Back to resultsEvaluation of the Efficacy, Safety and Toleration of CT327 Ointment in Patients With Psoriasis Vulgaris
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CT327 0.05%
CT327 0.1%
CT327 0.5%
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring psoriasis vulgaris, topical ointment
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
0.05% (w/w) CT327 ointment
0.1% (w/w) CT327 ointment
0.5% (w/w) CT327 ointment
Placebo ointment
Arm Description
0.05% (w/w) CT327 ointment applied BID for up to 8 weeks.
0.1% (w/w) CT327 ointment applied BID for up to 8 weeks.
0.5% (w/w) CT327 ointment applied BID for up to 8 weeks.
Placebo ointment
Outcomes
Primary Outcome Measures
Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment.
Secondary Outcome Measures
Local and systemic toleration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01465282
Brief Title
Evaluation of the Efficacy, Safety and Toleration of CT327 Ointment in Patients With Psoriasis Vulgaris
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 Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creabilis SA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
Keywords
psoriasis vulgaris, topical ointment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.05% (w/w) CT327 ointment
Arm Type
Experimental
Arm Description
0.05% (w/w) CT327 ointment applied BID for up to 8 weeks.
Arm Title
0.1% (w/w) CT327 ointment
Arm Type
Experimental
Arm Description
0.1% (w/w) CT327 ointment applied BID for up to 8 weeks.
Arm Title
0.5% (w/w) CT327 ointment
Arm Type
Experimental
Arm Description
0.5% (w/w) CT327 ointment applied BID for up to 8 weeks.
Arm Title
Placebo ointment
Arm Type
Placebo Comparator
Arm Description
Placebo ointment
Intervention Type
Drug
Intervention Name(s)
CT327 0.05%
Intervention Description
0.05% CT327 (w/w) ointment
Intervention Type
Drug
Intervention Name(s)
CT327 0.1%
Intervention Description
0.1% CT327 (w/w) ointment
Intervention Type
Drug
Intervention Name(s)
CT327 0.5%
Intervention Description
0.5% CT327 (w/w) ointment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Local and systemic toleration
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Hotsprings
State/Province
Arkansas
Country
United States
City
San Ramon
State/Province
California
Country
United States
City
Bay City
State/Province
Michigan
Country
United States
City
Fridley
State/Province
Minnesota
Country
United States
City
South Euclid
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Spanish Fork
State/Province
Utah
Country
United States
City
Birmingham
Country
United Kingdom
City
Cardiff
Country
United Kingdom
City
Glasgow
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Merseyside
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy, Safety and Toleration of CT327 Ointment in Patients With Psoriasis Vulgaris
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