NCT01781663Unknown4 期
Efficacy of KAM2904 Face Cream and KAM3008 Body Lotion Treatment in Children With Atopic Dermatitis (AD)
适应症
试验速览
- 阶段
- 4 期
- 发起方
- Kamedis Ltd.
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- • Change in SCORAD (Scoring Atopic Dermatitis)
研究概览
简要总结
The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of subjects treated with KAM2904 Face Cream and KAM3008 Body Lotion (the treatment group), versus a group of subjects treated with a petrolatum-based moisturizer (the control group). Safety will be determined by the number and severity of Adverse Events Device-Related.
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
- 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
- •• Male or female between 2 and 12 years of age
- •The subject suffers from moderate atopic dermatitis (SCORAD<40) that is amenable to treatment
- •Diagnosis of atopic dermatitis meets Hanifin's criteria (at least 3 basic features and at least 3 minor features)
- •Atopic dermatitis is, in the opinion of the investigator, stable for the past 7 days
- •The subject's parents are able to apply the study product twice a day (each morning and evening) for a consecutive period of 42 days
- •The subject's parents agree that the subject will not change his/her lifestyle during the study period (including: regular body hygiene product (soap), the number of baths and showers per day, the laundry detergent and fabric softener used to wash clothes)
- •The subject's parents agree to use only the test product during the study period
- •The subject's legal guardian is able and willing to sign the informed consent form and to comply with the study regulations of this protocol
排除标准
- •• The subject has another dermatological disease/condition that could interfere with the clinical evaluation, including infected atopic dermatitis lesions
- •The subject has a previous history of allergy to cosmetic products or to any of the ingredients included in the tested formulations (Appendices 1 and 2)
- •The subject received a topical or a systemic immune-modulator (such calcineurin inhibitors or cortico-steroids) for the treatment of atopic dermatitis, within 14 days prior to day 0
- •The subject underwent phototherapy within 28 days prior to day 0
- •The subject is expected to be extensively exposed to the sun during the trial
- •The subject underwent any experimental treatment within 14 days prior to day 0
结局指标
主要结局
• Change in SCORAD (Scoring Atopic Dermatitis)
时间窗: after 42 days of treatment
• Change in EASI (Eczema Area Severity Index)
时间窗: after 42 days of treatment
• Change in the scoring of individual symptoms of atopic dermatitis
时间窗: after 42 days of treatment
次要结局
- • Trend in the change of individual symptoms of atopic dermatitis(after 42 days of treatment)
- • Safety of KAM2904 Face Cream and KAM3008 Body Lotion(days D14, D28, D42 and unscheduled visits)
- • Trend in the change of SCORAD(after 42 days of treatment)
- • Trend in the change of EASI(after 42 days of treatment)
研究者
研究点 (1)
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