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

Sponsor

Chandan K Sen (Other)

Overall Status

Terminated

CT.gov ID

NCT00700791

Collaborator

(none)

168

Enrollment

Locations

Arms

120

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scar	Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT) Device: Natural Vitamin E Tocotrienol Cream (TCT) Other: Placebo Other: Placebo Cream	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group I Single Site Randomization Patients with 1 surgical scar will be given both oral placebo and topical cream placebo	Other: Placebo Oral Placebo Other: Placebo Cream Topical Placebo Cream
Active Comparator: Group II Single Site Randomization Single surgical site will be given oral placebo and topical TCT	Device: Natural Vitamin E Tocotrienol Cream (TCT) Natural Vitamin E Tocotrienol(TCT)Topical Cream Other Names: Topical TCT Other: Placebo Oral Placebo
Active Comparator: Group III Single Site Randomization 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) Oral Vitamin E Tocotrienol Supplement (TCT) Other Names: Oral TCT Other: Placebo Cream Topical Placebo Cream
Active Comparator: Group IV Single Site Randomization 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) Oral Vitamin E Tocotrienol Supplement (TCT) Other Names: Oral TCT Device: Natural Vitamin E Tocotrienol Cream (TCT) Natural Vitamin E Tocotrienol(TCT)Topical Cream Other Names: Topical 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.	Other: Placebo Oral Placebo Other: Placebo Cream Topical Placebo Cream
Active Comparator: Group II: Bilateral Site Randomization 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) Natural Vitamin E Tocotrienol(TCT)Topical Cream Other Names: Topical TCT Other: Placebo Oral Placebo
Active Comparator: Group III: Bilateral Site Randomization 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) Oral Vitamin E Tocotrienol Supplement (TCT) Other Names: Oral TCT Other: Placebo Cream Topical Placebo Cream
Active Comparator: Group IV: Bilateral Site Randomization 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) Oral Vitamin E Tocotrienol Supplement (TCT) Other Names: Oral TCT Device: Natural Vitamin E Tocotrienol Cream (TCT) Natural Vitamin E Tocotrienol(TCT)Topical Cream Other Names: Topical TCT
No Intervention: Normal Skin and Adipost Tissue Group Normal human skin and adipose tissue will be collected

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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