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
|
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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 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 |

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
|
- Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment. [ Time Frame: Week 8 ]
- Local and systemic toleration [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female subjects aged at least 18 years.
- Stable psoriasis vulgaris
Exclusion Criteria:
- Subjects with guttate, erythrodermic, exfoliative or pustular psoriasis.

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
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 |
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 |