Adhesive Tape Trauma Evaluation of Two Gentle Tapes in Healthy Human Infant Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Skin Trauma
研究概览
简要总结
The objective of this study is to determine the relative gentleness of two tapes recognized for gentleness. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.
详细描述
The objective of this study is to determine the relative gentleness of a new investigational tape compared to 3M Micropore tape, a gold standard tape recognized for its gentleness and used as a mainstay in cosmetic surgery and neonatal care. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Who are healthy and who have intact skin at the test site with a baseline score of 0 for erythema
- •Who are between the ages of 6 months - 4 years of age
- •Who has a Fitzpatrick Skin Type of I, II or III
- •Subject who's parent agrees to not use any products (i.e. topical medications, creams, powders or ointments) on the test sites for 24 hours prior to the study start date
- •Whose parent is willing to sign the Informed Consent Form.
排除标准
- •Who are known to be developmentally delayed
- •Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test sites
- •Who have had any exposure to other topical medications, creams, powders, or ointments on the test sites 24 hours prior to the start of the study.
- •Who have had a strep infection within the past 2 weeks
- •Who have a history of diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions
- •Who have allergies to isocyanates, or acrylate adhesive products
- •Who currently take any antihistamines or anti-inflammatory medication or who have taken any of these medications within 48 hours prior to the start of the study or does not agree to refrain from taking these medications for the 48 hours prior to the start of the study and for the duration of the study (Tylenol is an acceptable pain reliever).
研究组 & 干预措施
3M Kind Removal Silicone Tape
investigational medical Silicone tape, 1" x 1.5" sample, applied on time, worn for 24 hours.
干预措施: Skin Trauma (Device)
3M Micropore Medical Tape
Commercially available Medical Paper Tape, 1" x 1.5" sample, applied on time, worn for 24 hours. Study Control.
干预措施: Skin Trauma (Device)
结局指标
主要结局
Skin Trauma
时间窗: 24 hours
Expert grader using Erythema/Edema Scale 0=No visible response 1. mild response 2. moderate response 3. severe response 4. extreme response
次要结局
未报告次要终点