An Open-label, Single Centre Study, to Determine the Safety and Efficacy of Body Lotion and Body Wash in Adult Female Subjects with Mild To Moderate Eczema.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1.Selection of unaffected and affected test sites by the dermatologist using instrument evaluations.
研究概览
简要总结
The objective of this study is to evaluate the efficacy of body lotionon Eczema symptoms improvement infemale subjects with mild to moderate eczema in a 4-week home use test.
For this study, compatibility means that the Test product does notworsen the skin condition, determined by an assessment of the lesional andnon-lesional skin sites, also cutaneous tolerance of body lotion on Eczema skinwill be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age: 18 to 65 years (both inclusive) old healthy, non-pregnant, and non-lactating female at the time of consent.
- •Females who have childbearing potential should have a negative urine pregnancy test at the time of the screening visit.
- •Mild to Moderate Eczema determined by Eczema Area and Severity Index (EASI) score on screening visit.
- •Subjects with at least two active lesions on feet/face/hands or any part of the body.
- •Subjects have only a few or no pigmentation on the selected test site.
- •The subject’s in general good health as determined by Investigator based on medical history.
- •Subjects must agree to refrain from shower/bath or generally wet their skin within 3 hours before scheduled study visits.
- •Subjects must be able to understand and provide written informed consent to participate in the study.
- •Subjects should be willing and able to follow the study protocol to participate in the study.
排除标准
- 未提供
结局指标
主要结局
1.Selection of unaffected and affected test sites by the dermatologist using instrument evaluations.
时间窗: 1.On Day 01 before application and on Day 14 and Day 28 after product usage | 2.On Day 01 before application and Day 14 and Day 28 after product usage
2.Calculation of eczema area by dermatologist using Eczema Area and Severity Index (EASI).
时间窗: 1.On Day 01 before application and on Day 14 and Day 28 after product usage | 2.On Day 01 before application and Day 14 and Day 28 after product usage
次要结局
- 1.cutaneous tolerance/ local irritation i.e. Erythema, Oedema, Dryness, Flaking, Scaling, Itching, Peeling, Pigmentation for body wash and body lotion(2.Global Assessment Scale (IGA) for body wash and body lotion)