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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01151436
First received: June 24, 2010
Last updated: May 29, 2012
Last verified: May 2012
History of Changes

June 24, 2010
May 29, 2012
March 2010
November 2010   (final data collection date for primary outcome measure)
  • Full Face Global Aesthetic Improvement [ Time Frame: 3 weeks after last injection ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    Global aesthetic improvement scale score from baseline:

    -1: worse 0: no change

    1. improved
    2. much improved
    3. very much improved
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) ] [ Designated as safety issue: No ]
The investigator will assess at each post-baseline study visit the full face global aesthetic improvement.
Complete list of historical versions of study NCT01151436 on ClinicalTrials.gov Archive Site
  • NASOLABIAL FOLDS SEVERITY ASSESSMENT [ Time Frame: baseline ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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: 3 WEEKS AFTER LAST INJECTION ] [ Designated as safety issue: No ]

    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: 3 MONTHS AFTER LAST INJECTION ] [ Designated as safety issue: No ]

    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: 6 MONTHS AFTER LAST INJECTION ] [ Designated as safety issue: No ]

    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
  • UPPER LIP LINES SEVERITY ASSESSMENT [ Time Frame: BASELINE ] [ Designated as safety issue: No ]

    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
  • UPPER LIP LINES SEVERITY ASSESSMENT [ Time Frame: 3 WEEKS AFTER LAST INJECTION ] [ Designated as safety issue: No ]

    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
  • UPPER LIP LINES SEVERITY ASSESSMENT [ Time Frame: 3 MONTHS AFTER LAST INJECTION ] [ Designated as safety issue: No ]

    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
  • UPPER LIP LINES SEVERITY ASSESSMENT [ Time Frame: 6 MONTHS AFTER LAST INJECTION ] [ Designated as safety issue: No ]

    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
  • CHEEK FOLDS SEVERITY ASSESSMENT [ Time Frame: BASELINE ] [ Designated as safety issue: No ]

    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
  • CHEEK FOLDS SEVERITY ASSESSMENT [ Time Frame: 3 WEEKS AFTER LAST INJECTION ] [ Designated as safety issue: Yes ]

    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
  • CHEEK FOLDS SEVERITY ASSESSMENT [ Time Frame: 3 MONTHS AFTER LAST INJECTION ] [ Designated as safety issue: No ]

    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
  • CHEEK FOLDS SEVERITY ASSESSMENT [ Time Frame: 6 MONTHS AFTER LAST INJECTION ] [ Designated as safety issue: No ]

    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
  • LIP ENHANCEMENT ASSESSMENT [ Time Frame: baseline ] [ Designated as safety issue: No ]

    Lip fullness grading scale score:

    0: very thin lip

    1. thin lip
    2. moderately thick lip
    3. thick lip
    4. full lip
  • LIP ENHANCEMENT ASSESSMENT [ Time Frame: 3 WEEKS AFTER LAST INJECTION ] [ Designated as safety issue: No ]

    Lip fullness grading scale score:

    0: very thin lip

    1. thin lip
    2. moderately thick lip
    3. thick lip
    4. full lip
  • LIP ENHANCEMENT ASSESSMENT [ Time Frame: 3 MONTHS AFTER LAST INJECTION ] [ Designated as safety issue: No ]

    Lip fullness grading scale score:

    0: very thin lip

    1. thin lip
    2. moderately thick lip
    3. thick lip
    4. full lip
  • LIP ENHANCEMENT ASSESSMENT [ Time Frame: 6 MONTHS AFTER LAST INJECTION ] [ Designated as safety issue: No ]

    Lip fullness grading scale score:

    0: very thin lip

    1. thin lip
    2. moderately thick lip
    3. thick lip
    4. full lip
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Assessments will be based on the Lip fullness Grading Scale.
Not Provided
Not Provided
 
Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers
Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers - Investigator and Subject Satisfaction

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.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Facial Wrinkles
Device: hyaluronic acid dermal fillers
1 injection per indication and 1 touch-up injection if necessary
Other Name: Facial wrinkles
Experimental: hyaluronic acid
Intervention: Device: hyaluronic acid dermal fillers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
February 2011
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
NCT01151436
RD.03.CIP.29089, 2009-018163-28
No
Galderma
Galderma
Not Provided
Principal Investigator: Philippe KESTEMONT Investigational site Nice France
Galderma
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP