Use of lipid nanoparticles of virgin coconut oil complexed with ceramides and vitamin D for use in Icthyosis in children aged 5-15 years and to compare its effects to commercially available preparations.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- 1.primary outcome of this study would likely focus on clinical improvement in Ichthyosis symptoms,as evaluated by visual index for ichthyosis severity
研究概览
简要总结
Ichthyosis is a hereditary skin disorder resulting in chronic dry skin .It is characterized by a keratinization defect resulting in chronic dry skin .Icthyosis vulgaris is caused by the loss of function mutation in the filaggrin gene.This leads to loss of epidermal barrier leading to increased loss of transepidermal water.This study aims to utilize the anti inflammatory and hydrating properties of virgin coconut oil .By using nanoparticles of virgin coconut oil with ceramides ,it ensures delivery to skins deepest layers ,and helps retain moisture.This research is considered as a randomized ,single blinded parallel group study ,focussing on reducing scaling and dryness of the affected area .The results are analyzed with the help of Visual index for icthyosis severity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Paediatric population from 5-15 years will be included in the study.
排除标准
- •1.children with severe forms of icthyosis requiring systemic treatment 2.presence of other concurrent skin conditions 3.recent use of systemic retinoids in the past 3 months 4.immunocompromised 5.children with underlying medical condition such as renal or hepatic impairment.
结局指标
主要结局
1.primary outcome of this study would likely focus on clinical improvement in Ichthyosis symptoms,as evaluated by visual index for ichthyosis severity
时间窗: 1 month
次要结局
- improves overall skin health and skin hydration in children(1 month)
研究者
Suenera Kathrine P V
saveetha medical college and hospital