SCULPTRA™ – PLLA Collagen Biostimulator | 2 Vials *SALE*

SCULPTRA™ – PLLA Collagen Biostimulator | 2 Vials

Product Overview

SCULPTRA™ is an established injectable Poly-L-Lactic Acid (PLLA) collagen biostimulator developed by Galderma for progressive facial rejuvenation, collagen stimulation and restoration of age-related structural changes.

Unlike conventional Hyaluronic Acid dermal fillers, which primarily provide immediate physical volume through an injectable gel, SCULPTRA™ works progressively by stimulating the body's own regenerative response and supporting the production of new collagen.

Its principal active component is Poly-L-Lactic Acid (PLLA), a biocompatible and biodegradable synthetic polymer with an established history of medical use.

Following appropriate professional administration, PLLA microparticles initiate a controlled tissue response that supports fibroblast activity and progressive collagen production within the extracellular matrix.

This regenerative mechanism can contribute to gradual improvements in:

• Facial volume

• Skin firmness

• Skin structure

• Skin elasticity

• Skin thickness

• Facial contours

• Wrinkles and folds

• Overall skin quality

Rather than creating an immediate, focal filling effect, SCULPTRA™is designed to produce gradual and natural-looking improvement as new collagen develops over the weeks and months following treatment.

Galderma describes SCULPTRA™ as an established regenerative biostimulator supported by more than 25 years of clinical use and scientific evidence.

Results develop progressively and may remain visible for up to approximately 2 years following an appropriate treatment course, although individual outcomes and longevity vary.

SCULPTRA™ is intended strictly for appropriately qualified healthcare professionals with specific training in the product, facial anatomy, PLLA biostimulation, reconstitution and complication management.

Pack Contents

Each SCULPTRA™ pack contains:

• 2 × SCULPTRA™ vials

• Sterile freeze-dried product for reconstitution

• Poly-L-Lactic Acid (PLLA)

• Sodium Carboxymethylcellulose

• Mannitol

• Original sterile professional-use packaging

Pack Size: 2 vials

SCULPTRA™ is supplied as a sterile lyophilised powder and requires appropriate reconstitution with Sterile Water for Injection (SWFI) before administration.

Always follow the current Galderma Instructions for Use and product-specific professional training for preparation, reconstitution and administration.

Product CompositionPoly-L-Lactic Acid (PLLA)

The principal biostimulatory component of SCULPTRA™ is Poly-L-Lactic Acid (PLLA).

PLLA is a biocompatible and biodegradable synthetic polymer used within medicine for many years.

Unlike a conventional cross-linked Hyaluronic Acid filler, PLLA does not primarily function by leaving a volumising gel within the tissue.

Instead, the PLLA microparticles act as a biostimulatory scaffold, initiating a controlled tissue response that supports fibroblast activity and progressive collagen production.

Over time, the PLLA is gradually degraded while newly produced collagen contributes to improvement in the structure and quality of the treated tissues.

Sodium Carboxymethylcellulose

Sodium Carboxymethylcellulose forms part of the lyophilised SCULPTRA™ formulation and assists in producing the appropriate suspension following reconstitution.

Mannitol

Mannitol is also incorporated within the SCULPTRA™ formulation as an excipient.

The product must be correctly reconstituted before professional administration.

PLLA-SCA™ Regenerative Technology

SCULPTRA™ incorporates Galderma's PLLA-SCA™ technology, designed to stimulate regenerative activity within appropriately selected tissues.

Following administration into the appropriate treatment plane, PLLA microparticles initiate a controlled tissue response.

This process supports fibroblast activity and the formation of new extracellular matrix components.

Galderma research describes biological activity involving:

• Fibroblast activation

• Collagen production

• Elastin production

• Extracellular matrix regeneration

As this regenerative response develops, newly produced structural proteins can contribute to progressive improvements in tissue firmness, elasticity, thickness, volume and overall skin quality.

The process takes place gradually rather than producing the immediate structural result associated with traditional dermal fillers.

Collagen Biostimulation

Collagen is one of the principal structural proteins within the skin and contributes to:

• Strength

• Firmness

• Elasticity

• Thickness

• Structural support

Collagen quantity, organisation and quality change as part of the ageing process.

These changes can contribute to:

• Facial volume loss

• Reduced tissue firmness

• Skin laxity

• Wrinkles and folds

• Changes in facial contours

• Deterioration in overall skin quality

SCULPTRA™ is designed to address aspects of these changes by stimulating the patient's own collagen production.

Rather than simply replacing lost volume with an injectable gel, SCULPTRA™ supports progressive rebuilding of the underlying tissue framework.

This means the final treatment outcome develops gradually over the weeks and months following treatment.

Key Benefits

• Established PLLA collagen biostimulator

• Developed by Galderma

• More than 25 years of clinical experience

• Stimulates the body's own collagen production

• Supports fibroblast activity

• Supports extracellular matrix regeneration

• Supports collagen production

• Supports elastin production

• Helps progressively restore facial volume

• Helps improve skin firmness

• Helps improve elasticity

• Supports improvements in skin structure

• May improve skin thickness

• Helps improve facial contours

• Helps reduce the appearance of appropriate wrinkles and folds

• Progressive regenerative action

• Designed to produce natural-looking improvement

• Does not rely solely on immediate physical filling

• Results may remain visible for up to approximately 2 years

• Supplied as a professional 2-vial pack

• Reconstituted before administration

• Intended for appropriately qualified and specifically trained healthcare professionals

Common Treatment Areas

SCULPTRA™ may be incorporated into professionally designed facial rejuvenation programmes where progressive collagen stimulation, volume restoration and structural improvement are required.

Depending upon the patient's anatomy, treatment indication and current manufacturer guidance, appropriate treatment areas may include:

• Cheeks

• Mid-face

• Temples

• Nasolabial region

• Marionette region

• Lower face

• Jawline

• Selected areas of facial volume loss

• Areas demonstrating reduced tissue firmness

• Appropriate wrinkles and folds

SCULPTRA™ treatment should always be individually planned according to the patient's anatomy, tissue condition and treatment objectives rather than following a standardised approach.

Certain anatomical areas may require additional caution or may not be appropriate for SCULPTRA™ treatment.

Always follow the current Galderma Instructions for Use and SCULPTRA™ professional training when determining treatment areas and suitability.

SCULPTRA™ Treatment Approach

SCULPTRA™ is generally incorporated into a course-based treatment programme rather than being approached as a single conventional filler treatment.

The number of sessions and amount of product required depend upon factors including:

• Patient age

• Degree of facial volume loss

• Baseline tissue condition

• Treatment area

• Existing collagen support

• Individual treatment objectives

• Clinical response to previous sessions

A commonly referenced treatment approach involves up to approximately three treatment sessions, separated by several weeks and accompanied by progressive professional reassessment.

Galderma clinical data has evaluated treatment courses involving approximately three sessions spaced at least three weeks apart.

The exact treatment programme must always be individually determined.

Because SCULPTRA™ stimulates a progressive regenerative response, treatment should be approached conservatively.

The treated area should not be deliberately overcorrected during the initial procedure because further improvement is expected to develop as collagen production increases.

SCULPTRA™ Reconstitution

SCULPTRA™ is supplied as a sterile freeze-dried powder and must be appropriately reconstituted before administration.

Current Galderma guidance referenced in the supplied product information includes professional reconstitution protocols using Sterile Water for Injection (SWFI).

Depending upon the approved protocol and treatment requirements, reconstitution may involve:

• 5ml SWFI, or

• A higher-volume 8ml SWFI preparation

Current manufacturer guidance also describes circumstances in which appropriately reconstituted SCULPTRA™ may be used without the prolonged hydration period associated with older preparation protocols.

Where clinically appropriate and permitted by the current manufacturer guidance, Lidocaine may also be incorporated into the final preparation following assessment of patient suitability.

Preparation, dilution, equipment selection and administration must follow the current Galderma Instructions for Use and product-specific professional training.

Practitioners should not rely on historic SCULPTRA™ protocols or third-party online instructions where these differ from current manufacturer guidance.

Progressive Collagen Regeneration

One of the defining differences between SCULPTRA™ and traditional Hyaluronic Acid dermal fillers is the way the treatment result develops.

Immediately following treatment, some apparent volume may result from the fluid used during product reconstitution.

This should not be interpreted as the final SCULPTRA™ result.

As the reconstitution fluid is absorbed, this temporary initial volume reduces.

The regenerative phase then develops progressively as PLLA stimulates the surrounding tissue and supports new collagen production.

Over the following weeks and months, patients may progressively experience improvement in:

• Facial volume

• Skin firmness

• Skin elasticity

• Facial contours

• Skin thickness

• Wrinkle appearance

• Overall skin quality

This gradual process is responsible for the characteristic natural-looking development associated with SCULPTRA® treatment.

SCULPTRA™ vs Traditional HA Dermal Fillers

SCULPTRA™ should not be considered equivalent to a conventional Hyaluronic Acid dermal filler.

Traditional Hyaluronic Acid Fillers

Cross-linked HA fillers primarily provide:

• Immediate physical volume

• Structural support

• Facial contouring

• Projection

• Immediate correction of appropriate wrinkles or folds

SCULPTRA™

SCULPTRA™ primarily supports:

• Progressive collagen stimulation

• Regenerative tissue support

• Gradual volume restoration

• Improved tissue firmness

• Improved elasticity

• Improved structural quality

• Progressive improvement in treated tissues

The two product categories therefore work through fundamentally different mechanisms.

SCULPTRA™ may be considered where the professional treatment objective is progressive collagen regeneration and broader structural rejuvenation rather than immediate focal correction alone.

Clinical Evidence & Established Use

SCULPTRA™ has an extensive international clinical history and has been used for more than 25 years.

Clinical research has evaluated its use in facial rejuvenation, wrinkle correction, volume restoration and improvement in skin quality.

Galderma clinical research evaluating updated higher-volume reconstitution protocols has reported effectiveness and tolerability with appropriate use following reconstitution.

Clinical programmes have also demonstrated maintenance of improvements through Week 96, approximately two years following treatment.

Galderma therefore describes SCULPTRA™ as providing progressive, natural-looking results that may remain visible for up to approximately two years.

This should not be interpreted as a guaranteed duration for every patient.

Results & Longevity

SCULPTRA™ produces progressive regenerative results rather than the immediate final result associated with conventional volumising fillers.

Collagen production develops gradually following treatment.

Patients may progressively experience:

• Restoration of facial volume

• Improved facial contours

• Improved tissue firmness

• Improved elasticity

• Improved skin structure

• Improved skin thickness

• Reduction in the appearance of appropriate wrinkles and folds

• Improved overall skin quality

Changes may become increasingly apparent during the weeks and months following treatment.

Following an appropriate treatment course, results may remain visible for up to approximately 2 years in appropriately selected patients.

Individual outcomes and longevity vary according to factors including:

• Age

• Baseline collagen levels

• Degree of facial ageing

• Treatment area

• Number of treatment sessions

• Amount of product used

• Treatment technique

• Lifestyle

• Smoking

• UV exposure

• Metabolism

• Individual biological response

Maintenance treatment may subsequently be considered following professional reassessment.

Storage & Handling

SCULPTRA™ must be stored and handled according to the current Galderma Instructions for Use and information supplied with the original product.

Before reconstitution:

• Keep the product within its original packaging.

• Check the expiry date.

• Inspect each vial.

• Confirm packaging integrity.

• Verify batch and traceability information.

• Maintain the manufacturer's required storage conditions.

During professional preparation:

• Maintain strict aseptic technique.

• Use sterile single-use equipment.

• Use appropriate Sterile Water for Injection.

• Follow the current manufacturer reconstitution protocol.

• Ensure the prepared suspension is appropriate for administration.

During treatment, practitioners must maintain appropriate aseptic technique and follow current Galderma professional guidance.

Do not use the product if:

• A vial is damaged

• The seal has been compromised

• The product has passed its expiry date

• Product integrity is in doubt

• Contamination is suspected

• Authenticity or traceability cannot be established

Important Information

SCULPTRA™ is intended strictly for use by appropriately qualified and specifically trained healthcare professionals.

Professional knowledge of the following is essential:

• Facial anatomy

• Vascular anatomy

• PLLA biostimulation

• Appropriate treatment planes

• Patient selection

• Product preparation and reconstitution

• Aseptic technique

• Complication prevention

• Complication recognition

• Complication management

Patient Assessment

Before treatment, practitioners should undertake an appropriate assessment including:

• Comprehensive patient consultation

• Full medical history

• Facial assessment

• Assessment of volume loss

• Assessment of skin and tissue quality

• Review of previous aesthetic procedures

• Assessment of contraindications

• Discussion of realistic treatment expectations

• Explanation of the progressive nature of SCULPTRA™

• Discussion of potential adverse effects

• Appropriate informed consent

Contraindications & Precautions

SCULPTRA™ should not be used in patients with known allergy or hypersensitivity to any component of the product.

The supplied product information states that Galderma advises against use in patients with a history of:

• Keloid formation

• Hypertrophic scarring

Treatment should also be deferred where active inflammatory or infectious processes are present at or near the proposed treatment area.

The manufacturer's current Instructions for Use must be consulted for the complete list of contraindications, warnings and precautions.

Potential Treatment Reactions

Potential treatment-related reactions may include:

• Swelling

• Redness

• Bruising

• Tenderness

• Pain

• Localised bleeding

• Oedema

Delayed reactions, including palpable or visible nodules, may occur.

More serious complications associated with injectable procedures are also possible.

SCULPTRA™ must not be injected into blood vessels, as inadvertent intravascular administration may result in serious vascular complications.

Correct patient selection, product preparation, anatomical knowledge, professional technique and complication-management competence are therefore essential.

Contour deficiencies should not be deliberately overcorrected because improvement is expected to develop progressively as collagen production increases.

Always consult the current Galderma SCULPTRA™ Instructions for Use and professional training materials for complete information regarding preparation, indications, contraindications, precautions, treatment technique and potential adverse events.

For use by appropriately qualified and specifically trained healthcare professionals only.