KCT0003056招募中未知
?/?a clinical research to evaluate the safety and effectiveness of EBI-H (Auto-derived activated lymphocyte) for subacute above medium severity and chronic atopic dermatitis patients
GNSBIO0 个研究点目标入组 23 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 23
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1) A person under the age of 65 and above the age of 19 years old
- •2) The proper atopic dermatitis patients according to Hanifin and Rajka diagnostic criteria
- •3) The subacute and chronic atopic dermatitis patients with atopic dermatitis symptoms that have lasted for more than 6 months at least
- •4) The subacute above medium severity atopic dermatitis patients (EASI score over 7 points)
- •5) The specific patients who have not been improved through the general treatment or can not use the pre-developed medicine because of concern about potential side-effect
- •6) A fertile woman who is negative in the pregnancy test and agrees to use the permitted manner of contraception during clinical research
- •7) A patient who has voluntarily agreed to participate in this clinical research with written consent
排除标准
- •1) A patient who have other uncontrolled diseases including infection above medium severity and bleeding
- •2) A person who has positive in HBV, HCV, HIV and VDRL
- •3) A patient whose blood pressure cannot be controlled under SBP 140mmHg or DBP 90mmHg with injecting antihypertensive drug, during screening
- •4) An uncontrolled patient with diabetes whose HbA1c values is over 8.0 during screening
- •5) An asthmatic patient who needs high concentration of inhaled steroids with 2nd modifier or systemic steroid therapy or uncontrolled patient with those treatment
- •6) A patient who has skin autoimmune disease including psoriasis and systemic autoimmune diseases (Erythema lupus, rheumatism arthritis, severe muscle failure, etc)
- •7) A person who uses systemic adrenocortical hormone drug, systemic immune suppressor/immune modulator, high potency topical adrenocortical hormone drug (WHO Group I~III), topical immune modulator and biological drug within 4 weeks before screening
- •8) A patient who took topical adrenocortical hormone drug (WHO Group IV, V), systemic photochemotherapy and systemic antibiotic within 2 weeks before screening
- •9) A patient who took antihistamine through oral or injection methods within a week before participating in the clinical research
- •10) A patient who have taken a prohibited combinatory drug or have to take a prohibited combinatory drug during clinical research
- •11) A pregnant woman or lactating woman
- •12) A fertile woman who don’t want to follow a proper method of contraception during clinical research
- •13) A patient who has been participating in or had already participated in another clinical research within 30 days
- •14) A patient who is judged as improper for this research by researchers
研究者
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