NCT01579227

Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound

Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 101 (estimated)
• Sponsor: Chandan K Sen · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Scar

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-01-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2012-04-17
• Last updated: 2018-01-29

Locations

1 site across 1 country: United States