FRESH: Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: hyaluronic acid
|
Device: hyaluronic acid dermal fillers
1 injection per indication and 1 touch-up injection if necessary
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Full Face Global Aesthetic Improvement [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 [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 [6 months after last injection]
Global aesthetic improvement scale score from baseline: -1: worse 0: no change improved much improved very much improved
Secondary Outcome Measures
- NASOLABIAL FOLDS SEVERITY ASSESSMENT [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 [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 [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 [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 [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 [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 [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 [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 [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
- MARIONETTE LINES SEVERITY ASSESSMENT [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
- MARIONETTE LINES SEVERITY ASSESSMENT [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
- MARIONETTE LINES SEVERITY ASSESSMENT [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
- UPPER LIP LINES SEVERITY ASSESSMENT [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
- UPPER LIP LINES SEVERITY ASSESSMENT [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
- UPPER LIP LINES SEVERITY ASSESSMENT [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
- UPPER LIP LINES SEVERITY ASSESSMENT [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
- CHEEK FOLDS SEVERITY ASSESSMENT [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
- CHEEK FOLDS SEVERITY ASSESSMENT [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
- CHEEK FOLDS SEVERITY ASSESSMENT [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
- CHEEK FOLDS SEVERITY ASSESSMENT [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
- LIP ENHANCEMENT ASSESSMENT [baseline]
Lip fullness grading scale score: 0: very thin lip thin lip moderately thick lip thick lip full lip
- LIP ENHANCEMENT ASSESSMENT [3 WEEKS AFTER LAST INJECTION]
Lip fullness grading scale score: 0: very thin lip thin lip moderately thick lip thick lip full lip
- LIP ENHANCEMENT ASSESSMENT [3 MONTHS AFTER LAST INJECTION]
Lip fullness grading scale score: 0: very thin lip thin lip moderately thick lip thick lip full lip
- LIP ENHANCEMENT ASSESSMENT [6 MONTHS AFTER LAST INJECTION]
Lip fullness grading scale score: 0: very thin lip thin lip moderately thick lip thick lip full lip
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Galderma investigational site | Arras | France | ||
2 | Galderma investigational site | Nice | France | ||
3 | Galderma investigational site | Paris | France | ||
4 | Galderma investigational site | Berlin | Germany | ||
5 | Galderma investigational site | Darmstadt | Germany |
Sponsors and Collaborators
- Galderma R&D
Investigators
- Principal Investigator: Philippe KESTEMONT, Investigational site Nice France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RD.03.CIP.29089
- 2009-018163-28
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Period Title: Overall Study | |
STARTED | 77 |
COMPLETED | 76 |
NOT COMPLETED | 1 |
Baseline Characteristics
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Overall Participants | 77 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
66
85.7%
|
>=65 years |
11
14.3%
|
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
54.5
(8.2)
|
Sex: Female, Male (Count of Participants) | |
Female |
73
94.8%
|
Male |
4
5.2%
|
Region of Enrollment (participants) [Number] | |
France |
47
61%
|
Germany |
30
39%
|
Outcome Measures
Title | Full Face Global Aesthetic Improvement |
---|---|
Description | Global aesthetic improvement scale score from baseline: -1: worse 0: no change improved much improved very much improved |
Time Frame | 3 weeks after last injection |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 77 |
Mean (Standard Deviation) [units on a scale] |
2.5
(0.6)
|
Title | NASOLABIAL FOLDS SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | baseline |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 73 |
Measure wrinkle | 146 |
Mean (Standard Deviation) [units on a scale] |
3.4
(0.5)
|
Title | Full Face Global Aesthetic Improvement |
---|---|
Description | Global aesthetic improvement scale score from baseline: -1: worse 0: no change improved much improved very much improved |
Time Frame | 3 months after last injection |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 75 |
Mean (Standard Error) [units on a scale] |
2.4
(0.6)
|
Title | Full Face Global Aesthetic Improvement |
---|---|
Description | Global aesthetic improvement scale score from baseline: -1: worse 0: no change improved much improved very much improved |
Time Frame | 6 months after last injection |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 76 |
Mean (Standard Deviation) [units on a scale] |
1.8
(0.9)
|
Title | NASOLABIAL FOLDS SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 3 weeks after last injection |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 73 |
Measure wrinkle | 146 |
Mean (Standard Deviation) [units on a scale] |
1.4
(0.9)
|
Title | NASOLABIAL FOLDS SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 3 months after last injection |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 71 |
Measure wrinkle | 142 |
Mean (Standard Deviation) [units on a scale] |
1.6
(0.8)
|
Title | NASOLABIAL FOLDS SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 6 months after last injection |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 72 |
Measure wrinkle | 144 |
Mean (Standard Error) [units on a scale] |
2
(1)
|
Title | PERIORBITAL LINES SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | baseline |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 31 |
Measure WRINKLE | 62 |
Mean (Standard Deviation) [units on a scale] |
2.9
(1)
|
Title | PERIORBITAL LINES SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 3 weeks after last injection |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 31 |
Measure WRINKLE | 62 |
Mean (Standard Deviation) [units on a scale] |
1.7
(1)
|
Title | PERIORBITAL LINES SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 3 MONTHS AFTER LAST INJECTION |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 31 |
Measure WRINKLE | 62 |
Mean (Standard Deviation) [units on a scale] |
1.8
(1)
|
Title | PERIORBITAL LINES SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 6 MONTHS AFTER LAST INJECTION |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 31 |
Measure WRINKLE | 62 |
Mean (Standard Deviation) [units on a scale] |
2.1
(1.2)
|
Title | MARIONETTE LINES SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | BASELINE |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 68 |
Measure WRINKLES | 136 |
Mean (Standard Deviation) [units on a scale] |
3.1
(1)
|
Title | MARIONETTE LINES SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 3 WEEKS AFTER LAST INJECTION |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 68 |
Measure WRINKLE | 136 |
Mean (Standard Deviation) [units on a scale] |
1.4
(1)
|
Title | MARIONETTE LINES SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 3 MONTHS AFTER LAST INJECTION |
Outcome Measure Data
Analysis Population Description |
---|
ININTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 66 |
Measure WRINKLE | 132 |
Mean (Standard Deviation) [units on a scale] |
1.6
(1)
|
Title | MARIONETTE LINES SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 6 MONTHS AFTER LAST INJECTION |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 67 |
Measure WRINKLE | 134 |
Mean (Standard Deviation) [units on a scale] |
2
(1.1)
|
Title | UPPER LIP LINES SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | BASELINE |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 44 |
Measure WRINKLE | 44 |
Mean (Standard Deviation) [units on a scale] |
3.1
(1)
|
Title | UPPER LIP LINES SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 3 WEEKS AFTER LAST INJECTION |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 44 |
Measure WRINKLE | 44 |
Mean (Standard Deviation) [units on a scale] |
1.5
(0.9)
|
Title | UPPER LIP LINES SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 3 MONTHS AFTER LAST INJECTION |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 44 |
Measure WRINKLE | 44 |
Mean (Standard Deviation) [units on a scale] |
1.7
(0.9)
|
Title | UPPER LIP LINES SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 6 MONTHS AFTER LAST INJECTION |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 43 |
Measure WRINKLE | 43 |
Mean (Standard Deviation) [units on a scale] |
2.1
(0.9)
|
Title | CHEEK FOLDS SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | BASELINE |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 28 |
Measure WRINKLE | 55 |
Mean (Standard Deviation) [units on a scale] |
2.4
(0.6)
|
Title | CHEEK FOLDS SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 3 WEEKS AFTER LAST INJECTION |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 28 |
Measure WRINKLE | 55 |
Mean (Standard Deviation) [units on a scale] |
1.3
(0.6)
|
Title | CHEEK FOLDS SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 3 MONTHS AFTER LAST INJECTION |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 27 |
Measure WRINKLE | 53 |
Mean (Standard Deviation) [units on a scale] |
1.4
(0.6)
|
Title | CHEEK FOLDS SEVERITY ASSESSMENT |
---|---|
Description | 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 |
Time Frame | 6 MONTHS AFTER LAST INJECTION |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 27 |
Measure WRINKLE | 53 |
Mean (Standard Deviation) [units on a scale] |
1.8
(0.8)
|
Title | LIP ENHANCEMENT ASSESSMENT |
---|---|
Description | Lip fullness grading scale score: 0: very thin lip thin lip moderately thick lip thick lip full lip |
Time Frame | baseline |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 44 |
Measure number of lips (upper or lower) | 71 |
Mean (Standard Deviation) [units on a scale] |
1.2
(0.7)
|
Title | LIP ENHANCEMENT ASSESSMENT |
---|---|
Description | Lip fullness grading scale score: 0: very thin lip thin lip moderately thick lip thick lip full lip |
Time Frame | 3 WEEKS AFTER LAST INJECTION |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 44 |
Measure number of lips (upper or lower) | 71 |
Mean (Standard Deviation) [units on a scale] |
2.3
(0.8)
|
Title | LIP ENHANCEMENT ASSESSMENT |
---|---|
Description | Lip fullness grading scale score: 0: very thin lip thin lip moderately thick lip thick lip full lip |
Time Frame | 3 MONTHS AFTER LAST INJECTION |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 43 |
Measure number of lips (upper or lower) | 70 |
Mean (Standard Deviation) [units on a scale] |
2.2
(0.9)
|
Title | LIP ENHANCEMENT ASSESSMENT |
---|---|
Description | Lip fullness grading scale score: 0: very thin lip thin lip moderately thick lip thick lip full lip |
Time Frame | 6 MONTHS AFTER LAST INJECTION |
Outcome Measure Data
Analysis Population Description |
---|
INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE) |
Arm/Group Title | Hyaluronic Acid |
---|---|
Arm/Group Description | |
Measure Participants | 43 |
Measure number of lips (upper or lower) | 70 |
Mean (Standard Deviation) [units on a scale] |
2
(0.9)
|
Adverse Events
Time Frame | During the study period (maximum of 24 weeks) | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Hyaluronic Acid | |
Arm/Group Description | ||
All Cause Mortality |
||
Hyaluronic Acid | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Hyaluronic Acid | ||
Affected / at Risk (%) | # Events | |
Total | 0/77 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Hyaluronic Acid | ||
Affected / at Risk (%) | # Events | |
Total | 5/77 (6.5%) | |
Infections and infestations | ||
NASOPHARYNGITIS | 5/77 (6.5%) | 5 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Ma May |
---|---|
Organization | Galderma |
Phone | +33 4 92 38 67 33 |
may.ma@galderma.com |
- RD.03.CIP.29089
- 2009-018163-28