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OpenTrials
Completed

NCT Number: NCT01151436

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

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.

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Key information

Conditions

Facial Wrinkles

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galderma investigational site, Arras, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hyaluronic acid dermal fillers

Device

1 injection per indication and 1 touch-up injection if necessary

Other names: Facial wrinkles

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. MARIONETTE 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

  10. MARIONETTE 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

  11. MARIONETTE 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

  12. MARIONETTE 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

  13. UPPER LIP 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

  14. UPPER LIP 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

  15. UPPER LIP 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

  16. UPPER LIP 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

  17. CHEEK 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

  18. CHEEK 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

  19. CHEEK 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

  20. CHEEK 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

  21. LIP ENHANCEMENT ASSESSMENT

    Time frame: baseline

    Lip fullness grading scale score:

    0: very thin lip

    • thin lip
    • moderately thick lip
    • thick lip
    • full lip

  22. LIP ENHANCEMENT ASSESSMENT

    Time frame: 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

    Time frame: 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

    Time frame: 6 MONTHS AFTER LAST INJECTION

    Lip fullness grading scale score:

    0: very thin lip

    • thin lip
    • moderately thick lip
    • thick lip
    • full lip

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers - Investigator and Subject Satisfaction

Acronym: FRESH

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jun 28, 2010
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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