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

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

• 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.

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

• 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.

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