Development of a Bruise Scale in Healthy Normal Volunteers
试验速览
- 阶段
- 不适用
- 发起方
- Cearna, Inc.
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Bruise Healing over time
研究概览
简要总结
Subjects will have a mechanically induced bruise photographed over a period of 11 days to record the healing process. Assessors will rate the bruises to develop a bruising scale.
详细描述
Observational study. Healthy normal volunteers will come into the clinic and have a bruise induced. The bruised area will be photographed each day through Day 11. Images will be provided to the Validator Team to rate on a 0-5 scale of severity.
The actual numbers of volunteers will be adjusted to ensure there are at least 15 images for each Grade.
The clinical site will be provided photography equipment, and study staff will be trained on photography technique to standardize the image quality and resolution across the study.
The Validator Team will review the images and categorize them in to Grades 0-5.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fitzpatrick skin type 1-3
- •BMI 25 kg/m2
- •Self described bruisers
- •Intact skin in the target area, free of markings, blemishes and hair
排除标准
- •Use of recreational drugs, steroids, pain medications, other homeopathic remedies, anticoagulant therapies, antiplatelet therapy
- •Known history of dermal sensitivity, serious illness, hematological abnormality, impaired wound healing
- •Inability to forego application of topical products in the target area
- •Hair removal by laser, wax or chemicals within one week prior to Day 1
- •Avoid tanning beds
- •Active wound or infection in the target area
- •History of keloids or hypertrophic scarring
- •History of collagen or vascular disease
- •History of organ transplant
结局指标
主要结局
Bruise Healing over time
时间窗: 11 days
Record bruise images over 11 days
次要结局
未报告次要终点