An interventional study of Restylane Lyft with Lidocaine and Juvederm Voluma XC in Chin Augmentation and Chin Retrusion, sponsored by Galderma R&D. Completed at 12 sites in 2 countries. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Galderma R&D · Not applicable, Interventional, and Treatment
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.
Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.
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Exclusion Criteria:
hyaluronic acid dermal filler
Device: Restylane Lyft with Lidocaine
hyaluronic acid dermal filler
Device: Juvederm Voluma XC
hyaluronic acid
hyaluronic acid
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.
Time frame: Baseline (last non-missing observation prior to the first administration of study product) and Month 3
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.
Time frame: At Months 6, 9, and 12
This study was conducted at 12 investigational sites in the United States of America from 22 March 2023 to 10 July 2024.
| Milestone | Restylane Lyft With Lidocaine | Active Comparator: Juvederm Voluma XC |
|---|---|---|
| Started | 115 | 60 |
| Safety population | 115 | 59 |
| Completed | 108 | 53 |
| Not completed | 7 | 7 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Withdrew: Lost to follow-up | 3 | 5 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Other | 0 | 1 |
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.
| score on a scale | Restylane Lyft With Lidocaine | Active Comparator: Juvederm Voluma XC |
|---|---|---|
| Change From Baseline in the Blinded Evaluators' Live Assessment Using the Galderma Chin Retrusion Scale (GCRS) at Month 3 | -0.94 (-1.038 to -0.848) | -1.02 (-1.145 to -0.887) |
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.
| percentage of participants | Restylane Lyft With Lidocaine | Active Comparator: Juvederm Voluma XC |
|---|---|---|
| At Month 6 | 75.5 (66.33 to 83.16) | 80.0 (67.03 to 89.57) |
| At Month 9 | 69.1 (59.57 to 77.55) | 79.2 (65.89 to 89.16) |
| At Month 12 | 69.7 (60.19 to 78.16) | 77.8 (64.40 to 87.96) |
Collected over From Baseline up to 12 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Restylane Lyft With Lidocaine | 0/115 (0%) | 2/115 (1.7%) | 12/115 (10.4%) |
| Active Comparator: Juvederm Voluma XC | 0/60 (0%) | 0/59 (0%) | 2/59 (3.4%) |
| Event | Restylane Lyft With Lidocaine | Active Comparator: Juvederm Voluma XC |
|---|---|---|
| Atrial flutterCardiac disorders | 1/115 | 0/59 |
| Colon cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/115 | 0/59 |
| Event | Restylane Lyft With Lidocaine | Active Comparator: Juvederm Voluma XC |
|---|---|---|
| COVID-19Infections and infestations | 5/115 | 2/59 |
| SinusitisInfections and infestations | 4/115 | 0/59 |
| Implant site bruisingGeneral disorders | 3/115 | 0/59 |
| Age, Continuous(years) | Restylane Lyft With Lidocaine | Active Comparator: Juvederm Voluma XC | Total |
|---|---|---|---|
| Mean | 44.4 ± 12.14 | 47.0 ± 12.97 | 45.3 ± 12.46 |
| Sex: Female, Male(Participants) | Restylane Lyft With Lidocaine | Active Comparator: Juvederm Voluma XC | Total |
|---|---|---|---|
| Female | 104 | 52 | 156 |
| Male | 11 | 8 | 19 |
| Ethnicity (NIH/OMB)(Participants) | Restylane Lyft With Lidocaine | Active Comparator: Juvederm Voluma XC | Total |
|---|---|---|---|
| Hispanic or Latino | 37 | 17 | 54 |
| Not Hispanic or Latino | 78 | 43 | 121 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Galderma R&D