MedDataX Logo

Trial Outcomes & Findings for Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers (NCT NCT01151436)

NCT ID: NCT01151436

Last Updated: 2021-03-10

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

77 participants

Primary outcome timeframe

3 weeks after last injection

Results posted on

2021-03-10

Participant Flow

Participant milestones

Participant milestones
Measure
Hyaluronic Acid
Overall Study
STARTED
77
Overall Study
COMPLETED
76
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Hyaluronic Acid
n=77 Participants
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
66 Participants
n=5 Participants
Age, Categorical
>=65 years
11 Participants
n=5 Participants
Age, Continuous
54.5 years
STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male
Female
73 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
Region of Enrollment
France
47 participants
n=5 Participants
Region of Enrollment
Germany
30 participants
n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks after last injection

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=77 Participants
Full Face Global Aesthetic Improvement
2.5 units on a scale
Standard Deviation 0.6

PRIMARY outcome

Timeframe: 3 months after last injection

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=75 Participants
Full Face Global Aesthetic Improvement
2.4 units on a scale
Standard Error 0.6

PRIMARY outcome

Timeframe: 6 months after last injection

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=76 Participants
Full Face Global Aesthetic Improvement
1.8 units on a scale
Standard Deviation 0.9

SECONDARY outcome

Timeframe: baseline

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=146 wrinkle
NASOLABIAL FOLDS SEVERITY ASSESSMENT
3.4 units on a scale
Standard Deviation 0.5

SECONDARY outcome

Timeframe: 3 weeks after last injection

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=146 wrinkle
NASOLABIAL FOLDS SEVERITY ASSESSMENT
1.4 units on a scale
Standard Deviation 0.9

SECONDARY outcome

Timeframe: 3 months after last injection

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=142 wrinkle
NASOLABIAL FOLDS SEVERITY ASSESSMENT
1.6 units on a scale
Standard Deviation 0.8

SECONDARY outcome

Timeframe: 6 months after last injection

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=144 wrinkle
NASOLABIAL FOLDS SEVERITY ASSESSMENT
2 units on a scale
Standard Error 1

SECONDARY outcome

Timeframe: baseline

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=62 WRINKLE
PERIORBITAL LINES SEVERITY ASSESSMENT
2.9 units on a scale
Standard Deviation 1

SECONDARY outcome

Timeframe: 3 weeks after last injection

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=62 WRINKLE
PERIORBITAL LINES SEVERITY ASSESSMENT
1.7 units on a scale
Standard Deviation 1

SECONDARY outcome

Timeframe: 3 MONTHS AFTER LAST INJECTION

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=62 WRINKLE
PERIORBITAL LINES SEVERITY ASSESSMENT
1.8 units on a scale
Standard Deviation 1

SECONDARY outcome

Timeframe: 6 MONTHS AFTER LAST INJECTION

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=62 WRINKLE
PERIORBITAL LINES SEVERITY ASSESSMENT
2.1 units on a scale
Standard Deviation 1.2

SECONDARY outcome

Timeframe: BASELINE

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=136 WRINKLES
MARIONETTE LINES SEVERITY ASSESSMENT
3.1 units on a scale
Standard Deviation 1

SECONDARY outcome

Timeframe: 3 WEEKS AFTER LAST INJECTION

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=136 WRINKLE
MARIONETTE LINES SEVERITY ASSESSMENT
1.4 units on a scale
Standard Deviation 1

SECONDARY outcome

Timeframe: 3 MONTHS AFTER LAST INJECTION

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=132 WRINKLE
MARIONETTE LINES SEVERITY ASSESSMENT
1.6 units on a scale
Standard Deviation 1

SECONDARY outcome

Timeframe: 6 MONTHS AFTER LAST INJECTION

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=134 WRINKLE
MARIONETTE LINES SEVERITY ASSESSMENT
2 units on a scale
Standard Deviation 1.1

SECONDARY outcome

Timeframe: BASELINE

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=44 WRINKLE
UPPER LIP LINES SEVERITY ASSESSMENT
3.1 units on a scale
Standard Deviation 1

SECONDARY outcome

Timeframe: 3 WEEKS AFTER LAST INJECTION

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=44 WRINKLE
UPPER LIP LINES SEVERITY ASSESSMENT
1.5 units on a scale
Standard Deviation 0.9

SECONDARY outcome

Timeframe: 3 MONTHS AFTER LAST INJECTION

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=44 WRINKLE
UPPER LIP LINES SEVERITY ASSESSMENT
1.7 units on a scale
Standard Deviation 0.9

SECONDARY outcome

Timeframe: 6 MONTHS AFTER LAST INJECTION

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=43 WRINKLE
UPPER LIP LINES SEVERITY ASSESSMENT
2.1 units on a scale
Standard Deviation 0.9

SECONDARY outcome

Timeframe: BASELINE

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=55 WRINKLE
CHEEK FOLDS SEVERITY ASSESSMENT
2.4 units on a scale
Standard Deviation 0.6

SECONDARY outcome

Timeframe: 3 WEEKS AFTER LAST INJECTION

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=55 WRINKLE
CHEEK FOLDS SEVERITY ASSESSMENT
1.3 units on a scale
Standard Deviation 0.6

SECONDARY outcome

Timeframe: 3 MONTHS AFTER LAST INJECTION

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=53 WRINKLE
CHEEK FOLDS SEVERITY ASSESSMENT
1.4 units on a scale
Standard Deviation 0.6

SECONDARY outcome

Timeframe: 6 MONTHS AFTER LAST INJECTION

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=53 WRINKLE
CHEEK FOLDS SEVERITY ASSESSMENT
1.8 units on a scale
Standard Deviation 0.8

SECONDARY outcome

Timeframe: baseline

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=71 number of lips (upper or lower)
LIP ENHANCEMENT ASSESSMENT
1.2 units on a scale
Standard Deviation 0.7

SECONDARY outcome

Timeframe: 3 WEEKS AFTER LAST INJECTION

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=71 number of lips (upper or lower)
LIP ENHANCEMENT ASSESSMENT
2.3 units on a scale
Standard Deviation 0.8

SECONDARY outcome

Timeframe: 3 MONTHS AFTER LAST INJECTION

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=70 number of lips (upper or lower)
LIP ENHANCEMENT ASSESSMENT
2.2 units on a scale
Standard Deviation 0.9

SECONDARY outcome

Timeframe: 6 MONTHS AFTER LAST INJECTION

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

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

Outcome measures

Outcome measures
Measure
Hyaluronic Acid
n=70 number of lips (upper or lower)
LIP ENHANCEMENT ASSESSMENT
2 units on a scale
Standard Deviation 0.9

Adverse Events

Hyaluronic Acid

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Hyaluronic Acid
n=77 participants at risk
Infections and infestations
NASOPHARYNGITIS
6.5%
5/77 • Number of events 5 • During the study period (maximum of 24 weeks)

Additional Information

Ma May

Galderma

Phone: +33 4 92 38 67 33

Results disclosure agreements

  • Principal investigator is a sponsor employee 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.
  • Publication restrictions are in place

Restriction type: OTHER