Human Repeat Insult Patch Test of Wound Dressings
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Irritation
研究概览
简要总结
The purpose of this study is to determine whether contact sensitization occurs to the skin of normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and Silicone Vehicle Control dressings.
详细描述
A single center, within-subject randomized study design in healthy adult subjects. Qualified subjects will complete three phases of the study (induction, rest and challenge).
Data for irritation, adhesion and pain upon removal will be collected from the individual patch sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18 years or older
- •In good health, as determined by medical history and concomitant medication
- •Able to comprehend and sign informed consent
- •Unable to bear children or willing to use adequate birth control
- •Willing and able to follow study directions, to participate in the study and to return for all specific visit
排除标准
- •Subject pregnant, planning a pregnancy or lactating
- •Diabetes (any type)
- •Mastectomy involving removal of lymph nodes
- •Clinically significant skin disease, including but not limited to psoriasis, eczema, atopic dermatitis, and active cancer
- •Asthma or other severe respiratory disease requiring medication
- •Self-reported immunological disorders including (but not limited to) HIV positive, AIDS, rheumatoid arthritis, and systematic lupus erythematosus
- •Treatment of any type of cancer within the last two years or history of skin cancer in the test area
- •Use of any of the following: topically applied products (e.g. medicals, lotions, creams, etc.) at the application site within 3 days of first application of test articles, immunosuppressive drugs within 30 days of first application of test articles, systemic or topical corticosteroids within 30 days of first application of test articles, and systemic or topically applied anti-inflammatory and antihistamine medications within 3 days of first application of test articles
- •Participation in any patch test for irritation or sensitization within the last four weeks
- •Participation in any investigational drug study within the last four weeks
- •Damaged skin in or around the test sites which includes: sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfiguration
- •Known sensitization to adhesives, bandages, or materials used in test articles
- •Medical condition which, in investigator's judgment, makes the subject ineligible or places the subject at undue risk
研究组 & 干预措施
IV Clear™
干预措施: IV Clear™ (Device)
Tegaderm CHG™
干预措施: Tegaderm CHG™ (Device)
Control Vehicle Dressing
干预措施: Silicone Vehicle Control Dressing (Device)
结局指标
主要结局
Irritation
时间窗: Assessed at induction phase (evaluated before reapplication; 9 applications over 3 weeks, reapplied after every 48 or 72 hrs) and challenge phase (single 48-hr application of test article to naive sites and evaluation 30 mins, 24 and 48 hrs post-removal
Irritation assessed at the induction phase will be scored on a Berger and Bowman Scale. Irritation assessed at the challenge phase will be scored on a defined scale measuring erythema reactions, ranging from no reaction to strong erythema.
次要结局
- Adhesion(Assessed at each 72 hour evaluation over three weeks, and once for a single 48-hour challenge application)
- Pain upon removal(Assessed by subjects at 72 hour evaluations over three weeks and a single 48-hour challenge application)