Chin Retrusion, Chin Augmentation
Conditions
Brief summary
To demonstrate the effectiveness of Restylane Defyne for chin augmentation and correction of chin retrusion by demonstrating the superiority in responder rates relative to no treatment.
Detailed description
This was a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane Defyne in the chin for augmentation and correction of chin retrusion. This study was designed to enroll and randomize approximately 140 subjects in a 3:1 ratio of treatment to Restylane Defyne or no-treatment-control, including at least 21 subjects of Fitzpatrick skin type IV through VI. All randomized subjects were to have a Galderma Chin Retrusion Scale (GCRS) score of 1 (Mild) or 2 (Moderate). Eligible subjects randomized to receive treatment were injected by the Treating Investigator at Day 1. The method of injection was at the discretion of the Treating Investigator. A sufficient amount of product was injected to achieve optimal correction of the chin, in the opinion of the Treating Investigator and subject. Optimal appearance was defined as at least 1 GCRS grade improvement from baseline and the best correction that could be achieved as agreed by the Treating Investigator and the subject. At the 48-week visit, after all study procedures for the visit were completed, treated subjects had the option of receiving an additional treatment if optimal aesthetic improvement was not maintained with Restylane Defyne. Non-treated control subjects also had the option of receiving treatment with Restylane Defyne in the chin at Week 48. If an optional treatment was performed, a safety follow-up visits were scheduled
Interventions
DEVICERestylane Defyne
hyaluronic acid dermal filler gel
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects willing to comply with the requirements of the study and providing a signed written informed consent. * Males or non-pregnant, non-breastfeeding females, 22 years of age or older, seeking chin augmentation or correction of retrusion
Exclusion criteria
* Allergy of hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins * Allergy or hypersensitivity to lidocaine or other amide-type anesthetics, or topical anesthetics or nerve blocking agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale | 12 weeks after baseline | subjects achieving at least 1-grade improvement from baseline using the Galderma Chin Retrusion Scale (GCRS; 0=no retrusion, 1=mild retrusion, 2=moderate retrusion, 3=substantial retrusion) as assessed by blinded evaluator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Subject Satisfaction Using the FACE-Q (Baseline to Week 12) | 12 weeks after last injection | Summary of change from Baseline to Week 12 in the FACE-Q Satisfaction with Chin, where subjects were asked about their satisfaction with treatment outcome on their chin. Higher scores reflect a better outcome. Scale consists of 10 questions and subjects select level of satisfaction for each question from/to Very dissatisfied = 1, Somewhat dissatisfied = 2, Somewhat satisfied = 3, Very satisfied = 4. A Conversion Table converts raw scale summed score into a score from 0 (worst) to 100 (best). If missing data is less than 50% of the scale's items, the mean of the completed items is used (Rasch Transformed Total Score: BOCF (ITT Population). |
| Evaluate Effectiveness of the Treatment Using the Galderma Chin Retrusion | 24, 36, and 48 weeks after last injection | Response rates, defined by at least 1 point improvement from baseline using the Galderma Chin Retrusion Scale (GCRS), as assessed by the Blinded Evaluator, at 24,36, and 48 weeks after the last injection for the treatment group or after baseline if randomized to no treatment |
| Assess Overall Aesthetic Improvement Using the Global Aesthetic Improvement Scale | 12, 24, 36, and 48 weeks after last injection | Aesthetic improvement (overall appearance) after treatment with Restylane® Defyne compared to no-treatment control, as determined by assessments using the Global Aesthetic Improvement Scale (GAIS). Assessments were performed at 12, 24, 36, and 48 weeks after treatment. Treating Investigators and subjects separately rated aesthetic improvement of the chin from baseline appearance, where a higher score reflects reporting of greater improvement. The subjects and Investigators select a score from the following categorical scale: Very much improved = 3; Much improved = 2; Improved = 1; No change = 0; Worse = -1; Much worse = -2; Very much worse = -3. Scores range from -3 (worst) to 3 (best). Higher scores reflect a better outcome. The Responder Rate is defined as the number and percent of subjects with a rating of at least Improved based off of subject's/investigator's (as appropriate) assessment of the GAIS. |
| Evaluate Subject Satisfaction Using the FACE-Q (From Baseline to Week 24) | 24, 36, and 48 weeks after last injection | Summary of Change from Baseline to Week 24 in FACE-Q Satisfaction with Chin, where subjects were asked about their satisfaction with treatment outcome on their chin. Higher scores reflect a better outcome. Scale consists of 10 questions and subjects select level of satisfaction for each question from/to Very dissatisfied = 1, Somewhat dissatisfied = 2, Somewhat satisfied = 3, Very satisfied = 4. A Conversion Table converts raw scale summed score into a score from 0 (worst) to 100 (best). IIf missing data is less than 50% of the scale's items, the mean of the completed items is used (Rasch Transformed Total Score: BOCF (ITT Population). |
| Evaluate Volume Change in the Treated Area Using 3D Imaging | 12, 24, 36, and 48 weeks after last injection | Summary of Total Volume Change in the Chin Area Measured by Digital 3D Photography at Each Visit (ITT Population). Total volume change corresponds to net volume change from baseline in the chin area. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane Defyne Injection with Restylane Defyne
Restylane Defyne: hyaluronic acid dermal filler gel | 107 |
| Control no-treatment control | 33 |
| Total | 140 |
Baseline characteristics
| Characteristic | Total | Control | Restylane Defyne |
|---|---|---|---|
| Age, Continuous | 47.4 years STANDARD_DEVIATION 13.18 | 44.4 years STANDARD_DEVIATION 15.3 | 48.3 years STANDARD_DEVIATION 12.39 |
| Fitzpatrick Skin type (FST) FST I | 8 Participants | 1 Participants | 7 Participants |
| Fitzpatrick Skin type (FST) FST II | 35 Participants | 8 Participants | 27 Participants |
| Fitzpatrick Skin type (FST) FST III | 40 Participants | 10 Participants | 30 Participants |
| Fitzpatrick Skin type (FST) FST IV | 32 Participants | 8 Participants | 24 Participants |
| Fitzpatrick Skin type (FST) FST V | 14 Participants | 4 Participants | 10 Participants |
| Fitzpatrick Skin type (FST) FST VI | 11 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 107 Participants | 22 Participants | 85 Participants |
| Region of Enrollment United States | 140 participants | 33 participants | 107 participants |
| Sex: Female, Male Female | 125 Participants | 30 Participants | 95 Participants |
| Sex: Female, Male Male | 15 Participants | 3 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 107 |
| other Total, other adverse events | 10 / 33 | 65 / 107 |
| serious Total, serious adverse events | 0 / 33 | 1 / 107 |
Outcome results
Primary
Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale
subjects achieving at least 1-grade improvement from baseline using the Galderma Chin Retrusion Scale (GCRS; 0=no retrusion, 1=mild retrusion, 2=moderate retrusion, 3=substantial retrusion) as assessed by blinded evaluator
Time frame: 12 weeks after baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Restylane Defyne | Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale | 87 Participants |
| Control | Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale | 2 Participants |
Secondary
Assess Overall Aesthetic Improvement Using the Global Aesthetic Improvement Scale
Aesthetic improvement (overall appearance) after treatment with Restylane® Defyne compared to no-treatment control, as determined by assessments using the Global Aesthetic Improvement Scale (GAIS). Assessments were performed at 12, 24, 36, and 48 weeks after treatment. Treating Investigators and subjects separately rated aesthetic improvement of the chin from baseline appearance, where a higher score reflects reporting of greater improvement. The subjects and Investigators select a score from the following categorical scale: Very much improved = 3; Much improved = 2; Improved = 1; No change = 0; Worse = -1; Much worse = -2; Very much worse = -3. Scores range from -3 (worst) to 3 (best). Higher scores reflect a better outcome. The Responder Rate is defined as the number and percent of subjects with a rating of at least Improved based off of subject's/investigator's (as appropriate) assessment of the GAIS.
Time frame: 12, 24, 36, and 48 weeks after last injection
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Restylane Defyne | Assess Overall Aesthetic Improvement Using the Global Aesthetic Improvement Scale | 100 Participants |
| Control | Assess Overall Aesthetic Improvement Using the Global Aesthetic Improvement Scale | 0 Participants |
Secondary
Evaluate Effectiveness of the Treatment Using the Galderma Chin Retrusion
Response rates, defined by at least 1 point improvement from baseline using the Galderma Chin Retrusion Scale (GCRS), as assessed by the Blinded Evaluator, at 24,36, and 48 weeks after the last injection for the treatment group or after baseline if randomized to no treatment
Time frame: 24, 36, and 48 weeks after last injection
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Restylane Defyne | Evaluate Effectiveness of the Treatment Using the Galderma Chin Retrusion | 87 Participants |
| Control | Evaluate Effectiveness of the Treatment Using the Galderma Chin Retrusion | 2 Participants |
Secondary
Evaluate Subject Satisfaction Using the FACE-Q (Baseline to Week 12)
Summary of change from Baseline to Week 12 in the FACE-Q Satisfaction with Chin, where subjects were asked about their satisfaction with treatment outcome on their chin. Higher scores reflect a better outcome. Scale consists of 10 questions and subjects select level of satisfaction for each question from/to Very dissatisfied = 1, Somewhat dissatisfied = 2, Somewhat satisfied = 3, Very satisfied = 4. A Conversion Table converts raw scale summed score into a score from 0 (worst) to 100 (best). If missing data is less than 50% of the scale's items, the mean of the completed items is used (Rasch Transformed Total Score: BOCF (ITT Population).
Time frame: 12 weeks after last injection
Population: ITT Population; NOTE: Of the 140 subjects enrolled, 1 subject was randomized but did not complete baseline FACE-Q before withdrawing consent and is, therefore, not included in this table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Restylane Defyne | Evaluate Subject Satisfaction Using the FACE-Q (Baseline to Week 12) | 78.6 Rasch Transformed Score | Standard Deviation 22.14 |
| Control | Evaluate Subject Satisfaction Using the FACE-Q (Baseline to Week 12) | 35.1 Rasch Transformed Score | Standard Deviation 21.2 |
Secondary
Evaluate Subject Satisfaction Using the FACE-Q (From Baseline to Week 24)
Summary of Change from Baseline to Week 24 in FACE-Q Satisfaction with Chin, where subjects were asked about their satisfaction with treatment outcome on their chin. Higher scores reflect a better outcome. Scale consists of 10 questions and subjects select level of satisfaction for each question from/to Very dissatisfied = 1, Somewhat dissatisfied = 2, Somewhat satisfied = 3, Very satisfied = 4. A Conversion Table converts raw scale summed score into a score from 0 (worst) to 100 (best). IIf missing data is less than 50% of the scale's items, the mean of the completed items is used (Rasch Transformed Total Score: BOCF (ITT Population).
Time frame: 24, 36, and 48 weeks after last injection
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Restylane Defyne | Evaluate Subject Satisfaction Using the FACE-Q (From Baseline to Week 24) | 75.9 FACE-Q Satisfaction with Chin Rasch Tran | Standard Deviation 21.76 |
| Control | Evaluate Subject Satisfaction Using the FACE-Q (From Baseline to Week 24) | 33.2 FACE-Q Satisfaction with Chin Rasch Tran | Standard Deviation 20.77 |
Secondary
Evaluate Volume Change in the Treated Area Using 3D Imaging
Summary of Total Volume Change in the Chin Area Measured by Digital 3D Photography at Each Visit (ITT Population). Total volume change corresponds to net volume change from baseline in the chin area.
Time frame: 12, 24, 36, and 48 weeks after last injection
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restylane Defyne | Evaluate Volume Change in the Treated Area Using 3D Imaging | Week 12 | 3.0 mL | Standard Deviation 2.61 |
| Restylane Defyne | Evaluate Volume Change in the Treated Area Using 3D Imaging | Week 24 | 2.5 mL | Standard Deviation 2.34 |
| Restylane Defyne | Evaluate Volume Change in the Treated Area Using 3D Imaging | Week 36 | 2.5 mL | Standard Deviation 2.61 |
| Restylane Defyne | Evaluate Volume Change in the Treated Area Using 3D Imaging | Week 48 | 2.6 mL | Standard Deviation 2.51 |
| Control | Evaluate Volume Change in the Treated Area Using 3D Imaging | Week 48 | -0.5 mL | Standard Deviation 1.14 |
| Control | Evaluate Volume Change in the Treated Area Using 3D Imaging | Week 12 | -0.6 mL | Standard Deviation 1.46 |
| Control | Evaluate Volume Change in the Treated Area Using 3D Imaging | Week 36 | -0.5 mL | Standard Deviation 1.45 |
| Control | Evaluate Volume Change in the Treated Area Using 3D Imaging | Week 24 | -0.3 mL | Standard Deviation 1.5 |