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

Study Overview
=================
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.

Official Title
-----------------
Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars

Conditions
-----------------
Scar

Intervention / Treatment
-----------------
* Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT)
* Device: Natural Vitamin E Tocotrienol Cream (TCT)
* Other: Placebo
* Other: Placebo Cream


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group I Single Site Randomization<br>Patients with 1 surgical scar will be given both oral placebo and topical cream placebo | Other: Placebo<br>* Oral Placebo<br>Other: Placebo Cream<br>* Topical Placebo Cream<br>|
| Active Comparator: Group II Single Site Randomization<br>Single surgical site will be given oral placebo and topical TCT | Device: Natural Vitamin E Tocotrienol Cream (TCT)<br>* Natural Vitamin E Tocotrienol(TCT)Topical Cream<br>* Other names: Topical TCT;Other: Placebo<br>* Oral Placebo<br>|
| Active Comparator: Group III Single Site Randomization<br>Patients with 1 surgical scar will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream | Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT)<br>* Oral Vitamin E Tocotrienol Supplement (TCT)<br>* Other names: Oral TCT;Other: Placebo Cream<br>* Topical Placebo Cream<br>|
| Active Comparator: Group IV Single Site Randomization<br>Patients with 1 surgical scar will be given both Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT). | Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT)<br>* Oral Vitamin E Tocotrienol Supplement (TCT)<br>* Other names: Oral TCT;Device: Natural Vitamin E Tocotrienol Cream (TCT)<br>* Natural Vitamin E Tocotrienol(TCT)Topical Cream<br>* Other names: Topical TCT;|
| Placebo Comparator: Group I: Bilateral Site Randomization<br>Patients with bilateral surgical scars will be given both oral placebo and topical cream placebo on one surgical site. | Other: Placebo<br>* Oral Placebo<br>Other: Placebo Cream<br>* Topical Placebo Cream<br>|
| Active Comparator: Group II: Bilateral Site Randomization<br>Patients with bilateral surgical scars will be given oral placebo and Natural Vitamin E Tocotrienol Cream (TCT) to one of the surgical sites. | Device: Natural Vitamin E Tocotrienol Cream (TCT)<br>* Natural Vitamin E Tocotrienol(TCT)Topical Cream<br>* Other names: Topical TCT;Other: Placebo<br>* Oral Placebo<br>|
| Active Comparator: Group III: Bilateral Site Randomization<br>Patients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream on one surgical site. | Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT)<br>* Oral Vitamin E Tocotrienol Supplement (TCT)<br>* Other names: Oral TCT;Other: Placebo Cream<br>* Topical Placebo Cream<br>|
| Active Comparator: Group IV: Bilateral Site Randomization<br>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. | Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT)<br>* Oral Vitamin E Tocotrienol Supplement (TCT)<br>* Other names: Oral TCT;Device: Natural Vitamin E Tocotrienol Cream (TCT)<br>* Natural Vitamin E Tocotrienol(TCT)Topical Cream<br>* Other names: Topical TCT;|
| No Intervention: Normal Skin and Adipost Tissue Group<br>Normal human skin and adipose tissue will be collected | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Single and bilateral body contouring surgical sites.