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A Study to Evaluate the Safety and Efficacy of Restylane Defyne for Chin Augmentation and Correction of Chin Retrusion
NA trial testing Restylane Defyne in Chin Retrusion in 140 participants. Completed in 20 February 2020.
| Lead sponsor | Galderma R&D |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 21 August 2018 |
| Primary completion | 7 March 2019 |
| Estimated completion | 20 February 2020 |
| Sites | 11 locations across United States |
Galderma R&D — full company profile →
22 and older, any sex, with Chin Retrusion or Chin Augmentation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| Restylane Defyne | 87 | |
| Control | 2 |
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 T
| Group | Value | 95% CI |
|---|---|---|
| Restylane Defyne | 78.6 | ± 22.14 |
| Control | 35.1 | ± 21.20 |
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
| Group | Value | 95% CI |
|---|---|---|
| Restylane Defyne | 87 | |
| Control | 2 |
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 =
| Group | Value | 95% CI |
|---|---|---|
| Restylane Defyne | 100 | |
| Control | 0 |
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 Tran
| Group | Value | 95% CI |
|---|---|---|
| Restylane Defyne | 75.9 | ± 21.76 |
| Control | 33.2 | ± 20.77 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Restylane Defyne | 3.0 | ± 2.61 |
| Control | -0.6 | ± 1.46 |
| Group | Value | 95% CI |
|---|---|---|
| Restylane Defyne | 2.5 | ± 2.34 |
| Control | -0.3 | ± 1.5 |
| Group | Value | 95% CI |
|---|---|---|
| Restylane Defyne | 2.5 | ± 2.61 |
| Control | -0.5 | ± 1.45 |
| Group | Value | 95% CI |
|---|---|---|
| Restylane Defyne | 2.6 | ± 2.51 |
| Control | -0.5 | ± 1.14 |
Time frame: 1 year, 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Control | Restylane Defyne |
|---|---|---|---|
| Stage IV metastatic lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Reaction | System | Control | Restylane Defyne |
|---|---|---|---|
| Implant site pain | General disorders | — | — |
| Implant site bruising | General disorders | — | — |
| Implant site swelling | General disorders | — | — |
| Implant site erythema | General disorders | — | — |
| Implant site hemorrhage | General disorders | — | — |
| contusion | Injury, poisoning and procedural complications | — | — |
| acne | Skin and subcutaneous tissue disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Implant site nodule | General disorders | — | — |
| Implant site mass | General disorders | — | — |
| Implant site oedema | General disorders | — | — |
| Implant site eczema | General disorders | — | — |
| Tooth Infection | Infections and infestations | — | — |
| fatigue | General disorders | — | — |
| implant site cyst | General disorders | — | — |
| influenza like illness | General disorders | — | — |
| injection site eczema | General disorders | — | — |
| nodule | General disorders | — | — |
| pain | General disorders | — | — |
| pyrexia | General disorders | — | — |
| cystitis | Infections and infestations | — | — |
| gastroenteritis | Infections and infestations | — | — |
| influenza | Infections and infestations | — | — |
| tonsillitis | Infections and infestations | — | — |
| oral herpes | Infections and infestations | — | — |
| tooth abscess | Infections and infestations | — | — |
| upper respiratory tract infection | Infections and infestations | — | — |
| urinary tract infection | Infections and infestations | — | — |
| sinusitis | Infections and infestations | — | — |
| ligament sprain | Injury, poisoning and procedural complications | — | — |
| procedural anxiety | Injury, poisoning and procedural complications | — | — |
| procedural pain | Injury, poisoning and procedural complications | — | — |
| skin abrasion | Injury, poisoning and procedural complications | — | — |
| tooth fracture | Injury, poisoning and procedural complications | — | — |
| lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| metastases to CNS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| dermal cyst | Skin and subcutaneous tissue disorders | — | — |
| perioral dermatitis | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: Stage IV metastatic lung cancer.
Data from ClinicalTrials.gov NCT03624816 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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