title: Development and validation of a photographic scale for assessment of lip fullness.
abstract: BACKGROUND
  As lip augmentation becomes more popular, validated measures of lip fullness for quantification of outcomes are needed.
  
  
  OBJECTIVE
  Develop a scale for rating lip fullness and establish its reliability and sensitivity for assessing clinically meaningful differences.
  
  
  METHODS
  The initial Allergan Lip Fullness Scale (iLFS; a four-point photographic scale with verbal descriptions) was validated by eight physicians rating 55 live subjects during two rounds, conducted on one day. In addition, subjects performed self-evaluations. The revised Allergan Lip Fullness Scale (LFS), a five-point scale with a broader range of lip presentations, was validated by 21 clinicians in two online image rating sessions, ≥14 days apart, in which they used the LFS to rate overall, upper, and lower lip fullness of 144 3-dimensional (3D) images. Physician inter- and intra-rater agreement, subject intra-rater agreement (iLFS), and subject-physician agreement (iLFS) were evaluated. Additionally, during online rating session 1, raters ranked 38 pairs of 3D images, taken before and after lip augmentation, as "clinically different" or "not clinically different." The median LFS score difference for clinically different pairs was calculated to determine the clinically meaningful difference.
  
  
  RESULTS
  Clinician inter- and intra-rater agreement for the iLFS and LFS was substantial to almost perfect. Subject self-assessments (iLFS) had substantial intra-rater reliability and a high level of agreement with physician assessments. Median LFS score differences for overall, upper, and lower lip fullness were 1 (mean: 0.63-0.69) for "clinically different" and 0 (mean: 0.28-0.36) for "not clinically different" image pairs; thus, clinical significance of a 1-point difference in LFS score was established.
  
  
  CONCLUSIONS
  The LFS is a reliable instrument for physician classification of lip fullness. A 1-point score difference can detect clinically meaningful differences in lip fullness.
authors: Dr Werschler is Assistant Clinical Professor of Dermatology at the University of Washington School of Medicine, Seattle, Washington. Dr Fagien is a plastic surgeon in private practice in Boca Raton, Florida. Ms. Thomas is an employee of Kythera Biopharmaceuticals, Inc., Calabasas, California. Dr Paradkar-Mitragotri is an Employee of Allergan, Inc., Santa Barbara, California. Dr Rotunda is an Assistant Clinical Professor, Division of Dermatology, David Geffen School of Medicine, UCLA, Los Angeles, California, and Assistant Clinical Professor, University of California, Irvine, California. Dr Beddingfield is an Associate Clinical Professor, Division of Dermatology, David Geffen School of Medicine (UCLA), Los Angeles, California, and is an employee of Kythera Biopharmaceuticals, Inc., Calabasas, California.
authors: W Philip
authors: WP
authors: Werschler
authors: Dr Werschler is Assistant Clinical Professor of Dermatology at the University of Washington School of Medicine, Seattle, Washington. Dr Fagien is a plastic surgeon in private practice in Boca Raton, Florida. Ms. Thomas is an employee of Kythera Biopharmaceuticals, Inc., Calabasas, California. Dr Paradkar-Mitragotri is an Employee of Allergan, Inc., Santa Barbara, California. Dr Rotunda is an Assistant Clinical Professor, Division of Dermatology, David Geffen School of Medicine, UCLA, Los Angeles, California, and Assistant Clinical Professor, University of California, Irvine, California. Dr Beddingfield is an Associate Clinical Professor, Division of Dermatology, David Geffen School of Medicine (UCLA), Los Angeles, California, and is an employee of Kythera Biopharmaceuticals, Inc., Calabasas, California.
authors: Steven
authors: S
authors: Fagien
authors: Dr Werschler is Assistant Clinical Professor of Dermatology at the University of Washington School of Medicine, Seattle, Washington. Dr Fagien is a plastic surgeon in private practice in Boca Raton, Florida. Ms. Thomas is an employee of Kythera Biopharmaceuticals, Inc., Calabasas, California. Dr Paradkar-Mitragotri is an Employee of Allergan, Inc., Santa Barbara, California. Dr Rotunda is an Assistant Clinical Professor, Division of Dermatology, David Geffen School of Medicine, UCLA, Los Angeles, California, and Assistant Clinical Professor, University of California, Irvine, California. Dr Beddingfield is an Associate Clinical Professor, Division of Dermatology, David Geffen School of Medicine (UCLA), Los Angeles, California, and is an employee of Kythera Biopharmaceuticals, Inc., Calabasas, California.
authors: Jane
authors: J
authors: Thomas
authors: Dr Werschler is Assistant Clinical Professor of Dermatology at the University of Washington School of Medicine, Seattle, Washington. Dr Fagien is a plastic surgeon in private practice in Boca Raton, Florida. Ms. Thomas is an employee of Kythera Biopharmaceuticals, Inc., Calabasas, California. Dr Paradkar-Mitragotri is an Employee of Allergan, Inc., Santa Barbara, California. Dr Rotunda is an Assistant Clinical Professor, Division of Dermatology, David Geffen School of Medicine, UCLA, Los Angeles, California, and Assistant Clinical Professor, University of California, Irvine, California. Dr Beddingfield is an Associate Clinical Professor, Division of Dermatology, David Geffen School of Medicine (UCLA), Los Angeles, California, and is an employee of Kythera Biopharmaceuticals, Inc., Calabasas, California.
authors: Deepali
authors: D
authors: Paradkar-Mitragotri
authors: Dr Werschler is Assistant Clinical Professor of Dermatology at the University of Washington School of Medicine, Seattle, Washington. Dr Fagien is a plastic surgeon in private practice in Boca Raton, Florida. Ms. Thomas is an employee of Kythera Biopharmaceuticals, Inc., Calabasas, California. Dr Paradkar-Mitragotri is an Employee of Allergan, Inc., Santa Barbara, California. Dr Rotunda is an Assistant Clinical Professor, Division of Dermatology, David Geffen School of Medicine, UCLA, Los Angeles, California, and Assistant Clinical Professor, University of California, Irvine, California. Dr Beddingfield is an Associate Clinical Professor, Division of Dermatology, David Geffen School of Medicine (UCLA), Los Angeles, California, and is an employee of Kythera Biopharmaceuticals, Inc., Calabasas, California.
authors: Adam
authors: A
authors: Rotunda
authors: Dr Werschler is Assistant Clinical Professor of Dermatology at the University of Washington School of Medicine, Seattle, Washington. Dr Fagien is a plastic surgeon in private practice in Boca Raton, Florida. Ms. Thomas is an employee of Kythera Biopharmaceuticals, Inc., Calabasas, California. Dr Paradkar-Mitragotri is an Employee of Allergan, Inc., Santa Barbara, California. Dr Rotunda is an Assistant Clinical Professor, Division of Dermatology, David Geffen School of Medicine, UCLA, Los Angeles, California, and Assistant Clinical Professor, University of California, Irvine, California. Dr Beddingfield is an Associate Clinical Professor, Division of Dermatology, David Geffen School of Medicine (UCLA), Los Angeles, California, and is an employee of Kythera Biopharmaceuticals, Inc., Calabasas, California.
authors: Frederick C
authors: FC
authors: Beddingfield
mesh_terms: D000328:Adult; D003357:Cosmetic Techniques; D005260:Female; D006801:Humans; D008046:Lip / Q000033:anatomy & histology*; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D010781:Photography; D015203:Reproducibility of Results; D055815:Young Adult