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

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

Tracking Information

• First Submitted Date: June 17, 2008
• First Posted Date: June 19, 2008
• Last Update Posted Date: November 18, 2021
• Study Start Date: July 2008
• Actual Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 18, 2008): 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. ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars
• Official Title: Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars
• 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.

• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Other
• Condition: Scar

Intervention

• 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
• Other: Placebo
  Oral Placebo
• Other: Placebo Cream
  Topical Placebo Cream

Study Arms

• Placebo Comparator: Group I Single Site Randomization
  Patients with 1 surgical scar will be given both oral placebo and topical cream placebo
  Interventions:

  • Other: Placebo
  • Other: Placebo Cream
• Active Comparator: Group II Single Site Randomization
  Single surgical site will be given oral placebo and topical TCT
  Interventions:

  • Device: Natural Vitamin E Tocotrienol Cream (TCT)
  • Other: 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
  Interventions:

  • Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT)
  • Other: 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).
  Interventions:

  • Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT)
  • Device: Natural Vitamin E Tocotrienol Cream (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.
  Interventions:

  • Other: Placebo
  • Other: 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.
  Interventions:

  • Device: Natural Vitamin E Tocotrienol Cream (TCT)
  • Other: 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.
  Interventions:

  • Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT)
  • Other: 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.
  Interventions:

  • Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT)
  • Device: Natural Vitamin E Tocotrienol Cream (TCT)
• No Intervention: Normal Skin and Adipost Tissue Group
  Normal human skin and adipose tissue will be collected

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Estimated Enrollment (submitted: June 18, 2008): 168
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2018
• Actual Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00700791
• Other Study ID Numbers: 2008H0001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Chandan K Sen, Ohio State University
• Original Responsible Party: Dr Chandan Sen, The Ohio State University Department of Surgery
• Current Study Sponsor: Chandan K Sen
• Original Study Sponsor: Ohio State University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Chandan K Sen, PhD; Ohio State University

• PRS Account: Ohio State University
• Verification Date: November 2021