A prospective, randomised, double-blinded trial to study the efficacy of topical tocotrienol in the prevention of hypertrophic scars.

BACKGROUND: Despite widespread beliefs regarding the use of topical tocotrienol in the prevention of hypertrophic scars, there is very little evidence from well controlled and randomised clinical trials to justify its benefits for surgical scars. OBJECTIVE: This study was conducted to evaluate the efficacy of topical tocotrienol in preventing the development of hypertrophic scars. METHODS: A prospective, randomised, double-blinded study was performed on 122 patients with recently healed (<2 weeks) surgical scars, who were randomised into either a treatment group with 5% topical tocotrienol or a placebo group. The patients were required to apply the preparation to their scars twice a day for 6 weeks starting at 2 weeks after surgery. Assessments of the scars were performed at weeks 0, 2, 6 and 16 following the onset of topical application using three methods: a clinical assessment using the Patient and Observer Scar Assessment Scale (POSAS), a photographic scar assessment by two independent assessors using a visual analogue scale and laser Doppler imaging (LDI). Data analysis was performed on 85 patients (tocotrienol group: 45 patients; placebo group: 40 patients), who had completed four assessments. RESULTS: There was no statistically significant difference in scar parameters between the tocotrienol and the placebo groups in the POSAS, photographic scar assessment or mean flux of LDI (p>0.05) categories. The mean LDI flux showed a decreasing trend over time, which was positively correlated with vascularity (correlation coefficient=0.325, p=0.008) and total scores (correlation coefficient=0.248, p=0.034) of the observer scar assessment scale on week 0. No significant adverse effect was observed. CONCLUSIONS: Twice-daily application of 5% topical tocotrienol had no significant effect on the appearance and vascularity of scars over 4 months post-surgery. LDI has a promising role as a scar assessment tool.