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| Sponsored by: |
Ohio State University |
|---|---|
| Information provided by: | Ohio State University |
| ClinicalTrials.gov Identifier: | NCT00700791 |
Purpose
The overall goal of this study is to determine the efficacy of tocotrienol (TCT), a natural form of vitamin E, in preventing or reducing scar formation in human skin wounds.
| Condition | Intervention | Phase |
|---|---|---|
|
Scar |
Other: both oral placebo and topical cream placebo Other: oral placebo and topical tocotrienol Other: Oral vitamin E supplement and topical cream placebo Other: Oral vitamin E supplement and topical vitamin E cream Other: Oral placebo & topical cream placebo & vitamin-E cream Other: Oral vitamin-E supplement & cream placebo & vitamin-E cream |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
| Official Title: | Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars |
| Estimated Enrollment: | 168 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
One surgical site scar will be given (unilateral surgery):both oral placebo and topical cream placebo
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Other: both oral placebo and topical cream placebo
placebo 2 capsules twice a day and the topical placebo cream will be applied once daily beginning the day after surgery.
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2
Patients with one surgical site will be given:oral placebo and topical tocotrienol.
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Other: oral placebo and topical tocotrienol
Oral placebo 2 capsules twice a day and topical tocotrienol apply topically once a day.
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3
Patients with one surgical site will be given: oral tocotrienol and topical placebo.
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Other: Oral vitamin E supplement and topical cream placebo
Oral tocotrienol capsules 100 mg 2 capsules twice a day and topical placebo apply topically once a day.
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4
Patients with one surgical site will be given: oral tocotrienol and topical tocotrienol on the surgical site.
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Other: Oral vitamin E supplement and topical vitamin E cream
Oral tocotrienol capsules 100 mg 2 twice a day and topical tocotrienol once aday.
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5
Patient with bilateral surgical site will be given:Oral placebo with topical placebo on one surgical site and topical tocotrienol on the other site.
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Other: Oral placebo & topical cream placebo & vitamin-E cream
Oral and topical placebo to one side and topical tocotrienol to the other side once a day.
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6
Patient with bilateral surgical site will be given:Oral tocotrienol with topical placebo on one surgical site and topical tocotrienol on the other site.
|
Other: Oral vitamin-E supplement & cream placebo & vitamin-E cream
Oral tocotrienol 100 mg 2 twice a day and topical placebo to one side daily and topical tocotrienol to the other daily.
|
Scar formation is the physiological and inevitable end point of mammalian wound healing and there is substantial evidence that inflammation is an essential prerequisite for scarring [19]. Although scar tissue restores the normal skin barrier, the new tissue is inferior in structural, aesthetic, and functional respects. The mammalian wound healing response may have originated during the time of high susceptibility to infection. Therefore, we may have developed speed optimized wound healing where a multiple redundant compensating rapid inflammatory response allows the wound to heal quickly without infection. The scar is then the price mammalians have to pay for evolutionary survival after wounding [20].
Tocotrienol may be an effective tool to prevent or reduce normal, hypertrophic, or keloid scarring by mediating the inflammatory response. Tocotrienol is a safe and convenient treatment that could be used by mouth or topically. There has never been a study on the effectiveness of tocotrienol in preventing or reducing scar formation. Our observations from an ongoing IRB protocol(#2005C0034) led us to evaluate the potential of tocotrienol in such respect.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Urmila S. Gnyawali, RN | 614-366-3515 | urmila.gnyawali@osumc.edu |
| United States, Ohio | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43221 | |
| Principal Investigator: | Chandan K Sen, PhD | Ohio State University |
More Information
| Responsible Party: | The Ohio State University Department of Surgery ( Dr Chandan Sen ) |
| Study ID Numbers: | 2008H0001 |
| Study First Received: | June 17, 2008 |
| Last Updated: | June 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00700791 |
| Health Authority: | United States: Institutional Review Board |
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Single and bilateral body contouring surgical sites. |
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Tocopherols Tocopherol acetate Vitamin E Skin Diseases |
Tocotrienols Alpha-Tocopherol Cicatrix |
|
Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins |
Physiological Effects of Drugs Micronutrients Protective Agents Pharmacologic Actions |
