CT 327 in the Treatment of Psoriasis Vulgaris

This study has been completed.

Sponsor:

Information provided by:

Creabilis SA

ClinicalTrials.gov Identifier:

NCT00995969

First received: October 15, 2009

Last updated: February 9, 2011

Last verified: February 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 15, 2009
Last Updated Date	February 9, 2011
Start Date ^ICMJE	March 2010
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 15, 2009)	Improvements from baseline on m-Psoriasis Area Severity Index Scale (m-PASI - modified to exclude area assessment): Proportion of subjects with a reduction in score of > 50% at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00995969 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 15, 2009)	To assess the efficacy of an 8-week treatment of CT 327 vs Placebo in terms of improvements from baseline on: Proportion of subjects with a reduction in m-PASI-score of > 75% a Week 8 [ 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	CT 327 in the Treatment of Psoriasis Vulgaris
Official Title ^ICMJE	A Randomized, Double-Blind, Placebo Controlled Phase II, Multi-Centre, Study of the Efficacy and Safety of CT 327, a Topical Cream Formulation of Pegylated K252a, When Administered Twice Daily for Eight Weeks to Patients With Mild to Moderate Psoriasis Vulgaris
Brief Summary	This study will look at how safe and effective, a novel agent, CT 327 cream is in treating patients with mild to moderate psoriasis vulgaris (PV). Patients will be treated twice daily for 8 weeks on specific lesions of PV and safety and symptoms of PV will be assessed throughout the treatment period.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Psoriasis
Intervention ^ICMJE	Drug: placebo 1.0 g (w/w) placebo cream applied to both target lesions twice daily Drug: CT 327 1.0 g CT 327 cream will be applied to one target lesion twice daily and 1.0 g placebo cream will be applied to the remaining target lesion twice daily
Study Arm (s)	Placebo Comparator: Placebo only Subjects will apply placebo cream to both target lesions Intervention: Drug: placebo Active Comparator: Active plus placebo Subjects will apply CT 327 to one target lesion and placebo to the other target lesion Intervention: Drug: CT 327
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	58
Completion Date	January 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age > 18 and < 71 years of age Able to give informed consent Diagnosis of mild (affecting < 3% BSA) to moderate (affecting < 10% BSA) Psoriasis Vulgaris, including, at baseline visit, two symmetrical lesions of at least 10 cm2 each Exclusion Criteria: If female of childbearing potential not using an adequate and appropriate form of contraception such as oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch If female, are pregnant or lactating, or intend to become pregnant during the study period and one month thereafter Allergy to test drug or excipients Usage of topical corticosteroids or other topical treatments for PV within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment Within 4 weeks prior to study entry, have received systemic treatment for psoriasis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light). Received treatment with systemic or locally acting medications which might counter or influence the study aim Presence of major medical illness requiring systemic therapy including cancers Clinical diagnosis of bacterial infection of the skin including impetigo and abscesses Any clinical relevant ECG abnormality Have any clinically significant abnormal clinical laboratory test results at screening Received any investigational drug or taking part in any clinical study within three months prior to this study History of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug Have immune-compromised status (such as known human immunodeficiency virus infection) Have a history of malignancy, excluding basal cell carcinoma of the skin Have an active intercurrent infection Suffer from erythrodermic psoriasis, psoriasis punctata and pustular psoriasis or extended chronic stationary forms of psoriasis Have symptoms of a clinically significant illness that may influence the outcome of the study Have any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in or complete the trial, or which places the subject at undue risk
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Switzerland, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00995969
Other Study ID Numbers ^ICMJE	CT 327 PV 01-09
Has Data Monitoring Committee	No
Responsible Party	Professor Nikhil Yawalkar, Inselspital Bern
Study Sponsor ^ICMJE	Creabilis SA
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Creabilis SA
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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