Ongoing

Objectives: 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 TCT vs placebo in bilateral punch biopsy

Objective 2, (oral and topical – referred to as “OTOP”) – Combined oral supplementation and topical application of TCT vs placebo in bilateral punch biopsy

Study Type: Observational

Study Design: Cohort Prospective Study

Subjects: Healthy volunteers

Intervention: Tocotrienol, placebo

Primary Outcome: Safety Issue

Methodology: Biospecimen Retention:   Samples With DNA

Tissue biopsy will be collected twice in the study period.

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Ongoing

Objective: 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.

Study Type: Interventional

Study Design: Randomized, Double-blind Trial

Subjects: Patients with surgical scars

Intervention: Vitamin E Tocotrienol, Placebo

Primary Outcome: To determine the efficacy of TCT in improving the appearance of post-surgical scars following oral supplementation 2.To determine the efficacy of TCT in improving the appearance of post-surgical scars following topical application [ Time Frame: 4 weeks prior to surgery and 12 weeks post surgery. ]

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Published

Objectives: In view of experimental evidence for the photoprotective properties of these antioxidants, we evaluated in 30 patients with photosensitivity, the prophylactic efficacy of a new topical agent, containing tocopherols 10% and tocotrienols 0.3%, compared with retinol, simple vehicle and untreated areas.

Subjects: Patients with photosensitivity

Intervention: Tocotrienol and tocopherol containing formulation

Primary outcome: Photosensitivity (erythema/oedema/itch/vesciculation) scores

Methodology: After determination of the minimal UVB erythema dose (MED), two areas of 2 × 2 cm were selected on the buttocks of each subject, one of which was treated with the antioxidant formulation whereas the other field did not undergo any treatment. Therefore, both areas were irradiated with a twofold MED. As further controls, other two similar areas, selected on the forearm of 15 patients, were photo-irradiated similarly, 30 min after application of the simple vehicle to a field and of vitamin A in the same vehicle to the other. Reactions (erythema/oedema/itch/vesciculation) assessment was carried out assigning scores indicative of their intensity; then, mean values +DS of scores were calculated. Results  The pre-treatment with the vitamin E formulation highly protects against photosensitivity, and all reactions to irradiation were significantly lower in the areas treated with the topical vitamin E formulation compared to those treated with the simple vehicle or vitamin A.

Results: The pre-treatment with the vitamin E formulation highly protects against photosensitivity, and all reactions to irradiation were significantly lower in the areas treated with the topical vitamin E formulation compared to those treated with the simple vehicle or vitamin A.

Conclusions: The use of a new topical formulation containing significant concentrations of tocotrienols and tocopherols represents a promising strategy to reduce the photo-induced skin damage.