Emervel Classic Lidocaine Versus Juvederm® Ultra in Treatment of Moderate to Severe Facial Wrinkles and Folds
This study has been completed.
Sponsor:
Galderma
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01205048
First received: September 16, 2010
Last updated: August 28, 2012
Last verified: August 2012
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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 (Adult, Senior) |
| 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
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
| 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 Hyaluronic Acid Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents |
Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adjuvants, Immunologic Immunologic Factors Viscosupplements Protective Agents |
ClinicalTrials.gov processed this record on September 23, 2016