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
- 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
- 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
| Arm | Description | Assigned 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. |
|
Recruiting Locations
Galderma Investigational Site # 8680
Westport, Connecticut 06880
Westport, Connecticut 06880
Contact:
Galderma Project Manager
Galderma Project Manager
Galderma Investigational Site # 8774
Boynton Beach, Florida 33437
Boynton Beach, Florida 33437
Contact:
Galderma Project Manager
Galderma Project Manager
Galderma Investigational Site # 7030
Coral Gables, Florida 33134
Coral Gables, Florida 33134
Contact:
Galderma Project Manager
Galderma Project Manager
Galderma Investigational Site # 8682
Coral Gables, Florida 33134
Coral Gables, Florida 33134
Contact:
Galderma Project Manager
Galderma Project Manager
Galderma Investigational Site # 7042
Atlanta, Georgia 30331
Atlanta, Georgia 30331
Contact:
Galderma Project Manager
Galderma Project Manager
Galderma Investigational Site # 7118
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Contact:
Galderma Project Manager
Galderma Project Manager
Galderma Investigational Site # 8662
Spring, Texas 77388
Spring, Texas 77388
Contact:
Galderma Project Manager
Galderma Project Manager
More Details
- Status
- Recruiting
- Sponsor
- Galderma R&D