SHP-141C in Plaque Type Psoriasis
The purpose of this study is to assess the safety, tolerability and clinical activity of the SHP-141C topical cream formulations in patients with plaque type psoriasis.
Plaque Type Psoriasis
Drug: Placebo to SHP-141C
Drug: Betamethasone Valerate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Within-Subject Randomised, Placebo-Controlled, Proof of Concept, Comparison Study of SHP-141C Topical Cream in Psoriasis, Using the Microplaque Assay.|
- Change from baseline in Local Plaque Severity Index (LPSI) [ Time Frame: Baseline, day 15, day 33 ] [ Designated as safety issue: No ]Measurement of plaque severity including erythema, induration, and desquamation.
- The number of patients with adverse events [ Time Frame: daily to and including Day33 ] [ Designated as safety issue: Yes ]Adverse event data for each subject will be collected.
|Study Start Date:||September 2012|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate
A 100 mg dose of SHP-141C cream at three concentrations (0.5%, 1.0% and 2.0%), a matched placebo cream and two reference treatments: Calcipotriol 0.005% cream and Betamethasone Valerate 0.02% cream, applied topically to a selected plaque on each subject, six times per week over 28 days for a total of 24 doses.
Other Name: SHAPEDrug: Placebo to SHP-141C
Placebo Topical Cream
Other Name: Placebo to SHAPEDrug: Betamethasone Valerate
Topical cream, 0.02%
Other Name: Celestone-MDrug: Calcipotriol
Topical cream, 0.005%
Other Name: Daivonex
Psoriasis is a chronic, relapsing immunoinflammatory disorder. Chronic plaque psoriasis is the most common (85% - 90%) type. Cutaneous features of individual plaques include circular with centrifugal expansion, induration with sharp demarcation from surrounding skin, erythema and hyperkeratosis. Psoriasis has a negative impact on physical and mental aspects of life that is similar to other major chronic conditions. The modalities of psoriasis treatments can be divided into four main categories: topical, phototherapy, systemic drug therapies and systemic biological treatments. The currently available treatments for psoriasis result in either disease suppression or disease remission.There are many treatment options for the management of psoriasis using topical modalities; however all are lacking with respect to patient satisfaction and durability of treatment. Most current topical treatments, and many treatments in development, are based on modifications of a steroid structure or on Vitamin D. Recent research has identified a broad role for histone deacetylase (HDAC) proteins in numerous signaling pathways critical to cancer cell survival, such as epigenetic inheritance, gene regulation, mitosis,signal transduction and importantly, inflammation. Theoretically modulation of HDAC could lead to clinical benefit in inflammatory diseases.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646567
|Nucleus Network Limited|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator:||Peter Foley||The Alfred|