N/A
Completed N=140
A Study to Evaluate the Safety and Efficacy of Restylane Defyne for Chin Augmentation and Correction of Chin Retrusion
Chin Retrusion · Chin Augmentation
Source: ClinicalTrials.gov NCT03624816 ↗
Enrolled (actual)
140
Serious AEs
0.7%
Results posted
Oct 2022
Primary outcomePrimary: Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale — 87; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale |
87; 2 | — |
| SECONDARY Evaluate Subject Satisfaction Using the FACE-Q (Baseline to Week 12) |
78.6; 35.1 | — |
| SECONDARY Evaluate Effectiveness of the Treatment Using the Galderma Chin Retrusion |
87; 2 | — |
| SECONDARY Assess Overall Aesthetic Improvement Using the Global Aesthetic Improvement Scale |
100; 0 | — |
| SECONDARY Evaluate Subject Satisfaction Using the FACE-Q (From Baseline to Week 24) |
75.9; 33.2 | — |
| SECONDARY Evaluate Volume Change in the Treated Area Using 3D Imaging |
3.0; -0.6; 2.5; -0.3; 2.5; -0.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03624816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.