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

Completed · Not applicable

Conditions studied: Wrinkles in Decolletage

In brief

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.

Key facts

Study ID

NCT05538728

Run by

Galderma R&D

People needed

30

Starts

2022-08-31

Expected to finish

2023-08-08

Last updated by the study team

2024-08-20

Who can join

Age: 22 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Non-pregnant, non-breastfeeding females over the age of 22
• subjects seeking treatment for the décolletage
• subjects with moderate (Grade 2) or severe (Grade 3) on the Galderma Décolletage Scale
• subjects willing to abstain from any other surgical or cosmetic procedures in the décolletage area for the duration of the study.

You may not qualify if…

• Known/previous allergy or hypersensitivity to Sculptra
• Previous tissue augmenting therapy, contouring or revitalization treatment in the décolletage prior to baseline
• Any plastic surgery or permanent surgical implant in the treatment area
• Previous treatment/procedure in the treatment area in the previous 6 months that would interfere with study injections or study assessments

Where it is running

• Galderma Study Site — Encino, California, United States
• Galderma Study Site — Solana Beach, California, United States

Full record on ClinicalTrials.gov

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