Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds

Study Overview
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Brief Summary
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Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of nasolabial folds.

Conditions
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Nasolabial Folds

Intervention / Treatment
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* Device: Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine
* Device: A gel of hyaluronic acid (concentration of 20 mg/mL)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Juvederm Ultra Injectable Gel with Lidocaine | Device: Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine<br>* Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL<br>* Other names: Juvederm® Ultra Injectable Gel with Lidocaine;|
| Active Comparator: 2<br>Restylane Injectable Gel | Device: A gel of hyaluronic acid (concentration of 20 mg/mL)<br>* Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL<br>* Other names: Restylane® Injectable Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 
| 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 | Day 0, Day 14 | 
| 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 | Day 0, Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aesthetic correction of nasolabial folds