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

NCT01205048 | Completed Results

• 1 other identifier: RD.06.CIP.18156
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Skin Wrinkling

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection

  WSRS is a validated 5-point reference scale with photographs that classifies facial wrinkles (nasolabial folds). WSRS represents clinically meaningful change in NLF severity from the adjacent grades where 1= absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 millimeter (mm) visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.

  Baseline, Week 24 after final initial injection

Secondary Outcomes (8)

• Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 3 After the Final Initial Injection

  Baseline, Week 3 after final initial injection

• Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 12 After Final Initial Injection

  Baseline, Week 12 after final initial injection

• Mean Change From Baseline in Wrinkle Severity Scale (WSRS) at Week 36 After Final Initial Injection

  Baseline, Week 36 after final initial injection

• Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 48 After Final Initial Injection

  Baseline, Week 48 after final initial injection

• Mean Change From Baseline in Participant Self-Assessment of Wrinkle Severity at Week 24 After Final Initial Injection

  Baseline, Week 24 after final initial injection

Study Arms (2)

Emervel Classic Lidocaine

EXPERIMENTAL

NLFs (Nasolabial Folds) were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine).

Device: Emervel Classic Lidocaine

Juvederm® Ultra

ACTIVE COMPARATOR

NLFs were injected with Juvéderm Ultra (24 mg/mL).

Device: Juvederm® Ultra

Interventions

Emervel Classic Lidocaine DEVICE

20 mg/mL + 0.3% lidocaine

Emervel Classic Lidocaine

Juvederm® Ultra DEVICE

24mg/mL

Juvederm® Ultra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (12)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 35202, United States

Location

Skin Care & Laser Physicians of Beverly Hills

Los Angeles, California, 90069, United States

Location

FacesPlus Aesthetic Facility

San Diego, California, 92122, United States

Location

Therapeutics Research

San Diego, California, 92123, United States

Location

Steven Fagien

Boca Raton, Florida, 33431, United States

Location

Dermatology Research Institute

Coral Gables, Florida, 33146, United States

Location

Laser & Skin Surgery Center in Indiana

Carmel, Indiana, 46032, United States

Location

Callender Center for Clinical Research

Glendale, Maryland, 20769, United States

Location

The Center for Dermatology, Cosmetic & Laser Surgery

Mount Kisco, New York, 10549, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Oregon Medical Research PC

Portland, Oregon, 97223, United States

Location

DermResearch

Austin, Texas, 78759, United States

Location

Results Point of Contact

• Title: Clinical Scientist
• Organization: Galderma

reception.seupp@galderma.com

+46184749000

Study Officials

• Clinical Operations

  Galderma R&D

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 20, 2010
• Study Start: September 1, 2010
• Primary Completion: June 27, 2011
• Study Completion: January 19, 2012
• Last Updated: July 25, 2023
• Results First Posted: July 25, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)