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POLYPHIL HAIR (PHILART) (1x2ml)

POLYPHIL HAIR (PHILART) (1x2ml)

Croma

Injectable hair and scalp biostimulator
  • CE Marked Class III medical device within the Croma PhilArt/PolyPhil polynucleotide range for intradermal use by healthcare professionals
  • Manufactured by Croma Pharma GmbH under certified quality management systems (including ISO 13485 for medical devices)
  • Intended exclusively for professional medical use in compliance with EU Medical Device Regulation (MDR) requirements and applicable local regulations
  • Distributed only through authorised medical and aesthetic channels to licensed professionals, with professional proof often required prior to shipment
Polynucleotide hair booster for scalp and eyebrows

Description

POLYPHIL HAIR (PHILART) (1x2ml) is a polynucleotide-based injectable biostimulator from Croma’s PolyPhil/PhilArt range, specifically developed for the scalp and eyebrow areas. It contains PN-HPT® (Polynucleotides Highly Purified Technology) at 15 mg/2 ml to support revitalization of hair follicles, promote hair growth, reduce hair loss and improve scalp health. The product is supplied as a sterile, intradermal Class III medical device intended strictly for use by trained healthcare professionals in aesthetic and trichology settings.

Bnefits

  • Targets hair-bearing scalp and eyebrow arches to improve hair density and quality
  • Stimulates revitalization of hair follicles to promote and accelerate hair growth
  • Helps reduce hair loss, particularly in non-androgen-dependent female hormonal alopecia, as documented in clinical data
  • Improves scalp condition, hydration and microcirculation, creating an optimal environment for healthy hair growth
  • Enhances the quality and tonicity of the skin in the treated areas, including sensitive and delicate zones
  • Biostimulating effect based on long-chain, highly purified polynucleotides (PN-HPT®), not a volumizing filler
  • Can be used as a standalone therapy or in combination with other interventions (e.g., biotin, hyaluronic acid, carboxytherapy, topical therapies) to enhance treatment outcomes
  • Useful as an adjuvant treatment after hair transplantation to support graft take and scalp regeneration

Indications

  • Hair and scalp revitalization
  • Eyebrow arches (to stimulate eyebrow hair growth and density)
  • Hair thinning and early-stage hair loss
  • Non-androgen-dependent female hormonal alopecia (as per clinical protocol data)
  • Reduced hair quality (fragile, dull or lifeless hair related to poor scalp condition)
  • Scalp dehydration or compromised scalp microcirculation
  • Supportive treatment after hair transplantation procedures
  • Sensitive skin and other delicate areas identified as suitable by the treating physician

Composition

  • PN-HPT® polynucleotides (Polynucleotides Highly Purified Technology) 15 mg/2 ml
  • Buffered physiological solution (vehicle maintaining isotonicity and physiological pH for safe intradermal administration; excipients as per official instructions for use)
  • No hyaluronic acid (according to manufacturer and technical fact sheet information)

Formulation

  • Sterile, clear injectable polynucleotide gel/solution for intradermal administration
  • Active concentration: 15 mg PN-HPT® polynucleotides per 2 ml pre-filled syringe
  • Non-crosslinked biostimulating polynucleotide formulation (not a traditional hyaluronic acid filler)
  • Class III medical device intended exclusively for professional medical use
  • Pyrogen-free, single-use, pre-filled syringe presentation

Packaging

  • Box containing 1 pre-filled syringe x 2 ml of POLYPHIL HAIR (PHILART)
  • Includes 2 x 30G 1/2 needles, length 13 mm, for intradermal injection
  • Single-patient, single-use device supplied in sterile blister packaging
  • Accompanied by instructions for use (IFU) and professional labelling
  • Often referenced under customs/tariff classification HS code 30049000 (medicaments and related products)

Usage

  • For intradermal injection only and strictly for use by appropriately trained and legally authorised healthcare professionals experienced in injectable aesthetic and trichology procedures.
  • Anatomical treatment areas specified in manufacturer technical sheet: scalp, arches of the eyebrows, and sensitive or delicate areas deemed appropriate by the practitioner.
  • Depth of injection: intradermal.
  • Injection protocol from technical fact sheet: 2 ml per session.
  • Initial treatment cycle: one session every 7 or 14 days for a total of 4 sessions.
  • Follow-up cycle: one session every 21–30 days for a further 4 sessions (total initial program of 8 sessions over approximately 3–4 months).
  • Recommended injection technique: needle microdroplets (multipoint intradermal injections), typically using the supplied 30G 1/2 (13 mm) needles; practitioners may adapt technique according to clinical training and patient needs.
  • The product can be used as a standalone therapy or as a Skin Enhancement Technique (SET) to generate synergistic effects in combination with other interventions such as biotin, hyaluronic acid, carboxytherapy, topical therapies and post-surgery support after hair transplantation, in line with consensus guidelines.
  • Practitioners should adhere to aseptic technique, avoid intravascular injection and follow the official instructions for use (IFU) and any local clinical guidelines.
  • Patients should receive appropriate pre- and post-treatment advice, including avoiding aggressive hair/scalp treatments, extreme temperatures, and vigorous manipulation of the treated area for a short period after injection, as per clinic protocol.

Contraindications

  • Known hypersensitivity or allergy to polynucleotides (PN-HPT®) or any other component of the formulation
  • Active infection, inflammation, dermatitis, psoriasis or other lesions at or near the planned injection sites on the scalp or eyebrows
  • History of severe allergic reactions or anaphylaxis to injectable implants or similar biostimulating products, where the clinician judges use unsafe
  • Autoimmune diseases, immunodeficiency conditions or systemic disorders in which stimulation of tissue repair is contraindicated, unless carefully assessed and approved by a specialist
  • Pregnancy and breastfeeding (use is generally not recommended due to lack of safety data in these populations)
  • Uncontrolled coagulation disorders or patients on anticoagulant/antiplatelet therapy where the risk of bleeding or significant bruising is considered unacceptable
  • Severe systemic illness or uncontrolled chronic disease where elective aesthetic injectable treatments are inappropriate in the judgement of the treating physician
  • Previous serious adverse reaction to polynucleotide-based injectables if considered relevant by the treating practitioner

Adverse Effects

  • Common, usually transient injection-site reactions such as erythema (redness), mild swelling or oedema, tenderness, pain, pruritus (itching) and small bruises or ecchymoses on the scalp or eyebrow area
  • Transient palpable papules or small nodules related to intradermal microdroplet placement, generally resolving spontaneously within days
  • Localized hematoma or increased sensitivity/tenderness in treated areas, typically self-limiting
  • As with other injectable procedures, there is a low but possible risk of infection, granuloma formation, or inflammatory nodules if aseptic technique is not strictly followed
  • Very rare but more serious complications associated with injectable treatments in general may include hypersensitivity reactions or vascular compromise; clinicians should be trained to recognise and manage complications according to best practice guidelines
  • Patients should be instructed to contact their practitioner promptly in case of persistent or worsening pain, significant swelling, signs of infection (heat, redness, pus, fever) or any unexpected symptoms following treatment

Storage Conditions

  • Store in a clean, dry place at a controlled temperature, typically between 2°C and 25°C, in line with Croma’s general storage recommendations for PhilArt/PolyPhil injectables and the product’s instructions for use.
  • Keep the pre-filled syringe in its original blister and outer packaging until the time of use to maintain sterility and protect from light.
  • Do not freeze the product; avoid exposure to excessive heat or direct sunlight.
  • Do not use the syringe if the packaging is damaged, if the solution appears cloudy or contains visible particles, or after the expiry date indicated on the packaging.
  • Keep out of reach of children and non-medical personnel.

Duration

The manufacturer\u2019s technical protocol recommends an initial course of 8 sessions: 4 sessions performed every 7\u201314 days, followed by 4 additional sessions every 21\u201330 days, for a total treatment duration of approximately 3\u20134 months. Maintenance sessions may be scheduled according to clinical judgment, often every 6\u201312 months or as needed to sustain results.

Onset

Clinical data in female hormonal alopecia show progressive improvement over a 4-month treatment period, with early signs of reduced hair shedding and improved scalp condition emerging within the first 1\u20132 months and more pronounced increases in hair density and anagen/telogen ratio by around 4 months. In practice, patients may start noticing reduced hair loss and better hair quality after the first few sessions, with continued improvement as the full protocol is completed; results may persist for many months (often up to or beyond a year) depending on individual factors and maintenance.

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