The primary objective of the study was to demonstrate non-inferiority of Restylane Lyft with Lidocaine versus a comparator-control for augmentation of the chin region to improve the chin profile.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
175
hyaluronic acid
hyaluronic acid
Galderma Research Site
Los Angeles, California, United States
United States, California
Manhattan Beach, California, United States
Galderma Research Site
Westport, Connecticut, United States
Change From Baseline in the Blinded Evaluators' Live Assessment Using the Galderma Chin Retrusion Scale (GCRS) at Month 3
GCRS is a validated 4-grade scale to assess the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Higher scores indicated more severity. Least squares (LS) mean, and 95 percent (%) confidence interval (CI) were obtained from a general linear mixed random intercept model with treatment group and baseline Galderma Chin Retrusion Scale score as fixed factors.
Time frame: Baseline (last non-missing observation prior to the first administration of study product) and Month 3
Responder Rate Based on the Blinded Evaluator's Live Assessment Using the GCRS at Months 6, 9, and 12
GCRS is a validated 4-grade scale to assess the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Higher scores indicated more severity. Responder rate was defined as percentage of participants with an improvement of at least one grade on the GCRS from baseline. 95% CI was calculated using Clopper-Pearson method.
Time frame: At Months 6, 9, and 12
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Galderma Research Site
Aventura, Florida, United States
Galderma Research Site
Coral Gables, Florida, United States
Galderma Research Site
Alpharetta, Georgia, United States
Galderma Research Site
Atlanta, Georgia, United States
Galderma Research Site
Rockville, Maryland, United States
Galderma Research Site
Chestnut Hill, Massachusetts, United States
Galderma Research Site
Nashville, Tennessee, United States
...and 2 more locations