Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- 1.To determine the efficacy of TCT in improving the appearance of post-surgical scars following oral supplementation 2.To determine the efficacy of TCT in improving the appearance of post-surgical scars following topical application
研究概览
简要总结
The overall goal of this study is to determine the efficacy of tocotrienol (TCT), a natural form of vitamin E, in preventing or reducing scar formation in human skin wounds as well as the basal levels of TCT in normal human skin and adipose tissue.
详细描述
Scar formation is the physiological and inevitable end point of mammalian wound healing and there is substantial evidence that inflammation is an essential prerequisite for scarring. Although scar tissue restores the normal skin barrier, the new tissue is inferior in structural, aesthetic, and functional respects. The mammalian wound healing response may have originated during the time of high susceptibility to infection. Therefore, we may have developed speed optimized wound healing where a multiple redundant compensating rapid inflammatory response allows the wound to heal quickly without infection. The scar is then the price mammals have to pay for evolutionary survival after being wounded.
Tocotrienol may be an effective tool to prevent or reduce normal, hypertrophic, or keloid scarring by mediating the inflammatory response. Tocotrienol is a safe and convenient treatment that could be used by mouth or topically. There has never been a study on the effectiveness of tocotrienol in preventing or reducing scar formation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older.
- •Non- smoker
- •No current medications that alter liver metabolism (e.g., Phenobarbital, HmG co-A inhibitors, etc.)
- •Non- pregnant or non-breastfeeding
- •No current use of dietary supplements containing vitamin-E
- •Not actively abusing drugs or alcohol
排除标准
- •Under 18 years of age
- •Prisoners
- •Current smoker
- •Pregnant or breastfeeding
- •HIV diagnosis
- •Viral hepatitis diagnosis
- •Immunosuppressive therapy
- •Actively abusing drugs or alcohol
- •Current use of dietary supplements containing vitamin-E
研究组 & 干预措施
Group I Single Site Randomization
Patients with 1 surgical scar will be given both oral placebo and topical cream placebo
干预措施: Placebo (Other)
Group I Single Site Randomization
Patients with 1 surgical scar will be given both oral placebo and topical cream placebo
干预措施: Placebo Cream (Other)
Group II Single Site Randomization
Single surgical site will be given oral placebo and topical TCT
干预措施: Natural Vitamin E Tocotrienol Cream (TCT) (Device)
Group II Single Site Randomization
Single surgical site will be given oral placebo and topical TCT
干预措施: Placebo (Other)
Group III Single Site Randomization
Patients with 1 surgical scar will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream
干预措施: Natural Vitamin E Tocotrienol supplement (TCT) (Dietary Supplement)
Group III Single Site Randomization
Patients with 1 surgical scar will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream
干预措施: Placebo Cream (Other)
Group IV Single Site Randomization
Patients with 1 surgical scar will be given both Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT).
干预措施: Natural Vitamin E Tocotrienol supplement (TCT) (Dietary Supplement)
Group IV Single Site Randomization
Patients with 1 surgical scar will be given both Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT).
干预措施: Natural Vitamin E Tocotrienol Cream (TCT) (Device)
Group I: Bilateral Site Randomization
Patients with bilateral surgical scars will be given both oral placebo and topical cream placebo on one surgical site.
干预措施: Placebo (Other)
Group I: Bilateral Site Randomization
Patients with bilateral surgical scars will be given both oral placebo and topical cream placebo on one surgical site.
干预措施: Placebo Cream (Other)
Group II: Bilateral Site Randomization
Patients with bilateral surgical scars will be given oral placebo and Natural Vitamin E Tocotrienol Cream (TCT) to one of the surgical sites.
干预措施: Natural Vitamin E Tocotrienol Cream (TCT) (Device)
Group II: Bilateral Site Randomization
Patients with bilateral surgical scars will be given oral placebo and Natural Vitamin E Tocotrienol Cream (TCT) to one of the surgical sites.
干预措施: Placebo (Other)
Group III: Bilateral Site Randomization
Patients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream on one surgical site.
干预措施: Natural Vitamin E Tocotrienol supplement (TCT) (Dietary Supplement)
Group III: Bilateral Site Randomization
Patients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream on one surgical site.
干预措施: Placebo Cream (Other)
Group IV: Bilateral Site Randomization
Patients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT) on one surgical site.
干预措施: Natural Vitamin E Tocotrienol supplement (TCT) (Dietary Supplement)
Group IV: Bilateral Site Randomization
Patients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT) on one surgical site.
干预措施: Natural Vitamin E Tocotrienol Cream (TCT) (Device)
Normal Skin and Adipost Tissue Group
Normal human skin and adipose tissue will be collected
结局指标
主要结局
1.To determine the efficacy of TCT in improving the appearance of post-surgical scars following oral supplementation 2.To determine the efficacy of TCT in improving the appearance of post-surgical scars following topical application
时间窗: 4 weeks prior to surgery and 12 weeks post surgery.
次要结局
未报告次要终点
研究者
Chandan K Sen
Professor
Ohio State University