Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers

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 linked to the global management of facial rejuvenation with a new range of hyaluronic acid dermal fillers.

Detailed Description
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The range of fillers tested in this study includes 5 different hyaluronic acid dermal fillers: Emervel Touch, Emervel Classic, Emervel Deep, Emervel Volume and Emervel Lips. The study will last 6 month. Injections will be performed at baseline. If necessary, the investigator will perform touch-up injections at the following visit (3 weeks later). Investigator and subject satisfaction will be collected through questionnaires.

Official Title
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Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers - Investigator and Subject Satisfaction

Conditions
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Facial Wrinkles

Intervention / Treatment
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* Device: hyaluronic acid dermal fillers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seeking tissue augmentation treatment on the face, Presenting a score of 3 (Moderately deep wrinkle)or 4 (Deep wrinkle) on the Lemperle Rating Scale (LRS) of both nasolabial folds. Exclusion Criteria: At risk in term of precautions, warnings and contra-indication referred in the package insert of the study devices, 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<br> | Device: hyaluronic acid dermal fillers<br>* 1 injection per indication and 1 touch-up injection if necessary<br>* Other names: Facial wrinkles;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full Face Global Aesthetic Improvement | Global aesthetic improvement scale score from baseline: -1: worse 0: no change improved much improved very much improved | 3 weeks after last injection | 
| Full Face Global Aesthetic Improvement | Global aesthetic improvement scale score from baseline: -1: worse 0: no change improved much improved very much improved | 3 months after last injection | 
| Full Face Global Aesthetic Improvement | Global aesthetic improvement scale score from baseline: -1: worse 0: no change improved much improved very much improved | 6 months after last injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NASOLABIAL FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | baseline | 
| NASOLABIAL FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 3 weeks after last injection | 
| NASOLABIAL FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 3 months after last injection | 
| NASOLABIAL FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 6 months after last injection | 
| PERIORBITAL LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | baseline | 
| PERIORBITAL LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 3 weeks after last injection | 
| PERIORBITAL LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 3 MONTHS AFTER LAST INJECTION | 
| PERIORBITAL LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 6 MONTHS AFTER LAST INJECTION | 
| MARIONETTE LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | BASELINE | 
| MARIONETTE LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 3 WEEKS AFTER LAST INJECTION | 
| MARIONETTE LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 3 MONTHS AFTER LAST INJECTION | 
| MARIONETTE LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 6 MONTHS AFTER LAST INJECTION | 
| UPPER LIP LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | BASELINE | 
| UPPER LIP LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 3 WEEKS AFTER LAST INJECTION | 
| UPPER LIP LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 3 MONTHS AFTER LAST INJECTION | 
| UPPER LIP LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 6 MONTHS AFTER LAST INJECTION | 
| CHEEK FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | BASELINE | 
| CHEEK FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 3 WEEKS AFTER LAST INJECTION | 
| CHEEK FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 3 MONTHS AFTER LAST INJECTION | 
| CHEEK FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles just perceptible wrinkle shallow wrinkle moderately deep wrinkle deep wrinkle, well-defined edges very deep wrinkle redundant fold | 6 MONTHS AFTER LAST INJECTION | 
| LIP ENHANCEMENT ASSESSMENT | Lip fullness grading scale score: 0: very thin lip thin lip moderately thick lip thick lip full lip | baseline | 
| LIP ENHANCEMENT ASSESSMENT | Lip fullness grading scale score: 0: very thin lip thin lip moderately thick lip thick lip full lip | 3 WEEKS AFTER LAST INJECTION | 
| LIP ENHANCEMENT ASSESSMENT | Lip fullness grading scale score: 0: very thin lip thin lip moderately thick lip thick lip full lip | 3 MONTHS AFTER LAST INJECTION | 
| LIP ENHANCEMENT ASSESSMENT | Lip fullness grading scale score: 0: very thin lip thin lip moderately thick lip thick lip full lip | 6 MONTHS AFTER LAST INJECTION | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facial wrinkle correction