Nasolabial Folds
Conditions
Keywords
Aesthetic correction of nasolabial folds
Brief summary
Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of nasolabial folds.
Interventions
DEVICEHyaluronic acid gel (24 mg/mL) with 0.3% lidocaine
Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL
DEVICEA gel of hyaluronic acid (concentration of 20 mg/mL)
Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL
Sponsors
Allergan Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Desires correction of moderate to severe nasolabial folds (NLFs) * Both NLFs have the same pre-treatment NLF severity score (either moderate or severe) * Females of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study
Exclusion criteria
* Cosmetic facial procedures \[e.g., facelift, resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel or other ablative or non-ablative procedures), tissue augmentation with dermal fillers or fat injections, BOTOX Cosmetic injections, or mesotherapy\] in the lower 2/3 of the face, including the neck, within 1 month prior to study entry or be planning to undergo any of these procedures at any time during the study * Initiating 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 during the study * Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment is within 5mL of the recommended annual maximum volume for HA dermal fillers * Previous injection of semi-permanent fillers or placement of facial implants anywhere in the head and neck or implantation of any of these products during the study * Allergy or sensitivity to lidocaine, hyaluronic acid products, or Streptococcal protein * Active inflammation, infection, cancerous or pre-cancerous lesion or unhealed wound in the NLF region * Current treatment with anti-coagulation therapy or use of non-steroidal anti-inflammatory drugs or other substances known to increase coagulation time within 10 days of undergoing study injections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Pain Score | 1 day | Subjects evaluated the pain associated with the procedure 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 = Juvéderm with Lidocaine less painful than Restylane; -1 = Juvéderm with Lidocaine slightly less painful than Restylane; 0 = No difference; 1 = Juvéderm with Lidocaine slightly more painful than Restylane; 2 = Juvéderm with Lidocaine more painful than Restylane). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented. |
| Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity | Day 0, Day 14 | Investigator 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 Juvéderm with Lidocaine in one NLF and Restylane in the other NLF |
| Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity | Day 0, Day 14 | Subject 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 Juvéderm with Lidocaine in one NLF and Restylane in the other NLF |
Countries
Canada
Participant flow
Recruitment details
Enrollment:32 Study Start Date: November 2008 Study Completion Date: February 2009 Primary Completion Date: November 2008
Participants by arm
| Arm | Count |
|---|---|
| Total Participants Each participant received Juvederm on one side of the face and Restylane on the other side. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Total Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 51.8 years STANDARD_DEVIATION 7.82 |
| Region of Enrollment Canada | 32 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 32 | 8 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Procedural Pain Score
Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Juvederm(R) Ultra Injectable Gel With Lidocaine | Procedural Pain Score | 2.0 units on a scale | Standard Deviation 1.84 |
| Restylane(R) Injectable Gel | Procedural Pain Score | 4.1 units on a scale | Standard Deviation 1.88 |
Secondary
Comparative Pain
A 5-point scale (-2 = Juvéderm with Lidocaine less painful than Restylane; -1 = Juvéderm with Lidocaine slightly less painful than Restylane; 0 = No difference; 1 = Juvéderm with Lidocaine slightly more painful than Restylane; 2 = Juvéderm with Lidocaine more painful than Restylane). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.
Time frame: 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Juvederm(R) Ultra Injectable Gel With Lidocaine | Comparative Pain | Juvederm with Lidocaine less painful than Restylan | 34 percent of participants |
| Juvederm(R) Ultra Injectable Gel With Lidocaine | Comparative Pain | Juvederm with Lidocaine slightly less painful than | 50 percent of participants |
| Juvederm(R) Ultra Injectable Gel With Lidocaine | Comparative Pain | No difference | 3 percent of participants |
| Juvederm(R) Ultra Injectable Gel With Lidocaine | Comparative Pain | Juvederm with Lidocaine slightly more painful than | 9 percent of participants |
| Juvederm(R) Ultra Injectable Gel With Lidocaine | Comparative Pain | Juvederm with Lidocaine more painful than Restylan | 3 percent of participants |
Secondary
Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity
Investigator 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 Juvéderm with Lidocaine in one NLF and Restylane in the other NLF
Time frame: Day 0, Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Juvederm(R) Ultra Injectable Gel With Lidocaine | Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity | 1.4 units on a scale | Standard Deviation 0.91 |
| Restylane(R) Injectable Gel | Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity | 1.3 units on a scale | Standard Deviation 0.9 |
Secondary
Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity
Subject 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 Juvéderm with Lidocaine in one NLF and Restylane in the other NLF
Time frame: Day 0, Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Juvederm(R) Ultra Injectable Gel With Lidocaine | Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity | 1.5 units on a scale | Standard Deviation 0.88 |
| Restylane(R) Injectable Gel | Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity | 1.4 units on a scale | Standard Deviation 0.84 |