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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Defyne | Experimental | injection with Restylane Defyne |
|
| Control | No Intervention | no-treatment control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Defyne | Device | hyaluronic acid dermal filler gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westside Aesthetics | Los Angeles | California | 90025 | United States | ||
| Ablon Skin Institute and Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Defyne | Injection with Restylane Defyne Restylane Defyne: hyaluronic acid dermal filler gel |
| FG001 | Control | no-treatment control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Oct 11, 2019 | Feb 19, 2021 |
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| 12 weeks after last injection |
| 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 | 24, 36, and 48 weeks after last injection |
| 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. | 12, 24, 36, and 48 weeks after last injection |
| 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). | 24, 36, and 48 weeks after last injection |
| 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. | 12, 24, 36, and 48 weeks after last injection |
| Manhattan Beach |
| California |
| 90266 |
| United States |
| Marcus Facial Plastic Surgery | Redondo Beach | California | 90277 | United States |
| Moradi M.D. | Vista | California | 92083 | United States |
| Skin Research Institute, LLC | Coral Gables | Florida | 33146 | United States |
| Etre Cometic Dermatology and Laser Center | New Orleans | Louisiana | 70130 | United States |
| WIDLS Chevy Chase | Chevy Chase | Maryland | 20815 | United States |
| Maryland Laser Skin and Vein Institute | Hunt Valley | Maryland | 21030 | United States |
| Union Square Laser Dermatology | New York | New York | 10003 | United States |
| Wilmington Dermatology and Laser Center | Wilmington | North Carolina | 28405 | United States |
| Dallas Plastic Surgery Institute | Dallas | Texas | 75231 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Defyne | Injection with Restylane Defyne Restylane Defyne: hyaluronic acid dermal filler gel |
| BG001 | Control | no-treatment control |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| ||||||||||||||||
| Fitzpatrick Skin type (FST) | FST I: white; very fair; red or blond hair; blue eyes; freckles. always burns, never tans. FST II: white; fair; red or blond hair; blue, hazel or green eyes. usually burns, tans with difficulty. FST III: cream white; fair with any eye or hair color; very common. sometimes mild burn, gradually tans. FST IV: brown; typical Mediterranean Caucasian skin. rarely burns, tans with ease. FST V: dark brown; Middle Eastern skin types. very rarely burns, tans very easily. FST VI: Skin color - black. Skin Characteristics - never burns, tans very easily. | Count of Participants | 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 | 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 | Posted | Count of Participants | Participants | 12 weeks after baseline |
|
|
| ||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | Rasch Transformed Score | 12 weeks after last injection |
|
| |||||||||||||||||||||||||||||
| 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 | ITT population | Posted | Count of Participants | Participants | 24, 36, and 48 weeks after last injection |
|
| ||||||||||||||||||||||||||||||
| 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. | ITT population | Posted | Count of Participants | Participants | 12, 24, 36, and 48 weeks after last injection |
| |||||||||||||||||||||||||||||||
| 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). | ITT population | Posted | Mean | Standard Deviation | FACE-Q Satisfaction with Chin Rasch Tran | 24, 36, and 48 weeks after last injection |
|
| |||||||||||||||||||||||||||||
| 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. | ITT Population | Posted | Mean | Standard Deviation | mL | 12, 24, 36, and 48 weeks after last injection |
|
|
1 year, 6 months
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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 | Control | Subjects randomized to no treatment/control at baseline | 0 | 33 | 0 | 33 | 10 | 33 |
| EG001 | Restylane Defyne | Subjects randomized to treatment with Restylane Defyne at baseline Restylane Defyne: hyaluronic acid dermal filler gel | 0 | 107 | 1 | 107 | 65 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stage IV metastatic lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Implant site bruising | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Implant site swelling | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Implant site erythema | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Implant site hemorrhage | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Implant site nodule | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Implant site mass | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Implant site oedema | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Implant site eczema | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| implant site cyst | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| influenza like illness | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| injection site eczema | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| nodule | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| cystitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| gastroenteritis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| influenza | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| tonsillitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| oral herpes | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| tooth abscess | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| urinary tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| nasopharyngitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| sinusitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| contusion | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| ligament sprain | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| procedural anxiety | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| procedural pain | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| skin abrasion | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| tooth fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| metastases to CNS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| acne | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| perioral dermatitis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| ear discomfort | Ear and labyrinth disorders | MedDRA (12.0) | Systematic Assessment |
| |
| middle ear effusion | Ear and labyrinth disorders | MedDRA (12.0) | Systematic Assessment |
| |
| vertigo | Ear and labyrinth disorders | MedDRA (12.0) | Systematic Assessment |
| |
| food poisoning | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| GERD | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| presyncope | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Meibomian gland dysfunction | Eye disorders | MedDRA (12.0) | Systematic Assessment |
| |
| glaucoma | Eye disorders | MedDRA (12.0) | Systematic Assessment |
| |
| hepatic mass | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| food allergy | Immune system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (12.0) | Systematic Assessment |
| |
| insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
PIs agree not to present or publish any data or reports collected individually or by subgroup of sites prior to full, initial publication based on all data obtained from all sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | QMedAB | (817) 961-5000 | aestheticclinicaltrials@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2018 | Feb 19, 2021 | SAP_001.pdf |
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| FST II |
|
| FST III |
|
| FST IV |
|
| FST V |
|
| FST VI |
|
| Participants |
|
|
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| Units | Counts |
|---|---|
| Participants |
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