JUVÉDERM® VOLITE™ XC for Cheek Skin Smoothness

An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical device which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study device. An AE was considered a treatment emergent adverse event (TEAE) if the AE began or worsened (increased in severity or became serious) after first administration of VOLITE for the treatment group and after the date of randomization for the control group.

Time frame: From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)

Population: Safety Population included all participants who are randomized and received study intervention (VOLITE or no treatment). A participant was randomized to the JUVÉDERM VOLITE™ XC arm, but not treated in the study. Therefore, this participant was included in the treatment group for the mITT population and in the control group for the safety population

The ACSS is a validated 5-point ordinal scale developed by Allergan to grade the severity of skin smoothness on the cheeks. The score ranges from 0 (smooth visual skin texture) to 4 (extremely coarse visual skin texture, crosshatched deep creases, extreme elastosis. Responders are participants with at least 1-point improvement (decrease) from baseline on the ACSS on both cheeks based on evaluating investigator (EI) assessment. Baseline is the last non-missing EI assessment on or before the latter of randomization date or first study treatment date in the control period. The multiple imputation method for the missing data imputation was used for analysis.

Time frame: Baseline to Month 1

Population: mITT Population included all randomized participants who have baseline assessment on the ACSS scale for both cheeks, and are not in the Fitzpatrick V/VI safety cohort. Missing data in ACSS at Month 1 was imputed using the Multiple Imputation method.

The participant assessed satisfaction using the 12 items on the FACE-Q: Satisfaction with Skin questionnaire measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, 4=very satisfied. The responses to the 12 items were summed and converted to a scale score that ranges from 0 (worst) to 100 (best). Higher score indicates more satisfaction. A positive change from baseline indicates improvement.

Time frame: Baseline and Month 1

Population: mITT Population included all randomized participants who had baseline assessment on the ACSS scale for both cheeks, and are not in the Fitzpatrick V/VI safety cohort. Number analyzed are the number of participants with data available for analysis at the given timepoint.

The AFLS is a validated 5-point ordinal scale developed by Allergan to grade the severity of fine lines on the cheeks. The score ranges from 0 (no fine lines) to 4 (diffuse superficial lines, crosshatching). Responders are participants with at least 1-point improvement (decrease) from baseline on the AFLS on both cheeks based on observed data of EI assessment. Baseline is the last non-missing EI assessment on or before the latter of randomization date or first study treatment date in the control period.

Time frame: Baseline to Month 1

Population: mITT Population included all randomized participants who had baseline assessment on the ACSS scale for both cheeks, and are not in the Fitzpatrick V/VI safety cohort. Overall number analyzed are the number of participants available for analyses.