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

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ClinicalTrials.gov Identifier: NCT00700791
Recruitment Status : Terminated (The PI moved to another Institution)
First Posted : June 19, 2008
Last Update Posted : November 18, 2021
Sponsor:
Information provided by (Responsible Party):
Chandan K Sen, Ohio State University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2008
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars Vitamin E

Arms and Interventions
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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 Name: 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 Name: 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 Name: Oral TCT

Device: Natural Vitamin E Tocotrienol Cream (TCT)
Natural Vitamin E Tocotrienol(TCT)Topical Cream
Other Name: 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 Name: 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 Name: 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 Name: Oral TCT

Device: Natural Vitamin E Tocotrienol Cream (TCT)
Natural Vitamin E Tocotrienol(TCT)Topical Cream
Other Name: Topical TCT
No Intervention: Normal Skin and Adipost Tissue Group
Normal human skin and adipose tissue will be collected


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 4 weeks prior to surgery and 12 weeks post surgery. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700791


Locations
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United States, Ohio
OSU Plastic Surgery - Knightsbridge
Columbus, Ohio, United States, 43214
The Ohio State University
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Chandan K Sen
Investigators
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Principal Investigator: Chandan K Sen, PhD Ohio State University
More Information
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Responsible Party: Chandan K Sen, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00700791    
Other Study ID Numbers: 2008H0001
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: November 18, 2021
Last Verified: November 2021
Keywords provided by Chandan K Sen, Ohio State University:
Single and bilateral body contouring surgical sites.
Additional relevant MeSH terms:
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Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
 Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents