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

History of Changes

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 Intervention Model: Single Group Assignment Masking: Double Blind (Participant, Care Provider, 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:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

Local and systemic toleration [ Time Frame: 8 weeks ]


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 (Adult, Senior)
Sexes Eligible for Study:	All
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


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

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 June 23, 2017

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