A Single-center, Open-label Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging
Galderma R&D
Summary
Adult subjects with moderate-to-severe cheek wrinkles will be treated with Sculptra for correction of fine lines and wrinkles in the cheek area.
Eligibility
- Age range
- 45–65 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Adult subjects aged 45-65 years old * Females only * Subject with moderate-to-severe cheek wrinkles on the GCWS * Subject with intent to undergo correction of cheek wrinkles on both sides of the face * Subject who in the opinion of the Investigator would need 3 treatments for optimal clinical outcomes * Subject willing to be photographed at each visit. * Subjects willing to stop using current facial skincare products for the duration of the study. * Subject willing to replace the current facial skincare products with the provided facial skincare products, including clean…
Interventions
- DeviceSculptra®
Sculptra injection will be performed to the cheeks using 25 G needle size. Injections will be performed subdermally, i.e., in the subcutaneous and supraperiosteal region. A maximum of 18 mL (2 vials) of Sculptra will be administered per treatment session with a maximum of 9 mL (1 vial) per cheek, evenly distributed within the treatment area.
Location
- LuxurgeryNew York, New York