N/A
N=140
Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition
Jawline Definition
Bottom Line
View on ClinicalTrials.gov: NCT05622812 ↗Enrolled (actual)
140
Serious AEs
2.1%
Results posted
Mar 2025
Primary outcome: Primary: Percentage of Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded Evaluator — 67.6; 28.6 percentage of responders — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane Lyft Lidocaine (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded Evaluator |
67.6; 28.6 | <0.001 sig |
| SECONDARY Percentage of Responders Having at Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on GJS at Month 6, 9 and 12 as Assessed by Blinded Evaluator |
62.2; 21.9; 57.8; 16.1; 49.5; 19.4 | <0.001 sig |
| SECONDARY Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12 |
99.0; 0.0; 97.0; 9.4; 90.2; 9.7 | <0.001 sig |
| SECONDARY Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12 |
93.1; 0.0; 87.9; 0.0; 80.4; 0.0 | <0.001 sig |
Summary
This study is designed to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition
Eligibility Criteria
Inclusion Criteria
- Male and female adults willing to comply with the requirements of the study and providing a signed written informed consent
- Consent the use of facial images for marketing purposes and educational material
- Subject with moderate to very severe (Grade 2 to 4) on the GJS
- Subject is willing to abstain from any other facial, submental, and/or neck aesthetic procedure(s) or implant
- Female of childbearing potential with a negative urine pregnancy test before treatment
Exclusion Criteria
- Subjects presenting with known/previous allergy or hypersensitivity to hyaluronic acid (HA) filler, lidocaine or other amide-type local anesthetics
- Subjects presenting with known/previous allergy or hypersensitivity to streptococcal proteins
- Subject with bleeding disorders or taking thrombolytics or anticoagulants
- Prior surgical procedure in the treatment area
- History of other facial treatment/procedure in the previous 6 months HA in or near the intended treatment site
- Presence of any disease or lesions near or on the area to be treated
- Presence of any condition, in the opinion of the Treating Investigator, makes the subject unable to complete the study per protocol
- Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period
- Study site personnel, close relatives of the study site personnel, employees, or close relatives of employees at the Sponsor Company
- Participation in any other interventional clinical study within 30 days before treatment
Data sourced from ClinicalTrials.gov (NCT05622812). 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.