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

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ClinicalTrials.gov Identifier: NCT01465282
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Creabilis SA

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: CT327 0.05% Drug: CT327 0.1% Drug: CT327 0.5% Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (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
Study Start Date : December 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment. [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Local and systemic toleration [ Time Frame: 8 weeks ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Creabilis SA
ClinicalTrials.gov Identifier: NCT01465282     History of Changes
Other Study ID Numbers: CT327-2003
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: March 8, 2013
Last Verified: March 2013

Keywords provided by Creabilis SA:
psoriasis vulgaris
topical ointment

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