A monocentric baseline controlled, prospective clinical study to evaluate the efficacy of test product regimen [Cetaphil Restoraderm cleanser & moisturizer] in improving hydration and managing mild to moderate atopic dermatitis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. Improvement in skin hydration using Corneometer CM 825 at T1, Week 2 and Week 4 as compared to baseline.
研究概览
简要总结
Atopic dermatitis (AD) is characterized by dry skin. The condition involves a compromised skin barrier, which leads to increased transepidermal water loss and reduced ability to retain moisture. Managing dryness through effective moisturization and gentle cleansing is a cornerstone of treatment to help restore the skin barrier and alleviate symptoms. This study aims at evaluation of Cleanser and Moisturizer regimen in improve skin moisturization and providing relief or maintenance of AD skin conditions.
Efficacy of the test regime in improving skin hydration will be evaluated using dermatological assessments, corneometer, tewameter, visioscan, skin pH meter, self-assessment questionnaires at baseline, T1, week 2 and week 4.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Prospective adult subjects who have mild to moderate atopic dermatitis as determined on SCORAD by dermatologist evaluation and having dry skin concern, evaluated with Corneometer reading less than 30 at the screening visit.
- •Subjects who have not used Class I-III topical steroid in the last 4 weeks prior to baseline visit can be included in the study.
- •In case of subjects who have used Class I-III topical steroid in the last 4 weeks prior to baseline visit, and are stable on it, and continue to remain stable after discontinuing topical steroid for 4 weeks prior to baseline visit.
- •Such subjects should additionally refrain from using TCS during the course of the study
- •Subjects who present with a SCORAD score of 15 and 35 at the baseline visit will be deemed eligible for the study.
排除标准
- •Scarring, tattoos or any other skin reaction that may impact the result.
- •Having been diagnosed with known allergies to facial or body skin care products.
- •Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report.
- •4.Having a history of skin cancer within the past 5 years.
- •Having used systemic steroid in the last 1 week and not agree to undergo a wash out period of at least 2 weeks or wish to take systemic steroids during the course of the study period
- •Having used skin moisturizing products to treat eczema in the 3 days before the screening visit.
- •Having used oral isotretinoin within 6 months.
- •Have undergone phototherapy in the last 4 weeks
- •Have used retinoids on the test area in the last 6 months.
结局指标
主要结局
1. Improvement in skin hydration using Corneometer CM 825 at T1, Week 2 and Week 4 as compared to baseline.
时间窗: T1, week 2 and week 4
2. Improvement in Trans-epidermal water loss using Tewameter TM 300 at Week 2 and Week 4 as compared to baseline.
时间窗: T1, week 2 and week 4
次要结局
- 1.Improvement in Trans-epidermal water loss using Tewameter TM 300 at T1 as compared to baseline.(2.Clinical Improvement in SCORAD graded by Dermatologist at Week 2 and Week 4 as compared to baseline.)