About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Males or non-pregnant, non-breastfeeding females, 22 years of age or older.
Intent to receive treatment for augmentation and correction of retrusion in the chin region.
Disqualifiers
Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.
Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from subnasale.
Trial design
Single group
Treatments tested in this trial
Restylane Lyft with Lidocaine
DeviceSterile gel of hyaluronic acid.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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