Sculptra Aesthetic Post-Approval Study

Completed · Phase 4

Conditions studied: Nasolabial Fold Contour Deficiencies, Wrinkles

In brief

Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and other facial wrinkles.

Key facts

Study ID

NCT02425943

Run by

Galderma R&D

People needed

867

Starts

2015-05-21

Expected to finish

2021-05-28

Last updated by the study team

2023-07-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects seeking correction of shallow to deep NLF contour deficiencies.

You may not qualify if…

• Subjects seeking, at entry into the study, correction of other facial wrinkles with Sculptra Aesthetic in the following anatomical sites/lines: horizontal forehead lines, glabellar frown lines, periorbital lines, periauricular lines, upper lip lines, lower lip lines, corner of the mouth lines and/or horizontal neck folds.
• Subjects that are less than 18 or greater than 75 years of age.

Where it is running

• Galderma Study Site — Birmingham, Alabama, United States
• Galderma Study Site — Encino, California, United States
• Galderma Study Site — Hermosa Beach, California, United States
• Galderma Study Site — San Diego, California, United States
• Galderma Study Site — Solana Beach, California, United States
• Galderma Study Site — Aventura, Florida, United States
• Galderma Study Site — Boca Raton, Florida, United States
• Galderma Study Site — Coral Gables, Florida, United States
• Galderma Study Site — Miami, Florida, United States
• Galderma Study Site — Buffalo Grove, Illinois, United States
• Galderma Study Site — Hackensack, New Jersey, United States
• Galderma Study Site — New York, New York, United States
• Galderma Study Site — White Plains, New York, United States
• Galderma Study Site — Nashville, Tennessee, United States
• Galderma Study Site — Austin, Texas, United States
• Galderma Study Site — Houston, Texas, United States
• Galderma Study Site — Plano, Texas, United States
• Galderma Study Site — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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