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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier:
NCT00850889
First received: February 23, 2009
Last updated: October 6, 2014
Last verified: December 2013
  Purpose

Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of nasolabial folds.


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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Procedural Pain Score [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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:
  • Comparative Pain [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.

  • Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity [ Time Frame: Day 0, Day 14 ] [ Designated as safety issue: No ]
    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

  • Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity [ Time Frame: Day 0, Day 14 ] [ Designated as safety issue: No ]
    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


Enrollment: 32
Study Start Date: November 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00850889

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

No publications provided

Responsible Party: Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier: NCT00850889     History of Changes
Other Study ID Numbers: MA-JULIDO-0801
Study First Received: February 23, 2009
Results First Received: February 24, 2011
Last Updated: October 6, 2014
Health Authority: Canada: IRB

Keywords provided by Allergan:
Aesthetic correction of nasolabial folds

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

ClinicalTrials.gov processed this record on October 23, 2014