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

Purpose

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.

Condition

  • Chin Augmentation

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dermal Filler for Indication: Restylane Lyft with Lidocaine
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.
  • Device: Restylane Lyft with Lidocaine
    Sterile gel of hyaluronic acid.

Recruiting Locations

Galderma Investigational Site # 8680
Westport, Connecticut 06880
Contact:
Galderma Project Manager

Galderma Investigational Site # 8774
Boynton Beach, Florida 33437
Contact:
Galderma Project Manager

Galderma Investigational Site # 7030
Coral Gables, Florida 33134
Contact:
Galderma Project Manager

Galderma Investigational Site # 8682
Coral Gables, Florida 33134
Contact:
Galderma Project Manager

Galderma Investigational Site # 7042
Atlanta, Georgia 30331
Contact:
Galderma Project Manager

Galderma Investigational Site # 7118
Nashville, Tennessee 37203
Contact:
Galderma Project Manager

Galderma Investigational Site # 8662
Spring, Texas 77388
Contact:
Galderma Project Manager

More Details

Status
Recruiting
Sponsor
Galderma R&D

Study Contact

Clinical Project Manager
817-961-5000
clinical.studies@galderma.com