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Emervel Classic Lidocaine Versus Juvederm® Ultra in Treatment of Moderate to Severe Facial Wrinkles and Folds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01205048
First received: September 16, 2010
Last updated: August 28, 2012
Last verified: August 2012

September 16, 2010
August 28, 2012
September 2010
January 2012   (final data collection date for primary outcome measure)
Mean change in wrinkle severity score from baseline to 24 weeks after final initial injection [ Time Frame: Baseline to 24 weeks after final initial injection ] [ Designated as safety issue: No ]
The wrinkle severity is measured by using a wrinkle severity rating scale with 1 being absent and 5 being extreme.
Mean change in wrinkle severity score from baseline [ Time Frame: 24 weeks after final initial injection ] [ Designated as safety issue: No ]
The wrinkle severity is measured by using a wrinkle severity rating scale with 1 being absent and 5 being extreme.
Complete list of historical versions of study NCT01205048 on ClinicalTrials.gov Archive Site
  • Mean change in wrinkle severity score from baseline to 12 weeks after final initial injection [ Time Frame: Baseline to 12 weeks after final initial injection ] [ Designated as safety issue: No ]
    The wrinkle severity is measured by using a wrinkle severity rating scale with 1 being absent and 5 being extreme.
  • Mean change in wrinkle severity score from baseline to 3 weeks after final initial injection [ Time Frame: Baseline to 3 weeks after final initial injection ] [ Designated as safety issue: No ]
    The wrinkle severity is measured by using a wrinkle severity rating scale with 1 being absent and 5 being extreme.
  • Mean change in wrinkle severity score from baseline to 36 weeks after final initial injection [ Time Frame: Baseline to 36 weeks after final initial injection ] [ Designated as safety issue: No ]
    The wrinkle severity is measured by using a wrinkle severity rating scale with 1 being absent and 5 being extreme.
  • Mean change in wrinkle severity score from baseline to 48 weeks after final initial injection [ Time Frame: Baseline to 48 weeks after final initial injection ] [ Designated as safety issue: No ]
    The wrinkle severity is measured by using a wrinkle severity rating scale with 1 being absent and 5 being extreme.
  • Mean change in subject self assessment of wrinkle severity from baseline to 24 weeks after final initial injection [ Time Frame: Baseline to 24 weeks after final initial injection ] [ Designated as safety issue: No ]
    The wrinkle severity is measured by using a wrinkle severity rating scale with 1 being absent and 5 being extreme.
  • Comparison of pain assessment after initial injection (Baseline) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Subject's pain as evaluated by the Numeric pain intensity scale. 0 is no pain and 10 is the worst possible pain. Pain is asssesed at Time 0 (the most severe pain during the initial injection), 15, 30, 45, 60 minutes and 24 hours after each injection session.
  • Comparison of pain assessment after initial touch-up injection (3 weeks after initial injection) [ Time Frame: 3 weeks after initial injection ] [ Designated as safety issue: No ]
    Subject's pain as evaluated by the Numeric pain intensity scale. 0 is no pain and 10 is the worst possible pain. Pain is asssesed at Time 0 (the most severe pain during the initial touch-up injection), 15, 30, 45, 60 minutes and 24 hours after each injection session.
  • Mean change in wrinkle severity score from baseline [ Time Frame: 12 weeks after final initial injection ] [ Designated as safety issue: No ]
    The wrinkle severity is measured by using a wrinkle severity rating scale with 1 being absent and 5 being extreme.
  • Mean change in wrinkle severity score from baseline [ Time Frame: 3 weeks after final initial injection ] [ Designated as safety issue: No ]
    The wrinkle severity is measured by using a wrinkle severity rating scale with 1 being absent and 5 being extreme.
  • Mean change in wrinkle severity score from baseline [ Time Frame: 36 weeks after final initial injection ] [ Designated as safety issue: No ]
    The wrinkle severity is measured by using a wrinkle severity rating scale with 1 being absent and 5 being extreme.
  • Mean change in wrinkle severity score from baseline [ Time Frame: 48 weeks after final initial injection ] [ Designated as safety issue: No ]
    The wrinkle severity is measured by using a wrinkle severity rating scale with 1 being absent and 5 being extreme.
  • Mean change in subject self assessment of wrinkle severity from baseline [ Time Frame: 24 weeks after final initial injection ] [ Designated as safety issue: No ]
    The wrinkle severity is measured by using a wrinkle severity rating scale with 1 being absent and 5 being extreme.
  • Comparison of pain assessment after each injection [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Subject's pain as evaluated by the Numeric pain intensity scale. 0 is no pain and 10 is the worst possible pain. Pain is asssesed at Time 0 (the most severe pain during the Initial Injection and if appropriate Initial Touch-up injection), 15, 30, 45, 60 minutes and 24 hours after each injection session.
Not Provided
Not Provided
 
Emervel Classic Lidocaine Versus Juvederm® Ultra in Treatment of Moderate to Severe Facial Wrinkles and Folds
A Pivotal USA Randomized, Evaluator-blinded, Active-controlled, Multi-center, Split-face Comparison Study of Emervel Classic Lidocaine Versus Juvederm® Ultra in the Treatment of Moderate to Severe Facial Wrinkle Folds

The purpose of this study is to compare the effectiveness and safety of Emervel Classic Lidocaine versus Juvederm® Ultra in the treatment of moderate to severe facial wrinkles and folds.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Skin Wrinkling
  • Device: Emervel Classic Lidocaine
    20 mg/ml + 0.3% lidocaine
  • Device: Juvederm® Ultra
    24mg/ml
  • Experimental: Emervel Classic Lidocaine
    Emervel Classic Lidocaine injected into left nasolabial fold. Juvederm® Ultra injected into right nasolabial fold.
    Intervention: Device: Emervel Classic Lidocaine
  • Active Comparator: Juvederm® Ultra
    Juvederm® Ultra injected into left nasolabial fold. Emervel Classic Lidocaine injected into right nasolabial fold.
    Intervention: Device: Juvederm® Ultra
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
April 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The subject is a male or female 18 years of age or older
  • The subject has bilateral nasolabial folds that, in the opinion of both the Blinded Evaluating Investigator and the Unblinded Injecting Investigator, can be corrected with an injectable dermal implant
  • The subject has the same Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe) for each nasolabial fold

Exclusion Criteria:

  • The subject has active skin disease or inflammation on or near a nasolabial fold that, in the Principal Investigator's opinion, would interfere with the study device injections and/or study assessments.
  • The subject has a history of sensitivity to hyaluronic acid
  • The subject has a history of sensitivity to lidocaine or other amide type anesthetics
  • The subject is, in the Principal Investigator's opinion, at undue risk based on the precautions, warnings and contraindications for local lidocaine anesthetics.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01205048
RD.06.CIP.18156
No
Galderma
Galderma
Not Provided
Study Director: Michael Graeber, M.D. Galderma R&D, Inc.
Principal Investigator: David Bank, M.D. The Center for Dermatology, Cosmetic, & Laser Surgery
Principal Investigator: Frederic Brandt, M.D. Dermatology Research Institute
Principal Investigator: Valerie Callender, M.D. Callender Center for Clinical Research
Principal Investigator: Steven Cohen, M.D. FacesPlus Aesthetic Facility
Principal Investigator: Steven Fagien, M.D.
Principal Investigator: William Hanke, M.D. Laser & Skin Surgery Center in Indiana
Principal Investigator: Michael Jarratt, M.D. Derm Research, PLLC
Principal Investigator: Derek Jones, M.D. Skin Care & Laser Physicians of Beverly Hills
Principal Investigator: Robert Matheson, M.D. Oregon Medical Research PC
Principal Investigator: Gary Monheit, M.D. Total Skin and Beauty Dermatology Center, PC
Principal Investigator: Neil Sadick, M.D. Sadick Research Group
Principal Investigator: Sandra Adsit, M.D. Therapeutics Clinical Research
Galderma
August 2012

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