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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
a sterile gel of hyaluronic acid (HA)
Facial Plastic and Cosmetic Surgery
Beverly Hills, California, United States
Skin Care and Laser Physicians of Beverly Hills
Los Angeles, California, United States
Hessler Plastic Surgery
Palo Alto, California, United States
Union Square Laser Dermatology
New York, New York, United States
Number of Participants With Treatment-Emergent Adverse Events [Safety]
To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula.
Time frame: 16 weeks
Number of Participants With Aesthetic Improvement
To assess effectiveness using the Global Aesthetic Improvement Scale (GAIS). Responders defined as "Improved" or better on the GAIS as assessed by the investigator and participant at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16).
Time frame: 16 weeks
Number of Participants That Responded to Treatment
To assess effectiveness using the 4-point Midface Volume Scale. Responder defined as at least a one point improvement from the baseline score at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16).
Time frame: 16 weeks
Subject Satisfaction
To assess subject satisfaction with the treatment using the FACE-Q. Score range 1-100. The higher total score indicate greater subject satisfaction.
Time frame: 8 weeks
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