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 Medical
ClinicalTrials.gov Identifier:
NCT00850889
First received: February 23, 2009
Last updated: December 3, 2013
Last verified: December 2013

February 23, 2009
December 3, 2013
November 2008
November 2008   (final data collection date for primary outcome measure)
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.
Subject Assessment of Procedural Pain [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00850889 on ClinicalTrials.gov Archive Site
  • 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
  • Subject Comparison of Procedural Pain Right Side versus Left Side [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Investigator assessment of nasolabial fold severity [ Time Frame: Day 0, Day 14 ] [ Designated as safety issue: No ]
  • Subject assessment of nasolabial fold severity [ Time Frame: Day 0, Day 14 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds
Not Provided

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Nasolabial Folds
  • 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
  • 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
  • Active Comparator: 1
    Juvederm Ultra Injectable Gel with Lidocaine
    Intervention: Device: Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine
  • Active Comparator: 2
    Restylane Injectable Gel
    Intervention: Device: A gel of hyaluronic acid (concentration of 20 mg/mL)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00850889
MA-JULIDO-0801
Not Provided
Allergan Medical
Allergan Medical
Not Provided
Study Director: Medical Director Allergan
Allergan Medical
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP