Creation and Validation of a Photonumeric Scale for Assessment of Infraorbital Hollows.

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.

Creation and validation of a photonumeric scale for assessment of lip fullness.

BACKGROUND: Validated, objective clinical scales are needed to assess aesthetic improvement of the lips after augmentation with dermal fillers. OBJECTIVE: To develop a lip fullness rating scale and establish its reliability for grading subjects in clinical trials or routine practice, and sensitivity for detecting clinically meaningful changes. METHODS: The Teoxane Lip Fullness Scale (TLFS), a proprietary, 5-grade photonumeric scale, was developed by clinical experts based on real subject photographs and was validated through both photographic and live subjects' evaluation. RESULTS: Clinician intra- and inter-rater agreement for the TLFS was substantial to almost perfect. Mean intra-rater weighted Kappa score between the two rounds of photographic validation was 0.92, and inter-rater agreement was substantial with an ICC of 0.93 for the combined rounds. Average intra-rater weighted Kappa score and inter-rater ICC for the live validation were equally high, reaching 0.91 and 0.89 respectively. Additionally, evaluators identified clinically significant differences between photographs of subjects presenting a 1-grade or 2-grade difference on the scale in 90% and 98% of cases, respectively. CONCLUSIONS: The intra-rater Kappa scores and inter-rater ICC met their pre-determined acceptance criteria of >0.70 in the photographic and live validation. The TLFS was shown to be a repeatable and reproducible Clinician Reported Outcome (Clin-RO) for healthcare providers to classify lip fullness both in clinical trials and in routine patient care. A 1-grade difference on the TLFS can detect a clinically meaningful difference in lip fullness.