Effect of a Topical Spray on Itch Relief in Moderate-to-severe Childhood Eczema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- SCORing Atopic Dermatitis (SCORAD)
研究概览
简要总结
Pruritus is defined as an unpleasant sensation of the skin that provoke the desire to scratch or rub. Its presence is an essential diagnostic feature. According to some European studies, 91% of patients with Atopic Dermatitis report suffering from pruritus at least once daily. And 58.1% of them experience chronic pruritus, leading to great deterioration in quality of life. Various internal and external factors may trigger pruritus. Mediators secretion such as keratinocyte-derived Thymic Stromal Lymphopoietin (TSLP) and Nerve Growth Factor (NGF) could activate nerve fibres which will eventually transmit signals to the brain causing the sensation of itching.
Although being one of the major annoying symptoms faced by patients with Atopic Dermatitis, effective anti-itching treatments are not available. There is no consistent evidence that topical antihistamines can relief itch.
Recently, a new spray named Atoderm 'SOS' is developed. The skin relief technology (by ambora extract and Epigallocatechin gallate (EGCG), associated to enoxolone) claimed to inhibit the release TSLP and NGF which eventually could reduce nerve signals to the brain for itchy feelings. Therefore, our group would like to test the efficacy of this proprietary anti-itch product with our paediatric patients using a wait-list approach as a control. It is aimed to demonstrate that the using the Atoderm 'SOS' spray topically whenever necessary can reduce the unpleasant itchy Atopic Dermatitis's symptom, improve quality of life, as well as to reduce the need for topical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A pruritus frequency of more than 3 days in previous week recorded by Q1 in The Patient Oriented Eczema Measure (POEM)
- •History of known moderate-to-severe eczema
- •Able to read Chinese
- •voluntarily willing to participate into the study by written consents endorsed by patients and their legal guardians
排除标准
- •No history of known eczema
- •Concurrently participating into another clinical trial
- •History of known drug allergy
- •unable to read Chinese
研究组 & 干预措施
Active Treatment Group
Patients will be instructed to use the anti-pruritic spray for four weeks starting from the day which informed consent was signed in active treatment group. A follow-up visit will be on week 2 for a mid-term review.
干预措施: Atoderm SOS spray Aerosol 200ml (Drug)
Wait-list Control Group
Patients will be instructed to start the treatment after two weeks from the day which consent was signed and for a duration of two weeks in wait-list control group. A follow-up visit will be on week 2 for a mid-term review and for the dispense of treating material.
干预措施: Atoderm SOS spray Aerosol 200ml (Drug)
结局指标
主要结局
SCORing Atopic Dermatitis (SCORAD)
时间窗: 4 weeks
A questionnaire to examine the difference in eczema severity between two arms
The Patient Oriented Eczema Measure (POEM)
时间窗: 4 weeks
A questionnaire to examine the difference in eczema severity between two arms
Nottingham Eczema Severity Score (NESS)
时间窗: 4 weeks
A questionnaire to examine the difference in eczema severity between two arms
The Children's Dermatology Life Quality Index (CDLQI)
时间窗: 4 weeks
A questionnaire to examine the difference in quality of life between two arms
Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ)
时间窗: 4 weeks
A questionnaire to examine the difference in quality of life between two arms
次要结局
- seromarkers(4 weeks)
- Bacterial colonization(4 weeks)
- dermatological parameters on skin(4 weeks)
研究者
Prof. HON Kam Lun Ellis
Department of Paediatrics, 6/F, Lui Chee Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong
Chinese University of Hong Kong