跳至主要内容
临床试验/NCT05101421
NCT05101421已完成不适用

The Effects of Rice Ceramide Supplementation in Improving Skin Health

Nexus Wise Sdn Bhd4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
4
主要终点
Change in skin firmness and elasticity

研究概览

简要总结

Ceramides have been added to newer cosmetic products to improve skin barrier function and exogenously replenish skin ceramides. Of the stratum corneum intercellular lipids, Ceramides are the most effective at restoring barrier function and increasing skin hydration. Different ceramides have been incorporated into cosmetic formulations, but understanding the differences between ceramides used in formulations, or even identifying ceramides in formulations can be complex. This is mostly because of an archaic nomenclature system that is fundamentally flawed based on current scientific evidence. In the recent past, due to the unique bioactive components of rice, it has been explored to a certain limit for its components. Further, much attention has been paid to the plant ceramide with its incorporation into cosmetics and food preparations owing to its safety in contrast to animal/synthetic origin. There are reports on plant ceramide deciphering its protective effects on human skin by preventing moisture loss. It has been anticipated that ceramides, fatty acids, and cholesterol in combination with hydrocortisone (HC) can be an useful therapeutic agents against xerosis and atopic dermatitis.

The beneficial effects of oral intake of plant-derived ceramides for skin hydration and skin barrier reinforcement have been established in several studies involving animal models as well as human subjects. Ingestion of konjac ceramides has also shown positive effects in atopic dermatitis patients as well as healthy volunteers. Results showed improved skin symptoms and reduced skin allergic responses. The foregoing studies support the beneficial effects of oral intake of plant ceramides and their potential complementary and alternative therapeutic applications in the restoration and maintenance of skin barrier function. However, the findings from human study are still very limited, more detailed and comprehensive studies are still required to document the clinical efficacy of oral supplementation of ceramides. Thus, this study aims to evaluate the effects of rice ceramides consumption in improving skin health.

详细描述

EFFECTS OF RICE CERAMIDES IN IMPROVING SKIN HEALTH - STUDY PROTOCOL

INTRODUCTION

Background

Ceramides are important structural components of the epidermis, which plays a key role in maintaining homeostasis of the human body. Specifically, its outermost layer, known as the stratum corneum, forms a barrier between the external environment and the internal body. This barrier function serves multiple purposes including prevention of water loss and protection from foreign insult. The structure of the stratum corneum is often referred to as ''brick and mortar''. The ''bricks'' are terminally differentiated keratinocytes composed mostly of keratin filaments and filaggrin. The ''mortar'' is composed of intercellular lipids arranged into lamellar layers consisting of ceramides, free fatty acids, and cholesterol. Ceramides are the predominant lipid comprising approximately 50% of the intercellular lipid content by mass. Stratum corneum lipids are essential for maintaining skin barrier function and preventing transepidermal water loss (TEWL). Disruptions or damage to the stratum corneum can impair skin barrier function and result in TEWL.

Ceramides have been added to newer cosmetic products to improve skin barrier function and exogenously replenish skin ceramides. Of the stratum corneum intercellular lipids, Ceramides are the most effective at restoring barrier function and increasing skin hydration. Different ceramides have been incorporated into cosmetic formulations, but understanding the differences between ceramides used in formulations, or even identifying ceramides in formulations can be complex. This is mostly because of an archaic nomenclature system that is fundamentally flawed based on current scientific evidence. In the recent past, due to the unique bioactive components of rice, it has been explored to a certain limit for its components. Further, much attention has been paid to the plant ceramide with its incorporation into cosmetics and food preparations owing to its safety in contrast to animal/synthetic origin. There are reports on plant ceramide deciphering its protective effects on human skin by preventing moisture loss. It has been anticipated that ceramides, fatty acids, and cholesterol in combination with hydrocortisone (HC) can be an useful therapeutic agents against xerosis and atopic dermatitis. In addition, report also showed that topical emulsions containing ceramides possessed anti-inflammatory and skin beneficial properties. Hence, isolation of ceramide from natural source possessing anti-inflammatory and skin protective properties becomes vital.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Good general health
  • Free from any skin diseases
  • Willing to comply with rice ceramide consumption plan
  • Willing to give consent

排除标准

  • Undergoing medication plan for skin condition
  • Undergone major surgical procedures in the past six months
  • Pregnant or lactating woman

结局指标

主要结局

Change in skin firmness and elasticity

时间窗: Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3)

To be assessed using Courage \& Khazaka Cutometer®, MPA580

Change in skin pH

时间窗: Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3)

To be assessed using Courage \& Khazaka pH meter®, PH900

Change in skin hydration

时间窗: Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3)

To be assessed using Courage \& Khazaka Corneometer®, CM825

Change in skin whitening

时间窗: Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3)

To be assessed using Courage \& Khazaka Mexameter®, MX18

Change in sebum secretion

时间窗: Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3)

To be assessed using Courage \& Khazaka Sebumeter®, SM815

Wrinkle change

时间窗: Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3)

To be assessed using Total Wrinkle Score (TWS). TWS has a minimum value of 4 and maximum value of 20, with higher values indicating higher severity.

Change in transepidermal water loss and skin barrier function

时间窗: Time point 1 (month 0), time point 2 (follow-up visit month 1), time point 3 (follow-up visit month 2) and time point 4 (follow-up visit month 3)

To be assessed using Tewameter® TM 300

次要结局

  • Adverse events(Follow-up visit month 3)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Tan Chung Keat

Clinical Assistant Professor

Nexus Wise Sdn Bhd

研究点 (4)

Loading locations...

相似试验

Rice Ceramide Supplementation and Skin Health | 临床试验