A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Investigators' Global Assessment score
研究概览
简要总结
A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the "Атопик Soothing Cream" in Children with Mild to Moderate Atopic Dermatitis
详细描述
"Атопик Soothing Cream" is a lipid complex composed of barley grain, Butyrospermum Parkii and Argania Spinosa Kernel oil, in a mixture with panthenol and bisabolol.
Investigators concure that combination of these substances in "Атопик Soothing Cream" will be efficacious non-steroidal treatment of Atopic Dermatiti ( AD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have clinical diagnosis of mild to moderate atopic dermatitis (AD) at both Screening and Baseline Visits, defined as IGA score of 2 or 3 ( Rothe 1996) or EASI score between 2 and 21 (Leshem 2015)
- •Must have AD affecting >5% total body surface area (TBSA) at Baseline
- •History of AD for at least 3 months prior to Baseline
- •Informed consent/assent in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline and applicable regulations, before completing any study-related procedures
排除标准
- •Use of topical corticosteroids within 7 days prior to Baseline
- •Use of systemic corticosteroids, topical calcineurin inhibitors, photo-therapy (PUVA, UVB) or immunosuppressive therapy (eg, cyclosporine) within 14 days prior to Baseline
- •Subjects that require systemic therapy for the treatment of AD
- •Use of systemic anti-infective or antibiotic treatment within 14 days prior to Baseline
- •Subjects who present with clinical conditions other than AD that may interfere with the evaluation (eg, generalized erythroderma, acne, Netherton's Syndrome, psoriasis)
- •Any clinically significant skin disease other than AD
- •Secondary infection of AD (bacterial, viral or fungal) within the skin area under study or open skin infections in any area at Baseline
- •History of severe anxiety and/or depression; any history of suicide attempt
- •Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history
- •Subjects who, in the opinion of the Investigator(s), would be non-compliant with the visit schedule or study procedures
- •Participation in any other investigational trial within 6 weeks of Baseline, or during study conduct
- •Chronic condition(s) which are either unstable or not adequately controlled
- •Drug or alcohol abuse, mental dysfunction, or other condition limiting the subject's ability to be compliant with study-related procedures
- •Any medical condition that may, in the opinion of the Investigator(s), preclude the safe administration of test article or safe participation in the study
研究组 & 干预措施
"Атопик" phase 1
For the first phase of the study, subjects will be randomized to receive treatment with "Атопик Soothing Cream".
干预措施: "Атопик Soothing Cream" (Device)
"Атопик" phase 1
For the first phase of the study, subjects will be randomized to receive treatment with "Атопик Soothing Cream".
干预措施: Placebo (Device)
Placebo - phase 1
For the first phase of the study, subjects will be randomized to receive treatment with Placebo Cream.
干预措施: "Атопик Soothing Cream" (Device)
Placebo - phase 1
For the first phase of the study, subjects will be randomized to receive treatment with Placebo Cream.
干预措施: Placebo (Device)
"Атопик" phase 2
The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".
干预措施: "Атопик Soothing Cream" (Device)
"Атопик" phase 2
The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".
干预措施: Placebo (Device)
Placebo - phase 2
The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".
干预措施: "Атопик Soothing Cream" (Device)
Placebo - phase 2
The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".
干预措施: Placebo (Device)
结局指标
主要结局
Investigators' Global Assessment score
时间窗: 28 days
次要结局
- Eczema Area & Severity Index (EASI)(28 days)
- Pruritus intensity(28 days)