Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.

Completed · Not applicable

Conditions studied: Nasolabial Folds

In brief

This study has been designed to evaluate the safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.

Key facts

Study ID

NCT03780244

Run by

Galderma R&D

People needed

80

Starts

2018-12-18

Expected to finish

2020-02-28

Last updated by the study team

2022-11-14

Who can join

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

You may qualify if…

• Intent to undergo correction of both left and right NLFs with a Wrinkle Assessment Scale (WAS) score of greater than or equal to 2 (shallow wrinkles) to less than or equal to 4 (deep wrinkles) as assessed on Day 1 (and also at screening, if screening was performed prior to Day 1) by the Blinded Evaluator. A one grade difference between sides is allowed at inclusion.

You may not qualify if…

• Previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area with any filler prior to Baseline visit.
• Collagen, Hyaluronic Acid- 12 months
• Calcium Hydroxyapatite (CaHa), Poly-L-lactic Acid (PLLA) or permanent (non-biodegradable)- Prohibited
• Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.

Where it is running

• Galderma Study Site — Scottsdale, Arizona, United States
• Galderma Study Site — Solana Beach, California, United States
• Galderma Study Site — Bradenton, Florida, United States
• Galderma Study Site — Austin, Texas, United States
• Galderma Study Site — Spring, Texas, United States

Full record on ClinicalTrials.gov

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