A Clinical Evaluation of the Safety and Efficacy of a Moisturizing Cream and Baby Wash in the Management of Mild to Moderate Atopic Dermatitis in Infants, Toddlers and Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Change From Baseline in Atopic Dermatitis Severity Index (ADSI) After 4 Weeks of Product Use
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness (assessed by clinical evaluation of eczema/atopic dermatitis severity and parent-perceived benefits) and tolerability (assessed by clinical grading and parent-perception) of the investigational cream when used in conjunction with a baby wash in babies, toddlers, and children with mild to moderate atopic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fitzpatrick skin type I to VI
- •Child must have at least 1 target lesion based on the atopic dermatitis severity index (ADSI) with a score of 2-12 and an erythema sub score of at least 2 (moderate)
- •Has mild to moderate atopic dermatitis (as per Rajka-Langeland Severity Index; graded as 3.0 to 7.5 inclusive)
- •Child must have parent-assessed history of itch
- •Has parent-perceived sensitive skin For Parents
- •Willing to undergo a 3-day washout period prior to the baseline assessments. During this run-in period, parents will be asked to refrain from using prescription and over-the-counter (OTC) eczema treatments on their child; Acute rescue treatment will be permitted (type of rescue treatment will be determined by principal investigator [PI])
- •Has signed the informed consent document (ICD), including Health Insurance Portability and Accountability Act (HIPAA) disclosure
排除标准
- •Has known allergies or adverse reactions to common topical skincare products or ingredients of the investigational products (IPs)
- •Has a history of a confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 30 days prior to Visit 1 For Child
- •Presents with a skin condition that may influence the outcome of the study (specifically psoriasis or active skin cancer)
- •Severe atopic dermatitis (AD) as determined by the Rajka-Langeland Severity Index For Parent
- •Is self-reported to be pregnant or planning to become pregnant during the study
结局指标
主要结局
Change From Baseline in Atopic Dermatitis Severity Index (ADSI) After 4 Weeks of Product Use
时间窗: Baseline, Week 4
ADSI is a scoring system that reflects the severity of a target eczema lesion. The ADSI score is a sum of scores for 5 different parameters - erythema, itching, exudation, excoriation, lichenification - which are each measured on a scale of 0 (none) to 3 (severe). The total score can range from 0 (no eczema signs) to 15 (severe eczema lesion).
Change From Baseline in Eczema Area Severity Index (EASI) After 4 Weeks of Product Use
时间窗: Baseline, Week 4
EASI is a composite scoring system index which is used to measure the severity of 4 clinical manifestations of atopic dermatitis (erythema, edema/induration/papulation, excoriations, and lichenification) according to the percentage of affected area in each of the 4 body regions (head/neck, trunk, upper limbs, and lower limbs). Final scores range from 0 (no disease anywhere on the body) to 72 (severest disease on all body areas).
次要结局
- Change From Baseline in ADSI(Baseline, Day 1, 3 and 7)
- Change From Baseline in Skin Microbiome(Baseline, Day 1, 3, 7 and Week 4)
- Change From Baseline in Infant Dermatitis Quality of Life Index (IDQoL)(Baseline, Day 1, 3, 7 and Week 4)
- Parent Perceived Product Efficacy as Assessed by Parental Questionnaire(Baseline (immediately after first use) and Week 4)
- TEWL Measurement Difference Between Lesion and Adjacent Non-lesional Site(Day 1, 3, 7 and Week 4)
- Change from Baseline in Skin Hydration in Lesion and Adjacent Non-lesional Site(Baseline, Day 1, 3, 7 and Week 4)
- Change From Baseline in Skin pH in Lesion Versus Adjacent Non-lesional Site(Baseline, Day 1, 3, 7 and Week 4)
- Change From Baseline in EASI(Baseline, Day 1, 3 and 7)
- Change From Baseline in Caregiver Itch Assessment Score(Baseline, Day 1, 3, 7 and Week 4)
- Change From Baseline in Brief Infant Sleep Questionnaire-Revised (BISQ-R) Scale Score(Baseline, Day 1, 3, 7 and Week 4)
- Change From Baseline in Transepidermal Water Loss (TEWL) Measurement in Lesion and Adjacent Non-lesional Site(Baseline, Day 1, 3, 7 and Week 4)
- Skin Hydration Difference between Lesion and Adjacent Non-lesional Site(Day 1, 3, 7 and Week 4)
- Skin pH Difference between Lesion and Adjacent Non-lesional Site(Day 1, 3, 7 and Week 4)