The primary objective of this study is to evaluate the safety of Restylane Lyft with Lidocaine for augmentation of the chin region 3 months after retreatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Sterile gel of hyaluronic acid.
Galderma Investigational Site # 8680
Westport, Connecticut, United States
Galderma Investigational Site # 8774
Boynton Beach, Florida, United States
Galderma Investigational Site # 7030
Coral Gables, Florida, United States
Galderma Investigational Site # 8682
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Device And/Or Injection Procedure After the Month 12 Optional Retreatment
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users or other persons, in the context of a clinical investigation, whether or not related to the investigational product (IP). TEAEs that are related to the device and/or injection procedure after the Month 12 optional retreatment will be reported.
Time frame: From Month 12 up to 3 months after optional retreatment (i.e. Month 15)
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Coral Gables, Florida, United States
Galderma Investigational Site # 7042
Atlanta, Georgia, United States
Galderma Investigational Site # 7043
Bethesda, Maryland, United States
Galderma Investigational Site # 7118
Nashville, Tennessee, United States
Galderma Investigational Site # 8662
Spring, Texas, United States