The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction further to pan-facial volume restoration with a new cross-linked hyaluronic acid dermal filler containing lidocaine 0.3%.
Clinical hypothesis: The global approach of the subject pan-facial dermal volume depletion and face soft-tissue contour defects correction using specific dermal filler for all indications to be injected will satisfy both subjects and investigators. This device will be used for full face correction of volume loss: chin, temporal areas, jawline, cheek, cheekbones, deep to very deep nasolabial folds (only if cheekbones are injected concomitantly). Study duration will be up to 19 months. Injections will be performed at baseline. If necessary, investigator will perform touch-up injections at the following visit (3 weeks after baseline injection).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
1 Emervel Volume injection per indication and 1 touch-up injection if necessary
Galderma Investigational Center
Botucatu, Brazil
Galderma Investigational Center
Rio de Janeiro, Brazil
Galderma Investigational Center
Saö Paulo, Brazil
Mean Change From Baseline in Volume Loss Assessment
Overall loss of volume on full face was graded on a volume loss scale (VLS) of 0 to 3 by the investigator as follow: 0= normal, 1= evidence of early soft tissue ptosis or atrophy slightly visible, 2=visible depression or descent, 3= severe depression or atrophy. Last injections were given either at baseline or touch-up injections (if needed) on previously injected areas at 3 Weeks after baseline.
Time frame: Baseline and 18 Months after last injection
Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection
Participants satisfaction with the overall, full face aesthetic results were assessed by use of participants global satisfaction questionnaire. Participants rated their satisfaction by answering question ; Rate overall, full face aesthetic outcome using the following options: not satisfied, somewhat satisfied, satisfied or very satisfied. Percentage of participants satisfied and very satisfied with the full face aesthetic outcome at 3 weeks after last injection were reported.
Time frame: At 3 Weeks after last injection
Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler
The study investigators (injectors) were requested to complete a questionnaire about their satisfaction with the use of study hyaluronic acid dermal filler (Emervel® Volume Lidocaine). The percentage of investigators who agreed to use Emervel® Volume Lidocaine again were reported in this outcome measure.
Time frame: Baseline up to 18 Months after last injection
Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Baseline up to 18 Months after last injection
Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection
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Participants satisfaction with the overall, full face aesthetic results were assessed by use of participants global satisfaction questionnaire. Participants rated their satisfaction by answering question; rate overall, full face aesthetic outcome using the following options : not satisfied, somewhat satisfied, satisfied or very satisfied. Percentage of participants satisfied and very satisfied with the full-face aesthetic outcome at 18 Months after last injection were reported.
Time frame: At 18 Months after last injection