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

Allergan

Status and phase: Completed; Phase 4

Conditions: Nasolabial Folds

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00850889

MA-JULIDO-0801

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

32 participants in 2 patient groups

1

Active Comparator group

Description:

Juvederm Ultra Injectable Gel with Lidocaine

Treatment:

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

2

Active Comparator group

Description:

Restylane Injectable Gel

Treatment:

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