Moderate to Severe Nasolabial Folds
Conditions
Brief summary
A prospective, open-label, multi-center, observational, post-market study evaluating JUVÉDERM VOLIFT™ for the correction of moderate to severe nasolabial folds
Interventions
DEVICECrosslinked hyaluronic acid dermal filler
All treatment details are at the discretion of the Investigator and should be guided by the Directions for Use. Up to 3 treatments will be administered: Initial treatment, optional top-up treatment at Day 14 post-initial treatment, and optional repeat treatment at Month 12 post-initial treatment.
Sponsors
Allergan
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
Yes
Inclusion criteria
* Male or female 18 years of age or older * Have 2 fully visible, approximately symmetrical nasolabial folds and has severity scores of 2 or 3 on the 5-point photographic nasolabial fold severity scale (range 0-4) for both nasolabial folds, as judged by the Investigator * Have a reasonable expectation for correction by injection via deep dermis, as described in the protocol * Agree to refrain from undergoing other anti-wrinkle/volumizing treatments in the lower two-thirds of the face (below the orbital rim) for the duration of the study * Understand and be willing to follow all aspects of the study protocol and have signed and dated the Informed Consent prior to any study-related procedures being performed * Be in good health as in the opinion of the Investigator
Exclusion criteria
* Has undergone cosmetic facial procedures (e.g., face lift or other surgeries) which may alter the appearance of the nasolabial fold area * Cosmetic injections in the lower two-thirds of the face (below the orbital rim), within 6 months prior to entry in the study, or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry * Has undergone volumizing of the mid/lower face within 9 months prior to study entry * Has ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded poly-tetrafluoroethylene) anywhere in the lower face (below the orbital rim), or be planning to be implanted with any of these products at any time during the study * Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to lidocaine (an any amide-based anesthetics), HA products, or Streptococcal protein, or be planning to undergo a desensitization therapy during the term of the study * Be a pregnant female, lactating, or planning to become pregnant at any time during the study * Be a female of childbearing potential not using a reliable means of contraception * Have received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study * Suffer from an uncontrolled personality disorder (e.g., body dysmorphia, depression) * Have a history of or currently suffer from autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease) * Have a history of streptococcal disease (e.g., strep throat or rheumatic fever with or without heart complications) * Have a history of skin cancer * Suffer from porphyria * Have epilepsy, which is not controlled by anti-epilepsy therapy * Current cutaneous inflammatory and/or infectious processes (e.g., acne, herpes) * Have a history of treatment with interferon * Be on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or have taken non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or ginkgo biloba) within 10 days of undergoing study device injection. NOTE: Study device injection may be delayed as necessary to accommodate this 10-day period * Be on a concurrent regimen of high doses of lidocaine (more than 400 mg) which may cause acute toxic reactions * Be on a concurrent regimen of other local anesthetics structurally related to amide-type local anesthetics * Have impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction * Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS) | Month 12 | Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale | Day 14, Month 1, Month 9, Month 12 | Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied). |
| Investigator Assessment of Ease of Injection Use on a 10-Point Scale | Day 0, Day 14 | Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard). |
| Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Day 0, Day 14, Month 1, Month 9 | Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme). |
| Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale | Day 14, Month 1, Month 9, Month 12 | Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied). |
| Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Day 0, Day 14, Month 12, Month 12.5 | Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable). |
| Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Day 0, Day 14, Month 1, Month 9, Month 12 | Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme). |
Countries
Germany, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| JUVÉDERM VOLIFT™ All subjects receiving treatment with JUVÉDERM VOLIFT™. | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | JUVÉDERM VOLIFT™ |
|---|---|
| Age, Continuous | 49.3 Years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
Primary
Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)
Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
Time frame: Month 12
Population: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUVÉDERM VOLIFT™ | Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS) | 12 Months - Right | 2.8 Scores on a Scale | Standard Deviation 0.8 |
| JUVÉDERM VOLIFT™ | Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS) | 12 Months - Left | 2.8 Scores on a Scale | Standard Deviation 0.8 |
Secondary
Investigator Assessment of Ease of Injection Use on a 10-Point Scale
Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard).
Time frame: Day 0, Day 14
Population: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUVÉDERM VOLIFT™ | Investigator Assessment of Ease of Injection Use on a 10-Point Scale | Day 0 | 1.2 Scores on a Scale | Standard Deviation 1.3 |
| JUVÉDERM VOLIFT™ | Investigator Assessment of Ease of Injection Use on a 10-Point Scale | Day 14 (N=27) | 0.9 Scores on a Scale | Standard Deviation 0.5 |
Secondary
Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
Time frame: Day 0, Day 14, Month 1, Month 9
Population: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUVÉDERM VOLIFT™ | Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Day 0 - Right | 3.6 Scores on a Scale | Standard Deviation 0.5 |
| JUVÉDERM VOLIFT™ | Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Day 0 -Left | 3.7 Scores on a Scale | Standard Deviation 0.5 |
| JUVÉDERM VOLIFT™ | Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Day 14 - Right | 1.7 Scores on a Scale | Standard Deviation 0.5 |
| JUVÉDERM VOLIFT™ | Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Day 14 - Left | 1.7 Scores on a Scale | Standard Deviation 0.5 |
| JUVÉDERM VOLIFT™ | Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Month 1 - Right (N=66) | 1.8 Scores on a Scale | Standard Deviation 0.6 |
| JUVÉDERM VOLIFT™ | Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Month 1 - Left (N=66 | 1.9 Scores on a Scale | Standard Deviation 0.6 |
| JUVÉDERM VOLIFT™ | Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Month 9 - Right (N=66) | 2.5 Scores on a Scale | Standard Deviation 0.7 |
| JUVÉDERM VOLIFT™ | Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Month 9 - Left (N=66) | 2.4 Scores on a Scale | Standard Deviation 0.7 |
Secondary
Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale
Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).
Time frame: Day 14, Month 1, Month 9, Month 12
Population: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUVÉDERM VOLIFT™ | Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale | Day 14 | 4.6 Scores on a Scale | Standard Deviation 0.6 |
| JUVÉDERM VOLIFT™ | Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale | Month 1 (N=66) | 4.5 Scores on a Scale | Standard Deviation 0.7 |
| JUVÉDERM VOLIFT™ | Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale | Month 9 (N=65) | 4.0 Scores on a Scale | Standard Deviation 1.1 |
| JUVÉDERM VOLIFT™ | Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale | Month 12 (N=65) | 4.4 Scores on a Scale | Standard Deviation 1 |
Secondary
Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
Time frame: Day 0, Day 14, Month 1, Month 9, Month 12
Population: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUVÉDERM VOLIFT™ | Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Day 0 - Left | 3.9 Scores on a Scale | Standard Deviation 0.7 |
| JUVÉDERM VOLIFT™ | Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Day 0 - Right | 3.8 Scores on a Scale | Standard Deviation 0.7 |
| JUVÉDERM VOLIFT™ | Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Day 14 - Right | 1.8 Scores on a Scale | Standard Deviation 0.7 |
| JUVÉDERM VOLIFT™ | Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Day 14 - Left | 1.8 Scores on a Scale | Standard Deviation 0.7 |
| JUVÉDERM VOLIFT™ | Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Month 1 - Right (N=66) | 2.0 Scores on a Scale | Standard Deviation 0.9 |
| JUVÉDERM VOLIFT™ | Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Month 1 - Left (N=65) | 2.1 Scores on a Scale | Standard Deviation 0.8 |
| JUVÉDERM VOLIFT™ | Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Month 9 - Right (N=66) | 2.6 Scores on a Scale | Standard Deviation 0.8 |
| JUVÉDERM VOLIFT™ | Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Month 9 - Left (N=66) | 2.6 Scores on a Scale | Standard Deviation 0.8 |
| JUVÉDERM VOLIFT™ | Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Month 12 - Right (N=54) | 2.9 Scores on a Scale | Standard Deviation 0.8 |
| JUVÉDERM VOLIFT™ | Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Month 12 - Left (N=54) | 3.0 Scores on a Scale | Standard Deviation 0.9 |
Secondary
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable).
Time frame: Day 0, Day 14, Month 12, Month 12.5
Population: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Pain Intensity Day 0 - Right | 2.0 Scores on a Scale | Standard Deviation 1.8 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Pain Intensity Day 0 - Left | 2.0 Scores on a Scale | Standard Deviation 1.8 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Pain Intensity Day 14 - Right (N=66) | 0.8 Scores on a Scale | Standard Deviation 1.7 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Pain Intensity Day 14 - Left (N=66) | 0.7 Scores on a Scale | Standard Deviation 1.5 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Pain Intensity Month 12 - Right (N=51) | 1.5 Scores on a Scale | Standard Deviation 1.8 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Pain Intensity Month 12 - Left (N=51) | 1.5 Scores on a Scale | Standard Deviation 2.1 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Pain Intensity Month 12.5 - Right (N=12) | 0.0 Scores on a Scale | Standard Deviation 0 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Pain Intensity Month 12.5 - Left (N=12) | 0.0 Scores on a Scale | Standard Deviation 0 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Swelling Intensity Day 0 - Right | 1.7 Scores on a Scale | Standard Deviation 1.6 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Swelling Intensity Day 0 - Left | 1.7 Scores on a Scale | Standard Deviation 1.6 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Swelling Intensity Day 14 - Right (N=66) | 1.5 Scores on a Scale | Standard Deviation 2.2 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Swelling Intensity Day 14 - Left (N=66) | 1.4 Scores on a Scale | Standard Deviation 2.2 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Swelling Intensity Month 12 - Right (N=51) | 1.4 Scores on a Scale | Standard Deviation 1.5 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Swelling Intensity Month 12 - Left (N=51) | 1.4 Scores on a Scale | Standard Deviation 1.6 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Swelling Intensity Month 12.5 - Right (N=12) | 0.1 Scores on a Scale | Standard Deviation 0.3 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Swelling Intensity Month 12.5 - Left (N=12) | 0.2 Scores on a Scale | Standard Deviation 0.4 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Bruising Intensity Day 0 - Right | 0.3 Scores on a Scale | Standard Deviation 0.9 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Bruising Intensity Day 0 - Left | 0.3 Scores on a Scale | Standard Deviation 0.9 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Bruising Intensity Day 14 - Right (N=66) | 0.9 Scores on a Scale | Standard Deviation 1.9 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Bruising Intensity Day 14 - Left (N=66) | 0.5 Scores on a Scale | Standard Deviation 1.3 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Bruising Intensity Month 12 - Right (N=51) | 0.4 Scores on a Scale | Standard Deviation 0.8 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Bruising Intensity Month 12 - Left (N=51) | 0.4 Scores on a Scale | Standard Deviation 0.9 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Bruising Intensity Month 12.5 - Right (N=12) | 0.3 Scores on a Scale | Standard Deviation 0.7 |
| JUVÉDERM VOLIFT™ | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Bruising Intensity Month 12.5 - Left (N=12) | 0.5 Scores on a Scale | Standard Deviation 0.8 |
Secondary
Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale
Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).
Time frame: Day 14, Month 1, Month 9, Month 12
Population: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JUVÉDERM VOLIFT™ | Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale | Day 14 | 4.2 Scores on a Scale | Standard Deviation 1 |
| JUVÉDERM VOLIFT™ | Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale | Month 1 (N=66) | 4.2 Scores on a Scale | Standard Deviation 1 |
| JUVÉDERM VOLIFT™ | Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale | Month 9 (N=66) | 3.2 Scores on a Scale | Standard Deviation 2.4 |
| JUVÉDERM VOLIFT™ | Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale | Month 12 (N=54) | 3.3 Scores on a Scale | Standard Deviation 1.9 |