Sculptra® Poly‑L‑Lactic Acid (2 x 5 ml)
Sculptra®
Medical device – Biostimulatory dermal fillerInjectable poly\u2011L\u2011lactic acid (PLLA) collagen stimulator
Certifications
- CE‑marked according to EU medical device regulations for injectable PLLA fillers (marketed in EU/UK markets).
- Approved by regulatory authorities (e.g. U.S. FDA for Sculptra Aesthetic) for indicated uses in facial volume restoration and soft‑tissue correction.
- CE‑marked according to EU medical device regulations for injectable PLLA fillers (marketed in EU/UK markets).
- Approved by regulatory authorities (e.g. U.S. FDA for Sculptra Aesthetic) for indicated uses in facial volume restoration and soft‑tissue correction.
Injectable poly\u2011L\u2011lactic acid (PLLA) collagen stimulator
Description
Sculptra® is an injectable biostimulatory filler comprising microparticles of poly‑L‑lactic acid (PLLA), supplied as sterile lyophilised powder in vials. Once reconstituted with sterile water for injection (and optionally lidocaine for comfort), the suspension is injected into deep dermis, subcutaneous tissue or supraperiosteal planes. Over weeks to months, PLLA microparticles stimulate fibroblast activity and collagen synthesis, gradually restoring facial volume, improving skin firmness and smoothness, and reducing wrinkles and folds for a natural, long‑lasting rejuvenation effect.
Bnefits
- Stimulates natural collagen production to restore lost facial volume and improve skin structure.
- Provides progressive, natural-looking volumising without overfilling — ideal for age‑related volume loss, facial laxity and skin thinning.
- Long-lasting results — effects may persist up to 24 months or more with proper treatment plan.
- Completely synthetic and biocompatible (non‑animal derived), reducing risk of immunologic reactions associated with foreign tissue fillers.
Indications
- Correction of facial volume loss related to ageing or facial fat atrophy (e.g. cheeks, temples, chin, jaws).
- Treatment of deep wrinkles, folds and facial contour depressions (e.g. nasolabial folds, marionette lines, pre‑jowl sulcus).
- Reconstruction or restoration of facial volume for patients with facial lipoatrophy or soft‑tissue volume deficiency.
Composition
- Poly‑L‑lactic acid (PLLA) microparticles — lyophilised powder in each vial.
- Sodium carboxymethylcellulose (USP) — used as a suspending agent.
- Non‑pyrogenic Mannitol (USP) — stabiliser in lyophilised powder.
- Sterile water for injection (SWFI) added upon reconstitution; optional addition of lidocaine for comfort prior to injection.
Formulation
- Sterile, non‑pyrogenic freeze-dried (lyophilised) powder in glass vials intended for reconstitution.
- Reconstituted to a suspension with sterile water for injection (5–8 ml SWFI per vial) — forms injectable suspension of PLLA microparticles; optionally lidocaine can be added just before injection.
Packaging
- Pack contains 2 vials of 5 ml each (lyophilised powder) — professional-use packaging for aesthetic practitioners or clinics.
- Each vial sealed with rubber stopper and flip-off cap; outer carton labelled with product name, batch/lot number, manufacturer and instructions for use.
Usage
- Reconstitute each vial with 5–8 ml sterile water for injection (SWFI), swirl gently until fully suspended; allow reconstitution time per manufacturer instructions (usually ≥2 hours).
- Optionally add up to 1 ml of 2% lidocaine before injection to reduce discomfort.
- Inject only by trained and licensed healthcare professionals, using sterile single‑use syringes and 25G–26G needles; injection depth: deep dermis, subcutaneous tissue or supraperiosteal plane depending on treatment area.
- Treat conservatively — avoid overcorrection; allow collagen stimulation and volume build-up over several weeks; additional sessions spaced appropriately as per treatment protocol.
Contraindications
- Hypersensitivity to any component of Sculptra (PLLA, carboxymethylcellulose, mannitol).
- History of keloid formation or hypertrophic scarring.
- Active skin disease, inflammation, infection or acne in the treatment area.
- Injection into the red (vermilion) lip or peri‑ocular region is contraindicated.
- Use in under‑18s, pregnant or breastfeeding individuals not established or recommended.
Adverse Effects
- Common local effects: redness, swelling, pain, tenderness, bruising, itching or discomfort at injection sites.
- Nodules or small lumps under the skin — may be visible or palpable on pressure; delayed-onset nodules reported, sometimes associated with inflammation or skin discoloration.
- Risk (rare) of vascular occlusion if inadvertently injected intravascularly — standard filler safety precautions must be observed.
Storage Conditions
- Store unopened vials at controlled room temperature in original sealed packaging, away from direct sunlight and moisture.
- After reconstitution, the suspension should be used promptly as per manufacturer IFU; do not freeze.
Duration
Up to 24 months or more with full treatment protocol and maintenance. (Duration varies per patient, injection volume and treatment area.)
Onset
Gradual onset \u2014 visible skin firmness and volumising improvements typically appear after several weeks to months as new collagen forms.
