Clinical trial NCT01579227: Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound
Official title: Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scar
Keywords: Healthy participants
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Carotech Inc.
First posted: 2012-04-17
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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:

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

Primary outcomes:
measure: WOUND CLOSURE
timeFrame: 1-2 month(s)
Secondary outcomes:
measure: SCARRING
timeFrame: 1-2 month (s)
Other outcomes:
measure: Wound closure and Increased Angiogenesis
timeFrame: 1-2 months
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Chandan K Sen, PhD
role: PRINCIPAL_INVESTIGATOR
References: