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

Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00700791
• Other study ID #: 2008H0001
• Status: Terminated
• Phase: Early Phase 1
• Start date: July 2008
• Est. completion date: July 2018

Study information

• Verified date: November 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 168
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scar

Intervention

Dietary Supplement:
• Natural Vitamin E Tocotrienol supplement (TCT)
Oral Vitamin E Tocotrienol Supplement (TCT)

Device:
• Natural Vitamin E Tocotrienol Cream (TCT)
Natural Vitamin E Tocotrienol(TCT)Topical Cream

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

Locations

Country	Name	City	State
United States	OSU Plastic Surgery - Knightsbridge	Columbus	Ohio
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Chandan K Sen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		4 weeks prior to surgery and 12 weeks post surgery.