Clinical Description

SCULPTRA® is a class III injectable medical-device implant composed of microparticles of poly-L-lactic acid (PLLA) suspended in sterile water for injection, along with carboxymethylcellulose and mannitol excipients.It is indicated for the correction of shallow to deep nasolabial fold contour deficiencies, other facial wrinkles, and restoration and/or correction of the signs of facial fat loss (lipoatrophy) for immune-competent patients. Its mechanism of action involves gradual volumetric restoration via the PLLA microparticles stimulating fibroblasts and triggering new collagen type I synthesis over weeks to months.

What SCULPTRA® Is Similar To

SCULPTRA® may be compared with other collagen-stimulating injectables such as Radiesse (calcium hydroxylapatite) and certain high-concentration hyaluronic acid (HA) fillers used off-label for biostimulation. Both SCULPTRA® and Radiesse aim to gradually improve skin structure through endogenous collagen formation rather than instantaneous volumising. However, SCULPTRA® uses PLLA microparticles which degrade slowly while stimulating fibroblast activity and neocollagenesis, whereas HA fillers provide immediate volume and have different cross-linking profiles and duration. Longevity of SCULPTRA® effects has been reported up to 24-month intervals under complete protocols, whereas most HA fillers have shorter duration depending on cross-link density and anatomical location. This comparison is provided for clinical orientation only and does not imply interchangeability.

Treatment Areas / Indications

Indications as per the manufacturer:

• Shallow to deep nasolabial fold contour deficiencies

• Other facial wrinkles for immune-competent subjects

• Restoration and/or correction of signs of facial fat loss (lipoatrophy) in patients over the age of 21.
  Treatment areas: Face (nasolabial folds, cheek region, facial fat loss zones)
  If other anatomical zones are contemplated, the practitioner must verify suitability and approval.

Usage / Administration (IFU-only section)

Injection depth: The product is injected into the deep dermis or subcutaneous layer or supraperiosteal plane, depending on anatomical site.
Volume per point / injection site: The IFU states that the quantity depends on area to be treated and expected result, and that for the first treatment session, limited correction is advised.
Needle gauge: 25 G or 26 G needle is specified in the IFU.
Frequency / number of sessions: Up to four injection sessions scheduled approximately 3 weeks apart may be required (as per U.S. label). 
Professional-use disclaimer: Administered only by qualified medical professionals under sterile conditions.

Some practitioners apply grid-pattern cross-hatch injection techniques beyond the IFU; it is not part of the official manufacturer guidance.

Ingredient List

• Poly-L-lactic acid (PLLA) microparticles: 150 mg per vial (dry powder)

• Sodium carboxymethylcellulose: 90 mg per vial

• Non-pyrogenic mannitol: 127.5 mg per vial

• Add-on: Sterile Water for Injection (reconstitution)
  Lidocaine: Not provided by manufacturer as a permanent active; optional addition of 1 mL of 2 % lidocaine may be added for pain relief during injection.

Presentation & Longevity

Presentation: Supplied as 1 vial of dry powder; each vial to be reconstituted with sterile water for injection (5-8 mL) to form suspension.
Shelf life: Store at room temperature (up to 30 °C), do not freeze.
Longevity (treatment duration): Clinical data suggest effects may last up to 24 months when full treatment protocol is adhered to; however, the manufacturer does not guarantee a specific duration beyond the observed clinical trial range.

Safety Notes / Contraindications

• Use is contraindicated in patients with known hypersensitivity to any component of the product.

• Should not be used in patients with known history of hypertrophic scarring or keloid formation.

• Do not inject if active skin inflammation, infection, nodules, pimples or hives are present in the treatment area.

• Single-use vials only; do not reuse or resterilize.

Regulatory Status

CE-marked device in Europe under the appropriate category for aesthetic fillers / volumisers (verify local market authorisation).
FDA cleared as SCULPTRA® Aesthetic (injectable poly-L-lactic acid) for indication of facial lipoatrophy and wrinkles.
Regulatory classification: Class III injectable implant (in U.S.).

FAQ

1. How does SCULPTRA® stimulate collagen formation?
SCULPTRA® contains PLLA microparticles which, when injected into the deep dermis or subcutaneous tissue, are gradually absorbed and induce a mild foreign-body response. This in turn stimulates fibroblasts via TGF-β pathways to synthesise collagen type I and extrastructural matrix, thereby gradually restoring volume and improving tissue structure.

2. Is SCULPTRA® the same as a hyaluronic acid filler?
No. While HA fillers deliver immediate volume by gel deposition, SCULPTRA® works as a collagen stimulator over time. The mechanism is biostimulatory rather than purely volumetric, and the effect develops gradually over weeks rather than instantly.

3. What is the typical treatment schedule and how long do results last?
The IFU recommends up to four injection sessions spaced about 3 weeks apart. Clinical evidence suggests that results may persist up to 24 months when the full protocol is followed, though individual duration varies with anatomy, age and treatment plan.

4. Which anatomical areas can SCULPTRA® be used for?
Approved indications include nasolabial folds and other facial wrinkles, as well as facial fat loss (lipoatrophy). Use in other regions such as hands, body or off-label zones should be determined by practitioner assessment and local regulation.

5. What are important safety considerations for clinicians using SCULPTRA®?
Clinicians must employ strict aseptic technique, appropriate injection depth (deep dermis/subcutis), avoid over-correction in a single session (because the effect is gradual), and monitor for delayed complications such as nodules or granulomas. Knowing anatomy, avoiding vascular injection and informing patients about gradual onset and massage requirements are key.