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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2008-11-30

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.

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Detailed Description

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Conditions

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Nasolabial Folds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Juvederm Ultra Injectable Gel with Lidocaine

Group Type ACTIVE_COMPARATOR

Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine

Intervention Type DEVICE

Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL

2

Restylane Injectable Gel

Group Type ACTIVE_COMPARATOR

A gel of hyaluronic acid (concentration of 20 mg/mL)

Intervention Type DEVICE

Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL

Interventions

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Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine

Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL

Intervention Type DEVICE

A gel of hyaluronic acid (concentration of 20 mg/mL)

Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL

Intervention Type DEVICE

Other Intervention Names

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Juvederm® Ultra Injectable Gel with Lidocaine Restylane® Injectable Gel

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes