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Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00653861
First Posted: April 7, 2008
Last Update Posted: October 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan ( Allergan Medical )
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)

Resource links provided by NLM:


Further study details as provided by Allergan ( Allergan Medical ):

Primary Outcome Measures:
  • Procedural Pain Score [ Time Frame: 1 day ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653861


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

Publications:
Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT00653861     History of Changes
Other Study ID Numbers: JULIDO-001
First Submitted: April 2, 2008
First Posted: April 7, 2008
Results First Submitted: July 22, 2009
Results First Posted: December 30, 2009
Last Update Posted: October 13, 2014
Last Verified: December 2013

Keywords provided by Allergan ( Allergan Medical ):
Aesthetic correction

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