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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Ohio State University
Sponsor:
Collaborator:
Carotech Inc.
Information provided by (Responsible Party):
Chandan K Sen, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01579227
First received: April 13, 2012
Last updated: August 21, 2014
Last verified: January 2014
  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 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.


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:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • WOUND CLOSURE [ Time Frame: 1-2 month(s) ] [ Designated as safety issue: No ]
    Wound closure will be assessed by results of conventional camera and thermal imaging in Group 1 and Group 2 subjects.


Secondary Outcome Measures:
  • SCARRING [ Time Frame: 1-2 month (s) ] [ Designated as safety issue: No ]
    Scarring will be assessed in group 1 and group 2 subjects by the Vancouver Scar Scale (VSS). Scoring will be performed by three blinded observers. The VSS evaluates vascularity (redness), height (hypertrophy), pliability (contracture and elastic texture) and pigmentation.


Other Outcome Measures:
  • Wound closure and Increased Angiogenesis [ Time Frame: 1-2 months ] [ Designated as safety issue: No ]
    Test whether miR-200b is silenced with tamoxifen resulting in increased angiogenesis and faster wound closure


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: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 as well as oral supplementation. OTOP group 1 will have biopsy #2 collected 3 days after 1st biopsy collected.
OTOP group-2
OTOP will use topical cream as well as oral supplementation. OTOP group 2 will have biopsy #2 collected 30 days after 1st biopsy collected.
TAM Group 1
TAM group 1 will have #2 biopsy collected 21 days after 1st biopsy collected. Tamoxifen 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).

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 a standard laboratory 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.

    • Preliminary observations also made show down-regulation of microRNA-200b supports cutaneous angiogenesis, the most important step in cutaneous wound healing. Tamoxifen silences mircroRNA-200b and later work has recognized that under non-neoplastic conditions, tamoxifen may induce angiogenesis.
  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 the TOP group, 34 healthy adult subjects for the OTOP group, and 10 healthy adult subjects for the TAM 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579227

Contacts
Contact: Elizabeth Murphy, BS 614-366-3515 elizabeth.murphy@osumc.edu
Contact: David Paoletto, RN 614-685-3173 david.paoletto@osumc.edu

Locations
United States, Ohio
The Ohio state University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: David Paoletto, RN    614-685-3173    david.paoletto@osumc.edu   
Principal Investigator: Chandan K Sen, Ph.D.         
Sub-Investigator: Gayle Gordillo, MD         
Sponsors and Collaborators
Chandan K Sen
Carotech Inc.
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: August 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Healthy participants

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes
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 September 11, 2014