CT 327 in the treatment of psoriasis vulgaris: 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 - CT 327 in the treatment of psoriasis vulgaris

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 36

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,similar sized, target plaques, comparable in severity, on either side, of at least 10 cm2 each

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Subject or partner of subject not using an adequate and appropriate form of contraception such as condom (male) or oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch (female)
•Subject or partner of subject are pregnant or lactating, or intend to become pregnant during the study period and one month thereafter
•Allergy to test drug or any other ingredient
•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, immune-suppressants, or immune-modulating drugs, or treatment with light).
•Received treatment with systemic or locally acting medications which might counter or influence the study aim
•Clinical diagnosis of bacterial infection of the skin including impetigo and abscesses
•Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the patient'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