Chin Retrusion
Conditions
Keywords
Hyaluronic acid, Chin Retrusion
Brief summary
This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Chin Retrusion.
Interventions
DEVICERestylane Defyne
Intradermal injection
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participated with signed and dated informed consent form. 2. Men or women aged 18 years of age or older of Chinese origin. 3. Subjects who were seeking augmentation therapy for chin retrusion. 4. GCRS score of 1 or 2 as assessed by the Blinded Evaluator
Exclusion criteria
1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid gel. 2. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics. 3. History of severe or multiple allergies, manifested by anaphylaxis. 4. Previous facial surgery, or tissue revitalization treatment with laser or light, needling, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion below the level of the horizontal line from subnasale within 6 months before treatment. 5. Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated. 6. Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the horizontal line from subnasale. 7. Other condition that was preventing the subject from entering the study in the Investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method) | At Month 6 | GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; 0- No retrusion, 1- Mild retrusion, 2- Moderate retrusion, 3- Severe retrusion. Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders with at least 1-point improvement from baseline on the GCRS, as measured by the blinded evaluator at Month 6 (after last treatment in treatment group, and after randomization in control group). Missing values at Month 6 are imputed using the BOCF method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases) | Treatment group: At Months 3, 6, 9, and 12 after last treatment, Control group: At Month 3 after randomization and Months 3, 6, 9 and 12 after last treatment | GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; 0- No retrusion, 1- Mild retrusion, 2- Moderate retrusion, 3- Severe retrusion. Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders, defined by at least 1-point improvement from baseline on the GCRS, as measured by the Blinded Evaluator at 3, 6, 9 and 12 months after last treatment in Treatment group, and at 3 months after randomization, as well as 3, 6, 9 and 12 months after last treatment in Control group for observed cases. |
| Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator | At Week 4 and Months 3, and 6 | GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; 0- No retrusion, 1- Mild retrusion, 2- Moderate retrusion, 3- Severe retrusion. Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders, defined by at least 1-point improvement from baseline on the GCRS, as assessed by the Treating Investigator at week 4, months 3 and 6. |
Countries
China
Participant flow
Recruitment details
The study was conducted at 5 sites in China from 08 Oct 2018 to 09 Sep 2020.
Participants by arm
| Arm | Count |
|---|---|
| Restylane Defyne (Treatment Group) Participants received an initial treatment with maximum 2 mL of Restylane Defyne on Day 1 for chin retrusion and, if other areas of the chin were treated for optimal chin augumentation, another maximum dosage of 2 mL were recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. An optional touch-up treatment of maximum 2 mL Restylane Defyne were given at 4 weeks after initial treatment if optimal chin augmentation had not been achieved. | 111 |
| Control (No Treatment Then Restylane Defyne) Participants did not receive treatment at baseline but offered an initial treatment with 2 mL Restylane Defyne at Month 6 follow-up visit after randomization and optional touch-up treatment at 4 Weeks after initial treatment. | 37 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Could not return for treatment | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Moved from location | 0 | 1 |
| Overall Study | Not accepted the treatment | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Control (No Treatment Then Restylane Defyne) | Total | Restylane Defyne (Treatment Group) |
|---|---|---|---|
| Age, Continuous | 32.1 years STANDARD_DEVIATION 7.1 | 33.0 years STANDARD_DEVIATION 7.8 | 33.4 years STANDARD_DEVIATION 8 |
| Blinded Evaluator Galderma Chin Retrusion Scale Score 1 | 9 Participants | 48 Participants | 39 Participants |
| Blinded Evaluator Galderma Chin Retrusion Scale Score 2 | 28 Participants | 100 Participants | 72 Participants |
| Race/Ethnicity, Customized Ethnicity Han Chinese | 36 Participants | 145 Participants | 109 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Female | 35 Participants | 140 Participants | 105 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 0 / 37 | 0 / 34 |
| other Total, other adverse events | 19 / 111 | 4 / 37 | 5 / 34 |
| serious Total, serious adverse events | 2 / 111 | 1 / 37 | 1 / 34 |
Outcome results
Primary
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method)
GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; 0- No retrusion, 1- Mild retrusion, 2- Moderate retrusion, 3- Severe retrusion. Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders with at least 1-point improvement from baseline on the GCRS, as measured by the blinded evaluator at Month 6 (after last treatment in treatment group, and after randomization in control group). Missing values at Month 6 are imputed using the BOCF method.
Time frame: At Month 6
Population: FAS population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane Defyne (Treatment Group) | Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method) | 81.1 Percentage of participants |
| Control (No Treatment Then Restylane Defyne) | Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method) | 5.4 Percentage of participants |
Secondary
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)
GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; 0- No retrusion, 1- Mild retrusion, 2- Moderate retrusion, 3- Severe retrusion. Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders, defined by at least 1-point improvement from baseline on the GCRS, as measured by the Blinded Evaluator at 3, 6, 9 and 12 months after last treatment in Treatment group, and at 3 months after randomization, as well as 3, 6, 9 and 12 months after last treatment in Control group for observed cases.
Time frame: Treatment group: At Months 3, 6, 9, and 12 after last treatment, Control group: At Month 3 after randomization and Months 3, 6, 9 and 12 after last treatment
Population: FAS population included all participants who were treated with Restylane Defyne or randomized to no-treatment group. Here, number of overall participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane Defyne (Treatment Group) | Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases) | Month 3 (after last treatment) | 83.5 Percentage of participants |
| Restylane Defyne (Treatment Group) | Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases) | Month 6 (after last treatment) | 84.1 Percentage of participants |
| Restylane Defyne (Treatment Group) | Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases) | Month 9 (after last treatment) | 71.7 Percentage of participants |
| Restylane Defyne (Treatment Group) | Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases) | Month 12 (after last treatment) | 61.1 Percentage of participants |
| Control (No Treatment Then Restylane Defyne) | Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases) | Month 12 (after last treatment) | 68.8 Percentage of participants |
| Control (No Treatment Then Restylane Defyne) | Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases) | Month 9 (after last treatment) | 62.5 Percentage of participants |
| Control (No Treatment Then Restylane Defyne) | Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases) | Month 3 (after last treatment) | 78.1 Percentage of participants |
| Control (No Treatment Then Restylane Defyne) | Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases) | Month 3 (after randomization) | 8.6 Percentage of participants |
| Control (No Treatment Then Restylane Defyne) | Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases) | Month 6 (after last treatment) | 72.7 Percentage of participants |
Secondary
Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator
GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; 0- No retrusion, 1- Mild retrusion, 2- Moderate retrusion, 3- Severe retrusion. Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders, defined by at least 1-point improvement from baseline on the GCRS, as assessed by the Treating Investigator at week 4, months 3 and 6.
Time frame: At Week 4 and Months 3, and 6
Population: FAS population included all participants who were treated with Restylane Defyne or randomized to no-treatment group. Here, number of overall participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane Defyne (Treatment Group) | Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator | At Week 4 | 92.8 Percentage of participants |
| Restylane Defyne (Treatment Group) | Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator | At Month 3 | 84.4 Percentage of participants |
| Restylane Defyne (Treatment Group) | Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator | At Month 6 | 80.4 Percentage of participants |
| Control (No Treatment Then Restylane Defyne) | Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator | At Week 4 | 0 Percentage of participants |
| Control (No Treatment Then Restylane Defyne) | Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator | At Month 3 | 0 Percentage of participants |
| Control (No Treatment Then Restylane Defyne) | Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator | At Month 6 | 0 Percentage of participants |