Clinical Trial: Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers - Investigator and Subject Satisfaction
Brief Summary: 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 Summary:
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.
Sponsor: Galderma
Current Primary Outcome:
- Full Face Global Aesthetic Improvement [ Time Frame: 3 weeks after last injection ]
Global aesthetic improvement scale score from baseline:
-1: worse 0: no change
- improved
- much improved
- very much improved
- Full Face Global Aesthetic Improvement [ Time Frame: 3 months after last injection ]
Global aesthetic improvement scale score from baseline:
-1: worse 0: no change
- improved
- much improved
- very much improved
- Full Face Global Aesthetic Improvement [ Time Frame: 6 months after last injection ]
Global aesthetic improvement scale score from baseline:
-1: worse 0: no change
- improved
- much improved
- very much improved
Original Primary Outcome: Global aesthetic improvement [ Time Frame: 3 weeks after baseline injections (V2), 3 weeks after touch-up injections (V3 - Optional), 3months after last injections (V4), 6 months after last injections (V5) ]
Current Secondary Outcome:
- NASOLABIAL FOLDS SEVERITY ASSESSMENT [ Time Frame: baseline ]
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
- NASOLABIAL FOLDS SEVERITY ASSESSMENT [ Time Frame: 3 weeks after last injection ]
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
- NASOLABIAL FOLDS SEVERITY ASSESSMENT [ Time Frame: 3 months after last injection ]
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
- NASOLABIAL FOLDS SEVERITY ASSESSMENT [ Time Frame: 6 months after last injection ]
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
- PERIORBITAL LINES SEVERITY ASSESSMENT [ Time Frame: baseline ]
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
- PERIORBITAL LINES SEVERITY ASSESSMENT [ Time Frame: 3 weeks after last injection ]
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
- PERIORBITAL LINES SEVERITY ASSESSMENT [ Time Frame: 3 MONTHS AFTER LAST INJECTION ]
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
- PERIORBITAL LINES SEVERITY ASSESSMENT [ Time Frame: 6 MONTHS AFTER LAST INJECTION ]
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
- MARIONETTE LINES SEVERITY ASSESSMENT [ Time Frame: BASELINE ]
Severity scored on Lemperle Rating Scale:
0: no wrinkles
- PERIORBITAL LINES SEVERITY ASSESSMENT [ Time Frame: Baseline (V1), 3 weeks after baseline injections (V2), 3 weeks after touch-up injections (V3 - Optional), 3months after last injections (V4), 6 months after last injections (V5) ]Assessments will be based on the Lemperle Rating Scales.
- MARIONETTE LINES SEVERITY ASSESSMENT [ Time Frame: Baseline (V1), 3 weeks after baseline injections (V2), 3 weeks after touch-up injections (V3 - Optional), 3months after last injections (V4), 6 months after last injections (V5) ]Assessments will be based on the Lemperle Rating Scales.
- Upper lip lines severity assessment [ Time Frame: Baseline (V1), 3 weeks after baseline injections (V2), 3 weeks after touch-up injections (V3 - Optional), 3months after last injections (V4), 6 months after last injections (V5) ]Assessments will be based on the Lemperle Rating Scales.
- Cheek folds severity assessment [ Time Frame: Baseline (V1), 3 weeks after baseline injections (V2), 3 weeks after touch-up injections (V3 - Optional), 3months after last injections (V4), 6 months after last injections (V5) ]Assessments will be based on the Lemperle Rating Scales.
- Lip enhancement assessment [ Time Frame: Baseline (V1), 3 weeks after baseline injections (V2), 3 weeks after touch-up injections (V3 - Optional), 3months after last injections (V4), 6 months after last injections (V5) ]Assessments will be based on the Lip fullness Grading Scale.
Original Secondary Outcome:
Information By: Galderma
Dates:
Date Received: June 24, 2010
Date Started: March 2010
Date Completion:
Last Updated: May 29, 2012
Last Verified: May 2012
- PERIORBITAL LINES SEVERITY ASSESSMENT [ Time Frame: Baseline (V1), 3 weeks after baseline injections (V2), 3 weeks after touch-up injections (V3 - Optional), 3months after last injections (V4), 6 months after last injections (V5) ]