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Nucleofill 25

Nucleofill 25

Nucleofill

Aesthetic Medicine
  • Class III CE Marked medical device for aesthetic intradermal use in the EU/EEA market (as indicated by distributors describing Nucleofill 25 Strong as a CE Marked device).
  • Manufactured under quality systems compliant with ISO 13485 for medical devices (per typical Promoitalia Medical Aesthetics documentation and regulatory status).
  • Distributed in accordance with applicable EU Medical Device Regulation (MDR) / legacy Medical Device Directive (MDD) and local country regulations via authorised channels.
Injectable polynucleotide biostimulant / skin booster

Description

Nucleofill 25 (also marketed as Nucleofill Strong or Nucleofill 25 Strong) is a high-viscosity injectable biostimulant gel based on natural polymerised polynucleotides at a concentration of 25 mg/ml. It is designed for deep skin renewal and bio-restructuring, targeting advanced signs of ageing, moderate to deep wrinkles, loss of elasticity and dehydration. By delivering highly purified long-chain polynucleotides, Nucleofill 25 activates fibroblasts, stimulates type I collagen and elastin synthesis, provides strong antioxidant protection and improves tissue oxygenation and hydration. The product is supplied as a sterile, single-use 1.5 ml pre-filled syringe (needle not included) for professional mesotherapy / biorevitalisation treatments of the face, neck, décolleté, hands and selected body areas with scars or stretch marks.

Bnefits

  • Stimulates fibroblasts and promotes collagen and elastin production, improving skin density, firmness and elasticity.
  • Provides intensive bio-restructuring of mature, photo-damaged and oxygen-deprived skin.
  • Deeply hydrates the skin by increasing water binding capacity and improving extracellular matrix quality.
  • Improves the appearance of moderate to deep facial wrinkles while preserving natural facial expression.
  • Helps reduce the visibility of scars and stretch marks through tissue regeneration and remodelling.
  • Delivers strong antioxidant and free-radical scavenging activity, reducing oxidative stress and preventing premature ageing.
  • Lifting and tightening effect with more defined contours and improved skin tone.
  • Suitable for all skin types, including dehydrated and environmentally damaged skin.
  • No hyaluronic acid – based purely on highly purified polynucleotides.
  • Provides long-lasting results when used in a course of treatments with relatively short recovery time.

Indications

  • Mature, photo-aged or chronically dehydrated skin requiring deep regeneration and bio-restructuring.
  • Moderate to deep facial wrinkles and folds (e.g. cheeks, nasolabial areas, lower face).
  • Loss of skin firmness, elasticity and facial contour definition.
  • Dull, tired-looking or oxygen-deprived skin with reduced radiance.
  • Treatment of certain atrophic scars and stretch marks on the face and body, as assessed by a qualified practitioner.
  • Adjunctive biostimulatory therapy in aesthetic treatment plans to enhance overall skin quality prior to or in combination with other procedures (e.g. fillers, lasers), at the clinician’s discretion.

Composition

  • Highly purified polymerised polynucleotides (PDRN / polynucleotide chains) 25 mg/ml.
  • Buffering components and physiological saline solution suitable for injectable use.
  • Does not contain hyaluronic acid; free from animal-derived proteins and cross-linking agents according to supplier information.

Formulation

  • Sterile, apyrogenic viscoelastic gel based on natural polynucleotides.
  • Concentration: 25 mg/ml polynucleotides (2.5%).
  • Intended route: intradermal / subdermal injection for professional aesthetic use.
  • Single-use, pre-filled syringe presentation for precise dosing and minimally invasive application.

Packaging

  • 1 x 1.5 ml pre-filled glass or medical-grade polymer syringe containing Nucleofill 25 gel.
  • Sterile blister or box packaging including syringe and package insert (needle not included).
  • Outer carton printed with product name, concentration (25 mg/ml), batch number and expiry date.

Usage

  • For professional use only: Nucleofill 25 must only be administered by suitably trained and qualified healthcare professionals experienced in injectable aesthetic procedures.
  • Treatment protocol commonly consists of 2–3 sessions spaced approximately 2–4 weeks apart, with the exact number of sessions and intervals determined by the practitioner based on individual skin condition and treatment goals.
  • Injection areas typically include the face, neck, décolleté and hands; selected body areas with scars or stretch marks may also be treated at the clinician’s discretion.
  • Standard pre-treatment assessment and medical history must be performed to exclude contraindications and determine suitability.
  • Aseptic technique must be strictly observed throughout preparation and administration to minimise the risk of infection.
  • Post-treatment, patients should follow practitioner advice, including avoiding makeup, intense heat, UV exposure, saunas, swimming pools and vigorous exercise for a specified period (commonly 24–48 hours).
  • Patients should be advised not to massage or manipulate the treated areas unless specifically instructed and to report any unexpected or severe reactions immediately.
  • Maintenance treatments may be recommended periodically (for example every 6–12 months) depending on clinical response, skin type and lifestyle factors.

Contraindications

  • Known hypersensitivity or allergy to polynucleotides or any excipient in the formulation.
  • Active skin infections, inflammation or dermatological disease in the proposed treatment area (e.g. bacterial, viral, fungal or herpetic lesions).
  • Autoimmune diseases or systemic conditions in which injectable biostimulating treatments are considered inappropriate by the treating physician.
  • History of severe keloid or hypertrophic scarring in areas to be treated, unless carefully evaluated by a specialist.
  • Pregnancy and breastfeeding, due to lack of adequate safety data – use is generally not recommended.
  • Concurrent systemic illnesses, anticoagulant therapy or bleeding disorders where injectable procedures carry increased risk, unless specifically assessed and approved by the treating clinician.
  • Recent aggressive aesthetic procedures in the same area (e.g. deep chemical peels, ablative lasers, surgery) until full healing has occurred.

Adverse Effects

  • Common, usually transient reactions at injection sites: redness (erythema), swelling, tenderness, bruising, mild pain or itching.
  • Occasional small nodules, induration or unevenness at injection points, typically resolving spontaneously or with gentle management as directed by the practitioner.
  • Rare but more serious complications associated with any injectable procedure, such as infection, abscess, granuloma formation, hypersensitivity reactions or vascular compromise; these require prompt medical evaluation and management.
  • Temporary exacerbation of pre-existing inflammatory skin conditions in the treated area in susceptible individuals.
  • As with any aesthetic injectable, results and tolerance may vary; lack of satisfactory effect is possible despite correct administration.

Storage Conditions

  • Store between 2°C and 25°C in a dry place.
  • Do not freeze; protect from extreme heat and direct sunlight.
  • Keep in the original packaging until use to protect from light and contamination.
  • Do not use after the expiry date printed on the packaging.
  • Single-use only: any unused product remaining in an opened syringe must be discarded according to local regulations for clinical sharps and medical waste.

Duration

Typical initial treatment course consists of around 2\u20133 sessions over 4\u20138 weeks, with improvements often maintained for several months. Long-term outcomes and maintenance frequency depend on individual ageing patterns, lifestyle and concurrent aesthetic treatments.

Onset

Initial improvements in hydration and radiance may be visible within days to a few weeks after the first session, with progressive enhancement of firmness, elasticity and wrinkle reduction developing over subsequent sessions as collagen and tissue remodelling occur.

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