Study to Evaluate the Safety of Retreatment With Restylane® Lyft With Lidocaine for Augmentation of the Chin Region

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorGalderma R&D

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Restylane Lyft with Lidocaine

    Device

    Sterile gel of hyaluronic acid.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Dermal Filler for Indication: Restylane Lyft with LidocaineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

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