Creation and Validation of a Photonumeric Scale for Assessment of Midface Volume Deficit.

BACKGROUND

Validated clinical scales are needed to assess aesthetic improvement of the midface volume deficit after treatment with dermal fillers.

OBJECTIVE

To develop a midface volume deficit rating scale and establish its reliability and sensitivity for grading subjects in clinical trials and routine practice.

METHODS

A 5-grade photonumeric scale was developed by clinical experts based on real-subject photographs and validated through photographic and live subject evaluation.

RESULTS

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.

CONCLUSION

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.