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

Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT01151436
Collaborator
(none)
77
5
1
11.1
15.4
1.4

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
  • Device: hyaluronic acid dermal fillers
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

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers - Investigator and Subject Satisfaction
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Feb 1, 2011

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:
  • Facial wrinkles
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    1. 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

    2. 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

    3. 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

    4. 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

    5. 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

    6. 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

    7. 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

    8. 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

    9. 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

    10. 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

    11. 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

    12. 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

    13. 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

    14. 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

    15. 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

    16. 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

    17. 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

    18. 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

    19. 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

    20. 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

    21. LIP ENHANCEMENT ASSESSMENT [baseline]

      Lip fullness grading scale score: 0: very thin lip thin lip moderately thick lip thick lip full lip

    22. 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

    23. 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

    24. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    Galderma R&D
    ClinicalTrials.gov Identifier:
    NCT01151436
    Other Study ID Numbers:
    • RD.03.CIP.29089
    • 2009-018163-28
    First Posted:
    Jun 28, 2010
    Last Update Posted:
    Mar 10, 2021
    Last Verified:
    May 1, 2012
    Keywords provided by Galderma R&D
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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)
    2. Secondary Outcome
    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)
    3. Primary Outcome
    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)
    4. Primary Outcome
    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)
    5. Secondary Outcome
    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)
    6. Secondary Outcome
    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)
    7. Secondary Outcome
    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)
    8. Secondary Outcome
    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)
    9. Secondary Outcome
    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)
    10. Secondary Outcome
    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)
    11. Secondary Outcome
    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)
    12. Secondary Outcome
    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)
    13. Secondary Outcome
    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)
    14. Secondary Outcome
    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)
    15. Secondary Outcome
    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)
    16. Secondary Outcome
    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)
    17. Secondary Outcome
    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)
    18. Secondary Outcome
    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)
    19. Secondary Outcome
    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)
    20. Secondary Outcome
    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)
    21. Secondary Outcome
    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)
    22. Secondary Outcome
    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)
    23. Secondary Outcome
    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)
    24. Secondary Outcome
    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)
    25. Secondary Outcome
    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)
    26. Secondary Outcome
    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)
    27. Secondary Outcome
    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

    [Not Specified]

    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
    Email may.ma@galderma.com
    Responsible Party:
    Galderma R&D
    ClinicalTrials.gov Identifier:
    NCT01151436
    Other Study ID Numbers:
    • RD.03.CIP.29089
    • 2009-018163-28
    First Posted:
    Jun 28, 2010
    Last Update Posted:
    Mar 10, 2021
    Last Verified:
    May 1, 2012