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

NCT ID: NCT00700791

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Scar

Keywords

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Single and bilateral body contouring surgical sites.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group I Single Site Randomization

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral Placebo

Placebo Cream

Intervention Type OTHER

Topical Placebo Cream

Group II Single Site Randomization

Single surgical site will be given oral placebo and topical TCT

Group Type ACTIVE_COMPARATOR

Natural Vitamin E Tocotrienol Cream (TCT)

Intervention Type DEVICE

Natural Vitamin E Tocotrienol(TCT)Topical Cream

Placebo

Intervention Type OTHER

Oral Placebo

Group III Single Site Randomization

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

Group Type ACTIVE_COMPARATOR

Natural Vitamin E Tocotrienol supplement (TCT)

Intervention Type DIETARY_SUPPLEMENT

Oral Vitamin E Tocotrienol Supplement (TCT)

Placebo Cream

Intervention Type OTHER

Topical Placebo Cream

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).

Group Type ACTIVE_COMPARATOR

Natural Vitamin E Tocotrienol supplement (TCT)

Intervention Type DIETARY_SUPPLEMENT

Oral Vitamin E Tocotrienol Supplement (TCT)

Natural Vitamin E Tocotrienol Cream (TCT)

Intervention Type DEVICE

Natural Vitamin E Tocotrienol(TCT)Topical Cream

Group I: Bilateral Site Randomization

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral Placebo

Placebo Cream

Intervention Type OTHER

Topical Placebo Cream

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.

Group Type ACTIVE_COMPARATOR

Natural Vitamin E Tocotrienol Cream (TCT)

Intervention Type DEVICE

Natural Vitamin E Tocotrienol(TCT)Topical Cream

Placebo

Intervention Type OTHER

Oral Placebo

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.

Group Type ACTIVE_COMPARATOR

Natural Vitamin E Tocotrienol supplement (TCT)

Intervention Type DIETARY_SUPPLEMENT

Oral Vitamin E Tocotrienol Supplement (TCT)

Placebo Cream

Intervention Type OTHER

Topical Placebo Cream

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.

Group Type ACTIVE_COMPARATOR

Natural Vitamin E Tocotrienol supplement (TCT)

Intervention Type DIETARY_SUPPLEMENT

Oral Vitamin E Tocotrienol Supplement (TCT)

Natural Vitamin E Tocotrienol Cream (TCT)

Intervention Type DEVICE

Natural Vitamin E Tocotrienol(TCT)Topical Cream

Normal Skin and Adipost Tissue Group

Normal human skin and adipose tissue will be collected

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Natural Vitamin E Tocotrienol supplement (TCT)

Oral Vitamin E Tocotrienol Supplement (TCT)

Intervention Type DIETARY_SUPPLEMENT

Natural Vitamin E Tocotrienol Cream (TCT)

Natural Vitamin E Tocotrienol(TCT)Topical Cream

Intervention Type DEVICE

Placebo

Oral Placebo

Intervention Type OTHER

Placebo Cream

Topical Placebo Cream

Intervention Type OTHER

Other Intervention Names

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Oral TCT Topical TCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chandan K Sen

OTHER

Sponsor Role lead

Responsible Party

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Chandan K Sen

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chandan K Sen, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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OSU Plastic Surgery - Knightsbridge

Columbus, Ohio, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2008H0001

Identifier Type: -

Identifier Source: org_study_id