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Croma PolyPhil Next (1 x 2 ml)

Croma PolyPhil Next (1 x 2 ml)

PolyPhil Next (by Croma-Pharma)

Medical device – injectable skin booster / biostimulator
  • CE Marked injectable medical device for intradermal use in aesthetic medicine.
  • Manufactured by Croma Pharma under ISO 13485 Compliant quality management for medical devices in an EU Based facility.
  • Utilises Polynucleotide High Purification Technology (PN HPT®) to ensure high Purity polynucleotides and enhanced safety profile.
Intradermal polynucleotide (PN-HPT) and hyaluronic acid gel

Description

Croma PolyPhil Next (1 x 2 ml) is an innovative CE-marked injectable biostimulator developed by Croma-Pharma for intradermal use on the face, neck and décolletage. The product contains long-chain polynucleotides (PN-HPT®) at 10 mg/ml combined with non-crosslinked hyaluronic acid at 10 mg/ml and mannitol, in a sterile, apyrogenic gel. This hybrid formulation delivers deep hydration, stimulates fibroblast activity and collagen production, protects against free radicals and improves overall skin quality. It is particularly suited to mature or dehydrated skin with loss of elasticity, fine-to-medium wrinkles, acne scars and other textural irregularities, providing firmer, more elastic and radiant skin with a natural-looking result.

Bnefits

  • Stimulates collagen and elastin production via polynucleotides, improving firmness and elasticity of the skin.
  • Deeply hydrates tissues thanks to non-crosslinked hyaluronic acid and PN’s water-binding capacity, improving texture and softness.
  • Helps treat and remodel acne scars and other superficial scars by supporting tissue regeneration.
  • Protects against free radicals, reducing oxidative stress that contributes to premature skin ageing.
  • Improves overall skin quality, tone and luminosity in mature or dehydrated skin.
  • Enhances elasticity and hydration, reducing the appearance of fine and medium wrinkles on face, neck and décolletage.
  • Hybrid PN + HA formula provides both biostimulatory repair and immediate hydrating/viscoelastic support.
  • Manufactured using PN-HPT® (Polynucleotide High Purification Technology) for highly purified fish-derived polynucleotides and a strong safety profile.
  • CE-marked injectable medical device produced to high European quality standards.

Indications

  • Mature or dehydrated skin with loss of firmness and elasticity.
  • Visible wrinkles and creases (especially medium-depth facial lines).
  • Dull, tired-looking skin with impaired texture and tone.
  • Acne scars and other superficial scars, including some atrophic scars.
  • Skin quality improvement on face, neck and décolletage.
  • Supportive treatment for photoaged skin showing early to moderate ageing changes.
  • Complementary biostimulation prior to or in combination with other aesthetic procedures (e.g. fillers, lasers, microneedling) as part of a comprehensive rejuvenation plan.

Composition

  • Polynucleotides PN-HPT® (highly purified long-chain polynucleotides) 10 mg/ml (20 mg/2 ml).
  • Non-crosslinked hyaluronic acid 10 mg/ml (20 mg/2 ml).
  • Mannitol ~200 mM (slows hyaluronic acid degradation and provides antioxidant support).
  • Buffered sterile aqueous vehicle, apyrogenic, suitable for intradermal injection.

Formulation

  • Sterile, apyrogenic injectable gel for intradermal administration.
  • Hybrid composition of long-chain polynucleotides and non-crosslinked hyaluronic acid with mannitol.
  • Single-use pre-filled 2 ml glass syringe.
  • No lidocaine in the formulation; anaesthetic cream or local anaesthesia can be used separately according to clinical judgement.
  • Medical device developed using Polynucleotide High Purification Technology (PN-HPT®) in an EU facility.

Packaging

  • Box containing 1 x 2 ml pre-filled syringe of Croma PolyPhil Next.
  • Pack includes 2 x 30G ½" (13 mm) sterile needles for intradermal injection.
  • Each syringe is individually blister-packed and batch-coded for full traceability.

Usage

  • For professional use only – must be administered by suitably qualified healthcare professionals experienced in intradermal injection techniques.
  • Injection depth: intradermal. Recommended techniques include microdeposit / microdroplet, linear, fan or mixed techniques, depending on the treatment area and physician preference.
  • Do not exceed 2 ml per session. Typically the full 2 ml syringe is used per treatment, with dosing spread over the selected areas.
  • Treatment areas: face (especially mid-face for texture and wrinkles), neck, décolletage and selected scarred or acne-scarred regions.
  • Recommended course: generally 3 sessions for normal or mildly aged skin, or 4 sessions for mature/markedly aged skin, each session spaced 14–21 days apart.
  • Maintenance: repeat courses or top-up treatments are usually recommended every 4–6 months (based on patient response and clinical judgement) to sustain hydration, elasticity and texture improvement.
  • Prior to injection: take full medical history, obtain informed consent, disinfect the treatment area and adhere to aseptic technique.
  • After treatment: advise patients about normal post-injection reactions (redness, swelling, small bumps, tenderness or bruising) and standard aftercare (e.g. avoiding make-up, intense UV exposure, sauna and strenuous exercise for 24–48 hours or as per clinic protocol).

Contraindications

  • Known hypersensitivity or allergy to polynucleotides (including fish-derived DNA), hyaluronic acid, mannitol or any other component of the product.
  • Active skin infections, inflammatory dermatoses or open lesions at the intended injection sites.
  • Severe systemic diseases, active autoimmune diseases or immunosuppression, unless specifically assessed and cleared by the treating physician.
  • History of severe allergies or anaphylactic reactions.
  • Known coagulation disorders or current anticoagulant/antiplatelet therapy where intradermal injections are deemed unsafe by the physician.
  • Pregnancy and breastfeeding (use is generally not recommended due to absence of safety data).
  • History of keloid or hypertrophic scar formation in the planned treatment area.
  • Any other medical condition that, in the judgement of the treating healthcare professional, makes intradermal biostimulation unsafe or inappropriate.

Adverse Effects

  • Common, usually self-limiting injection-site reactions such as erythema (redness), local swelling, tenderness, small papules, and bruising, typically resolving within a few days.
  • Occasional itching, warmth or mild discomfort at or near injection points.
  • Rare events include infection, prolonged inflammation, palpable nodules or hypersensitivity reactions requiring medical assessment.
  • Very rare risk of allergic reaction to fish-derived polynucleotides or other components; immediate medical attention is required if signs of severe allergy or anaphylaxis occur.
  • As with all injectable procedures, improper technique may increase the risk of complications, underscoring the need for qualified professional administration.

Storage Conditions

  • Store in accordance with manufacturer’s instructions, typically between 2 °C and 25 °C.
  • Protect from direct sunlight and do not freeze.
  • Keep the syringe in its original blister and carton until use to maintain sterility and protect from light.
  • Do not use after the expiry date indicated on the packaging.
  • Single-use device: discard any unused product after the procedure in accordance with local regulations for clinical/medical waste.
  • Keep out of the sight and reach of children.

Duration

A typical initial protocol comprises 3\u20134 treatment sessions spaced every 14\u201321 days. Clinical improvements in hydration, elasticity and texture usually persist for approximately 4\u20136 months or longer, after which maintenance sessions every 4\u20136 months are recommended, tailored to individual needs.

Onset

Initial improvements in hydration and skin radiance are often noticeable within days to weeks after the first 1\u20132 sessions, with more pronounced benefits in elasticity, firmness, wrinkle softening and scar quality developing progressively over the full treatment course.

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