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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
1 injection per indication and 1 touch-up injection if necessary
Galderma investigational site
Arras, France
Galderma investigational site
Nice, France
Galderma investigational site
Paris, France
Galderma investigational site
Berlin, Germany
Galderma investigational site
Full Face Global Aesthetic Improvement
Global aesthetic improvement scale score from baseline: -1: worse 0: no change 1. improved 2. much improved 3. very much improved
Time frame: 3 weeks after last injection
Full Face Global Aesthetic Improvement
Global aesthetic improvement scale score from baseline: -1: worse 0: no change 1. improved 2. much improved 3. very much improved
Time frame: 3 months after last injection
Full Face Global Aesthetic Improvement
Global aesthetic improvement scale score from baseline: -1: worse 0: no change 1. improved 2. much improved 3. very much improved
Time frame: 6 months after last injection
NASOLABIAL FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: baseline
NASOLABIAL FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 3 weeks after last injection
NASOLABIAL FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 3 months after last injection
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Darmstadt, Germany
NASOLABIAL FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 6 months after last injection
PERIORBITAL LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: baseline
PERIORBITAL LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 3 weeks after last injection
PERIORBITAL LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 3 MONTHS AFTER LAST INJECTION
PERIORBITAL LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 6 MONTHS AFTER LAST INJECTION
MARIONETTE LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: BASELINE
MARIONETTE LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 3 WEEKS AFTER LAST INJECTION
MARIONETTE LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 3 MONTHS AFTER LAST INJECTION
MARIONETTE LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 6 MONTHS AFTER LAST INJECTION
UPPER LIP LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: BASELINE
UPPER LIP LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 3 WEEKS AFTER LAST INJECTION
UPPER LIP LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 3 MONTHS AFTER LAST INJECTION
UPPER LIP LINES SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 6 MONTHS AFTER LAST INJECTION
CHEEK FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: BASELINE
CHEEK FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 3 WEEKS AFTER LAST INJECTION
CHEEK FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 3 MONTHS AFTER LAST INJECTION
CHEEK FOLDS SEVERITY ASSESSMENT
Severity scored on Lemperle Rating Scale: 0: no wrinkles 1. just perceptible wrinkle 2. shallow wrinkle 3. moderately deep wrinkle 4. deep wrinkle, well-defined edges 5. very deep wrinkle redundant fold
Time frame: 6 MONTHS AFTER LAST INJECTION
LIP ENHANCEMENT ASSESSMENT
Lip fullness grading scale score: 0: very thin lip 1. thin lip 2. moderately thick lip 3. thick lip 4. full lip
Time frame: baseline
LIP ENHANCEMENT ASSESSMENT
Lip fullness grading scale score: 0: very thin lip 1. thin lip 2. moderately thick lip 3. thick lip 4. full lip
Time frame: 3 WEEKS AFTER LAST INJECTION
LIP ENHANCEMENT ASSESSMENT
Lip fullness grading scale score: 0: very thin lip 1. thin lip 2. moderately thick lip 3. thick lip 4. full lip
Time frame: 3 MONTHS AFTER LAST INJECTION
LIP ENHANCEMENT ASSESSMENT
Lip fullness grading scale score: 0: very thin lip 1. thin lip 2. moderately thick lip 3. thick lip 4. full lip
Time frame: 6 MONTHS AFTER LAST INJECTION