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

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.