Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine

Allergan

Status

Completed

Conditions

Nasolabial Folds

Treatments

Device: JUVÉDERM™ Injectable Gel

Device: JUVÉDERM™ Injectable Gel with Lidocaine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00653861

JULIDO-001

Details and patient eligibility

About

Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™ without Lidocaine for procedural pain in the treatment of nasolabial folds.

Full description

Controlled, randomized, split-face study in which subjects receive JUVÉDERM™ Injectable Gel with Lidocaine (Ultra or Ultra Plus) in one nasolabial fold and JUVÉDERM™ Injectable Gel without Lidocaine (Ultra or Ultra Plus) in the other nasolabial fold. The investigator determines whether the subject receives JUVÉDERM™ Ultra or Ultra Plus per the level of correction desired; the lidocaine assignment is randomized.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Be male or female, 18 years of age or older
Desire correction of moderate to severe nasolabial folds (NLFs)
Have approximately symmetrical NLFs, i.e., both NLFs have the same pretreatment NLF severity score

Exclusion criteria

Have undergone cosmetic facial procedures in the lower 2/3 of the face within 1 month prior to entry in the study or are planning to undergo these procedure during the study.
Begin 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 are planning to begin use of such products during the study.
Have undergone previous hyaluronic acid (HA)-based dermal filler treatments such that the total volume of HA injected within 12 months prior to study entry is within 5 mL of the recommended annual maximum volume for HA dermal fillers.
Has ever received semi-permanent fillers or permanent facial implants anywhere in the face or neck, or is planning to be implanted with these products during the study.
Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the study.
Have an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound in the NLF area