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Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds

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.
 
ClinicalTrials.gov Identifier: NCT00850889
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : April 21, 2011
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )

Study Description
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Brief Summary:
Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of nasolabial folds.

Condition or disease Intervention/treatment Phase
Nasolabial Folds Device: Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine Device: A gel of hyaluronic acid (concentration of 20 mg/mL) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Study Start Date : November 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Juvederm Ultra Injectable Gel with Lidocaine
 Device: Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine
Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL
Other Name: Juvederm® Ultra Injectable Gel with Lidocaine
Active Comparator: 2
Restylane Injectable Gel
 Device: A gel of hyaluronic acid (concentration of 20 mg/mL)
Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL
Other Name: Restylane® Injectable Gel


Outcome Measures
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Primary Outcome Measures :
  1. Procedural Pain Score [ Time Frame: 1 day ]
    Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.


Secondary Outcome Measures :
  1. Comparative Pain [ Time Frame: 1 day ]
    A 5-point scale (-2 = Juvéderm with Lidocaine less painful than Restylane; -1 = Juvéderm with Lidocaine slightly less painful than Restylane; 0 = No difference; 1 = Juvéderm with Lidocaine slightly more painful than Restylane; 2 = Juvéderm with Lidocaine more painful than Restylane). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.

  2. Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity [ Time Frame: Day 0, Day 14 ]
    Investigator 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 Juvéderm with Lidocaine in one NLF and Restylane in the other NLF

  3. Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity [ Time Frame: Day 0, Day 14 ]
    Subject 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 Juvéderm with Lidocaine in one NLF and Restylane in the other NLF


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Desires correction of moderate to severe nasolabial folds (NLFs)
  • Both NLFs have the same pre-treatment NLF severity score (either moderate or severe)
  • Females of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study

Exclusion Criteria:

  • Cosmetic facial procedures [e.g., facelift, resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel or other ablative or non-ablative procedures), tissue augmentation with dermal fillers or fat injections, BOTOX Cosmetic injections, or mesotherapy] in the lower 2/3 of the face, including the neck, within 1 month prior to study entry or be planning to undergo any of these procedures at any time during the study
  • Initiating 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 during the study
  • Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment is within 5mL of the recommended annual maximum volume for HA dermal fillers
  • Previous injection of semi-permanent fillers or placement of facial implants anywhere in the head and neck or implantation of any of these products during the study
  • Allergy or sensitivity to lidocaine, hyaluronic acid products, or Streptococcal protein
  • Active inflammation, infection, cancerous or pre-cancerous lesion or unhealed wound in the NLF region
  • Current treatment with anti-coagulation therapy or use of non-steroidal anti-inflammatory drugs or other substances known to increase coagulation time within 10 days of undergoing study injections
Contacts and Locations
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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): NCT00850889


Locations
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Canada, Ontario
Niagara Falls, Ontario, Canada
Sponsors and Collaborators
Allergan Medical
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications:

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Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT00850889    
Other Study ID Numbers: MA-JULIDO-0801
First Posted: February 25, 2009    Key Record Dates
Results First Posted: April 21, 2011
Last Update Posted: January 9, 2019
Last Verified: December 2018
Keywords provided by Allergan ( Allergan Medical ):
Aesthetic correction of nasolabial folds
Additional relevant MeSH terms:
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Lidocaine
Hyaluronic Acid
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
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents