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NEWEST One 5x4ml

NEWEST One 5x4ml

NEWEST

Injectable skin booster
  • Class III CE Marked medical device (CE0373) for intradermal infiltration, as part of Mastelli’s PN HPT® aesthetic medicine line.
  • Manufactured by Mastelli S.r.l. under quality management systems compliant with European medical device regulations (including ISO 13485 for medical devices, as reflected in Mastelli’s aesthetic medicine documentation).
  • Part of the Mastelli Aesthetic Medicine & Dermocosmetics PN HPT® device portfolio, which is subject to clinical evaluation and post Market surveillance requirements for high Risk devices.
Polynucleotide and hyaluronic acid mesotherapy solution (vials/ampoules)

Description

NEWEST One 5x4ml is a Class III CE-marked intradermal mesotherapy solution from Mastelli that combines highly purified polynucleotides PN-HPT® and non-crosslinked hyaluronic acid, with mannitol as an antioxidant stabiliser. Supplied as 5 vials of 4 ml each, it is suggested for treating atrophic scars, striae distensae (stretch marks) depressions and body blemishes, particularly in dehydrated and older patients. By deeply hydrating tissues, improving turgidity and elasticity, and promoting tissue remodelling in fibrous, depressed areas, NEWEST One helps restore smoother, firmer and more even-toned skin over the body and other extended areas.

Bnefits

  • Targets atrophic scars, striae distensae depressions and body blemishes, especially in dehydrated and older patients.
  • Provides intensive hydration and improved turgor through non-crosslinked hyaluronic acid combined with PN-HPT®.
  • Supports remodelling of areas with strong fibrous components and depressed scarring, such as stretch marks.
  • Enhances skin elasticity, firmness and overall tissue tone in extended body areas.
  • Mannitol acts as an antioxidant and helps inhibit enzymatic and oxidative degradation of hyaluronic acid, prolonging its effect.
  • Stimulates fibroblast activity and extracellular matrix renewal, promoting production of collagen and elastin.
  • Improves dull complexion and uneven skin tone, helping restore a healthy, radiant appearance.
  • Versatile mesotherapy solution in vials/ampoules that can be used across face and body areas by trained professionals.

Indications

  • Treatment of atrophic scars and depressed scarring on the body or face, as assessed by a qualified practitioner.
  • Remodelling and improvement of striae distensae (stretch marks) depressions.
  • Body blemishes and textural irregularities associated with dehydration and ageing.
  • Dehydrated skin and decreased tissue tone on extended areas such as abdomen, thighs, buttocks, hips and arms.
  • Dull complexion and uneven skin tone in treated regions.
  • General biorevitalisation of body and extended skin areas in dehydrated and older patients, within aesthetic medicine protocols.

Composition

  • Highly Purified Polynucleotides (PN-HPT®) 1 mg/ml.
  • Polynucleotides PN-HPT® 2 mg/ml (High Purification Technology) – additional concentration used depending on protocol, as stated in commercial descriptions.
  • Non-crosslinked hyaluronic acid 1 mg/ml.
  • Mannitol (antioxidant and inhibitor of hyaluronic acid degradation).
  • Isotonic aqueous solution with suitable excipients for intradermal injection in sterile, apyrogenic vials/ampoules.

Formulation

  • Sterile, isotonic intradermal solution containing PN-HPT®, non-crosslinked hyaluronic acid and mannitol.
  • Designed as a mesotherapy / skin booster ampoule for intradermal infiltration of extended body and selected facial areas.
  • Solution (not cross-linked filler gel) formulated for uniform dispersion through microinjections in the dermis.
  • Class III medical device for intradermal use under professional supervision.

Packaging

  • Pack contains 5 vials of 4 ml (5 x 4 ml) NEWEST One solution.
  • Vials/ampoules intended for drawing up into appropriate sterile syringes for intradermal injection.
  • Outer carton labelled with product name, composition (PN-HPT®, non-crosslinked HA, mannitol), volume, lot number and expiry date.
  • Packaging indicates that the device is a Class III MD with CE mark and identifies Mastelli S.r.l. as manufacturer.
  • Intended strictly for professional medical-aesthetic use; accompanied by instructions for use (IFU) supplied with the product or available from the manufacturer.

Usage

  • For intradermal use only by trained and authorised healthcare professionals (e.g., aesthetic physicians, dermatologists) experienced in mesotherapy and PN-HPT® protocols.
  • Perform a full medical and skin assessment to confirm indications (atrophic scars, striae distensae, body blemishes, dehydration, loss of tone) and rule out contraindications; obtain informed consent.
  • Cleanse and disinfect the treatment area using appropriate antiseptic measures according to local infection control guidelines.
  • Draw the required volume of NEWEST One solution from a 4 ml vial into a sterile syringe fitted with a fine needle (commonly 30G ½ or as per protocol).
  • Inject intradermally using mesotherapy techniques such as microdroplet, nappage, or linear retrograde threading, depending on the anatomical area and the severity of lesions (striae, scars, blemishes).
  • Distribute injections evenly across the affected area, adapting spacing and volume per point to lesion density and skin thickness.
  • Clinical protocols for striae distensae often use cycles of 6–8 intradermal sessions over about 3 months (e.g., weekly injections in the first month followed by bi-weekly sessions in subsequent months); specific frequency, number of sessions and maintenance treatments are determined by the treating physician.
  • After treatment, gently massage the area if required to optimise product distribution, avoiding excessive pressure over fragile skin.
  • Provide post-treatment care instructions, including avoidance of intense heat, UV exposure (with strict photoprotection), aggressive topical products and vigorous exercise for a short period.
  • Do not mix NEWEST One with other products in the same syringe or inject into blood vessels; avoid areas with active infection, inflammation, or compromised skin integrity.
  • Follow the detailed recommendations and precautions set out in the official instructions for use (IFU) and comply with local clinical guidelines and regulations.

Contraindications

  • Known hypersensitivity or allergy to polynucleotides (including fish-derived DNA/RNA where relevant), hyaluronic acid, mannitol or any other component of the formulation.
  • Active infection, inflammation, dermatitis, or ulcerative lesions in the intended treatment area (e.g., bacterial, viral, or fungal skin infections).
  • History of severe allergic reactions or anaphylaxis where injectable medical devices may pose heightened risk.
  • Significant coagulation or bleeding disorders, or current use of anticoagulant therapy, where intradermal injections may present unacceptable risk in the judgment of the treating physician.
  • Autoimmune diseases or immunosuppression in which injectable biorevitalisation is considered inappropriate by the clinician.
  • Pregnancy and breastfeeding, due to insufficient safety data in these populations.
  • Presence of malignancy or premalignant lesions in the target area, unless specifically cleared by the responsible specialist.
  • Any other contraindications or cautions listed in the official NEWEST One instructions for use and relevant local clinical guidelines.

Adverse Effects

  • Expected transient injection-site reactions such as erythema (redness), swelling, mild pain or tenderness, warmth, itching and a feeling of tightness.
  • Small bruises (ecchymoses), haematoma and local oedema at injection points, usually resolving spontaneously within a few days.
  • Palpable small papules or irregularities immediately after mesotherapy injections, normally dissipating as the solution diffuses in the dermis.
  • Occasional prolonged redness, sensitivity or local inflammatory response, which should be evaluated and managed by the treating practitioner.
  • Rare hypersensitivity or allergic reactions to one of the components, potentially requiring medical treatment.
  • As with all injectable intradermal procedures, there is a risk of infection, abscess, or delayed wound healing if aseptic technique is not strictly followed.
  • Very rare but possible complications related to injections, such as vascular compromise or nerve irritation, especially if the product is inadvertently injected too deeply or into inappropriate planes.
  • Healthcare professionals should follow the safety information and adverse event guidance in the IFU and report serious incidents according to local medical device vigilance regulations.

Storage Conditions

  • Store in accordance with the temperature range indicated on the product packaging (typically at controlled room temperature).
  • Protect from extremes of heat and cold; do not freeze the product.
  • Keep vials in their original packaging until use to maintain sterility and protect from light and physical damage.
  • Do not use after the expiry date indicated on the carton and vial, or if the packaging appears damaged or compromised.
  • Store out of reach of children and unauthorised persons; product is intended exclusively for professional use.

Duration

Typically used in treatment cycles of approximately 6\u20138 intradermal sessions over around 3 months for conditions such as striae distensae and depressed scars, with weekly injections in the initial phase and bi-weekly injections thereafter, as described in clinical practice and case reports. The exact number of sessions, interval between treatments and any maintenance protocol are tailored by the treating clinician based on the severity of lesions, patient age, skin condition and response.

Onset

Early improvements in hydration, turgidity and skin comfort can appear within weeks of initiating treatment, with progressive remodelling of fibrous, depressed areas (e.g., stretch marks and atrophic scars) developing over the full treatment cycle and subsequent weeks as collagen and extracellular matrix reorganisation occurs.

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