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Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound

NCT01579227 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2018-01-29

No results posted yet for this study

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

Interventions

DEVICE

Topical Tocotrienol (TCT)

Natural Form Vitamin E topical cream(TCT)

DIETARY_SUPPLEMENT

Oral Tocotrienol Capsules (TCT)

Natural Form Vitamin E Oral capsules (TCT)

DEVICE

Tamoxifen Cream

Tamoxifen cream

DEVICE

Placebo cream

Placebo cream

DIETARY_SUPPLEMENT

placebo capsule

placebo capsule

Sponsors & Collaborators

  • Carotech Inc.

    collaborator INDUSTRY

  • Chandan K Sen

    lead OTHER

Principal Investigators

  • Chandan K Sen, PhD · Ohio State University

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01579227 on ClinicalTrials.gov