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

Overview[ - collapse ][ - ]

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.
ConditionScar
InterventionDietary Supplement: Natural Vitamin E Tocotrienol (TCT)
Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
Other: Placebo
Other: Placebo Cream
PhasePhase 0
SponsorChandan K Sen
Responsible PartyOhio State University
ClinicalTrials.gov IdentifierNCT00700791
First ReceivedJune 17, 2008
Last UpdatedJanuary 21, 2014
Last verifiedJanuary 2014

Tracking Information[ + expand ][ + ]

First Received DateJune 17, 2008
Last Updated DateJanuary 21, 2014
Start DateJuly 2008
Estimated Primary Completion DateDecember 2014
Current Primary Outcome Measures1.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]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars
Official TitleEfficacy 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.
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 TypeInterventional
Study PhasePhase 0
Study DesignAllocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
ConditionScar
InterventionDietary 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
Study Arm (s)
  • Placebo Comparator: Group I Single Site Randomization
    Patients with 1 surgical scar will be given both oral placebo and topical cream placebo
  • Active Comparator: Group II Single Site Randomization
    Single surgical site will be given oral placebo and topical TCT
  • Active Comparator: Group III Single Site Randomization
    Patients with 1 surgical scar will be given oral TCT and topical placebo cream
  • Active Comparator: Group IV Single Site Randomization
    Patients with 1 surgical scar will be given both oral TCT and 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.
  • 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.
  • 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.
  • 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.

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment168
Estimated Completion DateDecember 2014
Estimated Primary Completion DateDecember 2014
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsContact: Andrea Colcord, RN
614-366-3515
andrea.colcord@osumc.edu
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00700791
Other Study ID Numbers2008H0001
Has Data Monitoring CommitteeNo
Information Provided ByOhio State University
Study SponsorChandan K Sen
CollaboratorsNot Provided
Investigators Principal Investigator: Chandan K Sen, PhD Ohio State University
Verification DateJanuary 2014

Locations[ + expand ][ + ]

The Ohio State University
Columbus, Ohio, United States, 43221
Contact: Andrea Colcord, RN | 614-366-3615 | andrea.colcord@osumc.edu
Principal Investigator: Chandan Sen, PhD
Recruiting
OSU Plastic Surgery - Knightsbridge
Columbus, Ohio, United States, 43214
Contact: Andrea Colcord, RN | 614-366-3515 | andrea.colcord@osumc.edu
Recruiting