Pan Facial Volume Restoration

Study Overview
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Brief Summary
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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%.

Detailed Description
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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).

Official Title
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Pan Facial Volume Restoration With a New Hyaluronic Acid Dermal Filler

Conditions
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Volume Loss (Soft Tissue Ptosis or Atrophy )

Intervention / Treatment
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* Device: Hyaluronic acid dermal filler gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects seeking treatment for correction of volume loss. Subjects presenting a score of at least 2 (visible depression or descent) for whole face on the volume loss scale and at least 2 indications affected by volume loss among the following: chin temporal areas, jawlines, cheeks, cheekbones, deep to very deep nasolabial folds (severity score 4 at least on Lemperle rating scale) if cheekbones are injected. Exclusion Criteria: Subjects at risk in term of precautions, warnings and contraindication referred in the package insert of the study device, Subjects who underwent previous injection of permanent filler in the injected area.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic acid dermal filler<br>One Emervel Volume injection at baseline and touch up injections 3 weeks after if needed | Device: Hyaluronic acid dermal filler gel<br>* 1 Emervel Volume injection per indication and 1 touch-up injection if necessary<br>* Other names: Study filler is Emervel Volume Lidocaine.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 18 Months after last injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline up to 18 Months after last injection | 
| Percentage of Participants Satisfied or Very Satisfied at 18 Months 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 18 Months after last injection were reported. | At 18 Months after last injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volume loss