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This is a randomized, split face, multicenter study to evaluate the efficacy and safety of Restylane Defyne compared to Restylane in correction of NLFs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Defyne | Experimental | Single injection and optional touch up injection with Restylane Defyne in NLF |
|
| Restylane | Active Comparator | Single injection and optional touch up injection with Restylane in NLF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Defyne | Device | Intradermal injection |
| |
| Restylane |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS. | The Wrinkle Severity Rating Scale (WSRS) is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Grade 1 Absent: No visible fold; continuous skin line Grade 2 Mild: Shallow but visible fold with a slight indentation; minor facial feature Implant is expected to produce a slight improvement in appearance Grade 3 Moderate: Moderately deep folds; clear facial feature visible at normal appearance but not when stretched. Excellent correction is expected from injectable implant Grade 4 Severe: Very long and deep fold; prominent facial feature; less than 2-mm visible fold when stretched Significant improvement is expected from injectable implant Grade 5 Extreme: Extremely deep and long fold; detrimental to facial appearance; 2- to 4-mm V-shaped fold when stretched. Unlikely to have satisfactory correction with injectable implant alone | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Med AB | Shanghai | China |
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Each subject have 2 NLFs, the right/left one. According to protocol that Each subject will be randomized to one of two treatment sequences; either Restylane Defyne in the right NLF followed by Restylane in the left NLF, or Restylane in the right NLF followed by Restylane Defyne in the left NLF. Arms/Groups are combined because right/left side is not statistical factors.
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF | Restylane Defyne treated in the right NLF followed by Restylane in the left NLF |
| FG001 | Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF | Restylane treated in the right NLF followed by Restylane Defyne in the left NLF |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Each subject will be randomized to one of two treatment sequences; either Restylane Defyne in the subject's right NLF followed by Restylane in the subject's left NLF, or Restylane in the subject's right NLF followed by Restylane Defyne in the subject's left NLF.
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF | Restylane Defyne treated in the right NLF followed by Restylane in the left NLF |
| BG001 | Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF |
| 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 Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS. | The Wrinkle Severity Rating Scale (WSRS) is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Grade 1 Absent: No visible fold; continuous skin line Grade 2 Mild: Shallow but visible fold with a slight indentation; minor facial feature Implant is expected to produce a slight improvement in appearance Grade 3 Moderate: Moderately deep folds; clear facial feature visible at normal appearance but not when stretched. Excellent correction is expected from injectable implant Grade 4 Severe: Very long and deep fold; prominent facial feature; less than 2-mm visible fold when stretched Significant improvement is expected from injectable implant Grade 5 Extreme: Extremely deep and long fold; detrimental to facial appearance; 2- to 4-mm V-shaped fold when stretched. Unlikely to have satisfactory correction with injectable implant alone | Posted | Number | 95% Confidence Interval | percentage of subjects | 6 month |
|
1 year.
According to the subject's treatment randomization.Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be: "Since your last clinical visit have you had any health problems?", and or obtained from signs and symptoms from examination, lab test, self observations, diary or spontaneous reports from subject. Since each subject will receive Restylane and Restylane Defyne, then AE was collected per subject, not per intervention.
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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 Defyne | Since all participants received both Restylane and Restylane Defyne treatments, the appropriate way to present Adverse Events to include two Arms eflecting all participants who received each intervention during the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment* | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Development | Q-Med AB | + 46 (0) 18 474 90 00 | 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 | Jul 5, 2017 | Jun 1, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 13, 2017 | Jun 1, 2023 | SAP_003.pdf |
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| Device |
Intradermal injection |
|
Restylane treated in the right NLF followed by Restylane Defyne in the left NLF
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF |
Restylane Defyne treated in the right NLF followed by Restylane in the left NLF |
| OG001 | Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF | Restylane treated in the right NLF followed by Restylane Defyne in the left NLF |
|
|
| 0 |
| 175 |
| 3 |
| 175 |
| 0 |
| 175 |
| EG001 | Restylane | Since all participants received both Restylane and Restylane Defyne treatments, the appropriate way to present Adverse Events to include two Arms eflecting all participants who received each intervention during the study. | 0 | 175 | 3 | 175 | 0 | 175 |
| Traumatic arthritis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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