NCT00700791

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 as well as the basal levels of TCT in normal human skin and adipose tissue.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2008

Longer than P75 for early_phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

10 years

First QC Date

June 17, 2008

Last Update Submit

November 10, 2021

Conditions

Scar

Keywords

Single and bilateral body contouring surgical sites.

Outcome Measures

Primary Outcomes (1)

  • 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

    4 weeks prior to surgery and 12 weeks post surgery.

Study Arms (9)

Group I Single Site Randomization

PLACEBO COMPARATOR

Patients with 1 surgical scar will be given both oral placebo and topical cream placebo

Other: PlaceboOther: Placebo Cream

Group II Single Site Randomization

ACTIVE COMPARATOR

Single surgical site will be given oral placebo and topical TCT

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

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).

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.

Other: PlaceboOther: 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.

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.

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.

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

Interventions

Natural Vitamin E Tocotrienol supplement (TCT)DIETARY_SUPPLEMENT

Oral Vitamin E Tocotrienol Supplement (TCT)

Also known as: Oral TCT
Group III Single Site RandomizationGroup III: Bilateral Site RandomizationGroup IV Single Site RandomizationGroup IV: Bilateral Site Randomization
Natural Vitamin E Tocotrienol Cream (TCT)DEVICE

Natural Vitamin E Tocotrienol(TCT)Topical Cream

Also known as: Topical TCT
Group II Single Site RandomizationGroup II: Bilateral Site RandomizationGroup IV Single Site RandomizationGroup IV: Bilateral Site Randomization
PlaceboOTHER

Oral Placebo

Group I Single Site RandomizationGroup I: Bilateral Site RandomizationGroup II Single Site RandomizationGroup II: Bilateral Site Randomization
Placebo CreamOTHER

Topical Placebo Cream

Group I Single Site RandomizationGroup I: Bilateral Site RandomizationGroup III Single Site RandomizationGroup III: Bilateral Site Randomization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OSU Plastic Surgery - Knightsbridge

Columbus, Ohio, 43214, United States

Location

The Ohio State University

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Cicatrix

Interventions

Thrombin Time

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Coagulation TestsHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Chandan K Sen, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 19, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

November 18, 2021

Record last verified: 2021-11

Locations

US(2)