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Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound (TOP/OTOP)

This study is currently recruiting participants.
Verified November 2012 by Ohio State University
Sponsor:
Collaborator:
Carotech
Information provided by (Responsible Party):
Chandan K Sen, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01579227
First received: April 13, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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 TCT vs placebo in bilateral punch biopsy

Objective 2, (oral and topical - referred to as "OTOP") - Combined oral supplementation and topical application of TCT vs placebo in bilateral punch biopsy


Condition
Scar

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound.

Resource links provided by NLM:

MedlinePlus related topics: Scars Vitamin E
U.S. FDA Resources

Further study details as provided by Ohio State University:

Biospecimen Retention:   Samples With DNA

Tissue biopsy will be collected twice in the study period.


Estimated Enrollment: 71
Study Start Date: January 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1-TOP group 1
TOP group 1 will get biopsy #2 collection 3 days after 1st biopsy collection.
TOP group 2
TOP group 2 will have tissue biopsy collection in day 30th after 1st biopsy collection.
OTOP group-1
OTOP will take topical cream as well as oral supplementation. this group will have second tissue biopsy in 3 days after 1st biopsy collection.
OTOP group-2
OTOP group will take topical study cream and oral capsules. This group will have 2nd tissue biopsy in 30 days after 1st biopsy collection.

Detailed Description:

  • In nature the vitamin E family is split into two classes: tocopherols (TCP) and tocotrienols (TCT). Members of the TCP and TCT family are biologically unique.

    • TCP are mainly found in green leafy vegetables while TCT are the primary vitamin E of seeds, including cereal grains such as wheat, rice, and barley.

  • Vitamin E is thought to improve wound healing by inhibiting collagen synthesis and attenuating fibroblast proliferation and inflammation. However, outcomes based scientific literature on the therapeutic efficacy of vitamin E in skin wound closure is scant and has primarily focused on TCP.

    • Oral supplementation of TCP showed modest improvement in rodent wound closure; but the relevance of oral TCP supplementation in rats already receiving high dose vitamin E in standard laboratory show is questionable.
    • Topical TCP on surgical wounds of children have been shown to improve wound healing; yet no mechanistic basis for the observed effect was described.
  • Preliminary observations from the PI's active IRB protocol to test TCT in scar appearance of surgical wounds led us to evaluate the potential of TCT vitamin E to improve wound closure in healthy subjects. To date, the therapeutic efficacy of TCT in either topical (TOP) or oral with topical (OTOP) applications for skin wound healing remains to be reported.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

We plan to recruit 27 healthy adult subjects for TOP, and 44 healthy adult subjects for OTOP group.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Over 50 years of age
  • Current smoker
  • Pregnant and breastfeeding
  • Diabetes or HIV diagnosis
  • Alcohol or drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579227

Contacts
Contact: Urmila Gnyawali, RN 614-366-3515 urmila.gnaywali@osumc.edu

Locations
United States, Ohio
The Ohio state University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Urmila Gnyawali, RN     614-366-3515     urmila.gnyawali@osumc.edu    
Principal Investigator: Chandan K Sen, Ph.D.            
Sub-Investigator: Gayle Gordillo, MD            
Sponsors and Collaborators
Chandan K Sen
Carotech
Investigators
Principal Investigator: Chandan K Sen, PhD Ohio State University
  More Information

No publications provided

Responsible Party: Chandan K Sen, Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01579227     History of Changes
Other Study ID Numbers: 2011H0286
Study First Received: April 13, 2012
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Healthy population are recruiting

Additional relevant MeSH terms:
Vitamin E
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013