Overview

This trial is active, not recruiting.

Condition scar
Treatments natural vitamin e tocotrienol supplement (tct), natural vitamin e tocotrienol cream (tct), placebo, placebo cream
Phase phase 0
Sponsor Chandan K Sen
Start date July 2008
End date December 2016
Trial size 168 participants
Trial identifier NCT00700791, 2008H0001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Arm
(Placebo Comparator)
Patients with 1 surgical scar will be given both oral placebo and topical cream placebo
placebo
Oral Placebo
placebo cream
Topical Placebo Cream
(Active Comparator)
Single surgical site will be given oral placebo and topical TCT
natural vitamin e tocotrienol cream (tct) Topical TCT
Natural Vitamin E Tocotrienol(TCT)Topical Cream
placebo
Oral Placebo
(Active Comparator)
Patients with 1 surgical scar will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream
natural vitamin e tocotrienol supplement (tct) Oral TCT
Oral Vitamin E Tocotrienol Supplement (TCT)
placebo cream
Topical Placebo Cream
(Active Comparator)
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 supplement (tct) Oral TCT
Oral Vitamin E Tocotrienol Supplement (TCT)
natural vitamin e tocotrienol cream (tct) Topical TCT
Natural Vitamin E Tocotrienol(TCT)Topical Cream
(Placebo Comparator)
Patients with bilateral surgical scars will be given both oral placebo and topical cream placebo on one surgical site.
placebo
Oral Placebo
placebo cream
Topical Placebo Cream
(Active Comparator)
Patients with bilateral surgical scars will be given oral placebo and Natural Vitamin E Tocotrienol Cream (TCT) to one of the surgical sites.
natural vitamin e tocotrienol cream (tct) Topical TCT
Natural Vitamin E Tocotrienol(TCT)Topical Cream
placebo
Oral Placebo
(Active Comparator)
Patients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream on one surgical site.
natural vitamin e tocotrienol supplement (tct) Oral TCT
Oral Vitamin E Tocotrienol Supplement (TCT)
placebo cream
Topical Placebo Cream
(Active Comparator)
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 supplement (tct) Oral TCT
Oral Vitamin E Tocotrienol Supplement (TCT)
natural vitamin e tocotrienol cream (tct) Topical TCT
Natural Vitamin E Tocotrienol(TCT)Topical Cream
(No Intervention)
Normal human skin and adipose tissue will be collected

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
time frame: 4 weeks prior to surgery and 12 weeks post surgery.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars
Principal investigator Chandan K Sen, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Ohio State University.