A Double-Blind, Randomized, Active-Controlled Clinical Trial To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline
研究概览
简要总结
The purpose of this study was to evaluate the safety of the investigational study product and see how well it works to relieve signs and symptoms of children with mild to moderate Atopic Dermatitis (AD), also known as eczema, in comparison to that of a similar marketed product. This study was conducted to assess the safety of the investigational new study product and how well it works to treat AD in children, by making AD visually better, and reducing the amount of itch.
详细描述
This was a multi-center, double-blind, randomized, active-controlled trial in children 2 to 12 years of age with mild to moderate AD. A sufficient number of subjects were screened to ensure that approximately 80 subjects were randomized, to yield 70 completed subjects. Subjects were randomized to one of the two treatment groups: the J&J Device or Atopiclair®. All subjects were to return to the clinical site for clinical assessments at baseline (Day 1) and at Days 3, 8, 15, 22, 29 and 43 after initial investigational product application. The investigational products were used topically during the duration of 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
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-menarchal female subjects must have a negative urine pregnancy test
- •Willing to provide written informed consent/assent
- •Diagnosed as having mild to moderate Atopic Dermatitis (AD)
- •Willing to stop all moisturizers and/or other skin barrier cream or emulsion treatments for the AD condition during the test period and replace with the investigational product assigned in this trial
- •Willing to replace their body wash and/or soaps with the one provided in this trial
排除标准
- •Severe AD as determined by the Rajka-Langeland Severity Index
- •AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If the subject requires any of these medications as rescue therapy during the study, the subject will be discontinued from the trial
- •History of allergy or hypersensitivity to the ingredients of the test devices, nuts or nut oil
- •Cutaneous or systemic viral (including HIV or AIDS), mycotic or bacterial disease requiring a topical or systemic therapy
- •Diabetes mellitus that cannot be controlled by diet alone (i.e., requires systemic medications for control)
研究组 & 干预措施
11054-010
F# 11054-010 Investigational Device
干预措施: F# 11054-010 (Device)
10495-053
F# 10495-053 Atopiclair
干预措施: F# 10495-053 (Device)
结局指标
主要结局
Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline
时间窗: Baseline to Day 43
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).
次要结局
- Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline(Baseline to Day 15)
- Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline(Baseline to Day 43)
- Itch Score on Day 43 - Change From Baseline(Baseline to Day 43)