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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-018163-28 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hyaluronic acid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyaluronic acid dermal fillers | Device | 1 injection per indication and 1 touch-up injection if necessary |
|
| Measure | Description | Time Frame |
|---|---|---|
| Full Face Global Aesthetic Improvement | Global aesthetic improvement scale score from baseline: -1: worse 0: no change
| 3 weeks after last injection |
| Full Face Global Aesthetic Improvement | Global aesthetic improvement scale score from baseline: -1: worse 0: no change
| 3 months after last injection |
| Full Face Global Aesthetic Improvement | Global aesthetic improvement scale score from baseline: -1: worse 0: no change
| 6 months after last injection |
| Measure | Description | Time Frame |
|---|---|---|
| NASOLABIAL FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| baseline |
| NASOLABIAL FOLDS SEVERITY ASSESSMENT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe KESTEMONT | Investigational site Nice France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma investigational site | Arras | France | ||||
| Galderma investigational site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hyaluronic Acid |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hyaluronic Acid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Full Face Global Aesthetic Improvement | Global aesthetic improvement scale score from baseline: -1: worse 0: no change
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Nov 2011 | Mean | Standard Deviation | units on a scale | 3 weeks after last injection |
|
|
During the study period (maximum of 24 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hyaluronic Acid |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ma May | Galderma | +33 4 92 38 67 33 | may.ma@galderma.com |
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Severity scored on Lemperle Rating Scale: 0: no wrinkles
|
| 3 weeks after last injection |
| NASOLABIAL FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| 3 months after last injection |
| NASOLABIAL FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| 6 months after last injection |
| PERIORBITAL LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| baseline |
| PERIORBITAL LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| 3 weeks after last injection |
| PERIORBITAL LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| 3 MONTHS AFTER LAST INJECTION |
| PERIORBITAL LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| 6 MONTHS AFTER LAST INJECTION |
| MARIONETTE LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| BASELINE |
| MARIONETTE LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| 3 WEEKS AFTER LAST INJECTION |
| MARIONETTE LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| 3 MONTHS AFTER LAST INJECTION |
| MARIONETTE LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| 6 MONTHS AFTER LAST INJECTION |
| UPPER LIP LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| BASELINE |
| UPPER LIP LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| 3 WEEKS AFTER LAST INJECTION |
| UPPER LIP LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| 3 MONTHS AFTER LAST INJECTION |
| UPPER LIP LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| 6 MONTHS AFTER LAST INJECTION |
| CHEEK FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| BASELINE |
| CHEEK FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| 3 WEEKS AFTER LAST INJECTION |
| CHEEK FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| 3 MONTHS AFTER LAST INJECTION |
| CHEEK FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| 6 MONTHS AFTER LAST INJECTION |
| LIP ENHANCEMENT ASSESSMENT | Lip fullness grading scale score: 0: very thin lip
| baseline |
| LIP ENHANCEMENT ASSESSMENT | Lip fullness grading scale score: 0: very thin lip
| 3 WEEKS AFTER LAST INJECTION |
| LIP ENHANCEMENT ASSESSMENT | Lip fullness grading scale score: 0: very thin lip
| 3 MONTHS AFTER LAST INJECTION |
| LIP ENHANCEMENT ASSESSMENT | Lip fullness grading scale score: 0: very thin lip
| 6 MONTHS AFTER LAST INJECTION |
| Nice |
| France |
| Galderma investigational site | Paris | France |
| Galderma investigational site | Berlin | Germany |
| Galderma investigational site | Darmstadt | Germany |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | NASOLABIAL FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | baseline | wrinkle | wrinkle |
|
|
|
| Primary | Full Face Global Aesthetic Improvement | Global aesthetic improvement scale score from baseline: -1: worse 0: no change
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Error | units on a scale | 3 months after last injection |
|
|
|
| Primary | Full Face Global Aesthetic Improvement | Global aesthetic improvement scale score from baseline: -1: worse 0: no change
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 6 months after last injection |
|
|
|
| Secondary | NASOLABIAL FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 3 weeks after last injection | wrinkle | wrinkle |
|
|
|
| Secondary | NASOLABIAL FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 3 months after last injection | wrinkle | wrinkle |
|
|
|
| Secondary | NASOLABIAL FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Error | units on a scale | 6 months after last injection | wrinkle | wrinkle |
|
|
|
| Secondary | PERIORBITAL LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Nov 2011 | Mean | Standard Deviation | units on a scale | baseline | WRINKLE | WRINKLE |
|
|
|
| Secondary | PERIORBITAL LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 3 weeks after last injection | WRINKLE | WRINKLE |
|
|
|
| Secondary | PERIORBITAL LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 3 MONTHS AFTER LAST INJECTION | WRINKLE | WRINKLE |
|
|
|
| Secondary | PERIORBITAL LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 6 MONTHS AFTER LAST INJECTION | WRINKLE | WRINKLE |
|
|
|
| Secondary | MARIONETTE LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | BASELINE | WRINKLES | WRINKLES |
|
|
|
| Secondary | MARIONETTE LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 3 WEEKS AFTER LAST INJECTION | WRINKLE | WRINKLE |
|
|
|
| Secondary | MARIONETTE LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| ININTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 3 MONTHS AFTER LAST INJECTION | WRINKLE | WRINKLE |
|
|
|
| Secondary | MARIONETTE LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 6 MONTHS AFTER LAST INJECTION | WRINKLE | WRINKLE |
|
|
|
| Secondary | UPPER LIP LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | BASELINE | WRINKLE | WRINKLE |
|
|
|
| Secondary | UPPER LIP LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 3 WEEKS AFTER LAST INJECTION | WRINKLE | WRINKLE |
|
|
|
| Secondary | UPPER LIP LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 3 MONTHS AFTER LAST INJECTION | WRINKLE | WRINKLE |
|
|
|
| Secondary | UPPER LIP LINES SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 6 MONTHS AFTER LAST INJECTION | WRINKLE | WRINKLE |
|
|
|
| Secondary | CHEEK FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | BASELINE | WRINKLE | WRINKLE |
|
|
|
| Secondary | CHEEK FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 3 WEEKS AFTER LAST INJECTION | WRINKLE | WRINKLE |
|
|
|
| Secondary | CHEEK FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 3 MONTHS AFTER LAST INJECTION | WRINKLE | WRINKLE |
|
|
|
| Secondary | CHEEK FOLDS SEVERITY ASSESSMENT | Severity scored on Lemperle Rating Scale: 0: no wrinkles
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 6 MONTHS AFTER LAST INJECTION | WRINKLE | WRINKLE |
|
|
|
| Secondary | LIP ENHANCEMENT ASSESSMENT | Lip fullness grading scale score: 0: very thin lip
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | baseline | number of lips (upper or lower) | number of lips (upper or lower) |
|
|
|
| Secondary | LIP ENHANCEMENT ASSESSMENT | Lip fullness grading scale score: 0: very thin lip
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 3 WEEKS AFTER LAST INJECTION | number of lips (upper or lower) | number of lips (upper or lower) |
|
|
|
| Secondary | LIP ENHANCEMENT ASSESSMENT | Lip fullness grading scale score: 0: very thin lip
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 3 MONTHS AFTER LAST INJECTION | number of lips (upper or lower) | number of lips (upper or lower) |
|
|
|
| Secondary | LIP ENHANCEMENT ASSESSMENT | Lip fullness grading scale score: 0: very thin lip
| INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) | Posted | Mean | Standard Deviation | units on a scale | 6 MONTHS AFTER LAST INJECTION | number of lips (upper or lower) | number of lips (upper or lower) |
|
|
|
| 0 |
| 77 |
| 5 |
| 77 |
Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor to review and approval at least 2 months prior to the date of intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.