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

Chandan K Sen

Status and phase: Terminated; Early Phase 1

Conditions: Scar

Treatments: Other: Placebo Cream; Device: Natural Vitamin E Tocotrienol Cream (TCT); Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00700791

2008H0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 9 patient groups, including a placebo group

Group I Single Site Randomization

Placebo Comparator group

Description:

Patients with 1 surgical scar will be given both oral placebo and topical cream placebo

Treatment:

Other: Placebo

Other: Placebo Cream

Group II Single Site Randomization

Active Comparator group

Description:

Single surgical site will be given oral placebo and topical TCT

Treatment:

Other: Placebo

Device: Natural Vitamin E Tocotrienol Cream (TCT)

Group III Single Site Randomization

Active Comparator group

Description:

Patients with 1 surgical scar will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream

Treatment:

Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT)

Other: Placebo Cream

Group IV Single Site Randomization

Active Comparator group

Description:

Patients with 1 surgical scar will be given both Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT).

Treatment:

Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT)

Device: Natural Vitamin E Tocotrienol Cream (TCT)

Group I: Bilateral Site Randomization

Placebo Comparator group

Description:

Patients with bilateral surgical scars will be given both oral placebo and topical cream placebo on one surgical site.

Treatment:

Other: Placebo

Other: Placebo Cream

Group II: Bilateral Site Randomization

Active Comparator group

Description:

Patients with bilateral surgical scars will be given oral placebo and Natural Vitamin E Tocotrienol Cream (TCT) to one of the surgical sites.

Treatment:

Other: Placebo

Device: Natural Vitamin E Tocotrienol Cream (TCT)

Group III: Bilateral Site Randomization

Active Comparator group

Description:

Patients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream on one surgical site.

Treatment:

Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT)

Other: Placebo Cream

Group IV: Bilateral Site Randomization

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT)

Device: Natural Vitamin E Tocotrienol Cream (TCT)

Normal Skin and Adipost Tissue Group

No Intervention group

Description:

Normal human skin and adipose tissue will be collected