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

    1. improved
    2. much improved
    3. 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

    1. improved
    2. much improved
    3. 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

    1. improved
    2. much improved
    3. 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) ]

The investigator will assess at each post-baseline study visit the full face global aesthetic improvement.


Current Secondary Outcome:

  • NASOLABIAL FOLDS SEVERITY ASSESSMENT [ Time Frame: baseline ]

    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
  • NASOLABIAL FOLDS SEVERITY ASSESSMENT [ Time Frame: 3 weeks after last injection ]

    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
  • NASOLABIAL FOLDS SEVERITY ASSESSMENT [ Time Frame: 3 months after last injection ]

    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
  • NASOLABIAL FOLDS SEVERITY ASSESSMENT [ Time Frame: 6 months after last injection ]

    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
  • PERIORBITAL LINES SEVERITY ASSESSMENT [ Time Frame: baseline ]

    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
  • PERIORBITAL LINES SEVERITY ASSESSMENT [ Time Frame: 3 weeks after last injection ]

    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
  • PERIORBITAL LINES SEVERITY ASSESSMENT [ Time Frame: 3 MONTHS AFTER LAST INJECTION ]

    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
  • PERIORBITAL LINES SEVERITY ASSESSMENT [ Time Frame: 6 MONTHS AFTER LAST INJECTION ]

    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
  • MARIONETTE LINES SEVERITY ASSESSMENT [ Time Frame: BASELINE ]

    Severity scored on Lemperle Rating Scale:

    0: no wrinkles


      Original Secondary Outcome:

      • 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.


      Information By: Galderma

      Dates:
      Date Received: June 24, 2010
      Date Started: March 2010
      Date Completion:
      Last Updated: May 29, 2012
      Last Verified: May 2012