Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound

Scar Clinical Trial

— TOP/OTOP  

Official title:

Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01579227
• Other study ID #: 2011H0286
• Status: Active, not recruiting
• Phase: N/A
• First received: April 13, 2012
• Last updated: January 25, 2018
• Start date: January 2012
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 101
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Scar

Intervention

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
• Placebo cream
Placebo cream

Dietary Supplement:
• placebo capsule
placebo capsule

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Chandan K Sen	Carotech Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Wound closure and Increased Angiogenesis	Test whether miR-200b is silenced with tamoxifen resulting in increased angiogenesis and faster wound closure	1-2 months
Primary	WOUND CLOSURE	Wound closure will be assessed by results of conventional camera and thermal imaging in Group 1 and Group 2 subjects.	1-2 month(s)
Secondary	SCARRING	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.	1-2 month (s)