NCT05538728

An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area

A Prospective Open-label Study to Evaluate Safety and Effectiveness of Two Different Reconstitution Volumes of Poly-l-lactic Acid (PLLA) for Correction of Wrinkles in the décolletage Area

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: Female
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

This is a prospective open-label study to evaluate safety and effectiveness of two different reconstitution volumes of poly-l-lactic acid (PLLA) for correction of wrinkles in the décolletage area.

Detailed description

A challenge for wrinkle correction of the decolletage/chest and other non-facial areas is that larger surface areas typically need to be treated than for facial indications, for which reason the Sponsor is investigating a larger reconstitution volume compared to the approved label. In this study, the total volume of 18mL, including 1mL of 2% lidocaine, is being explored and compared with results from the current labeled volume of 9mL, including lidocaine, to assess if the larger volume is well-tolerated for treatment for wrinkles in the decolletage area.

Conditions

• Wrinkles in Decolletage

Interventions

Type	Name	Description
DEVICE	poly-l-lactic acid (Sculptra)	Sculptra

Timeline

• Start date: 2022-08-31
• Primary completion: 2023-08-08
• Completion: 2023-08-08
• First posted: 2022-09-14
• Last updated: 2024-08-20
• Results posted: 2024-08-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study