Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound

NCT01579227 | Unknown

• 1 other identifier: 2011H0286
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The following two objectives are proposed in healthy subjects to characterize (1) wound closure, (2) scar formation/appearance, and (3) inflammatory response: Objective 1, (topical only - referred to as "TOP") - Topical application of Tocotrienol (TCT) vs placebo in bilateral punch biopsy Objective 2, (oral and topical - referred to as "OTOP") - Combined oral supplementation and topical application of tocotrienol (TCT) vs placebo in bilateral punch biopsy Objective 3, (topical only - referred to as "TAM") - Topical application of tamoxifen vs placebo in bilateral punch biopsy. Objective 4, (topical only to normal skin) - Topical application of TCT vs placebo on bilateral lets on normal skin.

Conditions

Scar

Keywords

Healthy participants

Outcome Measures

Primary Outcomes (1)

• WOUND CLOSURE

  Wound closure will be assessed by results of conventional camera and thermal imaging in Group 1 and Group 2 subjects.

  1-2 month(s)

Secondary Outcomes (1)

• SCARRING

  1-2 month (s)

Other Outcomes (1)

• Wound closure and Increased Angiogenesis

  1-2 months

Study Arms (6)

1-TOP group 1

TOP group 1 will have biopsy #2 collected 3 days after 1st biopsy collected.

TOP group 2

TOP group 2 will have biopsy #2 collected 30 days after 1st biopsy collected.

OTOP group-1

OTOP will use topical cream (either topical tocotrienol (TCT) or placebo cream) as well as oral supplementation (either oral Tocotrienol capsules (TCT) or placebo capsules). OTOP group 1 will have biopsy #2 collected 3 days after 1st biopsy collected.

Device: Topical Tocotrienol (TCT); Dietary Supplement: Oral Tocotrienol Capsules (TCT); Device: Placebo cream; Dietary Supplement: placebo capsule

OTOP group-2

OTOP will use topical cream (either topical tocotrienol (TCT) or placebo cream) as well as oral supplementation (either oral Tocotrienol capsules (TCT) or placebo capsules). OTOP group 2 will have biopsy #2 collected 30 days after 1st biopsy collected.

Device: Topical Tocotrienol (TCT); Dietary Supplement: Oral Tocotrienol Capsules (TCT); Device: Placebo cream; Dietary Supplement: placebo capsule

TAM Group 1

TAM group 1 will have #2 biopsy collected 21 days after 1st biopsy collected. Tamoxifen cream and placebo cream will be applied where biopsies are collected from 1 week prior to having the biopsy procedure until the second biopsy is collected (21 days later).

Device: Tamoxifen Cream

Normal Skin

Placebo group will apply placebo and TCT cream that will be applied daily to a specified area on the subjects legs (normal skin) for 5 weeks. One leg will be applied with placebo and the other will be applied with TCT cream. Subjects will return weekly for 5 weeks, where non-invasive measurements using Laser Speckle imaging, will be completed at each study visit

Device: Tamoxifen Cream; Device: Placebo cream

Interventions

Topical Tocotrienol (TCT) DEVICE

Natural Form Vitamin E topical cream(TCT)

Also known as: TCT

OTOP group-1; OTOP group-2

Oral Tocotrienol Capsules (TCT) DIETARY_SUPPLEMENT

Natural Form Vitamin E Oral capsules (TCT)

Also known as: TCT

OTOP group-1; OTOP group-2

Tamoxifen Cream DEVICE

Tamoxifen cream

Normal Skin; TAM Group 1

Placebo cream DEVICE

Placebo cream

Also known as: Placebo

Normal Skin; OTOP group-1; OTOP group-2

placebo capsule DIETARY_SUPPLEMENT

placebo capsule

Also known as: placebo

OTOP group-1; OTOP group-2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

We plan to recruit 27 healthy adult subjects for the TOP group, 34 healthy adult subjects for the OTOP group,10 healthy adult subjects for the TAM group and 30 healthy subjects for Normal Skin.

You may qualify if:

• Ages- 18-50 (Both Male \& Female)
• Non-smoker - having quit at least 3 months prior to enrollment
• Non-diabetic
• Non-pregnant or non-breastfeeding - verbal assent.
• If a female subject of childbearing age misses her menstrual period after the start of the study, she will inform the investigators and be given a pregnancy test to ensure, for safety reasons, that she is not pregnant. If she is pregnant, she will discontinue participation in the study.
• No current use of OTC medications or other form of supplements containing vitamin-E

You may not qualify if:

• Diabetes or HIV diagnosis
• Alcohol or drug abuse
• unable to provide informed consent
• Therapeutically anti-coagulated
• Prisoner
• Currently prescribed immunosuppressant medication

Sponsors & Collaborators

• Chandan K Sen: lead
• Carotech Inc.: collaborator

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue biopsy will be collected twice in the study period.

MeSH Terms

Conditions

Cicatrix

Interventions

Tocotrienols

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chandan K Sen, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 17, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 29, 2018

Record last verified: 2017-01

Locations

US (1)