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

Early Phase 1

Terminated

• Conditions: Scar
• Interventions: Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT); Other: Placebo Cream; Device: Natural Vitamin E Tocotrienol Cream (TCT); Other: Placebo

• Registration Number: NCT00700791
• Lead Sponsor: Chandan K Sen

Brief 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.

Study Timeline

• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Study Start: 2008-07
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I Single Site Randomization	Placebo Cream	Patients with 1 surgical scar will be given both oral placebo and topical cream placebo
Group IV Single Site Randomization	Natural Vitamin E Tocotrienol Cream (TCT)	Patients with 1 surgical scar will be given both Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT).
Group II Single Site Randomization	Placebo	Single surgical site will be given oral placebo and topical TCT
Group III Single Site Randomization	Natural Vitamin E Tocotrienol supplement (TCT)	Patients with 1 surgical scar will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream
Group I: Bilateral Site Randomization	Placebo	Patients with bilateral surgical scars will be given both oral placebo and topical cream placebo on one surgical site.
Group I: Bilateral Site Randomization	Placebo Cream	Patients with bilateral surgical scars will be given both oral placebo and topical cream placebo on one surgical site.
Group III: Bilateral Site Randomization	Natural Vitamin E Tocotrienol supplement (TCT)	Patients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream on one surgical site.
Group IV: Bilateral Site Randomization	Natural Vitamin E Tocotrienol Cream (TCT)	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.
Group I Single Site Randomization	Placebo	Patients with 1 surgical scar will be given both oral placebo and topical cream placebo
Group IV Single Site Randomization	Natural Vitamin E Tocotrienol supplement (TCT)	Patients with 1 surgical scar will be given both Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT).
Group II Single Site Randomization	Natural Vitamin E Tocotrienol Cream (TCT)	Single surgical site will be given oral placebo and topical TCT
Group II: Bilateral Site Randomization	Placebo	Patients with bilateral surgical scars will be given oral placebo and Natural Vitamin E Tocotrienol Cream (TCT) to one of the surgical sites.
Group IV: Bilateral Site Randomization	Natural Vitamin E Tocotrienol supplement (TCT)	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.
Group III Single Site Randomization	Placebo Cream	Patients with 1 surgical scar will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream
Group II: Bilateral Site Randomization	Natural Vitamin E Tocotrienol Cream (TCT)	Patients with bilateral surgical scars will be given oral placebo and Natural Vitamin E Tocotrienol Cream (TCT) to one of the surgical sites.
Group III: Bilateral Site Randomization	Placebo Cream	Patients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream on one surgical site.

Primary Outcome Measures

Name	Time	Method
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	4 weeks prior to surgery and 12 weeks post surgery.

Trial Locations

Locations (2)

OSU Plastic Surgery - Knightsbridge; 🇺🇸 Columbus, Ohio, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States