Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles

Completed · Not applicable

Conditions studied: Cheek Wrinkles

In brief

The study has been designed to evaluate the safety and effectiveness of Sculptra Aesthetic as a single regimen for correction of cheek wrinkles after changes in reconstitution and injection procedures compared to the approved label.

Key facts

Study ID

NCT04124692

Run by

Galderma R&D

People needed

149

Starts

2019-11-12

Expected to finish

2021-08-12

Last updated by the study team

2023-11-18

Who can join

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

You may qualify if…

• Intent to undergo correction of cheek wrinkles on both sides of the face and a Galderma Cheek Wrinkles Scale (GCWS) At Rest score of Moderate or Severe on EACH side of the face.

You may not qualify if…

• Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.
• Previous tissue augmenting therapy, contouring or revitalization treatment in the face, except the lips, with any of the following fillers prior to Baseline visit:
• Collagen, Hyaluronic Acid - 12 months
• Calcium Hydroxyapatite (CaHa), Poly L- Lactic Acid (PLLA) or permanent (nonbiodegradable)- Prohibited

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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