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| Name | Class |
|---|---|
| Carotech Inc. | INDUSTRY |
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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.
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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 group-1 | OTOP will use topical cream (either topical tocotrienol (TCT) or placebo cream) as well as oral supplementation (either oral Tocotrienol capsules (TCT) or placebo capsules). OTOP group 1 will have biopsy #2 collected 3 days after 1st biopsy collected. |
| |
| OTOP group-2 | OTOP will use topical cream (either topical tocotrienol (TCT) or placebo cream) as well as oral supplementation (either oral Tocotrienol capsules (TCT) or placebo capsules). 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 cream 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Tocotrienol (TCT) | Device | Natural Form Vitamin E topical cream(TCT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Wound closure and Increased Angiogenesis | Test whether miR-200b is silenced with tamoxifen resulting in increased angiogenesis and faster wound closure | 1-2 months |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Chandan K Sen, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 11, 2025 | |
| Reset | Apr 30, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 11, 2025 | Apr 30, 2025 |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D024508 | Tocotrienols |
| ID | Term |
|---|---|
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Tissue biopsy will be collected twice in the study period.
|
| Normal Skin | Placebo group will apply placebo and TCT cream that will be applied daily to a specified area on the subjects legs (normal skin) for 5 weeks. One leg will be applied with placebo and the other will be applied with TCT cream. Subjects will return weekly for 5 weeks, where non-invasive measurements using Laser Speckle imaging, will be completed at each study visit |
|
| Oral Tocotrienol Capsules (TCT) | Dietary Supplement | Natural Form Vitamin E Oral capsules (TCT) |
|
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| Tamoxifen Cream | Device | Tamoxifen cream |
|
| Placebo cream | Device | Placebo cream |
|
|
| placebo capsule | Dietary Supplement | placebo capsule |
|
|
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |