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Dermal Filler
Restylane Lyft Lidocaine for Jawline Definition
N/A
Waitlist Available
Research Sponsored by Galderma R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9, and 12 months
Awards & highlights
Study Summary
This trial tests how safe and effective Restylane Lyft Lidocaine is for improving jawline definition.
Who is the study for?
This trial is for adults with moderate to very severe jawline definition who consent to use their facial images. They must not have had recent facial treatments, be pregnant or breastfeeding, and should not plan pregnancy during the study. Excluded are those allergic to hyaluronic acid or lidocaine, with a history of certain medical conditions or treatments in the area.Check my eligibility
What is being tested?
The trial tests Restylane Lyft Lidocaine's effectiveness in enhancing jawline definition. Participants will receive this filler treatment and be monitored for results. The study ensures no other aesthetic procedures are done concurrently that could affect outcomes.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site like redness, swelling, pain, bruising; allergy symptoms due to hyaluronic acid or lidocaine; and less commonly infection or nodules.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 9, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 9, and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness of Restylane Lyft Lidocaine versus a no treatment control in jawline definition as measured by the Galderma Jawline Scale
Secondary outcome measures
Effectiveness of Restylane Lyft Lidocaine on the Galderma Jawline Scale
Evaluate the effectiveness of Restylane Lyft Lidocaine on Subject Satisfaction Questionnaire (SSQ)
Evaluate the effectiveness of Restylane Lyft Lidocaine on the Global Aesthetic Improvement Scale (GAIS)
Side effects data
From 2014 Phase 4 trial • 40 Patients • NCT0160269240%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment groupExperimental Treatment1 Intervention
Initial Restylane Lyft Lidocaine injection and one optional touch-up treatment at 1 month after treatment
Group II: No-treatment control groupActive Control1 Intervention
Optional treatment will be administered at 12 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Restylane Lyft Lidocaine
2021
N/A
~580
Find a Location
Who is running the clinical trial?
Galderma R&DLead Sponsor
298 Previous Clinical Trials
60,190 Total Patients Enrolled
Study DirectorStudy DirectorGalderma R&D
1,207 Previous Clinical Trials
489,540 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to follow the study rules and have signed the consent form.I am allergic to hyaluronic acid fillers, lidocaine, or similar anesthetics.My joint stiffness is moderate to very severe.I have a bleeding disorder or am taking medication to prevent blood clots.I am not pregnant, breastfeeding, and I use effective birth control.I agree not to have any cosmetic procedures on my face, neck, or chin.I haven't had facial treatments near the treatment area in the last 6 months.I have a disease or lesions near the area that needs treatment.I have had surgery in the area being considered for treatment.I am a woman who can have children and my pregnancy test before treatment was negative.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment group
- Group 2: No-treatment control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How extensively is this research effort being implemented across the city?
"At this current time, 8 sites are taking in patients for the trial. These locations - Burlington, London, Oakville and 5 others - can be accessed to reduce travel burdens if one decides to join the study."
Answered by AI
Has recruitment for this experiment commenced?
"This research study is still open to participant recruitment. The trial was initially announced on February 16th 2023 and the details have been most recently revised as of April 4th, 2023 according to information available from clinicaltrials.gov."
Answered by AI
How many participants are currently being observed in this research endeavor?
"Affirmative. Clinicaltrials.gov displays that this research trial, first published on February 16th 2023, is currently recruiting participants. The total number of enrollees required is 140 people from 8 different locations."
Answered by AI
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