NCT00700791

Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Chandan K Sen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Scar

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Natural Vitamin E Tocotrienol supplement (TCT)	Oral Vitamin E Tocotrienol Supplement (TCT)
DEVICE	Natural Vitamin E Tocotrienol Cream (TCT)	Natural Vitamin E Tocotrienol(TCT)Topical Cream
OTHER	Placebo	Oral Placebo
OTHER	Placebo Cream	Topical Placebo Cream

Timeline

• Start date: 2008-07-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2008-06-19
• Last updated: 2021-11-18

Locations

2 sites across 1 country: United States