CT 327 in the Treatment of Psoriasis Vulgaris

NCT ID: NCT00995969

Last Updated: 2011-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-01-31

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo only

Subjects will apply placebo cream to both target lesions

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

1.0 g (w/w) placebo cream applied to both target lesions twice daily

Active plus placebo

Subjects will apply CT 327 to one target lesion and placebo to the other target lesion

Group Type: ACTIVE_COMPARATOR

CT 327

Intervention Type: DRUG

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

Interventions

placebo

1.0 g (w/w) placebo cream applied to both target lesions twice daily

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Creabilis SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Inselspital Bern

Locations

Metrolina Medical Research

Charlotte, North Carolina, United States

New Hanover Medical Research

Wilmington, North Carolina, United States

Piedmont Medical Research, LLC

Winston-Salem, North Carolina, United States

Premier Medical Group, P.C.

Clarksville, Tennessee, United States

East Tennessee Medical Research

Johnson City, Tennessee, United States

University Hospital

Basel, , Switzerland

Inselspital

Bern, , Switzerland

Kantonsspital

Sankt Gallen, , Switzerland

University Hospital

Zurich, , Switzerland

Synexus Midlands

Birmingham, Midlands, United Kingdom

Synexus Scotland

Clydebank, Strathclyde, United Kingdom

Synexus Wales

Cardiff, , United Kingdom

Countries

United States; Switzerland; United Kingdom

Other Identifiers

CT 327 PV 01-09

Identifier Type: -

Identifier Source: org_study_id