HSP-27 and phospho (p) HSP-27 in protein lysates of skin biopsies at Day 8
|Study Start Date:||November 2006|
|Study Completion Date:||November 2007|