Development and Validation of a 6‐Point Grading Scale in Patients Undergoing Correction of Nasolabial Folds with a Collagen Implant

BACKGROUND Various scoring techniques prone to subjective interpretation have been used to evaluate soft tissue augmentation of nasolabial folds (NLFs). OBJECTIVE To design and validate a reliable wrinkle assessment scoring scale. MATERIALS AND METHODS Six photographed wrinkles of varying severity were electronically copied onto the same facial image to become a 6‐point grading scale (GGS). A pilot training program (13 investigators) determined reliability, and a 12‐week multicenter survey study validated the GGS scoring method. RESULTS Pilot study inter‐ and intrarater scoring reliability were high (weighted kappa scores of 0.85 and 0.86, respectively). Seventy‐five percent of survey investigators and independent review panel (IRP) members considered a GGS score difference of 0.5 to be a minimally perceivable difference. Interrater weighted kappa scores were 0.91 for the IRP and 0.80 for investigators. Intrarater agreements after repeat testing were 0.91 and 0.89, respectively. The baseline “live” assessment GGS mean score was 3.34, and the baseline blinded photographic assessment GGS mean score was 2.00 for the IRP and 2.16 for the investigators. CONCLUSIONS The GGS is a reproducible method of grading the severity of NLF wrinkles. Treatment effectiveness of a dermal filler can be reliably evaluated using the GGS by comparing “live” assessments with the standard GGS photographic panel. The Genzyme Corporation and Allergan, Inc. provided funding for this study. L. Fleming and N. Bachtell are paid employees of Genzyme. E. Garcia and D. Burkholder are employees of Mentor. B. Poff is an employee of Augmenix.