Galderma
Sculptra
An injectable poly-L-lactic acid biostimulator used in a staged series for gradual correction of labelled facial wrinkles and folds.
Poly-L-lactic acid collagen biostimulatorReviewed 7/30/2026Source recorded
At a glance
| Primary purpose | Correction of shallow to deep nasolabial-fold contour deficiencies, fine lines and wrinkles in the cheek region, and other facial wrinkles in immunocompetent adults under the US aesthetic labelling. |
|---|---|
| Mechanism | PLLA microparticles produce a local tissue response associated with gradual collagen deposition; initial water-related fullness subsides before the treatment effect develops. |
| When results appear | Most clinical-study participants saw results by about one month; improvement develops gradually. |
| Typical sessions | Average 2 to 3 sessions over several months; typical treatment is three sessions at least 3 to 4 weeks apart. |
| Downtime | Injection-site swelling, tenderness, redness, pain, bruising, bleeding, itching, and lumps can occur. |
| Longevity | The current manufacturer summary and cheek clinical program report sustained improvement for up to two years; individual response varies. |
| Reversibility | Not enzymatically reversible like an HA filler; effects and adverse nodules may be difficult to correct. |
| Documented risks | Injection reactions, papules or nodules including delayed inflammatory nodules, granuloma, infection, and intravascular injection with infarction or embolic phenomena. |
| Most common disappointment | Early post-injection fullness fades, results are gradual, and a multi-session course may be required. |
| Common marketing misconception | Sculptra is not an immediately shapeable HA filler and 'collagen stimulation' does not make it risk-free or reversible. |
| What varies by provider | Reconstitution, hydration time, dilution, injection plane, distribution, session spacing, massage instruction, and avoiding overcorrection. |
| When this treatment may not be appropriate | Contraindicated with ingredient hypersensitivity or a history of keloid formation or hypertrophic scarring; not for lip vermilion or periorbital injection under the IFU. |
| United States regulatory status | FDA-approved by PMA and supplements for specified facial contour deficiencies and wrinkles, including the 2023 cheek fine-line and wrinkle indication. |
| Canadian regulatory status | Health Canada MDALL lists Sculptra under active Class III licence 71658. |
| Evidence status | High for indication, treatment course, safety, and two-year cheek-study follow-up; aesthetic response and vial needs vary. |
Sources
- FDA PMA P030050/S039FDA PMA record · regulatory-primary · supports 2 profile fields
- FDA Summary of Safety and Effectiveness Data P030050/S039FDA SSED · regulatory-primary
- Health Canada MDALL: Q-Med licencesHealth Canada MDALL · regulatory-primary
- Sculptra Aesthetic Instructions for Useofficial manufacturer IFU · manufacturer-primary · supports 20 profile fields
- Sculptra Frequently Asked Questionsofficial manufacturer information · manufacturer-primary
- Sculptra Scienceofficial manufacturer information · manufacturer-primary
- SCULPTRA summary of safety and effectivenessregulator
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