Supplementary Material for: Multimodal Clinical Imaging Assessment of the Outcome in Mild-to-Moderate Acne: A Prospective Study

<b><i>Background:</i></b> The quality of outcome assessment in acne studies has been either subjective/insufficient or time consuming through the ordinary lesion counting. <b><i>Objective:</i></b> To evaluate the application of multimodal clinical imaging (MCI), a combination of imaging technology and computation, in the assessment of acne lesions in a clinical study setting. <b><i>Methods:</i></b> A prospective, monocentric, single-group open study designed to evaluate the efficacy and tolerance of a cosmetic product (IP/SG) in subjects with mild-to-moderate facial acne by classical clinical counting (CCC) – change in the total/inflammatory/noninflammatory acne lesion number compared with baseline (D0) – Investigator Global Assessment (IGA) and self-reported outcomes. Concomitantly, MCI was administered. The study was performed for 12 weeks (D84) with a 4-week follow-up (D112). <b><i>Results:</i></b> Mean age of patients (<i>n</i> = 49) was 18.2 ± 3.7 years (range 13–25). The mean acne duration was 3.8 ± 2.8 years. The total number of lesions did not differ significantly between D0/D84 by both CCC and MCI. However, the Cardiff Acne Disability Index (CADI) and uncomfortable feeling improved at D28/D0, the perception of oily skin improved at D14/D0, and the perception of sticky skin improved from D28/D0 to D56/D0. Deterioration was detected between D84/D0 and D112/D0, namely after product discontinuation. Interestingly, a change in trend was recorded for acne lesions at D14/D0 by MCI but not by CCC. <b><i>Conclusion:</i></b> MCI, applied for the first time in a small clinical study setting, is at least as reliable as CCC and may allow for a sensitive longitudinal evaluation of single acne lesions and their response to products, especially in conditions where clinical evaluation reaches its limits.

背景：痤疮相关研究中的结局评估质量，要么存在主观性或完整性不足的问题，要么通过常规皮损计数方式开展时耗时冗长。
目标：评估多模态临床成像（multimodal clinical imaging, MCI）——即成像技术与计算技术相结合的手段——在临床研究场景下用于痤疮皮损评估的应用价值。
方法：本研究为一项前瞻性单中心单组开放试验，旨在通过经典临床计数法（classical clinical counting, CCC，即与基线D0相比时，总皮损、炎性皮损及非炎性皮损的数量变化）、研究者整体评估（Investigator Global Assessment, IGA）以及自我报告结局，评估一款护肤产品（IP/SG）在轻中度面部痤疮受试者中的有效性与耐受性。试验同步开展多模态临床成像（MCI）评估。本研究周期为12周（至D84，即研究第84天），并设置4周随访期（至D112，即研究第112天）。
结果：本研究共纳入49例受试者，受试者平均年龄为18.2±3.7岁（年龄范围13~25岁），痤疮平均病程为3.8±2.8年。经典临床计数法（CCC）与多模态临床成像（MCI）均显示，D0与D84时的总皮损数量无显著差异。但在D28与D0的对比中，加的夫痤疮残疾指数量表（Cardiff Acne Disability Index, CADI）评分及受试者不适感均得到改善；在D14与D0的对比中，皮肤油腻感自评得到改善；而皮肤黏腻感自评则在D28与D0至D56与D0的对比中逐步改善。在D84与D0、以及D112与D0的对比中，可观察到皮损情况出现恶化，这一现象发生于受试产品停用之后。值得注意的是，多模态临床成像（MCI）可捕捉到D14与D0时痤疮皮损的趋势变化，而经典临床计数法（CCC）则无法检测到该变化。
结论：本研究首次在小型临床研究场景中应用多模态临床成像（MCI），结果显示其可靠性至少不劣于经典临床计数法（CCC）；其可实现对单个痤疮皮损及其对受试产品应答的高精度纵向评估，尤其适用于临床常规评估手段存在局限的场景。