Clinical trial NCT00700791: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Scar
Keywords: Single and bilateral body contouring surgical sites.
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2008-06-19
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
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
timeFrame: 4 weeks prior to surgery and 12 weeks post surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OSU Plastic Surgery - Knightsbridge
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Chandan K Sen, PhD
role: PRINCIPAL_INVESTIGATOR
References: