N/A
Completed N=162
Emervel® Deep Lidocaine vs. Juvederm® Ultra Plus in Treatment of Moderate to Severe Facial Wrinkles and Folds
Skin Wrinkling
Source: ClinicalTrials.gov NCT01205061 ↗
Enrolled (actual)
162
Serious AEs
4.3%
Results posted
Oct 2023
Primary outcomePrimary: Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection — -1.1; -1.1 Score on a scale
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.
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; -1.1 | — |
| SECONDARY Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 3 After Final Initial Injection |
-1.6; -1.6 | — |
| SECONDARY Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 12 After Final Initial Injection |
-1.3; -1.3 | — |
| SECONDARY Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 36 After Final Initial Injection |
-1.1; -1.1 | — |
| SECONDARY Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 48 After Final Initial Injection |
-0.8; -0.9 | — |
| SECONDARY Mean Change From Baseline in Participant Self-Assessment of Wrinkle Severity at Week 24 After Final Initial Injection |
-1.2; -1.3 | — |
| SECONDARY Participant Pain Assessment After the Initial Injection |
3.1; 5.3; 0.5; 1.8; 0.2; 1.0 | — |
| SECONDARY Participant Pain Assessment After the Initial Touch-up Injection |
3.3; 4.8; 0.7; 1.2; 0.3; 0.5 | — |
| SECONDARY Number of Participants With Adverse Event (AEs) |
66; 67 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01205061). 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. Informational only — not medical advice.