Open Label Extension for 43USSA1812

Completed · Not applicable

Conditions studied: Cheek, Wrinkle

In brief

To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.

Key facts

Study ID

NCT04595331

Run by

Galderma R&D

People needed

111

Starts

2019-11-12

Expected to finish

2022-07-20

Last updated by the study team

2025-06-26

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject completed Month 12 of study 43USSA1812
• Subjects willing to comply with the requirements of the extension of the study and providing a signed written informed consent.

You may not qualify if…

• For subjects eligible for treatment in the extension study, the exclusion criteria for study 43USSA1812 applies.

Where it is running

• Galderma Research Site — Scottsdale, Arizona, United States
• Galderma Research Site — Encino, California, United States
• Galderma Research Site — Redondo Beach, California, United States
• Galderma Research site — San Diego, California, United States
• Galderma Research Site — Washington D.C., District of Columbia, United States
• Galderma Research Site — Coral Gables, Florida, United States
• Galderma Research Site — Alpharetta, Georgia, United States
• Galderma Research Site — New Orleans, Louisiana, United States
• Galderma Research Site — Rockville, Maryland, United States
• Galderma Research Site — New York, New York, United States
• Galderma Research Site — New York, New York, United States
• Galderma Research Site — Dallas, Texas, United States
• Galderma Research Site — Spring, Texas, United States

Full record on ClinicalTrials.gov

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