Chin Augmentation, Chin Retrusion
Conditions
Brief 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.
Interventions
hyaluronic acid
DEVICEJuvederm Voluma XC
hyaluronic acid
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Blinded Evaluators' Live Assessment Using the Galderma Chin Retrusion Scale (GCRS) at Month 3 | Baseline (last non-missing observation prior to the first administration of study product) and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate Based on the Blinded Evaluator's Live Assessment Using the GCRS at Months 6, 9, and 12 | 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. |
Countries
Puerto Rico, United States
Contacts
STUDY_DIRECTORStudy Director
Galderma R&D
Participant flow
Recruitment details
This study was conducted at 12 investigational sites in the United States of America from 22 March 2023 to 10 July 2024.
Pre-assignment details
A total of 175 participants were randomized (2:1) to treatment with Restylane Lyft with Lidocaine and comparator control.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 12.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 115 | 0 / 60 |
| other Total, other adverse events | 12 / 115 | 2 / 59 |
| serious Total, serious adverse events | 2 / 115 | 0 / 59 |
Outcome results
None listed