Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars
Information source: Ohio State University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Scar
Intervention: Natural Vitamin E Tocotrienol supplement (TCT) (Dietary Supplement); Natural Vitamin E Tocotrienol Cream (TCT) (Device); Placebo (Other); Placebo Cream (Other)
Phase: Phase 0
Status: Recruiting
Sponsored by: Chandan K Sen Official(s) and/or principal investigator(s):
Chandan K Sen, PhD, Principal Investigator, Affiliation: Ohio State University
Overall contact:
Elizabeth Murphy, BS, Phone: 614-366-3515, Email: elizabeth.murphy@osumc.edu
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.
Clinical Details
Official title: Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: 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
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Elizabeth Murphy, BS, Phone: 614-366-3515, Email: elizabeth.murphy@osumc.edu
OSU Plastic Surgery - Knightsbridge, Columbus, Ohio 43214, United States; Recruiting
Elizabeth Murphy, BS, Phone: 614-366-3515, Email: elizabeth.murphy@osumc.edu
The Ohio State University, Columbus, Ohio 43221, United States; Recruiting
Elizabeth Murphy, BS, Phone: 614-366-3615, Email: elizabeth.murphy@osumc.edu
Lauren Allison, RN, Phone: 614-366-2783, Email: lauren.allison@osumc.edu
Chandan Sen, PhD, Principal Investigator
Additional Information
Starting date: July 2008
Last updated: January 23, 2015
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