N/A
N=170
Emervel Classic Lidocaine Versus Juvederm® Ultra in Treatment of Moderate to Severe Facial Wrinkles and Folds
Skin Wrinkling
Bottom Line
View on ClinicalTrials.gov: NCT01205048 ↗Enrolled (actual)
170
Serious AEs
1.2%
Results posted
Jul 2023
Primary outcome: Primary: Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection — -1.1; -1.2 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Emervel Classic Lidocaine (Device); Juvederm® Ultra (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection |
-1.1; -1.2 | — |
| SECONDARY Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 3 After the Final Initial Injection |
-1.7; -1.8 | — |
| SECONDARY Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 12 After Final Initial Injection |
-1.5; -1.5 | — |
| SECONDARY Mean Change From Baseline in Wrinkle Severity Scale (WSRS) at Week 36 After Final Initial Injection |
-1.0; -1.1 | — |
| SECONDARY Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 48 After Final Initial Injection |
-0.7; -0.9 | — |
| SECONDARY Mean Change From Baseline in Participant Self-Assessment of Wrinkle Severity at Week 24 After Final Initial Injection |
-1.3; -1.4 | — |
| SECONDARY Participant Pain Assessment After the Initial Injection |
2.9; 5.6; 0.5; 2.1; 0.2; 1.1 | — |
| SECONDARY Participant Pain Assessment After the Initial Touch-up Injection |
2.3; 4.4; 0.3; 1.4; 0.2; 0.6 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
66; 64 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01205048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.