Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine

This study has been completed.
Sponsor:
Information provided by:
Allergan Medical
ClinicalTrials.gov Identifier:
NCT00653861
First received: April 2, 2008
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Nasolabial Folds
Device: JUVÉDERM™ Injectable Gel with Lidocaine
Device: JUVÉDERM™ Injectable Gel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Resource links provided by NLM:


Further study details as provided by Allergan Medical:

Primary Outcome Measures:
  • Procedural Pain Score [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.


Secondary Outcome Measures:
  • Comparative Pain [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    A 5-point scale (-2 = Right NLF more painful than Left NLF; -1 = Right NLF slightly more painful than Left NLF; 0 = No difference; 1 = Left NLF slightly more painful than Right NLF; 2 = Left NLF more painful than Right NLF). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.

  • Nasolabial Fold (NLF) Severity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 Juvederm with Lidocaine (either Ultra or Ultra Plus) in one nasolabial fold and Juvederm (either Ultra or Ultra Plus) in the other nasolabial fold.


Enrollment: 72
Study Start Date: April 2008
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Juvederm with Lidocaine
Subjects receive Juvederm with Lidocaine (either Ultra or Ultra Plus at investigator's discretion) in one nasolabial fold.
Device: JUVÉDERM™ Injectable Gel with Lidocaine
Single treatment, volume determined by investigator
Active Comparator: Juvederm
Subjects receive Juvederm without Lidocaine (either Ultra or Ultra Plus at investigator's discretion) in the other nasolabial fold.
Device: JUVÉDERM™ Injectable Gel
Single treatment, volume determined by investigator

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653861

Locations
United States, New York
Mt. Kisco, New York, United States
Sponsors and Collaborators
Allergan Medical
  More Information

Publications:
Responsible Party: Medical Monitor, Allergan Medical
ClinicalTrials.gov Identifier: NCT00653861     History of Changes
Other Study ID Numbers: JULIDO-001
Study First Received: April 2, 2008
Results First Received: July 22, 2009
Last Updated: December 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Allergan Medical:
Aesthetic correction

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014