Clinical trial to evaluate the efficacy of botulinum toxin type A injection for reducing scars in patients with forehead laceration: A double-blinded, randomized controlled study.

Abstract

Background:Botulinum toxin type A (BoNTA) is known to prevent fibroblast proliferation and expression of transforming growth factor beta 1 (TGF-β1). It also induces temporary muscle paralysis and decreases tension vectors. Fibroblasts induce scar contracture and hypertrophy by producing collagen fibers in wound healing processes. The aim of this study is to identify the effect of BoNTA on the scar formation.Methods:Forty-five patients with forehead laceration were enrolled in this study and randomized into 2 groups with or without injection of BoNTA. When the patients presented to the clinic to remove the stitches, BoNTA was injected to the BoNTA group with 24 patients and saline was injected to the control group with 21 patients. The BoNTA was injected on dermal layer with 5 IU/cm. After that, follow-up was done in 1, 3, and 6 months. The scars were analyzed with the patient and observer scar assessment scale, Stony Brook scar evaluation scales (SBSESs), and visual analog scale (VAS) and analyzed with independent T-test, along with clinical photographs, cutometer, and biopsies.Results:In all scar scales, the scores changed into favorable direction in both groups and the changes were larger in BoNTA group compared with the control group. On SBSES and VAS, better improvements on BoNTA group showed statistical significance. Skin biopsy showed less collagen deposition on dermal layer in BoNTA group.Conclusion:Improvement of aesthetic, functional, and emotional aspect of the scar formation in the groups treated with BoNTA was illustrated. The application of BoNTA may be expanded to prevent hypertrophic scar after trauma, burns, or operations.