N/A
Completed N=60
Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation
Cheek Augmentation · Midface Contour Deficiencies
Source: ClinicalTrials.gov NCT03160716 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events [Safety] — 5 Participants
Summary
This is a multi-center, open-label, single-arm study to evaluate an injection tool with Restylane Lyft with Lidocaine for cheek augmentation and correction of age related midface contour deficiencies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events [Safety] |
5 | — |
| SECONDARY Number of Participants With Aesthetic Improvement |
43 | — |
| SECONDARY Number of Participants That Responded to Treatment |
43 | — |
| SECONDARY Subject Satisfaction |
77.3 | — |
Eligibility Criteria
Primary 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.
- Mild to Substantial Midface Volume Loss
Primary Exclusion Criteria:
- Allergy or hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins
- Allergy or hypersensitivity to lidocaine or other amide-type anaesthetics, or topical anaesthetics or nerve blocking agents
- Undergone prior surgery to midface
Data sourced from ClinicalTrials.gov (NCT03160716). 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.