Emervel Deep Lidocaine vs. Juvederm® Ultra Plus 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:
NCT01205061
First received: September 16, 2010
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Skin Wrinkling
Device: Emervel Deep Lidocaine
Device: Juvederm® Ultra Plus
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 Wrinkles and 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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: 24 weeks after final initial injection ] [ Designated as safety issue: No ]
    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: 162
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 Deep Lidocaine
Emervel Deep Lidocaine injected into left nasolabial fold. Juvederm® Ultra Plus injected into right nasolabial fold.
Device: Emervel Deep Lidocaine
20 mg/ml + 0.3% lidocaine
Active Comparator: Juvederm® Ultra Plus
Juvederm® Ultra Plus injected into left nasolabial fold. Emervel Deep Lidocaine injected into the right nasolabial fold.
Device: Juvederm® Ultra Plus
24 mg/ml

Detailed Description:

This is a 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 wrinkles and folds. Two physicians, an Unblinded Injecting Investigator and a Blinded Evaluating Investigator, are required at each study center. The Unblinded Injecting Investigator must be different from the Blinded Evaluating Investigator.

  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: NCT01205061

Locations
United States, California
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California, United States, 90036
The Maas Clinic
San Francisco, California, United States, 94115
United States, Connecticut
The Savin Center
New Haven, Connecticut, United States, 06511
United States, Florida
Baumann Cosmetic and Research Institute
Miami Beach, Florida, United States, 33140
United States, Georgia
Gwinnett Research Center
Snellville, Georgia, United States, 30078
United States, Maryland
Maryland Laser, Skin, & Vein Institute, LLC
Hunt Valley, Maryland, United States, 21030
United States, Michigan
Grekin Skin Care
Warren, Michigan, United States, 48088
United States, New York
Dermatology Surgery & Laser Center
White Plains, New York, United States, 10604
United States, North Carolina
Dermatology, Laser, & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States, 28207
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
Research Across America
Plano, Texas, United States, 75093
Sponsors and Collaborators
Galderma
Investigators
Study Director: Michael Graeber, M.D. Galderma R&D, Inc.
Principal Investigator: Jeffrey Adelglass, M.D. Research Across America
Principal Investigator: Leslie Baumann, M.D. Baumann Cosmetic and Research Institute
Principal Investigator: Lisa Donofrio, M.D. The Savin Center, PC
Principal Investigator: Michael Gold, M.D. Tennessee Clinical Research Center
Principal Investigator: Steven Grekin, D.O. Grekin Skin Care
Principal Investigator: Pearl Grimes, M.D. Vitiligo & Pigmentation Institute of Southern California
Principal Investigator: Corey Maas, M.D. The Maas Clinic
Principal Investigator: Girish Munavalli, M.D. Dermatology, Laser & Vein Specialists of the Carolinas
Principal Investigator: Rhoda Narins, M.D. Dermatology Surgery & Laser Center
Principal Investigator: Jonathan Weiss, M.D. Gwinnett Research Center
Principal Investigator: Robert Weiss, M.D. Maryland Laser, Skin, & Vein Institute, LLC
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01205061     History of Changes
Other Study ID Numbers: RD.06.CIP.18159
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
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 23, 2014