CTRI/2021/02/031309已完成不适用
An Open-label, Single Centre Study to Determine the Effect of Test Product 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 the moisturizeron eczema symptoms in female subjects with mild to moderate eczema in a 4-weekhome use test. For the purpose of this study, compatibility means that the testproduct does not worsen the skin condition, determined by an assessment of thelesional and non-lesional skin.
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
- •1.Age: 18to 65 years (both inclusive) old healthy, non-pregnant and non-lactating female at the time of consent.
- •2.Females who have childbearing potential should have a negative urine pregnancy test at the time of screening visit.
- •3.Mild to Moderate Eczema determined by Eczema Area and Severity Index (EASI) score on screening visit.
- •[Subjects with moderate erythema (Redness: score 2) and mild scratch mark (Scratching: score 1) will be enrolled into the study].
- •4.Subjects with at least two active lesion on feet/face/hands or any part of body.
- •5.Subjects have only few or no pigmentation on the selected test site.
- •6.Subject’s in general good health as determined by Investigator based on medical history.
- •7.Subjects must agree to refrain from shower/bath or generally wet their skin within 3 hours before a schedule study visits.
- •8.Subjects must agree to wear loose clothing to allow easy exposure to the entire body during study visits.
- •9.Subjects must be able to understand and provide written informed consent to participate in the study.
- •10.Subjects should be willing and able to follow the study protocol to participate in the study.
排除标准
- •1.Subjects with chronic or acute skin diseases, except atopic eczema on any part of the body.
- •2.Subjects with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product.
- •3.Subjects with any systemic illness that would impact on the subject’s safety or wellbeing and/or affect the response of the skin or the interpretation of the test results at screening.
- •4.Subjects who are receiving the following topical or systemic treatments.
- •5.Subjects with anti-inflammatory and/or anti-histaminesuse for 7 days previous to randomization and throughout the study.
- •6.Subjects with cough suppressants and/or topical or inhaled corticosteroids.Use for 7 days previous to randomization and throughout the study.
- •7.Subjects with use of retinoids and/or immunosuppressant’s during the previous 6 months.
- •8.Subjects have diabetes, acute cardiac and circulatory diseases, HIV, hepatitis.
- •9.Participation in a similar clinical study within the previous 90 days.
- •10.Any surgical treatment previous three months or planned during the study.
- •11.Any subject in the Principal investigators opinion not considered suitable for enrollment.
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 02, Day 07, Day 14 and Day 28 after product usage | 2.On Day 01 before application and on Day 02, Day 07, 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 02, Day 07, Day 14 and Day 28 after product usage | 2.On Day 01 before application and on Day 02, Day 07, Day 14 and Day 28 after product usage
次要结局
- 1.Dermatologist Visual Skin Assessment for erythema/redness and dryness.(2.To assess the effect of test product on Global Assessment Scale (IGA).)
研究者
研究点 (1)
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