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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creabilis SA
ClinicalTrials.gov Identifier:
NCT01465282
First received: November 1, 2011
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Psoriasis Vulgaris
Drug: CT327 0.05%
Drug: CT327 0.1%
Drug: CT327 0.5%
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Creabilis SA:

Primary Outcome Measures:
  • Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local and systemic toleration [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: December 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo ointment
Placebo ointment
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects with guttate, erythrodermic, exfoliative or pustular psoriasis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465282

Locations
United States, Arkansas
Hotsprings, Arkansas, United States
United States, California
San Ramon, California, United States
United States, Michigan
Bay City, Michigan, United States
United States, Minnesota
Fridley, Minnesota, United States
United States, Ohio
South Euclid, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Texas
San Antonio, Texas, United States
United States, Utah
Spanish Fork, Utah, United States
United Kingdom
Birmingham, United Kingdom
Cardiff, United Kingdom
Glasgow, United Kingdom
Manchester, United Kingdom
Merseyside, United Kingdom
Sponsors and Collaborators
Creabilis SA
  More Information

No publications provided

Responsible Party: Creabilis SA
ClinicalTrials.gov Identifier: NCT01465282     History of Changes
Other Study ID Numbers: CT327-2003
Study First Received: November 1, 2011
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Creabilis SA:
psoriasis vulgaris
topical ointment

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014