Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- WOUND CLOSURE
研究概览
简要总结
The following two objectives are proposed in healthy subjects to characterize (1) wound closure, (2) scar formation/appearance, and (3) inflammatory response:
Objective 1, (topical only - referred to as "TOP") - Topical application of Tocotrienol (TCT) vs placebo in bilateral punch biopsy
Objective 2, (oral and topical - referred to as "OTOP") - Combined oral supplementation and topical application of tocotrienol (TCT) vs placebo in bilateral punch biopsy
Objective 3, (topical only - referred to as "TAM") - Topical application of tamoxifen vs placebo in bilateral punch biopsy.
Objective 4, (topical only to normal skin) - Topical application of TCT vs placebo on bilateral lets on normal skin.
详细描述
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In nature, the vitamin E family is split into two classes: tocopherols (TCP) and tocotrienols (TCT). Members of the TCP and TCT family are biologically unique.
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TCP are mainly found in green leafy vegetables while TCT are the primary vitamin E of seeds, including cereal grains such as wheat, rice, and barley.
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Vitamin E is thought to improve wound healing by inhibiting collagen synthesis and attenuating fibroblast proliferation and inflammation. However, outcomes based scientific literature on the therapeutic efficacy of vitamin E in skin wound closure is scant and has primarily focused on TCP.
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Oral supplementation of TCP showed modest improvement in rodent wound closure, but the relevance of oral TCP supplementation in rats already receiving high dose vitamin E in a standard laboratory is questionable.
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Topical TCP on surgical wounds of children have been shown to improve wound healing; yet no mechanistic basis for the observed effect was described.
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Preliminary observations from the PI's active IRB protocol to test TCT in scar appearance of surgical wounds led us to evaluate the potential of TCT vitamin E to improve wound closure in healthy subjects. To date, the therapeutic efficacy of TCT in either topical (TOP) or oral with topical (OTOP) applications for skin wound healing remains to be reported.
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Preliminary observations also made show down-regulation of microRNA-200b supports cutaneous angiogenesis, the most important step in cutaneous wound healing. Tamoxifen silences mircroRNA-200b and later work has recognized that under non-neoplastic conditions, tamoxifen may induce angiogenesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages- 18-50 (Both Male & Female)
- •Non-smoker - having quit at least 3 months prior to enrollment
- •Non-diabetic
- •Non-pregnant or non-breastfeeding - verbal assent.
- •If a female subject of childbearing age misses her menstrual period after the start of the study, she will inform the investigators and be given a pregnancy test to ensure, for safety reasons, that she is not pregnant. If she is pregnant, she will discontinue participation in the study.
- •No current use of OTC medications or other form of supplements containing vitamin-E
排除标准
- •Diabetes or HIV diagnosis
- •Alcohol or drug abuse
- •unable to provide informed consent
- •Therapeutically anti-coagulated
- •Currently prescribed immunosuppressant medication
结局指标
主要结局
WOUND CLOSURE
时间窗: 1-2 month(s)
Wound closure will be assessed by results of conventional camera and thermal imaging in Group 1 and Group 2 subjects.
次要结局
- SCARRING(1-2 month (s))
研究者
Chandan K Sen
Professor
Ohio State University