CT 327 in the Treatment of Psoriasis Vulgaris

Creabilis

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Treatments

Drug: placebo

Drug: CT 327

Study type

Interventional

Funder types

Industry

Identifiers

NCT00995969

CT 327 PV 01-09

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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