Abstract
BACKGROUND: Validated clinical scales are needed to assess aesthetic improvement of the infraorbital hollows (IOHs) after treatment with dermal fillers. OBJECTIVE: To develop an IOHs scale and establish its reliability and sensitivity for grading subjects in clinical trials or routine practice. METHODS AND MATERIALS: The Teoxane IOHs Scale (TIOHS), a 5-grade photonumeric scale, was developed based on real-subject photographs and validated through photographic and live subjects' evaluation. RESULTS: Clinician intra- and inter-rater agreements during the TIOHS validation were excellent. The mean intrarater-weighted Kappa score between the 2 sessions of photographic validation was 0.92, while inter-rater interclass correlation coefficient (ICC) was 0.92 for the combined sessions. The average intrarater-weighted Kappa score and inter-rater ICC for the live validation reached 0.80 and 0.76, respectively. In addition, evaluators identified clinically significant differences between photographs of subjects presenting a 1-grade or 2-grade difference in 82% and 86% of cases, respectively. CONCLUSION: The intrarater Kappa scores and inter-rater ICCs met their predetermined acceptance criteria of >0.70. The TIOHS is a repeatable and reproducible clinician-reported outcome for health care providers to classify IOHs in clinical trials and routine patient care. A 1-grade difference on the TIOHS can detect a clinically meaningful difference in infraorbital hollowing.