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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Chandan K Sen, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00700791
First received: June 17, 2008
Last updated: August 21, 2014
Last verified: August 2014

June 17, 2008
August 21, 2014
July 2008
December 2015   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00700791 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars
Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars

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.

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.

Interventional
Phase 0
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Scar
  • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
    Oral Vitamin E Tocotrienol Supplement (TCT)
  • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
    Natural Vitamin E Tocotrienol(TCT)Topical Cream
  • Other: Placebo
    Oral Placebo
  • Other: Placebo Cream
    Topical Placebo Cream
  • 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:
    • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
    • Other: Placebo
  • Active Comparator: Group III Single Site Randomization
    Patients with 1 surgical scar will be given oral TCT and topical placebo cream
    Interventions:
    • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
    • Other: Placebo Cream
  • Active Comparator: Group IV Single Site Randomization
    Patients with 1 surgical scar will be given both oral TCT and topical TCT.
    Interventions:
    • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
    • Dietary Supplement: Natural Vitamin E Tocotrienol (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 topical TCT cream to one of the surgical sites.
    Interventions:
    • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
    • Other: Placebo
  • Active Comparator: Group III: Bilateral Site Randomization
    Patients with bilateral surgical scars will be given oral TCT and topical placebo cream on one surgical site.
    Interventions:
    • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
    • Other: Placebo Cream
  • Active Comparator: Group IV: Bilateral Site Randomization
    Patients with bilateral surgical scars will be given oral TCT and topical TCT cream on one surgical site.
    Interventions:
    • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
    • Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
  • No Intervention: Normal Skin and Adipost Tissue Group
    Normal human skin and adipose tissue will be collected
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
168
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Elizabeth Murphy, BS 614-366-3515 elizabeth.murphy@osumc.edu
Contact: Lauren Allison, RN 614-366-2783 lauren.allison@osumc.edu
United States
 
NCT00700791
2008H0001
No
Chandan K Sen, The Ohio State University
Chandan K Sen
Not Provided
Principal Investigator: Chandan K Sen, PhD Ohio State University
Ohio State University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP