Bury Agnès, Eaton-Jankov Laura, Cox Sue Ellen, Gondard Elise, Ballarini Stefania, Trevidic Patrick
Teoxane SA, Geneva, Switzerland.
UltaMed Corporation, Fort Lauderdale, Florida.
Dermatol Surg. 2025 Jul 2. doi: 10.1097/DSS.0000000000004756.
Validated clinical scales are needed to assess aesthetic improvement of the midface volume deficit after treatment with dermal fillers.
To develop a midface volume deficit rating scale and establish its reliability and sensitivity for grading subjects in clinical trials and routine practice.
A 5-grade photonumeric scale was developed by clinical experts based on real-subject photographs and validated through photographic and live subject evaluation.
The mean intra-rater weighted Kappa score between the 2 sessions of photographic validation was 0.92. Inter-rater intraclass correlation coefficient (ICC) was 0.89 for the combined sessions. The average intra-rater weighted Kappa score and inter-rater ICC for the live validation reached 0.81 and 0.78, respectively. In addition, evaluators identified clinically significant differences between photographs of subjects presenting a 1-grade or 2-grade difference in 80% and 89% of cases, respectively.
The Teoxane Midface Volume Deficit Scale can measure the degree of volume deficit, detect a clinically meaningful difference of 1-grade, and is applicable to the ethnic diversity of the population. This scale is a repeatable, reproducible clinician-reported outcome and a useful tool for health care providers to classify midface volume depletion both in clinical trials and routine patient care.
需要经过验证的临床量表来评估使用真皮填充剂治疗后中面部容积不足的美学改善情况。
开发一种中面部容积不足评级量表，并确定其在临床试验和常规实践中对受试者进行分级的可靠性和敏感性。
临床专家基于真实受试者照片开发了一种5级数字量表，并通过照片评估和活体受试者评估进行验证。
两次照片验证之间的平均评分者内加权Kappa分数为0.92。联合评估的评分者间组内相关系数（ICC）为0.89。活体验证的平均评分者内加权Kappa分数和评分者间ICC分别达到0.81和0.78。此外，评估者分别在80%和89%的病例中识别出呈现1级或2级差异的受试者照片之间具有临床显著差异。
Teoxane中面部容积不足量表可以测量容积不足的程度，检测出1级的临床有意义差异，并且适用于不同种族人群。该量表是一种可重复、可再现的临床医生报告结局，是医疗保健提供者在临床试验和常规患者护理中对中面部容积减少进行分类的有用工具。
