Validation of Fespixon in Postoperative Scar Cosmesis Using Quantitative Digital Photography Analysis

Abstract

Abstract Background Unsightly scarring after surgery remains a dilemma. One of the challenges is the lack of objective scar assessment tools. Objectives This study aimed to evaluate the efficacy of a novel medicine, Fespixon, for prevention and/or alleviation of post–skin incision scarring. A second aim was to demonstrate the practicality of our digital image analysis system to see if this could serve as a sensitive tool to assess scar improvement. Methods A prospective, placebo-controlled trial involving patients with postoperative transverse scars was conducted. Each patient received a topical formulation of Fespixon on the left part of the scar and placebo cream on the right. In addition to recording the subjective modified Vancouver Scar Scale and visual analog scale scores, we utilized digital photography for monthly scar analysis, with CIELAB and hue serving as the colorimetric information, and with contrast, correlation, homogeneity, and entropy providing texture information. Results Forty-six participants (mean age, 52 years) were enrolled in the trial. All the parameters of subjective assessment showed superior results for the Fespixon-treated side, with significant differences in pigmentation, vascularity, pliability, height, itchiness, and patient satisfaction (P = .043, .013, .026, .002, .039, .012, respectively). The trends in color and texture showed increased relative difference ratios, with significant differences in most of the eigenvalues towards the Fespixon-treated side, including CIELAB-L* (P < 0.001), hue-R,G,B (red, blue, green) values (P = .034, .001, .011), contrast (P < 0.001), homogeneity (P < 0.001), correlation (P = .011), and entropy (P < 0.001). Conclusions We validated the efficacy of Fespixon for postoperative scar healing based not only on subjective assessments but also on objective quantitative analyses. The results also indicated that our digital photography quantitative analysis system is an ideal tool for quantification of scar appearance. Level of Evidence: 3