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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00700791
First Posted: June 19, 2008
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chandan K Sen, The Ohio State University
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Chandan K Sen, The Ohio State University:

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 [ Time Frame: 4 weeks prior to surgery and 12 weeks post surgery. ]

Estimated Enrollment: 168
Study Start Date: July 2008
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
Principal Investigator: Chandan K Sen, PhD Ohio State University
  More Information

Responsible Party: Chandan K Sen, Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00700791     History of Changes
Other Study ID Numbers: 2008H0001
First Submitted: June 17, 2008
First Posted: June 19, 2008
Last Update Posted: January 24, 2017
Last Verified: January 2017

Keywords provided by Chandan K Sen, The Ohio State University:
Single and bilateral body contouring surgical sites.

Additional relevant MeSH terms:
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents