Carotech Inc., the world’s largest and only GMP-certified natural full spectrum palm tocotrienol complex producer, has announced the commencement of another human clinical trial to evaluate the efficacy of natural full spectrum palm tocotrienol complex in skin wound healing via topical application of Tocomin tocotrienol cream and topical as well as oral supplementation (Tocomin SupraBio).
The encouraging results of Tocomin natural palm tocotrienol complex in improving scar appearance of surgical wounds observed in another human study (NCT00700791) conducted by the same group of researchers from Ohio State University, has prompted this new clinical trial to further evaluate the therapeutic efficacy of Tocomin (topical) and Tocomin SupraBio (oral) natural palm tocotrienol complex in biopsy wounds. The main objectives of this study include characterization of wound closure, scar formation/appearance and inflammatory response.
Seventy-one healthy adults, ages 18 to 50, who meet pre-defined inclusion criteria will be recruited into this clinical trial. Twenty-seven subjects will be assigned to receive the topical cream with Tocomin (TOP group) and the other 44 subjects will be given both topical cream with Tocomin and oral supplementation with Tocomin SupraBio (OTOP group). These subjects will be randomized to receive either the preparation containing tocotrienols or a placebo. All subjects will undergo two tissue punch biopsy procedures during the study period.
“Lipid peroxidation and inflammation are key factors determining the ability for wound and scar to heal. Studies have shown that tocotrienol is a potent antioxidant and possesses anti-inflammatory property that, in theory and by anecdotal evidence, may help to improve wound healing,” says Dr. Sharon Ling, vice president, scientific affairs, Carotech.
“A recently published human clinical study in the Journal of Nutrition showed that tocotrienols from Tocomin SupraBio were well absorbed and distributed to vital human tissues and organs including the skin, even in the presence of alpha-tocopherol. This is the first ever actual tissue distribution study of tocotrienols on human that unequivocally dispelled claims that tocopherol inhibits the absorption of tocotrienols,” says WH Leong, vice president, Carotech Inc.
“This human study is an efficacy study to test the therapeutic potentials of Tocomin and Tocomin SupraBio in biopsy wounds in human and if proven, can help many patients who suffered disfiguration due to burns, or involved in vehicle accidents,” added Mr. Leong.