A 47 Hour, Single Application, Occlusive Forearm Skin Patch Test to Assess, Under Dermatological Control, the Acute Cutaneous Tolerance of Project Storm on the Forearm of Adult Subjects With Dry/Atopic and Very Dry/Atopic Skin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Skin tolerance assessment using the ISO 10993 scoring system through visual assessment
研究概览
简要总结
This is an open label, non-comparative investigation to determine the tolerance of Eczema Repair Emollient on healthy subjects with dry/atopic and very dry/atopic skin.
The Eczema Repair Emollient will be applied for 47 hours under occlusion. Skin tolerance will be assessed immediately and 1 hour, 24, 48 and 72 hours after patch removal.
详细描述
At immediate, 1, 24, 48, and 72 hours post-test patch removal (date & time of each assessment will be recorded), each test site will be scored for erythema and oedema by the trained investigator using the ISO 10993 scoring system.
Primary Endpoint The irritation of the test product according to the Cutaneous Irritancy Index value. The test product should be graded as 'non-irritant' and confirmed by the study dermatologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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
- 否
入选标准
- •Subjects who are able to give written informed consent and from whom written informed consent has been obtained
- •Generally healthy male and female subjects between the ages of 18 and 65 years inclusive
- •Subjects assessed by the dermatologist as having dry/atopic and very dry/ atopic skin
- •Subjects who are able to understand the study, co-operate with the study procedures and are able to attend for all study assessments
排除标准
- •Subjects with active Psoriasis or other active skin disorders or with present skin tumours or malignant disease or a history of those
- •Subjects taking antihistamine or corticoids, any medication for the treatment of diabetes mellitus, immuno-suppressive drugs or any other medication which in the opinion of the dermatologist may affect the test results.
- •Subjects with active skin disorders or a history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of the trainee dermatologist or SIT personnel may affect the test results
研究组 & 干预措施
Eczema Emollient
Eczema Repair Emollient
干预措施: Eczema Repair Emollient (Device)
结局指标
主要结局
Skin tolerance assessment using the ISO 10993 scoring system through visual assessment
时间窗: 47 hours
Irritation of test products assessed using the Cutaneous Irritancy Index (scores range from \<1 which is non-irritant to \>4 strongly irritating
次要结局
未报告次要终点