Emervel® Deep Lidocaine vs. Juvederm® Ultra Plus in Treatment of Moderate to Severe Facial Wrinkles and Folds

NCT01205061 | Completed Results FDA Device

• 1 other identifier: RD.06.CIP.18159
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of the study was 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.

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 deep 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 (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)

Secondary Outcomes (8)

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

  Baseline, Week 3 after final initial injection (Week 3 for participants without touch-up injection, Week 6 for participants with touch-up injection at Week 3)

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

  Baseline, Week 12 after final initial injection (Week 12 for participants without touch-up injection, Week 15 for participants with touch-up injection at Week 3)

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

  Baseline, Week 36 after final initial injection (Week 36 for participants without touch-up injection, Week 39 for participants with touch-up injection at Week 3)

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

  Baseline, Week 48 after final initial injection (Week 48 for participants without touch-up injection, Week 51 for participants with touch-up injection at Week 3)

• 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 (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)

Study Arms (2)

Emervel Deep Lidocaine

EXPERIMENTAL

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

Device: Emervel Deep Lidocaine

Juvederm Ultra Plus

ACTIVE COMPARATOR

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

Device: Juvederm Ultra Plus

Interventions

Emervel Deep Lidocaine DEVICE

20 mg/mL + 0.3% lidocaine

Emervel Deep Lidocaine

Juvederm Ultra Plus DEVICE

24mg/mL

Juvederm Ultra Plus

Eligibility Criteria

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

You may qualify if:

• The subject was a male or female 18 years of age or older
• The subject had bilateral nasolabial folds that, in the opinion of both the blinded evaluating investigator and the unblinded injecting investigator, was corrected with an injectable dermal implant
• The subject had 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 had 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 had a history of sensitivity to hyaluronic acid
• The subject had a history of sensitivity to lidocaine or other amide type anesthetics
• The subject was, 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 (11)

Galderma research site

Los Angeles, California, 90036, United States

Location

Galderma research site

San Francisco, California, 94115, United States

Location

Galderma research site

New Haven, Connecticut, 06511, United States

Location

Galderma research site

Miami Beach, Florida, 33140, United States

Location

Galderma research site

Snellville, Georgia, 30078, United States

Location

Galderma research site

Hunt Valley, Maryland, 21030, United States

Location

Galderma research site

Warren, Michigan, 48088, United States

Location

Galderma research site

White Plains, New York, 10604, United States

Location

Galderma research site

Charlotte, North Carolina, 28207, United States

Location

Galderma research site

Nashville, Tennessee, 37215, United States

Location

Galderma research site

Plano, Texas, 75093, United States

Location

Results Point of Contact

• Title: Clinical Scientist
• Organization: Galderma

reception.seupp@galderma.com

+46184749000

Study Officials

• Clinical Operations, M.D.

  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 27, 2010
• Primary Completion: June 20, 2011
• Study Completion: January 12, 2012
• Last Updated: October 23, 2023
• Results First Posted: October 23, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)