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

Tracking Information
First Received Date ^ICMJE	November 1, 2011
Last Updated Date	March 7, 2013
Start Date ^ICMJE	December 2011
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 2, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01465282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 2, 2011)	Local and systemic toleration [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of the Efficacy, Safety and Toleration of CT327 Ointment in Patients With Psoriasis Vulgaris
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Psoriasis Vulgaris
Intervention ^ICMJE	Drug: CT327 0.05% 0.05% CT327 (w/w) ointment Drug: CT327 0.1% 0.1% CT327 (w/w) ointment Drug: CT327 0.5% 0.5% CT327 (w/w) ointment Drug: Placebo Placebo
Study Arm (s)	Experimental: 0.05% (w/w) CT327 ointment 0.05% (w/w) CT327 ointment applied BID for up to 8 weeks. Intervention: Drug: CT327 0.05% Experimental: 0.1% (w/w) CT327 ointment 0.1% (w/w) CT327 ointment applied BID for up to 8 weeks. Intervention: Drug: CT327 0.1% Experimental: 0.5% (w/w) CT327 ointment 0.5% (w/w) CT327 ointment applied BID for up to 8 weeks. Intervention: Drug: CT327 0.5% Placebo Comparator: Placebo ointment Placebo ointment Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	160
Completion Date	September 2012
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male and female subjects aged at least 18 years. Stable psoriasis vulgaris Exclusion Criteria: Subjects with guttate, erythrodermic, exfoliative or pustular psoriasis.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01465282
Other Study ID Numbers ^ICMJE	CT327-2003
Has Data Monitoring Committee	No
Responsible Party	Creabilis SA
Study Sponsor ^ICMJE	Creabilis SA
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Creabilis SA
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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