Restylane Lyft with Lidocaine: Sterile gel of hyaluronic acid.
Study summary
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.
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
1. Males or non-pregnant, non-breastfeeding females, 22 years of age or older.
2. Intent to receive treatment for augmentation and correction of retrusion in the chin region.
Exclusion Criteria:
1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
2. Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.
3. Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
4. Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from subnasale.
5. Any previous aesthetic procedures or implants.
6. Presence of any disease or lesions near or on the area to be treated.
Primary outcome measure(s)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Device And/Or Injection Procedure After the Month 12 Optional Retreatment — From Month 12 up to 3 months after optional retreatment (i.e. Month 15) 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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