ACTRN12613000472774已完成2 期
Does twice daily application of a ceramide dominant cream (EpiCeram) for the first six months of life reduce the incidence of eczema by six months of age, when compared to standard skin care, in infants who have a family history of allergic disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
研究概览
简要总结
In this pilot study (80 infants), we assessed if the application of a specific cream (EpiCeram™) to the skin of new-born infant’s twice-daily for six months, would help build up skin barrier function and reduce the risk that these children would develop eczema and allergic sensitisation to foods. Our results revealed a trend towards a reduced risk of eczema and food sensitisation in infants from the ‘cream’ group at 12 months of age, particularly if it was used from within the first two weeks of life, and applied regularly. This was the first time that possible beneficial effects of this type of treatment beyond the treatment period have been demonstrated
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 1 Days 至 3 Weeks(—)
- 性别
- All
入选标准
- •Either mother and/or father has a self reported history of:
- •- asthma and/or
- •- eczema/atopic dermatitis and/or
- •- hayfever/allergic rhinitis and/or
- •- food allergy
排除标准
- •- A parent who has a known hypersensitivity to any of the ingredients of EpiCeram.
- •- Multiple births (twins, triplets etc.)
- •- Premature infants (<36 weeks)
- •- Infants with major birth or early life medical complications that require admission into a special care nursery.
- •- Infants whose parents are not able to comply with all protocol required visits and procedures.
研究者
相似试验
已完成
3 期
Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic DermatitisAtopic DermatitisNCT00351052Novartis184
已完成
4 期
Assessment of Pruritus Improvement With Pimecrolimus Treatment on the Areas Affected by Mild-to-moderate AD, in Patients 2- to 11- Year-oldAtopic DermatitisNCT00510003Novartis Pharmaceuticals117
已完成
不适用
Barrier Enhancement for Eczema PreventionEczemaNCT04680520University of Nottingham1,394
已完成
4 期
Pediatric Subjects With Tinea CorporisTinea CorporisNCT02227290Merz North America, Inc.230
已完成
不适用
Pilot study of ceramide cream for the skin toxicity of cetuximab in advanced colorectal cancer.colorectal cancerJPRN-UMIN000006578Aizawa Hospital5
