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This study is designed to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition
A randomized, evaluator-blinded, parallel group, no treatment controlled, multicenter study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition in Canada
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Initial Restylane Lyft Lidocaine injection and one optional touch-up treatment at 1 month after treatment |
|
| No-treatment control group | No Intervention | Optional treatment will be administered at 12 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Lyft Lidocaine | Device | Treatment for Jawline definition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded Evaluator | The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently. | Baseline, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders Having at Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on GJS at Month 6, 9 and 12 as Assessed by Blinded Evaluator | The GJS is a validated 5-point scale for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. Here, higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently. |
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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 | Vancouver | British Columbia | V5Z4E1 | Canada | ||
| Galderma Research Site |
A total of 150 participants were screened, of which 10 were screen failures. A total of 140 participants were enrolled and randomized in the study.
The study was conducted at 9 sites in Canada from 16 February 2023 to 14 June 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Lyft Lidocaine | Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment. |
| FG001 | No-treatment Control Group | Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis was performed on the intent-to-treat (ITT) population. The ITT population included all participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Lyft Lidocaine | Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment. |
| BG001 | No-treatment Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded Evaluator | The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently. | Analysis was performed on ITT population. The ITT population included all participants who were randomized. | Posted | Number | 95% Confidence Interval | percentage of responders | Baseline, Month 3 |
|
From Baseline up to 12 months after last treatment
The Safety population included all participants who were treated with Restylane Lyft Lidocaine or were randomized to the No Treatment group at Baseline.
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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 Lidocaine | Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site nodule | General disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Development | Q-Med AB | 1-817-961-5000 | reception.seupp@galderma.com |
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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 | Oct 21, 2022 | Dec 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 19, 2023 | Dec 20, 2024 | SAP_001.pdf |
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A prospective, randomized, evaluator-blinded, no treatment controlled, parallel group, multicenter phase IV study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for jawline definition.
A parallel study: two or more groups of participants receive different interventions. Trial participants are assigned to one of the treatment arms at the beginning of the trial and remain in that trial arm throughout the length of the trial. A randomized group is usually assigned.
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Investigator blinding will be accomplished by having a Treating Investigator administer the treatments and having a Blinded Evaluator, to whom randomization and treatment are concealed, conduct blinded assessments.
Investigator blinding will be accomplished by having a Treating Investigator administer the treatments and having a Blinded Evaluator, to whom randomization and treatment are concealed, conduct blinded assessments. Safety assessments will be performed by non-blinded personnel.
| Baseline, Months 6, 9 and 12 |
| Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12 | The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the Treating Investigator was reported here. | Baseline, Months 3, 6, 9 and 12 |
| Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12 | The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the participant was reported here. | Baseline, Months 3, 6, 9 and 12 |
| Vancouver |
| British Columbia |
| V6H4E1 |
| Canada |
| Galderma Research Site | Burlington | Ontario | L7N3N2 | Canada |
| Galderma Research Site | London | Ontario | N6H5L5 | Canada |
| Galderma Research Site | Oakville | Ontario | L6J7W5 | Canada |
| Galderma Research Site | Toronto | Ontario | M5R3N8 | Canada |
| Galderma Research Site | Windsor | Ontario | N8W5L7 | Canada |
| Galderma Research Site | Woodbridge | Ontario | L4L8E2 | Canada |
| Galderma Research Site | Westmount | Quebec | H3Z1C3 | Canada |
Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1).
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment. |
| OG001 | No-treatment Control Group | Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1). |
|
|
|
| Secondary | Percentage of Responders Having at Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on GJS at Month 6, 9 and 12 as Assessed by Blinded Evaluator | The GJS is a validated 5-point scale for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. Here, higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently. | Analysis was performed on ITT population. The ITT population included all participants who were randomized. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint. | Posted | Number | 95% Confidence Interval | percentage of responders | Baseline, Months 6, 9 and 12 |
|
|
|
|
| Secondary | Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12 | The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the Treating Investigator was reported here. | Analysis was performed on the ITT population. The ITT population included all randomized participants. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Months 3, 6, 9 and 12 |
|
|
|
|
| Secondary | Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12 | The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the participant was reported here. | Analysis was performed on the ITT population. The ITT population included all randomized participants. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Months 3, 6, 9 and 12 |
|
|
|
|
| 0 |
| 105 |
| 2 |
| 105 |
| 39 |
| 105 |
| EG001 | No-treatment Control Group | Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1). | 0 | 35 | 1 | 35 | 12 | 35 |
| Appendicitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Injection site discomfort | General disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Injection site cyst | General disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Injection site mass | General disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Injection site papule | General disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Device breakage | Product Issues | MedDRA 25.1 | Non-systematic Assessment |
|
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Urogenital prolapse | Reproductive system and breast disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Actinic cheilitis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Postmenopause | Social circumstances | MedDRA 25.1 | Non-systematic Assessment |
|
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| Month 9 |
|
|
| Month 12 |
|
|
Month 9 |
| Fisher's Exact Test. |
| <0.001 |
Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at <0.05. |
| Treatment difference |
| 41.7 |
| 2-Sided |
| 95 |
| 25.6 |
| 57.8 |
Difference confidence interval calculated using normal approximation. |
| Superiority |
| Month 12 | Fisher's Exact Test. | 0.003 | Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at <0.05. | Treatment difference | 30.2 | 2-Sided | 95 | 13.2 | 47.1 | Difference confidence interval calculated using normal approximation. | Superiority |
| Month 6 |
|
|
| Month 9 |
|
|
| Month 12 |
|
|
Month 6 |
| Fisher's Exact Test. |
| <0.001 |
Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at <0.05. |
| Treatment difference |
| 87.6 |
| 2-Sided |
| 95 |
| 76.9 |
| 98.2 |
Difference confidence interval calculated using normal approximation. |
| Superiority |
| Month 9 | Fisher's Exact Test. | <0.001 | Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at <0.05. | Treatment difference | 80.5 | 2-Sided | 95 | 68.6 | 92.4 | Difference confidence interval calculated using normal approximation. | Superiority |
| Month 12 | Fisher's Exact Test. | <0.001 | Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at <0.05. | Treatment difference | 73.7 | 2-Sided | 95 | 61.9 | 85.5 | Difference confidence interval calculated using normal approximation. | Superiority |
| Month 6 |
|
|
| Month 9 |
|
|
| Month 12 |
|
|
Month 6 |
| Fisher's Exact Test. |
| <0.001 |
Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at <0.05. |
| Treatment difference |
| 87.9 |
| 2-Sided |
| 95 |
| 81.4 |
| 94.3 |
Difference confidence interval calculated using normal approximation. |
| Superiority |
| Fisher's Exact Test. | <0.001 | Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at <0.05. | Treatment difference | 80.4 | 2-Sided | 95 | 72.7 | 88.1 | Difference confidence interval calculated using normal approximation. | Superiority |
| Month 12 | Fisher's Exact Test. | <0.001 | Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at <0.05. | Treatment difference | 71.6 | 2-Sided | 95 | 62.8 | 80.3 | Difference confidence interval calculated using normal approximation. | Superiority |