ACTRN12616001077459已完成1 期
A Proof of Concept Study to Assess The Efficacy and Safety of Single Intralesional Doses of DUR-928 in Psoriasis Patients.
INC Research0 个研究点目标入组 12 人开始时间: 2016年8月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Moderate to severe chronic plaque-type psoriasis;
- •Duration of Psoriasis of at least 6 months;
- •Nominated total target plaque(s) must have a total approximate area of at least 562 cm to allow application of the study treatments, and must exclude the face, scalp, shin, genitals, and groin area The total area available for treatment may be split over a maximum of two contralateral plaques of equivalent LPSI, both of which meet the eligibility requirements.
- •Generally healthy as determined by medical history and physical exam;
- •BMI less than 35 kg/m2;
- •Male subjects must agree to use a medically acceptable method of contraception/birth control throughout the study duration and for 90 days after the study is completed;
- •Female subjects must be of non-childbearing potential.
排除标准
- •Presence of non-plaque psoriasis (ie pustular, erythrodermic).
- •Presence of other skin condition other than psoriasis, in particular eczema, skin infections or an inherited skin disorder (other than psoriasis) that would interfere with the ability to perform study assessments.
- •Participation in an investigational drug study within 30 days prior to dosing.
- •Treatment of target plaque body region with topical medications within 2 weeks prior to dosing and during the study period.
- •Treatment with Vitimin A supplements within 2 weeks prior to dosing and during the study period.
- •Treatment with any systemic immunosuppressant medication within 6 months prior to dosing and during the study period.
- •Positive tests for HIV, hepatitis B/C, drugs of abuse or alcohol breath-test.
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