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
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

ClinicalTrials.gov processed this record on April 15, 2014