A Single Center Study in 22 Healthy Male and Female Subjects to Investigate the Skin Protectant and Anti-Inflammatory Properties of Omeza Collagen Matrix on Damaged Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Omeza, LLC
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Transepidermal Water Loss (TEWL)
研究概览
简要总结
Single-blind within subject comparison study conducted to investigate the skin protectant properties of Omeza Collagen Matrix on damaged skin
详细描述
This study was conducted in 22 healthy subjects to determine the skin protectant and anti-inflammatory properties of the test product.
For the skin protectant assay the test article was applied to the forearm and covered with gauze for 10 minutes before assessment of irritation and TEWL readings.
An inflammatory skin response was induced by a SLS solution 24 hours prior to application of the test article. The test article was applied for 10 minutes at the site of inflammation. The test site was then graded for irritation and TEWL readings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is a healthy male or female, aged 18 years or older.
- •Subject has signed a written Informed Consent.
排除标准
- •Pregnancy or lactation.
- •Inadequate precaution or procedure to prevent pregnancy (women of child bearing potential only).
- •A current skin disease of any type at the test site (e.g. eczema, psoriasis)
- •Heavy alcohol consumption in the opinion of the investigator.
- •A fever in the last 12 hours, prior to the initial patch application.
- •Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which in the opinion of the Investigator would compromise the safety of the subject.
- •History of malignant disease.
- •Insulin dependent or non-insulin dependent diabetes.
- •Concurrent medication likely to affect the response to the test articles or confuse the results of the study, i.e. routine high dosage use of antiinflammatory drugs (aspirin, ibuprofen, corticosteroids).
- •Known sensitivity to the treatment solutions or their constituents including patch materials.
- •Sensitisation or questionable sensitisation in a Repeat Insult Patch Test.
- •Use of self-tanning lotion on the test area, one week previous to the start of the study.
结局指标
主要结局
Transepidermal Water Loss (TEWL)
时间窗: 96 hours
Assessment of water evaporation (TWEL) based upon diffusion principle
次要结局
- Erythema(96 hours)