Text Size

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

This study is currently recruiting participants.
Verified November 2012 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Chandan K Sen, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00700791
First received: June 17, 2008
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  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.


Condition Intervention Phase
Scar
 Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
Other: Placebo
Other: Placebo Cream
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars

Resource links provided by NLM:

MedlinePlus related topics: Scars Vitamin E
U.S. FDA Resources

Further study details as provided by Ohio State University:

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 ]

Estimated Enrollment: 168
Study Start Date: July 2008
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group I Single Site Randomization
Patients with 1 surgical scar will be given both oral placebo and topical cream placebo
 Other: Placebo
Oral Placebo
Other: Placebo Cream
Topical Placebo Cream
Active Comparator: Group II Single Site Randomization
Single surgical site will be given oral placebo and topical TCT
 Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
Natural Vitamin E Tocotrienol(TCT)Topical Cream
Other: Placebo
Oral Placebo
Active Comparator: Group III Single Site Randomization
Patients with 1 surgical scar will be given oral TCT and topical placebo cream
 Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
Oral Vitamin E Tocotrienol Supplement (TCT)
Other: Placebo Cream
Topical Placebo Cream
Active Comparator: Group IV Single Site Randomization
Patients with 1 surgical scar will be given both oral TCT and topical TCT.
 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
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.
 Other: Placebo
Oral Placebo
Other: Placebo Cream
Topical Placebo Cream
Active Comparator: Group II: Bilateral Site Randomization
Patients with bilateral surgical scars will be given oral placebo and topical TCT cream to one of the surgical sites.
 Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
Natural Vitamin E Tocotrienol(TCT)Topical Cream
Other: Placebo
Oral Placebo
Active Comparator: Group III: Bilateral Site Randomization
Patients with bilateral surgical scars will be given oral TCT and topical placebo cream on one surgical site.
 Dietary Supplement: Natural Vitamin E Tocotrienol (TCT)
Oral Vitamin E Tocotrienol Supplement (TCT)
Other: Placebo Cream
Topical Placebo Cream
Active Comparator: Group IV: Bilateral Site Randomization
Patients with bilateral surgical scars will be given oral TCT and topical TCT cream on one surgical site.
 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

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 mammalians have to pay for evolutionary survival after wounding.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • To ensure higher enrollment we are not controlling for age of subjects as long as the subjects are 18 years of age or older.
  • Non- smoker
  • No current medications that alter liver metabolism, e.g Phenobarbital, HmG co-A inhibitors
  • 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
  • Immunosuppression therapy
  • Actively abusing drugs or alcohol
  • Current use of dietary supplements containing vitamin-E
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700791

Contacts
Contact: Urmila S. Gnyawali, RN 614-366-3515 urmila.gnyawali@osumc.edu

Locations
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: Urmila Gnyawali, RN     614-366-3615     urmila.gnyawali@osumc.edu    
Principal Investigator: Chandan Sen, PhD            
OSU Plastic Surgery - Knightsbridge Recruiting
Columbus, Ohio, United States, 43214
Contact: Urmila S Gnyawali, RN     614-366-3515     urmila.gnyawali@osumc.edu    
Sponsors and Collaborators
Chandan K Sen
Investigators
Principal Investigator: Chandan K Sen, PhD Ohio State University
  More Information

No publications provided

Responsible Party: Chandan K Sen, Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00700791     History of Changes
Other Study ID Numbers: 2008H0001
Study First Received: June 17, 2008
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Single and bilateral body contouring surgical sites.

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013