NCT01646567

SHP-141C in Plaque Type Psoriasis

A Double-Blind, Within-Subject Randomised, Placebo-Controlled, Proof of Concept, Comparison Study of SHP-141C Topical Cream in Psoriasis, Using the Microplaque Assay.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: TetraLogic Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Plaque Type Psoriasis

Interventions

Type	Name	Description
DRUG	SHP-141C	Topical Cream
DRUG	Placebo to SHP-141C	Placebo Topical Cream
DRUG	Betamethasone Valerate	Topical cream, 0.02%
DRUG	Calcipotriol	Topical cream, 0.005%

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-07-20
• Last updated: 2014-07-11

Locations

1 site across 1 country: Australia