Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation
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|ClinicalTrials.gov Identifier: NCT03160716|
Recruitment Status : Completed
First Posted : May 19, 2017
Results First Posted : May 15, 2019
Last Update Posted : May 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cheek Augmentation Midface Contour Deficiencies||Device: Restylane Lyft with Lidocaine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label, Prospective Study of Cannula Injection of Restylane Lyft With Lidocaine for Cheek Augmentation and the Correction of Age Related Midface Contour Deficiencies|
|Actual Study Start Date :||May 16, 2017|
|Actual Primary Completion Date :||October 31, 2017|
|Actual Study Completion Date :||October 31, 2017|
Device: Restylane Lyft with Lidocaine
a sterile gel of hyaluronic acid (HA)
- Number of Participants With Treatment-Emergent Adverse Events [Safety] [ Time Frame: 16 weeks ]To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula.
- Number of Participants With Aesthetic Improvement [ Time Frame: 16 weeks ]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).
- Number of Participants That Responded to Treatment [ Time Frame: 16 weeks ]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).
- Subject Satisfaction [ Time Frame: 8 weeks ]To assess subject satisfaction with the treatment using the FACE-Q. Score range 1-100. The higher total score indicate greater subject satisfaction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160716
|United States, California|
|Facial Plastic and Cosmetic Surgery|
|Beverly Hills, California, United States, 90210|
|Skin Care and Laser Physicians of Beverly Hills|
|Los Angeles, California, United States, 90069|
|Hessler Plastic Surgery|
|Palo Alto, California, United States, 94306|
|United States, New York|
|Union Square Laser Dermatology|
|New York, New York, United States, 10003|