Nasolabial Folds
Conditions
Keywords
Aesthetic correction
Brief summary
Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™ without Lidocaine for procedural pain in the treatment of nasolabial folds.
Detailed description
Controlled, randomized, split-face study in which subjects receive JUVÉDERM™ Injectable Gel with Lidocaine (Ultra or Ultra Plus) in one nasolabial fold and JUVÉDERM™ Injectable Gel without Lidocaine (Ultra or Ultra Plus) in the other nasolabial fold. The investigator determines whether the subject receives JUVÉDERM™ Ultra or Ultra Plus per the level of correction desired; the lidocaine assignment is randomized.
Interventions
DEVICEJUVÉDERM™ Injectable Gel with Lidocaine
Single treatment, volume determined by investigator
DEVICEJUVÉDERM™ Injectable Gel
Single treatment, volume determined by investigator
Sponsors
Allergan Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be male or female, 18 years of age or older * Desire correction of moderate to severe nasolabial folds (NLFs) * Have approximately symmetrical NLFs, i.e., both NLFs have the same pretreatment NLF severity score
Exclusion criteria
* Have undergone cosmetic facial procedures in the lower 2/3 of the face within 1 month prior to entry in the study or are planning to undergo these procedure during the study. * Begin use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the NLF area within 1 month prior to enrollment or are planning to begin use of such products during the study. * Have undergone previous hyaluronic acid (HA)-based dermal filler treatments such that the total volume of HA injected within 12 months prior to study entry is within 5 mL of the recommended annual maximum volume for HA dermal fillers. * Has ever received semi-permanent fillers or permanent facial implants anywhere in the face or neck, or is planning to be implanted with these products during the study. * Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the study. * Have an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound in the NLF area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Pain Score | 1 day | Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparative Pain | 1 day | 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. |
| Nasolabial Fold (NLF) Severity | 2 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
Other aesthetic procedures and products were not allowed 1 month prior to study entry or any time during the study.
Participants by arm
| Arm | Count |
|---|---|
| Total Study Participants Subjects who received Juvéderm with Lidocaine in one nasolabial fold and Juvéderm without Lidocaine in the other nasolabial fold. | 72 |
| Total | 72 |
Baseline characteristics
| Characteristic | Total Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants |
| Age, Continuous | 51.9 years STANDARD_DEVIATION 9.03 |
| Region of Enrollment United States | 72 participants |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 72 | 20 / 72 |
| serious Total, serious adverse events | 0 / 72 | 0 / 72 |
Outcome results
Primary
Procedural Pain Score
Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.
Time frame: 1 day
Population: Intention to treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Juvéderm Lidocaine Nasolabial Folds (NLFs) | Procedural Pain Score | 2.0 Units on a scale | Standard Deviation 1.71 |
| Juvéderm Nasolabial Folds (NLFs) | Procedural Pain Score | 5.4 Units on a scale | Standard Deviation 2.23 |
Secondary
Comparative Pain
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.
Time frame: 1 day
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Juvéderm Lidocaine Nasolabial Folds (NLFs) | Comparative Pain | Juvéderm Lidocaine is Less Painful than Juvéderm | 64 Percent of Participants |
| Juvéderm Lidocaine Nasolabial Folds (NLFs) | Comparative Pain | Juvéderm Lidocaine is Slightly Less Painful | 29 Percent of Participants |
| Juvéderm Lidocaine Nasolabial Folds (NLFs) | Comparative Pain | No Difference | 0 Percent of Participants |
| Juvéderm Lidocaine Nasolabial Folds (NLFs) | Comparative Pain | Juvéderm Lidocaine is Slightly More Painful | 4 Percent of Participants |
| Juvéderm Lidocaine Nasolabial Folds (NLFs) | Comparative Pain | Juvéderm Lidocaine is More Painful than Juvéderm | 3 Percent of Participants |
Secondary
Nasolabial Fold (NLF) Severity
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.
Time frame: 2 weeks
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm Lidocaine Nasolabial Folds (NLFs) | Nasolabial Fold (NLF) Severity | Improvement using Juvederm Ultra | 1.6 Units on a scale | Standard Deviation 0.6 |
| Juvéderm Lidocaine Nasolabial Folds (NLFs) | Nasolabial Fold (NLF) Severity | Improvement using Juvederm Ultra Plus | 1.8 Units on a scale | Standard Deviation 0.58 |
| Juvéderm Nasolabial Folds (NLFs) | Nasolabial Fold (NLF) Severity | Improvement using Juvederm Ultra | 1.6 Units on a scale | Standard Deviation 0.56 |
| Juvéderm Nasolabial Folds (NLFs) | Nasolabial Fold (NLF) Severity | Improvement using Juvederm Ultra Plus | 1.8 Units on a scale | Standard Deviation 0.65 |