Evaluation of the Efficacy, Safety and Toleration of CT327 Ointment in Patients With Psoriasis Vulgaris
This study has been completed.
Sponsor:
Creabilis SA
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
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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
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 Skin Diseases, Papulosquamous |
ClinicalTrials.gov processed this record on February 27, 2015