Poly-L-lactic acid / Galderma
Sculptra
PLLA, staged correction and a randomized cheek-wrinkle study with a clearly defined endpoint.
Product Atlas · September 2026
The exact product comes first
Scope of this monograph#
Sculptra, US aesthetic indications. HIV-associated lipoatrophy is documented separately in the IFU.
Clinical statements below summarize the attached documents. They are not a complete prescribing label. Match the exact local product and current instructions to the clinical decision.
Composition & formulation#
An implant containing PLLA microparticles, sodium carboxymethylcellulose and mannitol, supplied as a dry formulation for reconstitution.[2]
How it works#
PLLA is used for progressive tissue correction. The appearance immediately after reconstitution and injection should not be equated with the eventual result.[2]
Indications & treatment areas#
US labeling covers nasolabial contour deficiencies and facial wrinkles, including cheek lines, in immune-competent people. HIV lipoatrophy has its own instructions.[2]
Application considerations#
Preparation, treatment interval and placement are product-specific. The cheek-wrinkle trial allowed a course of treatments, not one isolated injection.[2][3]
Contraindications & precautions#
Component hypersensitivity and susceptibility to keloid or hypertrophic scar formation require exclusion under the IFU. Assess inflammation, infection and immune status.[2]
Adverse effects & safety#
Local reactions, papules and delayed nodules can occur. Avoid intravascular placement; superficial implantation increases local complication risk.[2]
Duration & follow-up#
The randomized cheek-wrinkle trial assessed response at month 12. Its endpoint and treatment course should accompany any duration claim.[3]
Distinctions that matter#
At month 12, one-grade improvement in both cheeks occurred in 71.6% versus 26.1% of untreated controls. This does not compare Sculptra with HA or CaHA.[3]
Four markets. Separate evidence.#
Documents below identify what has been attached in this research edition. “Source needed” means unverified here; it is not a statement that a product is unapproved.
A current, exact-product local label or regulatory record has not yet been reconciled in this edition. Regulatory status is unverified here.
Contribute a local source ↗A current, exact-product local label or regulatory record has not yet been reconciled in this edition. Regulatory status is unverified here.
Contribute a local source ↗US IFU separates aesthetic and HIV-lipoatrophy uses.[2]
ARTG 276929 identifies the Australian device record. The Australian IFU must be reconciled before importing US clinical claims.[1]
Studies worth a closer look.#
Read the endpoint behind the headline.
Pair the responder rate with the treatment course and the actual comparator.
Follow the evidence.#
Retrieved 6 September 2026. A retrieval date does not establish that an older document is the latest approved revision. Studies marked “abstract” have not completed full-text appraisal.
- [1] Sculptra — ARTG 276929 ↗Therapeutic Goods Administration · regulator · Document accessed · Checked 2026-09-06
- [2] Sculptra US instructions for use ↗Galderma · label · Document accessed · Checked 2026-09-06
- [3] Sculptra — randomized cheek-wrinkle trial ↗Journal of Drugs in Dermatology, 2024 · PMID 38206151 · study · Abstract accessed · Checked 2026-09-06
Cite this monograph#
Aesthetic Pass. Sculptra. Product Atlas research edition 2026.09.06.1. https://aestheticpass.com/products/monographs/sculptra/