Polycaprolactone-based collagen-stimulating hand rejuvenation dermal filler
Certifications
CE Marked Class III medical device under the European medical device regulatory framework for implantable dermal fillers
Manufactured in accordance with ISO 13485 Compliant quality management systems for medical devices
Biocompatibility and safety evaluated according to relevant ISO 10993 standards for implantable, bioresorbable materials
CE Marked Class III medical device under the European medical device regulatory framework for implantable dermal fillers
Manufactured in accordance with ISO 13485 Compliant quality management systems for medical devices
Biocompatibility and safety evaluated according to relevant ISO 10993 standards for implantable, bioresorbable materials
Sterilisation process and packaging validated to applicable EN/ISO standards for sterile, single Use injectable implants
Supported by a Summary of Safety and Clinical Performance (SSCP) for Ellansé dermal fillers as required for Class III implantable devices in the EU
Description
Ellansé S Hands (2 x 1ml) is a sterile, single-use, bioresorbable dermal filler specifically presented and marketed for hand rejuvenation. It is based on the Ellansé S poly-ɛ-caprolactone (PCL) collagen-stimulating technology and consists of smooth PCL microspheres suspended in a carboxymethylcellulose (CMC) gel carrier. Injected into the dorsum of the hands, it provides immediate volumisation to correct age-related volume loss and prominent veins and tendons, while stimulating the body’s own collagen production for long-lasting improvement in skin quality, firmness and texture. The product is fully bioresorbable and is intended for use only by qualified medical professionals.
Bnefits
Specifically designed and indicated for rejuvenation of the backs of the hands
Immediate visible volumisation to reduce the appearance of veins, tendons and bony contours
Long-lasting results (around 1 year for the S variant) through stimulation of the body’s own collagen
Improves skin density, firmness and elasticity, giving smoother and more youthful-looking hands
Restores lost volume and contours associated with age-related fat and collagen depletion
Dual action: CMC carrier gel provides instant correction while PCL microspheres trigger neocollagenesis
Bioresorbable and non-permanent implant that fully degrades over time into CO₂ and H₂O
May reduce the need for frequent maintenance sessions compared with many traditional hyaluronic acid fillers used in the hands
Soft, smooth gel designed for natural-looking results when injected with proper technique
Indications
Injectable implant for subdermal implantation in the hands for long-lasting correction of age-related volume loss and skin laxity on the dorsum of the hands
Rejuvenation of bony, veiny or tendinous-looking hands by restoring soft-tissue volume
Improvement of skin quality and texture on the backs of the hands through collagen stimulation
Reduction in the visible prominence of veins and tendons caused by loss of subcutaneous tissue
Use in appropriately selected adult patients seeking non-surgical hand rejuvenation performed by trained medical professionals
Sterilisation process and packaging validated to applicable EN/ISO standards for sterile, single Use injectable implants
Supported by a Summary of Safety and Clinical Performance (SSCP) for Ellansé dermal fillers as required for Class III implantable devices in the EU
Polycaprolactone-based collagen-stimulating hand rejuvenation dermal filler
Composition
Polycaprolactone (PCL) microspheres – approximately 30% of the gel by volume, smooth and spherical, with a typical particle size range of about 25–50 μm
Carboxymethylcellulose (CMC) gel carrier – approximately 70% of the gel by volume, fully resorbable over 2–3 months
Buffered aqueous excipients including water for injection, glycerin and phosphate-buffered saline (PBS) as part of the CMC system
Poly-ɛ-caprolactone-based dermal filler presented as a soft, absorbable gel containing PCL microspheres suspended in a CMC carrier gel
Bioresorbable, biocompatible injectable implant for subdermal use in hand rejuvenation
Non-permanent collagen stimulator that maintains full correction throughout its intended performance duration
CMC carrier gel provides the initial volume effect, while PCL microspheres provide a scaffold for new collagen formation as the CMC resorbs
Packaging
Box containing 2 x 1 ml prefilled syringes labelled for Ellansé S Hands
4 sterile 27G 3/4" needles supplied for use with the syringes (quantity and needle gauge as per standard Ellansé S presentation)
Sterile blister/foil packaging for each syringe
Package insert (Instructions for Use) detailing indications, contraindications, warnings and injection guidance
Traceability labels showing product name, batch/lot number, expiry date and CE Class III device information
Usage
Ellansé S Hands is strictly for medical use and must only be injected by qualified, trained healthcare professionals (e.g. dermatologists, plastic surgeons or aesthetic physicians) experienced in hand rejuvenation and familiar with Ellansé products.
Conduct a full medical history and hand examination to confirm suitability, including assessment of skin quality, degree of volume loss, vascular pattern and any contraindications.
Obtain informed consent, explaining expected benefits, longevity, potential risks and alternative treatment options.
Cleanse and disinfect the dorsum of the hands thoroughly; consider topical or local anaesthesia as appropriate to patient and practitioner preference.
Attach a supplied sterile needle (typically 27G 3/4") or an appropriate microcannula according to local practice and official guidance, expelling any air bubbles from the syringe.
Inject the product into the subdermal or deep dermal plane on the dorsum of the hand using appropriate techniques (such as retrograde linear threading, fanning, or small depot injections), carefully avoiding intravascular injection.
Distribute small aliquots evenly across the dorsum of the hand, avoiding injection close to tendons, joint spaces and superficial veins, and taking care not to overcorrect.
Gently massage the treated area if required to ensure even distribution and smooth contours, following the manufacturer’s Instructions for Use.
Advise patients to avoid heavy hand use, extreme temperature exposure (very hot water, saunas, intense cold), vigorous exercise and application of irritant products to treated areas for at least 24–48 hours or until initial redness and swelling have resolved.
Arrange a follow-up visit to review aesthetic outcomes, patient satisfaction and to assess for any early or delayed adverse events, managing any complications according to current clinical guidance and the Instructions for Use.
Contraindications
Known hypersensitivity or allergy to polycaprolactone, carboxymethylcellulose or any other component of the formulation
Active or recurrent skin disease, infection or inflammation at or near the intended injection sites on the hands (e.g. active dermatitis, psoriasis, bacterial or viral infection, including herpetic lesions)
Active systemic infection or uncontrolled systemic illness until appropriately treated and stabilised
History of severe allergies, anaphylaxis or multiple serious drug allergies, based on physician assessment
Patients with known tendency to keloid or hypertrophic scar formation
Patients with autoimmune disease, immunosuppression or significant uncontrolled systemic disorders where the treating physician considers risk unacceptable
Pregnant or breastfeeding women, or patients planning pregnancy, due to lack of adequate safety data
Patients under 18 years of age
Concomitant use of anticoagulant or antiplatelet therapy without appropriate risk-benefit assessment in relation to bruising and bleeding risk
Presence of permanent fillers or implants in the intended treatment area which may interact with Ellansé or distort results
Any contraindication listed in the official Instructions for Use (IFU), which should always take precedence over general guidance
Adverse Effects
Expected transient injection-site reactions: redness (erythema), swelling (oedema), tenderness or pain, warmth and bruising on the dorsum of the hands
Temporary lumps, nodules, firmness or palpable product at or near the injection site, typically resolving with time or appropriate management
Itching or mild inflammatory reactions in the treated areas
Delayed-onset inflammatory reactions or swelling, sometimes associated with systemic infection or immune activation
Local infection at the injection site, which may require medical treatment, including antibiotics, drainage or other interventions
Rare granulomatous or foreign-body reactions or persistent nodules, requiring specific management as per current clinical recommendations for PCL-based fillers
Vascular compromise due to intravascular injection or external compression, potentially leading to ischaemia and tissue necrosis if not recognised and treated promptly
Very rare but serious complications documented with dermal fillers in general, such as embolic events; although primarily associated with facial injections, vascular safety principles also apply to hand injections
Any unusual, worsening or persistent adverse effects should prompt immediate evaluation and appropriate management by an experienced medical professional
Storage Conditions
Store in the original packaging in a clean, dry environment at controlled room temperature, typically between 15 °C and 25 °C, as specified in the Instructions for Use.
Protect from direct sunlight, excessive heat and freezing; do not freeze or expose to temperatures outside the recommended storage range.
Do not use the product after the expiry date printed on the outer carton and syringe labels.
Do not use if the packaging, blister or syringe appears damaged, previously opened or if sterility is in doubt.
Keep out of the reach of children and unauthorised persons, in accordance with local regulations governing Class III medical devices.
Duration
For Ellans\u00e9 S Hands, the typical duration of effect is around 12 months, with sustained correction throughout this period depending on patient age, skin quality, metabolism, injection technique and lifestyle factors.
Onset
Immediate volumising and soft-tissue augmentation of the dorsum of the hands due to the CMC gel carrier, with progressive collagen stimulation and further improvements in skin density, firmness and texture over subsequent weeks and months.
