Trial Outcomes & Findings for Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine (NCT NCT00653861)
NCT ID: NCT00653861
Last Updated: 2014-10-13
Results Overview
Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.
COMPLETED
NA
72 participants
1 day
2014-10-13
Participant Flow
Other aesthetic procedures and products were not allowed 1 month prior to study entry or any time during the study.
Participant milestones
| Measure |
Total Study Participants
Subjects who received Juvederm with Lidocaine in one nasolabial fold and Juvederm without Lidocaine in the other nasolabial fold
|
|---|---|
|
Overall Study
STARTED
|
72
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine
Baseline characteristics by cohort
| Measure |
Total Study Participants
n=72 Participants
Subjects who received Juvéderm with Lidocaine in one nasolabial fold and Juvéderm without Lidocaine in the other nasolabial fold.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 9.03 • n=93 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Intention to treat (ITT)
Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.
Outcome measures
| Measure |
Juvéderm Lidocaine Nasolabial Folds (NLFs)
n=72 Participants
Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
|
Juvéderm Nasolabial Folds (NLFs)
n=72 Participants
Nasolabial folds on the corresponding side of the face injected with Juvederm
|
|---|---|---|
|
Procedural Pain Score
|
2.0 Units on a scale
Standard Deviation 1.71
|
5.4 Units on a scale
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: 1 dayPopulation: ITT
A 5-point scale (-2 = Right NLF more painful than Left NLF; -1 = Right NLF slightly more painful than Left NLF; 0 = No difference; 1 = Left NLF slightly more painful than Right NLF; 2 = Left NLF more painful than Right NLF). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.
Outcome measures
| Measure |
Juvéderm Lidocaine Nasolabial Folds (NLFs)
n=72 Participants
Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
|
Juvéderm Nasolabial Folds (NLFs)
Nasolabial folds on the corresponding side of the face injected with Juvederm
|
|---|---|---|
|
Comparative Pain
Juvéderm Lidocaine is Less Painful than Juvéderm
|
64 Percent of Participants
|
—
|
|
Comparative Pain
Juvéderm Lidocaine is Slightly Less Painful
|
29 Percent of Participants
|
—
|
|
Comparative Pain
No Difference
|
0 Percent of Participants
|
—
|
|
Comparative Pain
Juvéderm Lidocaine is Slightly More Painful
|
4 Percent of Participants
|
—
|
|
Comparative Pain
Juvéderm Lidocaine is More Painful than Juvéderm
|
3 Percent of Participants
|
—
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: ITT
Determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvederm with Lidocaine (either Ultra or Ultra Plus) in one nasolabial fold and Juvederm (either Ultra or Ultra Plus) in the other nasolabial fold.
Outcome measures
| Measure |
Juvéderm Lidocaine Nasolabial Folds (NLFs)
n=72 Participants
Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
|
Juvéderm Nasolabial Folds (NLFs)
n=72 Participants
Nasolabial folds on the corresponding side of the face injected with Juvederm
|
|---|---|---|
|
Nasolabial Fold (NLF) Severity
Improvement using Juvederm Ultra
|
1.6 Units on a scale
Standard Deviation 0.60
|
1.6 Units on a scale
Standard Deviation 0.56
|
|
Nasolabial Fold (NLF) Severity
Improvement using Juvederm Ultra Plus
|
1.8 Units on a scale
Standard Deviation 0.58
|
1.8 Units on a scale
Standard Deviation 0.65
|
Adverse Events
Juvéderm Lidocaine Nasolabial Folds (NLFs)
Juvéderm Nasolabial Folds (NLFs)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Juvéderm Lidocaine Nasolabial Folds (NLFs)
n=72 participants at risk
Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
|
Juvéderm Nasolabial Folds (NLFs)
n=72 participants at risk
Nasolabial folds on the corresponding side of the face injected with Juvederm
|
|---|---|---|
|
General disorders
Injection side induration
|
15.3%
11/72 • Number of events 11
|
15.3%
11/72 • Number of events 11
|
|
General disorders
Injection site nodule
|
15.3%
11/72 • Number of events 11
|
16.7%
12/72 • Number of events 12
|
|
General disorders
Injection site discoloration
|
11.1%
8/72 • Number of events 8
|
8.3%
6/72 • Number of events 6
|
|
General disorders
Application site bruising
|
8.3%
6/72 • Number of events 6
|
6.9%
5/72 • Number of events 5
|
|
General disorders
Injection site erythema
|
6.9%
5/72 • Number of events 5
|
6.9%
5/72 • Number of events 5
|
|
General disorders
Injection site edema
|
5.6%
4/72 • Number of events 4
|
8.3%
6/72 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At least ninety (90) days prior to any proposed submission for publication or presentation of Study data or other findings related to the Study, the Investigator will provide the Sponsor with a manuscript of such submission(s) for review and comment.
- Publication restrictions are in place
Restriction type: OTHER