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

Galderma

Status: Enrolling

Conditions: Chin Augmentation

Treatments: Device: Restylane Lyft with Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07566286

05DF2506

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Dermal Filler for Indication: Restylane Lyft with Lidocaine

Experimental group

Description:

Participants will receive initial treatment with Restylane Lyft with Lidocaine in the chin region at Baseline with an optional touch-up treatment at 1 month after initial treatment and an optional retreatment 12 months after the last treatment.

Treatment:

Device: Restylane Lyft with Lidocaine