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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01151436
Acronym
FRESH
Enrollment
77
Registered
2010-06-28
Start date
2010-03-31
Completion date
2011-02-28
Last updated
2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Wrinkles

Keywords

Facial wrinkle correction

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 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.

Interventions

DEVICEhyaluronic acid dermal fillers

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

Sponsors

Galderma R&D
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Full Face Global Aesthetic Improvement3 weeks after last injectionGlobal aesthetic improvement scale score from baseline: -1: worse 0: no change 1. improved 2. much improved 3. very much improved

Secondary

MeasureTime frameDescription
PERIORBITAL LINES SEVERITY ASSESSMENTbaselineSeverity 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 ASSESSMENTBASELINESeverity 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 ASSESSMENTbaselineSeverity 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 ASSESSMENTBASELINESeverity 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 ASSESSMENTbaselineLip fullness grading scale score: 0: very thin lip 1. thin lip 2. moderately thick lip 3. thick lip 4. full lip
UPPER LIP LINES SEVERITY ASSESSMENTBASELINESeverity 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

Countries

France, Germany

Participant flow

Participants by arm

ArmCount
Hyaluronic Acid77
Total77

Baseline characteristics

CharacteristicHyaluronic Acid
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
11 Participants
Age, Categorical
Between 18 and 65 years
66 Participants
Age, Continuous54.5 years
STANDARD_DEVIATION 8.2
Region of Enrollment
France
47 participants
Region of Enrollment
Germany
30 participants
Sex: Female, Male
Female
73 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
5 / 77
serious
Total, serious adverse events
0 / 77

Outcome results

Primary

Full Face Global Aesthetic Improvement

Global aesthetic improvement scale score from baseline: -1: worse 0: no change 1. improved 2. much improved 3. very much improved

Time frame: 3 weeks after last injection

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidFull Face Global Aesthetic Improvement2.5 units on a scaleStandard Deviation 0.6
Primary

Full Face Global Aesthetic Improvement

Global aesthetic improvement scale score from baseline: -1: worse 0: no change 1. improved 2. much improved 3. very much improved

Time frame: 6 months after last injection

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidFull Face Global Aesthetic Improvement1.8 units on a scaleStandard Deviation 0.9
Primary

Full Face Global Aesthetic Improvement

Global aesthetic improvement scale score from baseline: -1: worse 0: no change 1. improved 2. much improved 3. very much improved

Time frame: 3 months after last injection

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidFull Face Global Aesthetic Improvement2.4 units on a scaleStandard Error 0.6
Secondary

CHEEK FOLDS SEVERITY ASSESSMENT

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

Time frame: BASELINE

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidCHEEK FOLDS SEVERITY ASSESSMENT2.4 units on a scaleStandard Deviation 0.6
Secondary

CHEEK FOLDS SEVERITY ASSESSMENT

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

Time frame: 3 WEEKS AFTER LAST INJECTION

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidCHEEK FOLDS SEVERITY ASSESSMENT1.3 units on a scaleStandard Deviation 0.6
Secondary

CHEEK FOLDS SEVERITY ASSESSMENT

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

Time frame: 3 MONTHS AFTER LAST INJECTION

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidCHEEK FOLDS SEVERITY ASSESSMENT1.4 units on a scaleStandard Deviation 0.6
Secondary

CHEEK FOLDS SEVERITY ASSESSMENT

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

Time frame: 6 MONTHS AFTER LAST INJECTION

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidCHEEK FOLDS SEVERITY ASSESSMENT1.8 units on a scaleStandard Deviation 0.8
Secondary

LIP ENHANCEMENT ASSESSMENT

Lip fullness grading scale score: 0: very thin lip 1. thin lip 2. moderately thick lip 3. thick lip 4. full lip

Time frame: 6 MONTHS AFTER LAST INJECTION

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidLIP ENHANCEMENT ASSESSMENT2 units on a scaleStandard Deviation 0.9
Secondary

LIP ENHANCEMENT ASSESSMENT

Lip fullness grading scale score: 0: very thin lip 1. thin lip 2. moderately thick lip 3. thick lip 4. full lip

Time frame: baseline

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidLIP ENHANCEMENT ASSESSMENT1.2 units on a scaleStandard Deviation 0.7
Secondary

LIP ENHANCEMENT ASSESSMENT

Lip fullness grading scale score: 0: very thin lip 1. thin lip 2. moderately thick lip 3. thick lip 4. full lip

Time frame: 3 WEEKS AFTER LAST INJECTION

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidLIP ENHANCEMENT ASSESSMENT2.3 units on a scaleStandard Deviation 0.8
Secondary

LIP ENHANCEMENT ASSESSMENT

Lip fullness grading scale score: 0: very thin lip 1. thin lip 2. moderately thick lip 3. thick lip 4. full lip

Time frame: 3 MONTHS AFTER LAST INJECTION

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidLIP ENHANCEMENT ASSESSMENT2.2 units on a scaleStandard Deviation 0.9
Secondary

MARIONETTE LINES SEVERITY ASSESSMENT

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

Time frame: BASELINE

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidMARIONETTE LINES SEVERITY ASSESSMENT3.1 units on a scaleStandard Deviation 1
Secondary

MARIONETTE LINES SEVERITY ASSESSMENT

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

Time frame: 3 WEEKS AFTER LAST INJECTION

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidMARIONETTE LINES SEVERITY ASSESSMENT1.4 units on a scaleStandard Deviation 1
Secondary

MARIONETTE LINES SEVERITY ASSESSMENT

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

Time frame: 6 MONTHS AFTER LAST INJECTION

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidMARIONETTE LINES SEVERITY ASSESSMENT2 units on a scaleStandard Deviation 1.1
Secondary

MARIONETTE LINES SEVERITY ASSESSMENT

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

Time frame: 3 MONTHS AFTER LAST INJECTION

Population: ININTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidMARIONETTE LINES SEVERITY ASSESSMENT1.6 units on a scaleStandard Deviation 1
Secondary

NASOLABIAL FOLDS SEVERITY ASSESSMENT

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

Time frame: 3 months after last injection

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidNASOLABIAL FOLDS SEVERITY ASSESSMENT1.6 units on a scaleStandard Deviation 0.8
Secondary

NASOLABIAL FOLDS SEVERITY ASSESSMENT

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

Time frame: 6 months after last injection

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidNASOLABIAL FOLDS SEVERITY ASSESSMENT2 units on a scaleStandard Error 1
Secondary

NASOLABIAL FOLDS SEVERITY ASSESSMENT

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

Time frame: 3 weeks after last injection

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidNASOLABIAL FOLDS SEVERITY ASSESSMENT1.4 units on a scaleStandard Deviation 0.9
Secondary

NASOLABIAL FOLDS SEVERITY ASSESSMENT

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

Time frame: baseline

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidNASOLABIAL FOLDS SEVERITY ASSESSMENT3.4 units on a scaleStandard Deviation 0.5
Secondary

PERIORBITAL LINES SEVERITY ASSESSMENT

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

Time frame: 6 MONTHS AFTER LAST INJECTION

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidPERIORBITAL LINES SEVERITY ASSESSMENT2.1 units on a scaleStandard Deviation 1.2
Secondary

PERIORBITAL LINES SEVERITY ASSESSMENT

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

Time frame: baseline

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidPERIORBITAL LINES SEVERITY ASSESSMENT2.9 units on a scaleStandard Deviation 1
Secondary

PERIORBITAL LINES SEVERITY ASSESSMENT

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

Time frame: 3 weeks after last injection

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidPERIORBITAL LINES SEVERITY ASSESSMENT1.7 units on a scaleStandard Deviation 1
Secondary

PERIORBITAL LINES SEVERITY ASSESSMENT

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

Time frame: 3 MONTHS AFTER LAST INJECTION

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidPERIORBITAL LINES SEVERITY ASSESSMENT1.8 units on a scaleStandard Deviation 1
Secondary

UPPER LIP LINES SEVERITY ASSESSMENT

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

Time frame: BASELINE

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidUPPER LIP LINES SEVERITY ASSESSMENT3.1 units on a scaleStandard Deviation 1
Secondary

UPPER LIP LINES SEVERITY ASSESSMENT

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

Time frame: 3 MONTHS AFTER LAST INJECTION

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidUPPER LIP LINES SEVERITY ASSESSMENT1.7 units on a scaleStandard Deviation 0.9
Secondary

UPPER LIP LINES SEVERITY ASSESSMENT

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

Time frame: 6 MONTHS AFTER LAST INJECTION

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidUPPER LIP LINES SEVERITY ASSESSMENT2.1 units on a scaleStandard Deviation 0.9
Secondary

UPPER LIP LINES SEVERITY ASSESSMENT

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

Time frame: 3 WEEKS AFTER LAST INJECTION

Population: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

ArmMeasureValue (MEAN)Dispersion
Hyaluronic AcidUPPER LIP LINES SEVERITY ASSESSMENT1.5 units on a scaleStandard Deviation 0.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026