N/A
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
Bottom Line
View on ClinicalTrials.gov: NCT03624816 ↗Enrolled (actual)
140
Serious AEs
0.7%
Results posted
Oct 2022
Primary outcome: Primary: Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale — 87; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane Defyne (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Mar 2019
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 | — |
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.
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.