Analysis of the CeraVe Emollient Effect on Restoring the Hydration of the Skin Barrier as Maintenance Regimen in Subjects With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Changes in EASI score
研究概览
简要总结
This is an open-label, randomised, comparative, prospective, interventional study of a cosmetic product.
详细描述
Atopic dermatitis is a common chronic inflammatory skin condition that affects individuals with specific alterations to the epidermal barrier. It is also characterised by defective ceramide production. Emollients play an important role in managing atopic dermatitis, including during the maintenance phase following topical cortisone therapy. However, the effect of CeraVe emollient cream on restoring skin barrier hydration has yet to be investigated.
The primary objective is to evaluate the effect of the CeraVe emollient on restoring skin barrier hydration as a maintenance regimen in subjects with mild to moderate atopic dermatitis. The secondary objectives are to evaluate and compare the cosmetic acceptability of CeraVe with that of a commonly used emollient produced in a licensed pharmacy laboratory, and to assess the differences in ADCT (Atopic Dermatitis Control Tool) scores between groups.
Subjects with mild-to-moderate atopic dermatitis (AD), as defined by an EASI score of 1-21, will be enrolled in the study. Only individuals with an EASI score reduction of at least 90% between screening (Day -15) and Visit 1 (Day 1) will be randomised into two groups. Group 1 will enter the maintenance phase with CeraVe emollient, while group 2 will be treated with a standard emollient. Both groups will be provided with a basic detergent for washing.
If the participant experiences a relapse of atopic dermatitis (AD), as reported in their diary and in the eCRF, they should discontinue the application of CeraVe Emollient or a common soft emollient. The subject should be examined by a physician and treated according to the severity of the AD. In this case, they will be withdrawn from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with clinically confirmed mild-to-moderate atopic dermatitis (AD), as defined by an Eczema Area and Severity Index (EASI) score of 1-21, whose lesions will clear after treatment with a steroid and who will experience at least a 90% reduction in their EASI score.
- •- Participants of any gender, aged 18 years or over, from any phototype or ethnic group.
- •Participants must be willing and able to give informed consent to participate in the study.
排除标准
- •Age <18 years. Participants who are unwilling or unable to give informed consent to participate in the study.
- •Receiving any systemic treatment for atopic dermatitis (AD), including corticosteroids, cyclosporine, any approved biologics or JAK inhibitors.
- •Any dermatological disorder which, in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics (except AD).
结局指标
主要结局
Changes in EASI score
时间窗: From enrollment to the end of treatment at 6 weeks
Changes in EASI (Eczema Area and Severity Index) score. A clinical assessment of disease severity (EASI) will be conducted at three separate visits: a screening visit on Day -15, and two visits on Days 1 and 42. At the screening visit, subjects will be given a medical corticosteroid topical treatment (mometasone furoate cream) to improve their EASI score by at least 90% between Day -15 and Day 1. Only individuals with an EASI score reduction of at least 90% between Day -15 and Day 1 will be randomised into two groups. EASI score interpretation: 0: clear; 0.1-1: almost clear; 1.1-7: mild; 7.1-21: moderate; 21.1-50: severe; 50.1-72: very severe.
次要结局
- Cosmetic acceptability(From visit 1 to the end of treatment at 6 weeks)
- Changes in ADCT score(From enrollment to the end of treatment at 6 weeks)
- The number and proportion of subjects who experience a relapse of AD.(From enrollment to the end of treatment at 6 weeks)
- Changes in the visual appearance of the skin barrier over time, as observed by comparing images collected during the three scheduled study visits.(From enrollment to the end of treatment at 6 weeks)