NCT04595331

Open Label Extension for 43USSA1812

Open Label Extension for 43USSA1812 (A Randomized, Evaluator-blinded, No-treatment Controlled, Multi-center Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Cheek
• Wrinkle

Interventions

Type	Name	Description
DEVICE	Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection	Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles

Timeline

• Start date: 2019-11-12
• Primary completion: 2022-07-20
• Completion: 2022-07-20
• First posted: 2020-10-20
• Last updated: 2025-06-26
• Results posted: 2025-06-26

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study