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

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.

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 mammalians have to pay for evolutionary survival after wounding.

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.

• Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
  Oral Vitamin E Tocotrienol Supplement (TCT)
• Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
  Natural Vitamin E Tocotrienol(TCT)Topical Cream
• Other: Placebo
  Oral Placebo
• Other: Placebo Cream
  Topical Placebo Cream

• Placebo Comparator: Group I Single Site Randomization
  Patients with 1 surgical scar will be given both oral placebo and topical cream placebo
  Interventions:

  • Other: Placebo
  • Other: Placebo Cream
• Active Comparator: Group II Single Site Randomization
  Single surgical site will be given oral placebo and topical TCT
  Interventions:

  • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
  • Other: Placebo
• Active Comparator: Group III Single Site Randomization
  Patients with 1 surgical scar will be given oral TCT and topical placebo cream
  Interventions:

  • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
  • Other: Placebo Cream
• Active Comparator: Group IV Single Site Randomization
  Patients with 1 surgical scar will be given both oral TCT and topical TCT.
  Interventions:

  • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
  • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
• Placebo Comparator: Group I: Bilateral Site Randomization
  Patients with bilateral surgical scars will be given both oral placebo and topical cream placebo on one surgical site.
  Interventions:

  • Other: Placebo
  • Other: Placebo Cream
• Active Comparator: Group II: Bilateral Site Randomization
  Patients with bilateral surgical scars will be given oral placebo and topical TCT cream to one of the surgical sites.
  Interventions:

  • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
  • Other: Placebo
• Active Comparator: Group III: Bilateral Site Randomization
  Patients with bilateral surgical scars will be given oral TCT and topical placebo cream on one surgical site.
  Interventions:

  • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
  • Other: Placebo Cream
• Active Comparator: Group IV: Bilateral Site Randomization
  Patients with bilateral surgical scars will be given oral TCT and topical TCT cream on one surgical site.
  Interventions:

  • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
  • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)

Inclusion Criteria:

• To ensure higher enrollment we are not controlling for age of subjects as long as the subjects are 18 years of age or older.
• Non- smoker
• No current medications that alter liver metabolism, e.g Phenobarbital, HmG co-A inhibitors
• Non- pregnant or non-breastfeeding
• No current use of dietary supplements containing vitamin-E
• Not actively abusing drugs or alcohol

Exclusion Criteria:

• Under 18 years of age
• Prisoners
• Current smoker
• Pregnant or breastfeeding
• HIV diagnosis
• Viral hepatitis diagnosis
• Immunosuppression therapy
• Actively abusing drugs or alcohol
• Current use of dietary supplements containing vitamin-E