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Nucleofill Strong (25) Polynucleotide Gel 1 x 1.5 ml

Nucleofill Strong (25) Polynucleotide Gel 1 x 1.5 ml

Nucleofill

Injectable skin booster
  • CE Marked medical device (CE 0373) for injectable use in adults
  • Manufactured under European medical device quality and safety standards for sterile injectable gels
  • Intended exclusively for professional use by qualified healthcare practitioners
  • Distributed through regulated medical and aesthetic supply chains with batch traceability
Polynucleotide bio-stimulating gel for face and body

Description

Nucleofill Strong (25) is a high-viscosity, sterile injectable polynucleotide gel developed by Promoitalia Medical Aesthetics for deep skin biostimulation and regeneration. Containing a 2.5% concentration of polymerised polynucleotides (25 mg/ml) in a 1.5 ml pre-filled syringe, it is designed for the intensive treatment of visible skin ageing, deep wrinkles, laxity and structurally damaged or oxidatively stressed skin. Rather than acting as a conventional volumising filler, Nucleofill Strong works via a three-level mechanism: lifting and tissue redensification, powerful antioxidant action and iso-osmotic deep hydration. By stimulating fibroblasts, enhancing collagen synthesis and improving microcirculation, it restores skin density, elasticity and radiance on the face, neck, décolleté, hands and selected body areas such as abdomen, thighs and buttocks. Results are natural-looking and long-lasting, making it an advanced option for bio-restructuring in aesthetic medicine.

Bnefits

  • Deep bio-restructuring and regeneration of ageing or damaged skin
  • Provides a lifting and redensifying effect for tissues with loss of firmness and elasticity
  • Reduces the appearance of fine to deep wrinkles and furrows
  • Improves skin tone, density and overall quality
  • Offers strong antioxidant protection, helping to neutralise free radicals and oxidative stress
  • Delivers intense, long-lasting hydration through iso-osmotic water binding in the extracellular matrix
  • Helps treat scars and stretch marks by supporting tissue repair and remodelling
  • Suitable for tired, dull, dehydrated and structurally damaged skin
  • Non-volumising regenerative alternative or complement to traditional fillers
  • Designed for long-lasting results after a limited number of sessions

Indications

  • Deep and moderate facial wrinkles and furrows (e.g. nasolabial folds)
  • Marked skin laxity and loss of elasticity in the face and body
  • Cutaneous ageing with visible loss of tone and turgor
  • Dry, dehydrated or structurally damaged skin
  • Skin exposed to oxidative stress (pollution, sun, smoking and lifestyle factors)
  • Atrophic, thin or stressed skin with reduced resilience
  • Stretch marks and certain superficial to moderate scars
  • Redensification and lifting of cheeks, jawline and neck
  • Rejuvenation of neck and décolleté
  • Hand rejuvenation (backs of hands)
  • Selected body indications such as abdomen, thighs and buttocks, according to clinical judgement

Composition

  • Polymerised polynucleotides (sodium DNA) 25 mg/ml (2.5% polynucleotide gel)
  • Highly purified, natural-origin polynucleotides with high molecular weight (approximately 2,500 kDa)
  • Sterile, pyrogen-free injectable gel in a 1.5 ml glass syringe or vial
  • pH approximately 6.8–7.5
  • Viscosity approximately 48–65 Pa·s under specified shear conditions
  • Excipients such as water for injection and sodium chloride as per medical device formulation

Formulation

  • Sterile, injectable polynucleotide biostimulating gel for deep dermal and subdermal use
  • 2.5% polynucleotide concentration (25 mg/ml) for intensive biostimulation
  • High-viscosity viscoelastic gel allowing controlled placement and sustained effect
  • Non-crosslinked, non-hyaluronic acid formulation focused on regeneration rather than volumisation
  • Designed for deep dermis, adipose and, when indicated, subperiosteal planes in accordance with IFU
  • Medical device CE 0373 suitable for adult patients treated by qualified professionals

Packaging

  • Box containing 1 x 1.5 ml pre-filled sterile syringe of Nucleofill Strong (25 mg/ml polynucleotide gel)
  • 2 x disposable needles (commonly 30G x 12–13 mm) included in the pack
  • Sterile blister and outer carton with batch number and expiry date
  • Instructions for use (IFU) and clinical guidance leaflet
  • CE-marked medical device labelling (CE 0373) for professional use only

Usage

  • For professional use only; treatment must be carried out by trained, appropriately qualified medical practitioners experienced in injectable procedures.
  • Indicated for deep dermal and sub-dermal biostimulation using techniques such as linear threading, multipoint injection, fan technique with cannula, or deep micro-bolus injections according to the treatment plan and IFU.
  • Typical protocol involves injecting approximately 0.1 ml per point, spaced about 1 cm apart, in the deep dermis, adipose layer or, when indicated, on the periosteum for intensive lifting and redensification.
  • Commonly used areas include face (cheeks, nasolabial folds, jawline), neck, décolleté, backs of hands and selected body regions such as abdomen, thighs and buttocks.
  • Suggested treatment regimen from various clinical protocols: 2–4 sessions spaced 15–30 days apart, depending on indication, age, skin condition and practitioner’s judgement.
  • Some suppliers and protocols recommend a schedule such as sessions on days 0, 15, 30 and 45 for intensive courses, followed by maintenance sessions approximately every 6–12 months.
  • Before injection, cleanse and disinfect the area thoroughly; observe strict aseptic technique and avoid intravascular injection.
  • Needle choice is typically 30G x 12–13 mm, or an appropriate cannula size when using fan techniques.
  • Do not exceed recommended total volume per session and per area; adjust dose according to indication, severity of ageing and anatomical site.
  • Post-treatment advice usually includes avoiding makeup on the treated area for several hours, refraining from rubbing or massaging the area unless instructed, and avoiding intense heat exposure, saunas, vigorous exercise and excessive UV exposure for 24–48 hours.
  • Always follow the official instructions for use (IFU) and local clinical guidelines, and obtain informed consent after discussing benefits, risks and alternatives with the patient.

Contraindications

  • Known hypersensitivity or allergy to polynucleotides (sodium DNA) or any component of the product
  • Pregnancy and breastfeeding (as a precaution in the absence of dedicated safety data)
  • Patients under the legal age for aesthetic procedures according to local regulations (commonly under 18 years old)
  • Active skin infections, inflammation or dermatological diseases at or near the intended injection sites (e.g. bacterial, fungal or viral infections such as active herpes simplex)
  • Severe autoimmune or collagen disorders, unless specifically assessed and cleared by the treating physician
  • Uncontrolled systemic diseases or significant immunosuppression that would increase procedural risk
  • Coagulation disorders or current anticoagulant/antiplatelet therapy that significantly raises bleeding risk, unless managed appropriately by a physician
  • Recent aggressive dermatological procedures (e.g. deep chemical peels, ablative laser resurfacing) in the intended treatment area, where healing is incomplete
  • History of severe allergic reactions, anaphylaxis or serious adverse responses to injectable biostimulators
  • Any general contraindications to injectable aesthetic procedures as determined by a qualified healthcare professional

Adverse Effects

  • Transient redness (erythema) at injection sites
  • Mild to moderate swelling or oedema in the treated areas
  • Localized tenderness, discomfort or tightness following injection
  • Small bruises or haematomas, particularly in patients prone to bruising
  • Temporary itching, warmth or sensitivity of the treated skin
  • Short-lived nodules or palpable product deposits that usually resolve as the gel integrates, though persistent nodules may require medical management
  • Rare delayed inflammatory or hypersensitivity reactions
  • Very rare but serious risks associated with any injectable, including infection, vascular compromise or embolic events if improperly injected; strict adherence to anatomical knowledge and safe technique is essential

Storage Conditions

  • Store at a controlled temperature, generally between 2°C and 25°C, following the specific range indicated on the packaging.
  • Keep the product in its original outer carton to protect from light and contamination until use.
  • Do not freeze the product.
  • Store in a dry place, away from direct sunlight and heat sources.
  • Do not use after the expiry date printed on the packaging.
  • Single-use medical device: use immediately after opening and dispose of any unused product in accordance with medical waste regulations.
  • Keep out of reach of children and unauthorised persons.

Duration

Clinical protocols and manufacturer-associated materials indicate that, after a course of approximately 2\u20134 sessions spaced 2\u20134 weeks apart, results in terms of improved hydration, density and wrinkle reduction can last around 6\u201312 months, depending on the patient\u2019s age, skin condition, lifestyle and maintenance schedule.

Onset

Initial improvements in skin hydration, texture and radiance are often noticeable within a few weeks of the first treatment, with more significant lifting, redensifying and wrinkle-reducing effects developing progressively over the full series of sessions and continuing as collagen and extracellular matrix remodelling occurs in the following months.

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