N/A
N=60
Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation
Cheek Augmentation · Midface Contour Deficiencies
Bottom Line
View on ClinicalTrials.gov: NCT03160716 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events [Safety] — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane Lyft with Lidocaine (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Oct 2017
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 | — |
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.
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.