EUCTR2010-021207-25-GB进行中（未招募）不适用
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
Creabilis Sàrl0 个研究点目标入组 36 人开始时间: 2010年8月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
已完成
2 期
LEO 32731 for the Treatment of Moderate to Severe Psoriasis VulgarisPsoriasis VulgarisNCT02888236LEO Pharma36
未知
3 期
M518101 phase III study in plaque psoriasis patientsPlaque psoriasisJPRN-jRCT2080222894Maruho Co.,Ltd.
招募中
1 期
TCM syndrome study of psoriasis vulgaris based on intestinal microfloraITMCTR1900002445Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
未知
2 期
M518101 phase 2b study in plaque psoriasis patients - comparison study 2Plaque psoriasisJPRN-jRCT2080221434Maruho Co.,Ltd.
未知
2 期
M518101 phase 2b study in plaque psoriasis patients - comparison study 1Plaque psoriasisJPRN-jRCT2080221433Maruho Co.,Ltd.