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 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound.|
- 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.
- 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.
- 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.
|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)|
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 will use topical cream as well as oral supplementation. OTOP group 1 will have biopsy #2 collected 3 days after 1st biopsy collected.
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579227
|Contact: Elizabeth Murphy, BSemail@example.com|
|Contact: David Paoletto, RNfirstname.lastname@example.org|
|United States, Ohio|
|The Ohio state University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: David Paoletto, RN 614-685-3173 email@example.com|
|Principal Investigator: Chandan K Sen, Ph.D.|
|Sub-Investigator: Gayle Gordillo, MD|
|Principal Investigator:||Chandan K Sen, PhD||Ohio State University|