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Development and Validation of a Photonumeric Scale for Evaluation of Facial Fine Lines
Jean Carruthers1, Lisa Donofrio, Bhushan Hardas
1*Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada; †Department of Dermatology, Yale University School of Medicine, New Haven, Connecticut; ‡Allergan plc, Irvine, California; §Division of Dermatology, University of California, Los Angeles, Los Angeles, California; ‖Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada; ¶UC Davis Medical Group, Sacramento, California; #Peloton Advantage, LLC, Parsippany, New Jersey.
Background:
A validated scale is needed for objective and reproducible comparisons of facial fine lines before and after treatment in practice and clinical studies.
Objective:
To describe the development and validation of the 5-point photonumeric Allergan Fine Lines Scale.
Methods:
The Allergan Fine Lines Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live subject validation study (N = 289) completed during 2 sessions occurring 3 weeks apart.
Results:
A score difference of ≥1 point was shown to reflect a clinically significant difference (mean [95% CI] absolute score difference, 1.06 [0.92-1.21] for clinically different image pairs and 0.50 [0.38-0.61] for not clinically different pairs). Intrarater agreement between the 2 live subject validation sessions was almost perfect (weighted kappa = 0.85). Interrater agreement was substantial during the second rating session (0.76, primary end point).
Conclusion:
The Allergan Fine Lines Scale is a validated and reliable scale for physician rating of severity of superficial fine lines.
