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. |
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Condition | Scar |
Intervention | Dietary Supplement: Natural Vitamin E Tocotrienol (TCT) Dietary Supplement: Natural Vitamin E Tocotrienol (TCT) Other: Placebo Other: Placebo Cream |
Phase | Phase 0 |
Sponsor | Chandan K Sen |
Responsible Party | Ohio State University |
ClinicalTrials.gov Identifier | NCT00700791 |
First Received | June 17, 2008 |
Last Updated | January 21, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | June 17, 2008 |
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Last Updated Date | January 21, 2014 |
Start Date | July 2008 |
Estimated Primary Completion Date | December 2014 |
Current Primary Outcome Measures | 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] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars |
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Official Title | Efficacy 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 Type | Interventional |
Study Phase | Phase 0 |
Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator) |
Condition | Scar |
Intervention | 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 |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 168 |
Estimated Completion Date | December 2014 |
Estimated Primary Completion Date | December 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Contact: Andrea Colcord, RN 614-366-3515 andrea.colcord@osumc.edu |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00700791 |
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Other Study ID Numbers | 2008H0001 |
Has Data Monitoring Committee | No |
Information Provided By | Ohio State University |
Study Sponsor | Chandan K Sen |
Collaborators | Not Provided |
Investigators | Principal Investigator: Chandan K Sen, PhD Ohio State University |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
The Ohio State University | Columbus, Ohio, United States, 43221 Contact: Andrea Colcord, RN | 614-366-3615 | andrea.colcord@osumc.eduPrincipal Investigator: Chandan Sen, PhD Recruiting |
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OSU Plastic Surgery - Knightsbridge | Columbus, Ohio, United States, 43214 Contact: Andrea Colcord, RN | 614-366-3515 | andrea.colcord@osumc.eduRecruiting |