Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine

NCT ID: NCT00653861

Last Updated: 2014-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-07-31

Brief Summary

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

Detailed 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.

Conditions

Nasolabial Folds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Juvederm with Lidocaine

Subjects receive Juvederm with Lidocaine (either Ultra or Ultra Plus at investigator's discretion) in one nasolabial fold.

Group Type: EXPERIMENTAL

JUVÉDERM™ Injectable Gel with Lidocaine

Intervention Type: DEVICE

Single treatment, volume determined by investigator

Juvederm

Subjects receive Juvederm without Lidocaine (either Ultra or Ultra Plus at investigator's discretion) in the other nasolabial fold.

Group Type: ACTIVE_COMPARATOR

JUVÉDERM™ Injectable Gel

Intervention Type: DEVICE

Single treatment, volume determined by investigator

Interventions

JUVÉDERM™ Injectable Gel with Lidocaine

Single treatment, volume determined by investigator

Intervention Type: DEVICE

JUVÉDERM™ Injectable Gel

Single treatment, volume determined by investigator

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mount Kisco, New York, United States

Countries

United States

References

Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvederm injectable gel with and without lidocaine. J Cosmet Dermatol. 2009 Sep;8(3):205-10. doi: 10.1111/j.1473-2165.2009.00451.x.

Reference Type: RESULT

PMID: 19735519 (View on PubMed)

Other Identifiers

JULIDO-001

Identifier Type: -

Identifier Source: org_study_id