Chin AugmentationNCT05777759
Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile
A study testing Restylane Lyft with Lidocaine and Juvederm Voluma XC in people with Chin Augmentation and Chin Retrusion, run by Galderma R&D at 12 sites in 2 countries.
Trial summary
The primary objective of the study was to demonstrate non-inferiority of Restylane Lyft with Lidocaine versus a comparator-control for augmentation of the chin region to improve the chin profile. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chin Augmentation, Chin Retrusion
- What is being tested?
- Restylane Lyft with Lidocaine and Juvederm Voluma XC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 22 Mar 2023to 10 Jul 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or non-pregnant, non-breastfeeding females, 22 years of age or older
- Intent to receive treatment for augmentation and correction of retrusion in the chin region.
Who cannot join
- Known/previous allergy of hypersensitivity to any injectable hyaluronic acid (HA) gel or gram-positive bacterial proteins.
- Known/previous allergy or hypersensitivity to local anesthetics, e.g., lidocaine or other amide-type anesthetics.
- Previous or present multiple severe allergies or severe allergies, such as manifested by anaphylaxis or angioedema or family history of angioedema.
- Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from the subnasale.
- Any previous aesthetic procedures or implants
- Presence of any disease or lesion near or on the area to be treated.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Galderma Research Site
Alpharetta, Georgia, 30022
Galderma Research Site
Atlanta, Georgia, 30331
Galderma Research Site
Aventura, Florida, 33180
Galderma Research Site
Chestnut Hill, Massachusetts, 02467
Galderma Research Site
Coral Gables, Florida, 33143
Galderma Research Site
Los Angeles, California, 90025
United States, California
Manhattan Beach, California, 90266
Galderma Research Site
Nashville, Tennessee, 37203
Galderma Research Site
Pflugerville, Texas, 78660
Galderma Research Site
Rockville, Maryland, 20852
Galderma Research Site
Westport, Connecticut, 06880
About this study
Official title: A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile
The primary objective of the study was to demonstrate non-inferiority of Restylane Lyft with Lidocaine versus a comparator-control for augmentation of the chin region to improve the chin profile.
- Conditions
- Chin Augmentation, Chin Retrusion
- Being tested
- Restylane Lyft with Lidocaine, Juvederm Voluma XC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane Lyft with LidocaineDevice
hyaluronic acid
Juvederm Voluma XCDevice
hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| New Dermal Filler for indication: Restylane Lyft with Lidocaine | Experimental | hyaluronic acid dermal filler Receives: Device: Restylane Lyft with Lidocaine |
| Active Comparator: FDA approved Dermal Filler: Juvederm Voluma XC | Active comparator | hyaluronic acid dermal filler Receives: Device: Juvederm Voluma XC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Blinded Evaluators' Live Assessment Using the Galderma Chin Retrusion Scale (GCRS) at Month 3
GCRS is a validated 4-grade scale to assess the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Higher scores indicated more severity. Least squares (LS) mean, and 95 percent (%) confidence interval (CI) were obtained from a general linear mixed random intercept model with treatment group and baseline Galderma Chin Retrusion Scale score as fixed factors.
Measured: Baseline (last non-missing observation prior to the first administration of study product) and Month 3
Secondary outcomes (1)
Responder Rate Based on the Blinded Evaluator's Live Assessment Using the GCRS at Months 6, 9, and 12
GCRS is a validated 4-grade scale to assess the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Higher scores indicated more severity. Responder rate was defined as percentage of participants with an improvement of at least one grade on the GCRS from baseline. 95% CI was calculated using Clopper-Pearson method.
Measured: At Months 6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start22 Mar 2023
- Primary completion11 Nov 2023
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chin AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777759
- Sponsor's protocol ID
- 43USCH2208
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2023
- Last updated
- 28 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No