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
  Purpose

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.


Condition Intervention Phase
Skin Wrinkling
Device: Emervel Classic Lidocaine
Device: Juvederm® Ultra
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 171
Study Start Date: September 2010
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Emervel Classic Lidocaine
Emervel Classic Lidocaine injected into left nasolabial fold. Juvederm® Ultra injected into right nasolabial fold.
Device: Emervel Classic Lidocaine
20 mg/ml + 0.3% lidocaine
Active Comparator: Juvederm® Ultra
Juvederm® Ultra injected into left nasolabial fold. Emervel Classic Lidocaine injected into right nasolabial fold.
Device: Juvederm® Ultra
24mg/ml

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01205048

Locations
United States, Alabama
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35202
United States, California
Skin Care & Laser Physicians of Beverly Hills
Los Angeles, California, United States, 90069
FacesPlus Aesthetic Facility
San Diego, California, United States, 92122
Therapeutics Research
San Diego, California, United States, 92123
United States, Florida
Steven Fagien
Boca Raton, Florida, United States, 33431
Dermatology Research Institute
Coral Gables, Florida, United States, 33146
United States, Indiana
Laser & Skin Surgery Center in Indiana
Carmel, Indiana, United States, 46032
United States, Maryland
Callender Center for Clinical Research
Glendale, Maryland, United States, 20769
United States, New York
The Center for Dermatology, Cosmetic & Laser Surgery
Mt. Kisco, New York, United States, 10549
Sadick Research Group
New York, New York, United States, 10075
United States, Oregon
Oregon Medical Research PC
Portland, Oregon, United States, 97223
United States, Texas
DermResearch
Austin, Texas, United States, 78759
Sponsors and Collaborators
Galderma
Investigators
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
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01205048     History of Changes
Other Study ID Numbers: RD.06.CIP.18156
Study First Received: September 16, 2010
Last Updated: August 28, 2012
Health Authority: United States: Food and Drug Administration

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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014