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The purpose of the study is to investigate the degree of improvement in appearance after treatment with different hyaluronic acid (HA) fillers. Product selection is based on Investigator assessment of participant tissue coverage and main treatment goal (volumizing, lifting or contouring).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Volyme | Experimental | According to the treatment algorithm, treated with Restylane Volyme |
|
| Restylane Defyne | Experimental | According to the treatment algorithm, treated with Restylane Defyne |
|
| Restylane Lyft Lidocaine | Experimental | According to the treatment algorithm, treated with Restylane Lyft Lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Volyme | Device | Hyaluronic based filler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Aesthetic Improvement of Midface | A blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Improved Midface Volume | A blinded evaluator assessed the fullness of the midface by using a 4-graded scale where 1= fairly full and 4= substantial loss of fullness. Improved midface volume was defined as at least a 1-grade decrease from baseline. | 8 weeks |
| Percentage of Participants Assessed as Having Natural Treatment Results |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Q-Med AB | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research Site | Munich | 80636 | Germany | |||
| Galderma Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Volyme | According to the treatment algorithm, treated with Restylane Volyme Restylane Volyme: Hyaluronic based filler |
| FG001 | Restylane Defyne | According to the treatment algorithm, treated with Restylane Defyne Restylane Defyne: Hyaluronic based filler |
| FG002 | Restylane Lyft Lidocaine | According to the treatment algorithm, treated with Restylane Lyft Lidocaine Restylane Lyft Lidocaine: Hyaluronic based filler |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Volyme | According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency. Restylane Volyme: Hyaluronic based filler |
| BG001 | Restylane Defyne |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Participants With Aesthetic Improvement of Midface | A blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved. | Posted | Number | 95% Confidence Interval | percentage of participants | 8 weeks |
|
24-27 weeks (depending on how long screening period), from signature of informed consent to last study visit.
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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 Volyme | According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency. Restylane Volyme: Hyaluronic based filler |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA (21.0) | Systematic Assessment | Not related to study product or injection procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Q-Med AB | +4618 474 9000 | 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2018 | Mar 10, 2020 | Prot_SAP_000.pdf |
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| Restylane Defyne |
| Device |
Hyaluronic based filler |
|
| Restylane Lyft Lidocaine | Device | Hyaluronic based filler |
|
Blinded evaluator assessed participants by answering Strongly agree/Agree/Neither agree nor disagree/Disagree/Strongly disagree to the question "Are the subject's treatment results natural looking?". Having natural treatment results is defined as being assessed with answers Strongly agree or Agree. |
| 8 weeks |
| Palermo |
| 90141 |
| Italy |
| Galderma Research Site | Edinburgh | EH10 4BE | United Kingdom |
According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.
Restylane Defyne: Hyaluronic based filler
| BG002 | Restylane Lyft Lidocaine | According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring. Restylane Lyft Lidocaine: Hyaluronic based filler |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Restylane Lyft Lidocaine | According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring. Restylane Lyft Lidocaine: Hyaluronic based filler |
|
|
| Secondary | Percentage of Participants With Improved Midface Volume | A blinded evaluator assessed the fullness of the midface by using a 4-graded scale where 1= fairly full and 4= substantial loss of fullness. Improved midface volume was defined as at least a 1-grade decrease from baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | 8 weeks |
|
|
|
| Secondary | Percentage of Participants Assessed as Having Natural Treatment Results | Blinded evaluator assessed participants by answering Strongly agree/Agree/Neither agree nor disagree/Disagree/Strongly disagree to the question "Are the subject's treatment results natural looking?". Having natural treatment results is defined as being assessed with answers Strongly agree or Agree. | Posted | Number | percentage of participants | 8 weeks |
|
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| 0 |
| 31 |
| 0 |
| 31 |
| 3 |
| 31 |
| EG001 | Restylane Defyne | According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring. Restylane Defyne: Hyaluronic based filler | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Restylane Lyft Lidocaine | According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring. Restylane Lyft Lidocaine: Hyaluronic based filler | 0 | 34 | 0 | 34 | 0 | 34 |
|
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