ScarEarly Phase 1NCT00700791

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

A Early Phase 1 study testing Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT) in people with Scar, run by Chandan K Sen at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Scar
What is being tested?: Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT)
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 168 participants
Where: 2 sitesUnited States
Study dates: Jul 2008to Jul 2018
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Under 18 years of age
Prisoners
Current smoker
Pregnant or breastfeeding
HIV diagnosis
Viral hepatitis diagnosis

Show all 9Show fewer

Immunosuppressive therapy
Actively abusing drugs or alcohol
Current use of dietary supplements containing vitamin-E

Trial locations and contacts

2 sites in 1 country.

United States2 sites

OSU Plastic Surgery - Knightsbridge
Columbus, Ohio, 43214
The Ohio State University
Columbus, Ohio, 43221

Other trials in United States

About this study

Read the 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.

Conditions: Scar
Being tested: Natural Vitamin E Tocotrienol supplement (TCT), Natural Vitamin E Tocotrienol Cream (TCT), Placebo, Placebo Cream
Keywords: Single and bilateral body contouring surgical sites.
Medical subject headings: Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Natural Vitamin E Tocotrienol supplement (TCT)Dietary supplement
Also called Oral TCT
Oral Vitamin E Tocotrienol Supplement (TCT)
Natural Vitamin E Tocotrienol Cream (TCT)Device
Also called Topical TCT
Natural Vitamin E Tocotrienol(TCT)Topical Cream
PlaceboOther
Oral Placebo
Placebo CreamOther
Topical Placebo Cream

Study groups in NCT00700791
Study group	Role	What they receive
Group I Single Site Randomization	Placebo comparator	Patients with 1 surgical scar will be given both oral placebo and topical cream placebo Receives: Other: Placebo; Other: Placebo Cream
Group II Single Site Randomization	Active comparator	Single surgical site will be given oral placebo and topical TCT Receives: Device: Natural Vitamin E Tocotrienol Cream (TCT); Other: Placebo
Group III Single Site Randomization	Active comparator	Patients with 1 surgical scar will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream Receives: Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT); Other: Placebo Cream
Group IV Single Site Randomization	Active comparator	Patients with 1 surgical scar will be given both Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT). Receives: Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT); Device: Natural Vitamin E Tocotrienol Cream (TCT)
Group I: Bilateral Site Randomization	Placebo comparator	Patients with bilateral surgical scars will be given both oral placebo and topical cream placebo on one surgical site. Receives: Other: Placebo; Other: Placebo Cream
Group II: Bilateral Site Randomization	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. Receives: Device: Natural Vitamin E Tocotrienol Cream (TCT); Other: Placebo
Group III: Bilateral Site Randomization	Active comparator	Patients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream on one surgical site. Receives: Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT); Other: Placebo Cream
Group IV: Bilateral Site Randomization	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. Receives: Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT); Device: Natural Vitamin E Tocotrienol Cream (TCT)
Normal Skin and Adipost Tissue Group	No intervention	Normal human skin and adipose tissue will be collected

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 4 weeks prior to surgery and 12 weeks post surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Jul 2018

First posted19 Jun 2008 (estimated)
Study startJul 2008
Primary completionJul 2018
Study completionJul 2018

Why it stopped: The PI moved to another Institution

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ScarStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 168 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00700791
Sponsor's protocol ID: 2008H0001
Status last verified: Nov 2021
First submitted: 17 Jun 2008
Last updated: 18 Nov 2021
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars
ClinicalTrials.gov ID: NCT00700791
Acronym / sponsor ID: 2008H0001
Conditions: Scar
Keywords: Single and bilateral body contouring surgical sites.
Phase: Early Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The PI moved to another Institution
Enrolment: 168 participants (estimated)
Lead sponsor: Chandan K SenUniversity, hospital or other
Study start: Jul 2008
Primary completion: Jul 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 19 Jun 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
Group I Single Site Randomization	Placebo comparator	Other: Placebo, Other: Placebo CreamPatients with 1 surgical scar will be given both oral placebo and topical cream placebo
Group II Single Site Randomization	Active comparator	Device: Natural Vitamin E Tocotrienol Cream (TCT), Other: PlaceboSingle surgical site will be given oral placebo and topical TCT
Group III Single Site Randomization	Active comparator	Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT), Other: Placebo CreamPatients with 1 surgical scar will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream
Group IV Single Site Randomization	Active comparator	Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT), Device: Natural Vitamin E Tocotrienol Cream (TCT)Patients with 1 surgical scar will be given both Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT).
Group I: Bilateral Site Randomization	Placebo comparator	Other: Placebo, Other: Placebo CreamPatients with bilateral surgical scars will be given both oral placebo and topical cream placebo on one surgical site.
Group II: Bilateral Site Randomization	Active comparator	Device: Natural Vitamin E Tocotrienol Cream (TCT), Other: PlaceboPatients with bilateral surgical scars will be given oral placebo and Natural Vitamin E Tocotrienol Cream (TCT) to one of the surgical sites.
Group III: Bilateral Site Randomization	Active comparator	Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT), Other: Placebo CreamPatients with bilateral surgical scars will be given Natural Vitamin E Tocotrienol supplement (TCT) and topical placebo cream on one surgical site.
Group IV: Bilateral Site Randomization	Active comparator	Dietary Supplement: Natural Vitamin E Tocotrienol supplement (TCT), Device: Natural Vitamin E Tocotrienol Cream (TCT)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.
Normal Skin and Adipost Tissue Group	No intervention	–Normal human skin and adipose tissue will be collected

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

Under 18 years of age
Prisoners
Current smoker
Pregnant or breastfeeding
HIV diagnosis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Natural Vitamin E Tocotrienol supplement (TCT)Also: Oral TCTOral Vitamin E Tocotrienol Supplement (TCT)	Dietary supplement	Group III Single Site Randomization, Group III: Bilateral Site Randomization, Group IV Single Site Randomization, Group IV: Bilateral Site Randomization
Natural Vitamin E Tocotrienol Cream (TCT)Also: Topical TCTNatural Vitamin E Tocotrienol(TCT)Topical Cream	Device	Group II Single Site Randomization, Group II: Bilateral Site Randomization, Group IV Single Site Randomization, Group IV: Bilateral Site Randomization
PlaceboOral Placebo	Other	Group I Single Site Randomization, Group I: Bilateral Site Randomization, Group II Single Site Randomization, Group II: Bilateral Site Randomization
Placebo CreamTopical Placebo Cream	Other	Group I Single Site Randomization, Group I: Bilateral Site Randomization, Group III Single Site Randomization, Group III: Bilateral Site Randomization

Primary outcome

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.

Results and safety

The study was stopped early (reason given: The PI moved to another Institution). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chandan K Sen, PhD principal investigator

Ohio State University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Natural Vitamin E Tocotrienol supplement (TCT) and Natural Vitamin E Tocotrienol Cream (TCT) in people with Scar, run by Chandan K Sen at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The PI moved to another Institution). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00700791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.