Evaluation of the Efficacy, Safety and Toleration of CT327 Ointment in Patients With Psoriasis Vulgaris

A Randomized, Placebo-controlled, Phase IIb Study to Evaluate the Efficacy, Safety and Tolerability of 0.05%, 0.1% and 0.5% w/w Topical CT327 When Applied Twice Daily in Subjects With Psoriasis Vulgaris

The purpose of this study is to evaluate the effectiveness of 3 dose strengths of CT327 ointment (0.05%, 0.1% and 0.05% w/w) compared to a placebo, when applied twice daily for up to 8 weeks, to the psoriatic plaques of patients with psoriasis vulgaris.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Placebo; Drug: CT327 0.05%; Drug: CT327 0.1%; Drug: CT327 0.5%

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
  • Cardiff, United Kingdom
  • Glasgow, United Kingdom
  • Manchester, United Kingdom
  • Merseyside, United Kingdom
• United States
  • Arkansas
    • Hotsprings, Arkansas, United States
  • California
    • San Ramon, California, United States
  • Michigan
    • Bay City, Michigan, United States
  • Minnesota
    • Fridley, Minnesota, United States
  • Ohio
    • South Euclid, Ohio, United States
  • Oregon
    • Portland, Oregon, United States
  • Texas
    • San Antonio, Texas, United States
  • Utah
    • Spanish Fork, Utah, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects aged at least 18 years.
• Stable psoriasis vulgaris

Exclusion Criteria:

• Subjects with guttate, erythrodermic, exfoliative or pustular psoriasis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo ointment	Drug: Placebo; Placebo
Experimental: 0.05% (w/w) CT327 ointment; 0.05% (w/w) CT327 ointment applied BID for up to 8 weeks.	Drug: CT327 0.05%; 0.05% CT327 (w/w) ointment
Experimental: 0.1% (w/w) CT327 ointment; 0.1% (w/w) CT327 ointment applied BID for up to 8 weeks.	Drug: CT327 0.1%; 0.1% CT327 (w/w) ointment
Experimental: 0.5% (w/w) CT327 ointment; 0.5% (w/w) CT327 ointment applied BID for up to 8 weeks.	Drug: CT327 0.5%; 0.5% CT327 (w/w) ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment.	Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Local and systemic toleration	8 weeks

Collaborators and Investigators

• Sponsor: Creabilis SA

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: November 1, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 4, 2011

Study Record Updates

• Last Update Posted (Estimate): March 8, 2013
• Last Update Submitted That Met QC Criteria: March 7, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: psoriasis vulgaris; topical ointment
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CT327-2003