DRKS00000356已完成1 期
Safety evaluation of Hylase® Dessau 150 IU (bovine testicular hyaluronidase) vs. placebo as adjuvant to local anaesthesia in wound healing by means of a suction blister model in healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- All
入选标准
- •right hander
- •Caucasian origin
- •written informed consent given by volunteer after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug;
- •female subjects of childbearing potential willing to use contraception during the study period (i.e. abstinence, oral contraception, intrauterine device, diaphragm, condom, spermicide, implant contraception, systemic contraception) or have secondary infertility or whose partner had a vasectomy, or female subjects of non childbearing potential (i.e. had hysterectomy, bilateral ovariectomy, tubal ligation) or are post-menopausal defined as absence of menstrual bleeding for 1 year, or 6 month if laboratory confirmation of hormonal status
排除标准
- •atopic dermatitis or other skin diseases at the designated test areas (forearms);
- •known structure dysfunction of the skin with and without blister formation;
- •incompatibility against local anaesthesia or any ingredient of the study medication;
- •vegetarians and vegans;
- •patch incompatibility;
- •known deficiencies (i.e. iron, vitamin B12);
- •excessive hair growth on the forearms;
- •concomitant procedures which would interfere with trial medication (as massaging injection area);
- •volunteers with collapse, shock, severe electrolyte disturbance or major dehydration;
- •volunteers with increased risk of pulmonary congestion or oedema, severe congestive heart failure;
- •known hypersensitivity to hyaluronidase or bovine proteins;
- •congenital cardiac defect, venous congestion or shock symptoms;
- •infections;
- •volunteers with any type of cancer:
- •known contraindication for study medication;
- •unreliability and/ or lack of cooperation, evidence of non-compliance;
- •current or previous participation in another clinical trial within prior 12 weeks;
- •pregnancy or lactation in female volunteers;
- •signs of clinically relevant illness or mental illness up to four weeks prior to entry into the study;
- •history of or current alcohol or drug abuse;
- •other objections which avoid the participation in the study in the opinion of the investigator;
- •legal incapacity and/or other circumstances rendering the volunteer able to understand the nature, scope and possible consequences of the study
研究者
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