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This is a multi-center, open-label, single-arm study to evaluate an injection tool with Restylane Lyft with Lidocaine for cheek augmentation and correction of age related midface contour deficiencies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Lyft with Lidocaine | Device | a sterile gel of hyaluronic acid (HA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events [Safety] | To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Aesthetic Improvement | To assess effectiveness using the Global Aesthetic Improvement Scale (GAIS). Responders defined as "Improved" or better on the GAIS as assessed by the investigator and participant at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16). | 16 weeks |
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Primary Inclusion Criteria:
Primary Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facial Plastic and Cosmetic Surgery | Beverly Hills | California | 90210 | United States | ||
| Skin Care and Laser Physicians of Beverly Hills |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31490308 | Derived | Jones DH, Hessler J, Chapas A, Jonas B, Crider J, Chopra R. Microcannula Injection of Large Gel Particle Hyaluronic Acid for Cheek Augmentation and the Correction of Age-Related Midface Contour Deficiencies. Dermatol Surg. 2020 Apr;46(4):465-472. doi: 10.1097/DSS.0000000000002105. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA) |
| 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 | Number of Participants With Treatment-Emergent Adverse Events [Safety] | To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula. | Posted | Count of Participants | Participants | 16 weeks |
|
|
16 weeks
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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 | Treatment | Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Reception | Q-Med AB | +46184749000 | 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 | Apr 10, 2017 | Apr 25, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2017 | Apr 25, 2019 | SAP_001.pdf |
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| Number of Participants That Responded to Treatment | To assess effectiveness using the 4-point Midface Volume Scale. Responder defined as at least a one point improvement from the baseline score at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16). | 16 weeks |
| Subject Satisfaction | To assess subject satisfaction with the treatment using the FACE-Q. Score range 1-100. The higher total score indicate greater subject satisfaction. | 8 weeks |
| Los Angeles |
| California |
| 90069 |
| United States |
| Hessler Plastic Surgery | Palo Alto | California | 94306 | United States |
| Union Square Laser Dermatology | New York | New York | 10003 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Participants With Aesthetic Improvement | To assess effectiveness using the Global Aesthetic Improvement Scale (GAIS). Responders defined as "Improved" or better on the GAIS as assessed by the investigator and participant at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16). | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | Number of Participants That Responded to Treatment | To assess effectiveness using the 4-point Midface Volume Scale. Responder defined as at least a one point improvement from the baseline score at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16). | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | Subject Satisfaction | To assess subject satisfaction with the treatment using the FACE-Q. Score range 1-100. The higher total score indicate greater subject satisfaction. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 5 |
| 60 |
| Influenza | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
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