Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars
November 10, 2021 updated by: Chandan K Sen
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.
Study Overview
Status
Terminated
Conditions
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
Enrollment (Anticipated)
168
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43221
- The Ohio State University
-
Columbus, Ohio, United States, 43214
- OSU Plastic Surgery - Knightsbridge
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Group I Single Site Randomization
Patients with 1 surgical scar will be given both oral placebo and topical cream placebo
|
Oral Placebo
Topical Placebo Cream
|
|
Active Comparator: Group II Single Site Randomization
Single surgical site will be given oral placebo and topical TCT
|
Oral Placebo
Natural Vitamin E Tocotrienol(TCT)Topical Cream
Other Names:
|
|
Active Comparator: Group III Single Site Randomization
Patients with 1 surgical scar will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream
|
Topical Placebo Cream
Oral Vitamin E Tocotrienol Supplement (TCT)
Other Names:
|
|
Active Comparator: Group IV Single Site Randomization
Patients with 1 surgical scar will be given both Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT).
|
Natural Vitamin E Tocotrienol(TCT)Topical Cream
Other Names:
Oral Vitamin E Tocotrienol Supplement (TCT)
Other Names:
|
|
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.
|
Oral Placebo
Topical Placebo Cream
|
|
Active Comparator: Group II: Bilateral Site Randomization
Patients with bilateral surgical scars will be given oral placebo and Natural Vitamin E Tocotrienol Cream (TCT) to one of the surgical sites.
|
Oral Placebo
Natural Vitamin E Tocotrienol(TCT)Topical Cream
Other Names:
|
|
Active Comparator: Group III: Bilateral Site Randomization
Patients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream on one surgical site.
|
Topical Placebo Cream
Oral Vitamin E Tocotrienol Supplement (TCT)
Other Names:
|
|
Active Comparator: Group IV: Bilateral Site Randomization
Patients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT) on one surgical site.
|
Natural Vitamin E Tocotrienol(TCT)Topical Cream
Other Names:
Oral Vitamin E Tocotrienol Supplement (TCT)
Other Names:
|
|
No Intervention: Normal Skin and Adipost Tissue Group
Normal human skin and adipose tissue will be collected
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
4 weeks prior to surgery and 12 weeks post surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chandan K Sen, PhD, Ohio State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
June 17, 2008
First Submitted That Met QC Criteria
June 18, 2008
First Posted (Estimate)
June 19, 2008
Study Record Updates
Last Update Posted (Actual)
November 18, 2021
Last Update Submitted That Met QC Criteria
November 10, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008H0001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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