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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Dermal Filler for indication: Restylane Lyft with Lidocaine | Experimental | hyaluronic acid dermal filler |
|
| Active Comparator: FDA approved Dermal Filler: Juvederm Voluma XC | Active Comparator | hyaluronic acid dermal filler |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Lyft with Lidocaine | Device | hyaluronic acid |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (last non-missing observation prior to the first administration of study product) and Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research Site | Los Angeles | California | 90025 | United States | ||
| United States, California |
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A total of 175 participants were randomized (2:1) to treatment with Restylane Lyft with Lidocaine and comparator control.
This study was conducted at 12 investigational sites in the United States of America from 22 March 2023 to 10 July 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Lyft With Lidocaine | Participants received supraperiosteal or subcutaneous injections of Restylane Lyft with Lidocaine, up to a maximum volume of 4.0 milliliter (mL), administered using needles or cannulas in the chin area on Day 1. An optional touch-up treatment was permitted 1 month after the initial treatment. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2023 | Apr 30, 2026 |
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| Juvederm Voluma XC | Device | hyaluronic acid |
|
| At Months 6, 9, and 12 |
| Manhattan Beach |
| California |
| 90266 |
| United States |
| Galderma Research Site | Westport | Connecticut | 06880 | United States |
| Galderma Research Site | Aventura | Florida | 33180 | United States |
| Galderma Research Site | Coral Gables | Florida | 33143 | United States |
| Galderma Research Site | Alpharetta | Georgia | 30022 | United States |
| Galderma Research Site | Atlanta | Georgia | 30331 | United States |
| Galderma Research Site | Rockville | Maryland | 20852 | United States |
| Galderma Research Site | Chestnut Hill | Massachusetts | 02467 | United States |
| Galderma Research Site | Nashville | Tennessee | 37203 | United States |
| Galderma Research Site | Pflugerville | Texas | 78660 | United States |
| Galderma Research Site | San Juan | 00917 | Puerto Rico |
| Active Comparator: Juvederm Voluma XC |
Participants received supraperiosteal or subcutaneous injections of Juvederm Voluma XC, up to a maximum volume of 4.0 mL, administered using needles or cannulas in the chin area on Day 1. An optional touch-up treatment was permitted 1 month after the initial treatment. |
| Safety Population | The safety population included all participants who were treated with Restylane Lyft with Lidocaine or comparator control and were analyzed according to the actual treatment received. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Lyft With Lidocaine | Participants received subcutaneous injections of Restylane Lyft with Lidocaine, up to a maximum volume of 4.0 mL, administered using needles or cannulas in the chin area on Day 1. An optional touch-up treatment was permitted 1 month after the initial treatment. |
| BG001 | Active Comparator: Juvederm Voluma XC | Participants received subcutaneous injections of Juvederm Voluma XC in the chin area on Day 1, up to a maximum volume of 4.0 mL, administered using needles or cannulas. An optional touch-up treatment was permitted 1 month after the initial treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | The intention-to-treat (ITT) population included all participants who were randomized and were analyzed according to the randomization scheme. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline (last non-missing observation prior to the first administration of study product) and Month 3 |
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| Secondary | 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. | ITT population included all participants who were randomized and were analyzed according to the randomization scheme. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants who were evaluable for specified timepoints. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 6, 9, and 12 |
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From Baseline up to 12 months
The safety population included all participants who were treated with Restylane Lyft with Lidocaine or comparator control and were analyzed according to the actual treatment received. ITT population was used for all-cause mortality. ITT population included all participants who were randomized and were analyzed according to the randomization scheme.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Restylane Lyft With Lidocaine | Participants received subcutaneous injections of Restylane Lyft with Lidocaine, up to a maximum volume of 4.0 mL, administered using needles or cannulas in the chin area on Day 1. An optional touch-up treatment was permitted 1 month after the initial treatment. | 0 | 115 | 2 | 115 | 12 | 115 |
| EG001 | Active Comparator: Juvederm Voluma XC | Participants received subcutaneous injections of Juvederm Voluma XC in the chin area on Day 1, up to a maximum volume of 4.0 mL, administered using needles or cannulas. An optional touch-up treatment was permitted 1 month after the initial treatment. | 0 | 60 | 0 | 59 | 2 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA (25.1) | Non-systematic Assessment |
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| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA (25.1) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (25.1) | Non-systematic Assessment |
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| Implant site bruising | General disorders | MedDRA (25.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galderma Clinical Project Manager | Galderma | +1 817-961-5000 | Clinical.Studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 29, 2024 | Apr 30, 2026 | SAP_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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