Skin Boosters (Injectable HA)
Also known as: skin booster, injectable moisturiser, profhilo
Skin boosters are injectable products placed intradermally or in superficial tissue to spread rather than create projected volume. Named products discussed here are supplied as hyaluronic-acid medical devices for skin-quality claims, but exact formulation, intended purpose, classification and Great Britain market route must be verified product by product.
Evidence status
Manufacturer-supported
Hydration and TEWL are the best-supported outcomes for named skin boosters, but most efficacy evidence is manufacturer-generated and laxity, elasticity and ‘bio-remodelling’ rely on uncontrolled studies plus cell or animal models. In the only located placebo-controlled Profhilo trial (n=12, split-face; no conflicts or commercial funding stated), saline also thickened dermis and Profhilo did not exceed placebo for that endpoint. A single-institute active-comparator study with no published funding statement found no significant difference between Profhilo and lightly cross-linked HA, while concluding both improved skin quality, especially moisturisation.
What skin boosters are, and how formulations differ#
“Skin booster” is a market category for injectable hyaluronic-acid products used to target hydration, texture and related skin-quality outcomes. Placement is intradermal or in superficial tissue, and the product is intended to integrate and spread rather than hold the shape expected of a volumising filler.
There is no agreed category definition. Formulations vary in HA molecular weight, concentration, rheology and degree or method of stabilisation. Juvéderm Volite is explicitly described as a cross-linked HA gel, while Restylane Vital uses stabilised HA. “Non-cross-linked” is therefore not a valid definition of every skin booster.[8, 9]'Skin booster' is a marketing category, not a chemistry: Juvéderm Volite is described in its own pivotal study as 'an injectable crosslinked hyaluronic acid gel', and Restylane Vital is a stabilised HA — so low or absent cross-linking is a feature of some skin boosters, not a defining property of all of them.Directly tested by the source[8] Niforos F, Ogilvie P, Cavallini M, Leys C, Chantrey J, Safa M, Abrams S, Hopfinger R, Marx A. VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study. Clin Cosmet Investig Dermatol. 2019;12:791-798. PMID 31749628.Tier 3[9] Kerscher M, Bayrhammer J, Reuther T. Rejuvenating influence of a stabilized hyaluronic acid-based gel of nonanimal origin on facial skin aging. Dermatol Surg. 2008 May;34(5):720-6. PMID 18384619.Tier 3
Profhilo uses high- and low-molecular-weight HA in hybrid cooperative complexes produced by a patented thermal process. The manufacturer paper describes high flowability as a reason for tissue integration, but it does not state that the product is free of every chemical cross-linking agent.[11]Profhilo is a 2 mL prefilled syringe containing 32 mg of high-molecular-weight and 32 mg of low-molecular-weight hyaluronic acid, and is the first product made by NAHYCO Hybrid Technology, described by the manufacturer as 'an innovative patent protected thermal production process'. Its rheology is the point: 'high flowability (tanδ > 1)' is what makes it integrate through tissue rather than hold a shape. Note that the manufacturer's own paper does not say the process is free of chemical cross-linking agents — the widely repeated 'no BDDE, no cross-linkers' line is not sourced to it.Directly tested by the source[11] Salti G, Tateo A, Cassuto D, Arrigoni F, Godina C, Mazzola F, Cigni C, Grimolizzi F, Bellia G. Hyaluronic Acid Hybrid Cooperative Complexes Nearing 10 Years of Use: Update on Safety Assessment Based on Post-Marketing Surveillance Data. J Cosmet Dermatol. 2025 Jul;24(7):e70197. PMID 40654100. PMCID PMC12257262.Tier 4
Skin boosters remain closely related to dermal fillers in chemistry, regulation and injection risk. A different intended aesthetic effect does not create a separate safety category in law.
Use of skin boosters in aesthetic practice#
The named products discussed here are supplied as injectable medical devices, not routine topical skincare. Practice requires exact-product classification and market-route verification, anatomical and injection competence, asepsis, material consent, traceability, complication recognition, appropriate insurance and access to medical support.
Where a product falls within Great Britain device rules, it requires the applicable UKCA or transitionally accepted CE route, MHRA registration and a UK Responsible Person for a non-UK manufacturer. MDD/AIMDD CE-marked general devices remain acceptable only until certificate expiry or 30 June 2028, whichever comes first; MDR-compliant general devices may be accepted until 30 June 2030. The DHSC consultation records the MHRA’s intention to bring products with only aesthetic or non-medical purposes into device scope, so classification cannot be assumed from injectable HA alone and must be verified for the exact product.[1, 4]iNamed hyaluronic-acid skin boosters discussed in this entry are supplied as medical devices rather than medicinal products, with applicable Great Britain device routes requiring UKCA or accepted CE marking and MHRA registration. Purely aesthetic-purpose products require exact-product classification because the DHSC consultation records the MHRA's intention to bring such products into device scope; non-medicinal device status means no prescription is inherent to the product.Inferred from adjacent evidence[1] Department of Health and Social Care. The licensing of non-surgical cosmetic procedures in England: consultation document. Open 2 September 2023, closed 28 October 2023.Tier 1[4] Medicines and Healthcare products Regulatory Agency. Regulating medical devices in the UK (guidance). First published 31 December 2020, last updated 20 February 2026.Tier 1
A device is not a prescription-only medicine. The absence of an inherent prescription requirement does not remove the need for competence, medical oversight appropriate to risk or access to prescription medicines used in complication management. The 2023 English consultation separately identifies hyaluronidase, lidocaine and botulinum toxin as POM examples.[1]
England’s current framework places few restrictions on adult non-surgical cosmetic procedures, but the proposed green/amber/red licensing system is not in force. The consultation proposed putting “biorevitalization injections and/or any injection of hyaluronic acid” in amber, with named regulated-healthcare-professional oversight; the 2025 response deferred actual classification. This establishes the English policy position only. Scotland, Wales and Northern Ireland were not established by the listed sources and require separate current checks.[1]England's current framework places few restrictions on who may perform non-surgical cosmetic procedures on adults; the DHSC consultation states that 'the current regulatory framework places few restrictions on who can perform non-surgical cosmetic procedures'. This does not establish the position in Scotland, Wales or Northern Ireland.Directly tested by the source[1] Department of Health and Social Care. The licensing of non-surgical cosmetic procedures in England: consultation document. Open 2 September 2023, closed 28 October 2023.Tier 1[1]England's 2023 DHSC consultation PROPOSED placing 'biorevitalization injections and/or any injection of hyaluronic acid' in the amber tier, meaning non-healthcare practitioners could perform them only with oversight by a named regulated healthcare professional holding an accredited qualification to prescribe, administer and supervise aesthetic procedures.Directly tested by the source[1] Department of Health and Social Care. The licensing of non-surgical cosmetic procedures in England: consultation document. Open 2 September 2023, closed 28 October 2023.Tier 1[2]No licensing scheme is in force and no procedure has been assigned a tier: the August 2025 government response states that 'further work is required to determine where specific procedures will sit in the proposed tiering system', with legislative priority given to the highest-risk procedures such as buttock, breast and genital augmentation.Directly tested by the source[2] Department of Health and Social Care. The licensing of non-surgical cosmetic procedures in England: consultation response. Published 7 August 2025.Tier 1
Contraindications and cautions#
The complete instructions for the exact device govern. Treatment requires verified product identity, batch, sterile integrity, conformity documentation, intended anatomical use, current instructions, insurance cover and a complication pathway.
Cosmetic skin-booster injection into an under-18 is an offence in England. The statutory defence based on reasonable belief makes age verification and documentation important, but the Act’s clinical exceptions are limited.[3]
Active infection or inflammation at the intended site, an unexplained lesion, previous serious HA or injectable reaction, significant healing impairment or a medical history outside the practitioner’s competence requires deferral and medical assessment.
“Low viscosity”, “superficial” and “not a filler” do not eliminate vascular risk. The manufacturer’s post-market dataset includes one embolism and one vascular occlusion, alongside nodules and more common local reactions.[11]Low viscosity and intradermal placement do not eliminate vascular risk — embolism and vascular occlusion have each been reported to the manufacturer's safety database following skin booster treatment.Directly tested by the source[11] Salti G, Tateo A, Cassuto D, Arrigoni F, Godina C, Mazzola F, Cigni C, Grimolizzi F, Bellia G. Hyaluronic Acid Hybrid Cooperative Complexes Nearing 10 Years of Use: Update on Safety Assessment Based on Post-Marketing Surveillance Data. J Cosmet Dermatol. 2025 Jul;24(7):e70197. PMID 40654100. PMCID PMC12257262.Tier 4
The BAP technique is a named Profhilo manufacturer instruction, not a generic protocol for all skin boosters. The manufacturer-authored safety paper reports the IFU-based injection pattern. Alternative products, sites and planes require their own instructions and evidence; the available evidence does not establish a class-wide schedule.[11]The BAP technique is a named Profhilo manufacturer instruction rather than a generic skin-booster protocol; alternative products, sites and planes require their own instructions and evidence.Directly tested by the source[11] Salti G, Tateo A, Cassuto D, Arrigoni F, Godina C, Mazzola F, Cigni C, Grimolizzi F, Bellia G. Hyaluronic Acid Hybrid Cooperative Complexes Nearing 10 Years of Use: Update on Safety Assessment Based on Post-Marketing Surveillance Data. J Cosmet Dermatol. 2025 Jul;24(7):e70197. PMID 40654100. PMCID PMC12257262.Tier 4
Clinical uses and the evidence behind them#
Hydration and texture. A systematic review screened 2,996 records and included 13 small studies of injectable HA, mostly uncontrolled. It reported improvements across hydration, firmness, texture, radiance and elasticity and called the evidence promising, but provided no meta-analysis or formal risk-of-bias grading and concluded that large randomised trials are needed.[8, 10]Hydration is the outcome that reproduces most consistently: an independent systematic review of 13 studies found improvement in hydration, firmness, texture, radiance and elasticity across HA injectables, and the Volite study showed significantly improved instrument-measured hydration from baseline at every timepoint through month 9.Directly tested by the source[8] Niforos F, Ogilvie P, Cavallini M, Leys C, Chantrey J, Safa M, Abrams S, Hopfinger R, Marx A. VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study. Clin Cosmet Investig Dermatol. 2019;12:791-798. PMID 31749628.Tier 3[10] Ghatge AS, Ghatge SB. The Effectiveness of Injectable Hyaluronic Acid in the Improvement of the Facial Skin Quality: A Systematic Review. Clin Cosmet Investig Dermatol. 2023 Apr 4;16:891-899. PMID 37038447.Tier 2[10]The most independent systematic review of injectable HA for facial skin quality — 13 studies from 2,996 screened, authors declaring no conflicts — concluded the evidence is 'quite promising' but that 'large randomized controlled trials are required'.Directly tested by the source[10] Ghatge AS, Ghatge SB. The Effectiveness of Injectable Hyaluronic Acid in the Improvement of the Facial Skin Quality: A Systematic Review. Clin Cosmet Investig Dermatol. 2023 Apr 4;16:891-899. PMID 37038447.Tier 2
The pivotal Juvéderm Volite study enrolled 131 people in a prospective single-arm design. Skin-roughness responders fell from 96.2% at month one to 76.3% at month four and 34.9% at month six, while hydration remained significantly improved through month nine. The study had no control or blinding and was funded by Allergan, with several manufacturer employees or consultants among the authors.[8]Objective texture benefit fades faster than the marketing implies: in the Juvéderm Volite pivotal study the skin-roughness responder rate fell from 96.2% at month 1 to 76.3% at month 4 and 34.9% at month 6 — though the same study's hydration measurements remained significantly improved through month 9, and its authors concluded it 'improved skin smoothness up to 6 months and hydration lasting 9 months'. Texture and hydration decay on different clocks.Directly tested by the source[8] Niforos F, Ogilvie P, Cavallini M, Leys C, Chantrey J, Safa M, Abrams S, Hopfinger R, Marx A. VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study. Clin Cosmet Investig Dermatol. 2019;12:791-798. PMID 31749628.Tier 3
The founding Restylane Vital pilot involved 19 women, with significant elasticity and roughness improvement but no comparator, placebo or blinding.[9]The clinical foundation of the whole skin booster category is a 2008 uncontrolled pilot study of 19 women given three sessions of stabilised non-animal HA into the lower cheeks, which reported significant improvement in elasticity and surface roughness with no comparator or placebo arm.Directly tested by the source[9] Kerscher M, Bayrhammer J, Reuther T. Rejuvenating influence of a stabilized hyaluronic acid-based gel of nonanimal origin on facial skin aging. Dermatol Surg. 2008 May;34(5):720-6. PMID 18384619.Tier 3
Placebo-controlled Profhilo evidence. A triple-blind split-face study included 12 women aged 45–65 with perioral ageing. Dermal thickness increased on the Profhilo side (p=0.016) and saline side (p<0.001); the authors concluded that product impact on thickness did not exceed placebo. Visual wrinkle and pore improvements were reported, but 54.5% were dissatisfied with the outcome and 36.4% with the decision to undergo treatment. The tiny, female-only, single-site study cannot settle every outcome, but it directly challenges equating dermal thickening with a product-specific effect.[6]In the only placebo-controlled trial of Profhilo located — a randomised triple-blind split-face study of 12 women, product against saline, perioral region — dermal thickness increased on both the Profhilo side (p=0.016) and the saline side (p<0.001), and the authors concluded its impact on dermal thickness 'did not exceed the placebo effect'.Directly tested by the source[6] Zanella G, de Souza Ataíde FT, de Lima Bonato TC, Cordeiro JM, Machado RA, De La Torre Canales G, Câmara-Souza MB. Effects of Profhilo® Tissue Bioremodeling on Skin Texture and Perioral Wrinkles: A Randomized Controlled Triple-Blind Clinical Trial. Aesthetic Plast Surg. 2026 Jun;50(11):4324-4332. PMID 41731228.Tier 2[6]In that same trial 54.5% of participants were dissatisfied with the treatment outcome and 36.4% were dissatisfied with the decision to have it, despite statistically significant improvements in FACE-Q psychological and ageing scores.Directly tested by the source[6] Zanella G, de Souza Ataíde FT, de Lima Bonato TC, Cordeiro JM, Machado RA, De La Torre Canales G, Câmara-Souza MB. Effects of Profhilo® Tissue Bioremodeling on Skin Texture and Perioral Wrinkles: A Randomized Controlled Triple-Blind Clinical Trial. Aesthetic Plast Surg. 2026 Jun;50(11):4324-4332. PMID 41731228.Tier 2
Active comparison. In 24 healthy women, Profhilo and Belotero Revive each improved several measurements from baseline, with no significant difference between them over 14 weeks. The authors concluded both were effective and safe, especially for moisturisation.[7] This is a null on superiority, not a null on effect; without saline or untreated control it also cannot isolate product from needling or natural variation.
Manufacturer synthesis. A 2026 Profhilo review included nine studies and 278 participants, no placebo-controlled trial, no meta-analysis and no risk-of-bias appraisal. Three authors were IBSA employees and the other authors came from an institute that ran several included studies. It supports signals, not independent confirmation.[12]The largest synthesis of Profhilo evidence covers nine studies and 278 participants in total, contains no placebo-controlled trial, and was written by a team including three employees of the manufacturer alongside authors from the contract research institute that ran several of the included studies.Directly tested by the source[12] Sparavigna A, Cigni C, Tanzini L, Lualdi R, Grimolizzi F. A Systematic Review of the Efficacy and Safety of Profhilo® and Profhilo® Body. Plast Aesthet Nurs (Phila). 2026;46(2):80-92. PMID 41920062.Tier 3
Selecting a skin-booster device#
Selection begins with the intended outcome and the exact device. Hydration, texture, superficial roughness and laxity are not interchangeable endpoints, and a positive result for one does not prove the others.
Relevant checks include:
- formulation, HA concentration, cross-link or stabilisation method and rheology;
- intended purpose, route, plane and anatomical sites;
- conformity certificate, MHRA registration route and UK Responsible Person where applicable;
- current instructions, contraindications, storage, sterile integrity, batch and expiry;
- evidence for the named device rather than the category;
- practitioner training, indemnity, complication plan and access to medical support.
Cross-linked Volite evidence does not establish Profhilo performance, and Profhilo cell-culture findings do not establish Restylane or Seventy Hyal outcomes. No peer-reviewed clinical study of Seventy Hyal 2000 was located.[no source found]No peer-reviewed clinical study of Seventy Hyal 2000, one of the most widely sold skin boosters in the UK, could be located on PubMed.We looked and found no source either way
Brand chemistry should not be sold as proven superiority. The direct Profhilo-versus-Belotero comparison found no significant difference on measured characteristics, while showing within-baseline improvement for both.[7]
The JCCP guidance names dermal fillers among five core modalities but does not name skin boosters or biorevitalisation. It therefore does not resolve whether they sit within the filler modality or outside it as an adjunctive or orphan treatment. Any claim of JCCP endorsement would exceed what this source provides.[5]The JCCP and CPSA recognise five core modalities — hair restoration surgery, injectable toxins, dermal fillers, lasers and light, and skin rejuvenation (microneedling and chemical peels) — and their guidance on adjunctive and orphan treatments does not name skin boosters or biorevitalisation, stating that for treatments outside the five 'the Council has not set or adopted benchmark standards of proficiency'.Directly tested by the source[5] Joint Council for Cosmetic Practitioners. Press Release 31 — JCCP issues new guidelines on 'Adjunctive Therapies' and 'Orphan Treatments' (PDF, V1_1).Tier 4
Adverse effects and their management#
Expected local effects can include swelling, oedema, erythema, pain, bruising, pruritus and temporary lumps. Delayed nodules, infection, asymmetry and product-related reactions can occur. Published trials and post-market reports are not large enough to provide reliable rare-event incidence.
IBSA’s passive worldwide post-market dataset estimated 1,091,956 exposed patients and recorded 371 adverse events, a 0.034% complaint rate. It included six nodules, five injection-site nodules, one embolism and one vascular occlusion. The authors state that reporting was spontaneous, mild or expected events are often underreported and exposure was estimated from maximum syringe usage. The percentage is therefore a complaint rate, not a complication incidence.[11]In the manufacturer's worldwide post-marketing dataset covering an estimated 1,091,956 exposed patients over nearly six years, 371 adverse events were reported (0.034% complaint rate), dominated by swelling, oedema, erythema and pruritus, with nodule (n=6) and injection-site nodule (n=5) reported separately, and one embolism and one vascular occlusion.Directly tested by the source[11] Salti G, Tateo A, Cassuto D, Arrigoni F, Godina C, Mazzola F, Cigni C, Grimolizzi F, Bellia G. Hyaluronic Acid Hybrid Cooperative Complexes Nearing 10 Years of Use: Update on Safety Assessment Based on Post-Marketing Surveillance Data. J Cosmet Dermatol. 2025 Jul;24(7):e70197. PMID 40654100. PMCID PMC12257262.Tier 4[11]That complaint rate is not a complication rate: the authors themselves state reports arrive through physicians' spontaneous initiative, that mild and expected events 'are often underreported', that underreporting to the manufacturer 'might occur', and that patient exposure was estimated from maximum expected syringe usage.Directly tested by the source[11] Salti G, Tateo A, Cassuto D, Arrigoni F, Godina C, Mazzola F, Cigni C, Grimolizzi F, Bellia G. Hyaluronic Acid Hybrid Cooperative Complexes Nearing 10 Years of Use: Update on Safety Assessment Based on Post-Marketing Surveillance Data. J Cosmet Dermatol. 2025 Jul;24(7):e70197. PMID 40654100. PMCID PMC12257262.Tier 4
Severe or escalating pain, blanching, livedoid change, visual disturbance, neurological symptoms, tissue breakdown, breathing difficulty, widespread urticaria or rapidly progressive swelling requires urgent medical assessment. A clinic offering HA injections needs a written pathway for vascular, allergic, infectious and delayed inflammatory complications before treatment.
Hyaluronidase is a prescription-only medicine in the English consultation’s examples, so a non-prescriber does not automatically have lawful or timely access merely because the booster itself is non-prescription.[1] Governance must resolve access and clinical oversight in advance; the cited evidence does not establish a generic dissolution protocol.
Suspected serious device incidents should be documented with batch details and reported through manufacturer and MHRA vigilance routes where appropriate.[4]
No UK-specific incidence data for skin booster complications — MHRA device adverse incident counts, Save Face figures or any national registry — could be located.[no source found]No UK-specific incidence data for skin booster complications — MHRA device adverse incident counts, Save Face figures or any national registry — could be located.We looked and found no source either way
Referral and scope boundaries#
Medical assessment is indicated when the indication or diagnosis is uncertain; the treatment site contains infection, inflammation or an unexplained lesion; previous filler or HA complications are unresolved; or comorbidity, medication or healing history makes risk unclear.
Urgent escalation is required for suspected vascular compromise, visual or neurological symptoms, anaphylaxis, severe infection, tissue necrosis or another rapidly progressive adverse event.
A skin booster may aim to improve hydration and texture, but it remains an HA injection. The practitioner needs competence for facial anatomy, intravascular risk, delayed nodules and emergency recognition, not only product-specific point placement.
The Botulinum Toxin and Cosmetic Fillers (Children) Act 2021 applies in England and uses a broad definition of filler that captures intradermal HA used cosmetically.[3] Adult-practice restrictions and licensing proposals discussed here are also England-specific.[1, 2] The device market discussion is for Great Britain.[4] No UK-wide injector-scope conclusion follows from those sources.
Non-prescription status is a product classification, not a declaration that any person is suitably trained or insured. The JCCP ambiguity and absence of a skin-booster-specific named benchmark in the source reinforce the need for evidence of personal competence without pretending that voluntary guidance is statute.[5]
Mechanism of action#
Hyaluronic acid binds water and influences extracellular-matrix hydration. Injected low-viscosity or spreadable HA can therefore change tissue water content and surface appearance. Clinical hydration and TEWL findings are more direct evidence of that effect than broad regeneration language.[7, 8, 10]
The “bio-remodelling” mechanism for hybrid cooperative complexes comes principally from cultured keratinocytes and fibroblasts and a reconstructed 3D skin construct. Those models reported changes in collagen and elastin expression, but they are in vitro, not biopsies from treated people. The paper carries a PLOS ONE Expression of Concern over overlapping control panels and unavailable underlying data for two figures; the editors said the conclusions were not affected.[13]The bio-remodelling claim — upregulation of type I, III, IV and VII collagen and elastin — comes from cultured keratinocytes and fibroblasts and a reconstructed 3D skin model, not from human skin; no human biopsy study demonstrating new collagen or elastin deposition after skin booster injection was located.Directly tested by the source[13] Stellavato A, Corsuto L, D'Agostino A, La Gatta A, Diana P, Bernini P, De Rosa M, Schiraldi C. Hyaluronan Hybrid Cooperative Complexes as a Novel Frontier for Cellular Bioprocesses Re-Activation. PLoS One. 2016;11(10):e0163510. PMID 27723763. Expression of Concern: PLoS One. 2024;19(4):e0302213.Tier 3[13]The foundational in vitro paper on hyaluronan hybrid cooperative complexes carries a 2024 PLOS ONE Expression of Concern: control panels in one figure partially overlapped with a different experimental condition, and the underlying quantitative data for two figures were no longer available, though the editors judged the conclusions unaffected.Directly tested by the source[13] Stellavato A, Corsuto L, D'Agostino A, La Gatta A, Diana P, Bernini P, De Rosa M, Schiraldi C. Hyaluronan Hybrid Cooperative Complexes as a Novel Frontier for Cellular Bioprocesses Re-Activation. PLoS One. 2016;11(10):e0163510. PMID 27723763. Expression of Concern: PLoS One. 2024;19(4):e0302213.Tier 3
A 2026 study of Profhilo Structura used 15 female mice, not people, and examined dermal white adipose tissue after subcutaneous injection. All authors were IBSA employees. It cannot establish facial skin remodelling with classic Profhilo.[14]The most recent 'remodelling' evidence for this technology is a 15-mouse study of Profhilo Structura conducted entirely by employees of the manufacturer, showing larger dermal white adipose adipocytes and higher Collagen VI expression in treated animals.Directly tested by the source[14] Polvere I, Scrima M, Vito N, Signorino G, Iorio A, Giori AM, Ferravante A. Remodeling Effect of HA Hybrid Cooperative Complexes on Dermal White Adipose Tissue and Its Structure. Clin Cosmet Investig Dermatol. 2026;19:617588. PMID 42518882.Tier 3
In the small human placebo-controlled trial, saline also increased dermal thickness and the product did not exceed placebo for that endpoint.[6] Hydration, injection trauma and temporary tissue expansion must therefore remain plausible contributors unless human histology demonstrates product-specific new collagen or elastin.
Commonly misstated claims#
“Profhilo is not a filler, so vascular occlusion cannot happen”
The manufacturer’s post-market dataset contains one embolism and one vascular occlusion.[11] Supported statement: Skin boosters have a different aesthetic aim from volumising fillers but retain intravascular injection risk.
“Skin boosters are non-cross-linked by definition”
Volite is explicitly cross-linked and Restylane Vital is stabilised HA.[8, 9] Supported statement: Cross-link state varies; “skin booster” describes intended skin-quality use rather than one chemistry.
“Bio-remodelling and new collagen are proven in patients”
The collagen and elastin evidence comes from cell culture, a reconstructed model and mice, while the human saline-controlled trial did not show product-specific dermal thickening.[6, 13, 14] Supported statement: Human hydration evidence is stronger than evidence for new collagen or elastin deposition.
“Results last six to nine months”
In the uncontrolled Volite study, roughness responders fell markedly by month six while hydration remained improved through month nine.[8] Supported statement: Duration depends on the outcome measured and the named product; texture and hydration do not follow the same time course.
“CE marking means the treatment is clinically proven and only authorised people can inject”
Conformity marking governs device market access, not comparative benefit or practitioner competence.[4] Supported statement: Product compliance, clinical evidence and injector competence are separate questions.
Areas of remaining uncertainty#
- There is no agreed definition of “skin booster”, and a prominent 2024 classification paper was retracted in 2025 without a reason stated in the PubMed notice; specify the named product and formulation rather than rely on the category label.[15]The 2024 review 'Skin boosters: Definitions and varied classifications' was retracted in November 2025; the PubMed retraction record gives no reason.Directly tested by the source[15] RETRACTION: Skin Boosters: Definitions and Varied Classifications. Skin Research and Technology. 2025 Nov;31(11):e70297. doi:10.1111/srt.70297. PMID 41271445; PMCID PMC12638202. Retracting Yi KH, et al. Skin Research and Technology. 2024;30(3):e13627. doi:10.1111/srt.13627. PMID 38481069; PMCID PMC10938033.Tier 4
- Human histology demonstrating new collagen or elastin after injection was not located; consent to evidenced hydration and texture outcomes rather than promise regeneration.
- It is unclear how much change reflects hygroscopic HA, injection injury or product-specific remodelling; avoid treating uncontrolled baseline improvement as causal proof.
- The one direct Profhilo-versus-lightly-cross-linked-HA study found no measured superiority; do not build a clinical superiority claim from patent chemistry alone.[7]
- England’s eventual tier and oversight requirements remain undecided, while other UK jurisdictions were not established by the listed sources; check current country-specific law and local governance before practice.[1, 2]
- Passive post-market complaint rates undercount expected and unreported events; do not use 0.034% as a consent estimate of complication incidence.[11]
Frequently asked questions#
Are skin boosters dermal fillers?
They use injectable HA and share device and vascular-risk features with fillers, but are formulated and placed for diffuse skin-quality effects rather than projected volume.
Do they require a prescription?
For a named product supplied as a non-medicinal device, no prescription is inherent to that product. Complication medicines such as hyaluronidase are prescription-only, and non-prescription status does not establish injector competence or oversight. Exact classification and market route still require verification.[1, 4]
Is Profhilo better than another HA skin booster?
A 24-person active-comparator study found no significant difference on measured characteristics, while both improved from baseline.[7] Larger controlled comparisons are needed.
Do skin boosters make new collagen?
Cell, reconstructed-skin and mouse studies support a mechanistic hypothesis, but living-human biopsy evidence was not located.[13, 14]
Are they legal for under-18s?
Cosmetic injection of a filler, broadly defined, into an under-18 is an offence in England, subject to limited statutory defences.[3] This statement is England-specific.
References#
Each source is graded by evidence tier. Tier 4 material (manufacturer documents, expert consensus, practitioner experience) is useful for protocol and context, and is never presented as equivalent to independent clinical evidence.
- Department of Health and Social Care. The licensing of non-surgical cosmetic procedures in England: consultation document. Open 2 September 2023, closed 28 October 2023.Tier 1Supports: PROPOSAL ONLY, not law. Proposed a three-tier green/amber/red scheme under powers in the Health and Care Act 2022. Amber tier verbatim includes 'botulinum toxin injections', 'semi-permanent dermal fillers injected into the face only' and — the line that captures skin boosters — 'biorevitalization injections and/or any injection of hyaluronic acid'. Annex A defines biorevitalisation injections as: 'The skin is injected with small doses of pure hyaluronic acid with vitamins to encourage the production of collagen and elastin across the skin.' Amber means: 'Licensed aesthetic practitioners must have relevant oversight by a named regulated healthcare professional (who has gained an accredited qualification to prescribe, administer and supervise aesthetic procedures). Qualified and regulated healthcare professionals are eligible to perform these procedures without oversight where they meet agreed standards.' Green (lowest risk, any licensed practitioner) includes microneedling, mesotherapy, IPL/LED, superficial peels, 'no-needle' fillers and micropigmentation. Red (regulated healthcare professionals only, CQC premises) includes all thread lifts, hair restoration surgery, 'procedures aimed at augmenting any part of the body, in particular the breast, buttocks and genitals, typically using autologous fat or dermal fillers', deep peels, fully ablative CO2 lasers and all intravenous injectables. Also states verbatim: 'The current regulatory framework places few restrictions on who can perform non-surgical cosmetic procedures.' Separately proposes that 'any procedure that requires a prescription-only medicine (POM) must, at the very least, be overseen by a qualified and regulated healthcare professional' — listing toxins, lidocaine and hyaluronidase as the POM examples, not HA fillers. Notes MHRA 'intends to bring into scope of the UK medical devices regulations products for which a manufacturer claims only an aesthetic or another non-medical purpose... This suite of products will include dermal fillers'. Scope limit: England only; a consultation, not a legal instrument; lists are 'includes, but is not limited to'.
- Department of Health and Social Care. The licensing of non-surgical cosmetic procedures in England: consultation response. Published 7 August 2025.Tier 1Supports: Government response to the 2023 consultation. Does NOT assign individual procedures to tiers. States verbatim: 'While we recognise the desire for clarity and certainty within the sector, further work is required to determine where specific procedures will sit in the proposed tiering system and to determine which practitioners should be permitted to carry out certain procedures.' Government will prioritise 'the introduction of legislation which will ensure that those procedures deemed to pose the highest level of risk (including procedures aimed at augmenting the breast, buttocks and genitals with dermal fillers) can only be performed by suitably qualified regulated healthcare professionals working for CQC-registered providers', with 'The proposed changes will be detailed in a public consultation, to be launched early next year.' Confirms scope unchanged, verbatim: 'we are not proposing at this stage to remove any of the procedures currently included within the scope of the licensing scheme or associated regulation, nor are we proposing to add any further procedures'. On the tiers it says only that 'The majority of respondents also agreed with the proposed 3-tier structure' and that 'Of the 3 proposed categories of classification, there was the least amount of overall support for the amber category' — the amber tier, which is where skin boosters were proposed to sit, drew the least support of the three. Skin boosters are named in the response as a procedure respondents reported having: 'skin boosters - 847 responses (11%)', behind dermal filler (5,331, 70%) and Botox (5,095, 67%). Scope limit: England; still a policy statement, not legislation.
- Botulinum Toxin and Cosmetic Fillers (Children) Act 2021 (c. 19), section 1. In force in England from 1 October 2021.Tier 1Supports: In force, not a proposal. Verbatim s.1(1): 'It is an offence for a person to administer, in England, to another person ("A") — (a) botulinum toxin, or (b) a subcutaneous, submucous or intradermal injection of a filler for a cosmetic purpose, where A is under the age of 18.' s.1(2): 'A "filler" is any substance used for dermal or mucous membrane filling (whether or not designed to be so used).' s.1(3): cosmetic purpose is taken to include where 'the filler is generally used for such a purpose' or 'the likely effect of the injection is to alter the appearance of the person injected'. Defences under s.1(4) are limited to registered medical practitioners, regulated health professionals acting on a doctor's directions, or having taken reasonable steps to establish age and reasonably believing A was 18+. Liable on summary conviction to a fine. Scope limit: England only; the drafting of 'filler' plainly reaches intradermal HA skin boosters given they are injected to alter appearance, but no reported case law was located confirming this.
- Medicines and Healthcare products Regulatory Agency. Regulating medical devices in the UK (guidance). First published 31 December 2020, last updated 20 February 2026.Tier 1Supports: States that MHRA 'is responsible for regulating the UK medical devices market'. In Great Britain, 'Devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)'. UKCA marking is the GB route; CE-marked general medical devices compliant with EU MDD/AIMDD may be placed on the GB market until the sooner of certificate expiry or 30 June 2028, and EU MDR-compliant devices until 30 June 2030. All devices must be registered with MHRA before being placed on the GB market, and non-UK manufacturers must appoint a UK Responsible Person. Scope limit: this is device-market guidance. It says nothing about who may clinically administer a device, does not name dermal fillers or skin boosters, and carries no prescription-status statement.
- Joint Council for Cosmetic Practitioners. Press Release 31 — JCCP issues new guidelines on 'Adjunctive Therapies' and 'Orphan Treatments' (PDF, V1_1).Tier 4Supports: All quotations verified against the PDF itself, not the news landing page (the landing page at /NewsEvent/jccp-publish-guidelines-on-adjunctive-therapies-and-orphan-treatments contains none of this text and merely links the PDF). Names the five core modalities verbatim in footnote 1: 'Hair Restoration Surgery; Injectable Toxins; Dermal Fillers; Lasers and Light and Skin Rejuvenation (Micro-Needling and Chemical peels).' For anything outside those five, states verbatim: 'these treatments are not currently recognised by the JCCP or CPSA as "registered modalities" and as such the Council has not set or adopted benchmark standards of proficiency for these treatments and is unable endorse evidence of practitioner competence to perform them safely or effectively.' The worked examples of adjunctive/orphan treatments given are 'the adjunctive use of injectable local anaesthetic or stand-alone treatments such as plasma replacement therapy or threads' — skin boosters are not among them. Registrants may still offer them but must not 'suggest or imply to their clients/patients that the treatment being provided by them is recognised by the JCCP or that their competence to perform such procedures has been verified or endorsed by the Council'. Requires 'A minimum of 50 hours CPD per year' covering orphan and adjunctive treatments, indemnity insurance 'to cover all treatments performed within the context of their scope of practice', products 'appropriately and ethically sourced and licensed (where appropriate)', and self-assessment of risk and supervision — 'This is particularly important if you are not a registered healthcare prescriber or you have limited experience in any defined area of practice.' Scope limit: the document does not name skin boosters, biorevitalisation, Profhilo or hyaluronic acid anywhere, so whether skin boosters sit inside the 'Dermal Fillers' modality or count as adjunctive/orphan is not resolved by this source. Undated press release; JCCP is a voluntary self-regulator with PSA accreditation, not a statutory body.
- Zanella G, de Souza Ataíde FT, de Lima Bonato TC, Cordeiro JM, Machado RA, De La Torre Canales G, Câmara-Souza MB. Effects of Profhilo® Tissue Bioremodeling on Skin Texture and Perioral Wrinkles: A Randomized Controlled Triple-Blind Clinical Trial. Aesthetic Plast Surg. 2026 Jun;50(11):4324-4332. PMID 41731228.Tier 2Supports: The only placebo-controlled trial of Profhilo located. Split-face, randomised, triple-blind. n=12 women aged 45-65 with visible signs of perioral ageing; product one side, saline placebo the other, across two sessions; assessment by digital stereophotogrammetry, ultrasonography and FACE-Q. Results verified from the published abstract: stereophotogrammetry 'revealed visual improvements in wrinkles and pores after the application of Profhilo®'; ultrasonography showed increased dermal thickness on BOTH the Profhilo side (p=0.016) and the placebo side (p<0.001); 54.5% of participants were dissatisfied with the outcome and 36.4% with the decision to undergo treatment; statistically significant improvement in FACE-Q psychological (p=0.014) and ageing (p=0.008) scores. Authors' conclusion verbatim: 'Profhilo® reduced wrinkles and pore size; however, its impact on dermal thickness did not exceed the placebo effect, and patients were not fully satisfied with outcomes.' Journal-assigned Level of Evidence I. Authors declare no conflicts of interest and no commercial funding is stated. Scope limits: very small (n=12, with satisfaction percentages implying denominators of 11), single site in Brazil, women only, perioral region only, short endpoint, no long-term follow-up, and a split-face design cannot exclude systemic or contralateral carry-over — which is itself one reading of the placebo-side thickening. Verification note: the Springer full text was paywalled, so the fine protocol detail (injection volume per side, number of marked points, the 30-day inter-session interval and the 60-day assessment point) could not be independently confirmed and has been removed from this record; only 'two sessions' is confirmed. Two published comment letters (PMIDs 41954642, 42410190) contest aspects of the trial; their content was not retrievable.
- de Wit A, Siebenga PS, Wijdeveld RW, Koopmans PC, van Loghem JAJ. A split-face comparative performance evaluation of injectable hyaluronic acid-based preparations HCC and CPM-HA20G in healthy females. J Cosmet Dermatol. 2022 Nov;21(11):5576-5583. PMID 35699361.Tier 3Supports: Split-face, single-blinded, active-comparator study. n=24 healthy women. Hyaluronan hybrid cooperative complexes (HCC, Profhilo, IBSA) to the right cheek versus cohesive polydensified matrix HA 20 mg/mL with glycerol 17.5 mg/mL (CPM-HA20G, Belotero Revive, Merz) to the left, on three separate occasions; skin measurements at baseline, week 1, week 8 and week 14. Both products showed effect versus baseline on surface hydration, elasticity, TEWL and melanin; CPM-HA20G additionally on water content; HCC additionally on pore count and haemoglobin. Key finding verbatim: 'There were no significant differences between the tested products in the observed skin characteristics over time.' DIRECTION NOTE, so this is not read one-sidedly: the authors' own stated conclusion is positive — 'These devices are effective and safe treatments for skin quality improvement, especially moisturization, with high patient satisfaction and generally mild and transient side effects.' The null is a null on SUPERIORITY, not a null on effect. Scope limits: no untreated or saline control arm, so within-subject improvement cannot be separated from natural variation, seasonality or needling trauma; single-blinded only; n=24; 14-week horizon; healthy female volunteers. This study should NOT be described as independent: four of the five authors (de Wit, Siebenga, Wijdeveld, van Loghem) are affiliated with UMA Institute, Amsterdam — a private aesthetic practice — and the fifth (Koopmans) to a statistics consultancy, Signidat. No conflict-of-interest or funding statement appears in the PubMed or Europe PMC record and the Wiley full text was inaccessible (HTTP 402/403), so the study's sponsor could not be verified; both comparator products are commercial devices.Funding / interest: Not stated in any accessible record; sponsorship could not be verified. All clinical authors are affiliated with UMA Institute, Amsterdam (a private aesthetic practice); statistical author affiliated with Signidat, Roderwolde. Both tested products are manufacturer-supplied commercial devices (IBSA and Merz).
- Niforos F, Ogilvie P, Cavallini M, Leys C, Chantrey J, Safa M, Abrams S, Hopfinger R, Marx A. VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study. Clin Cosmet Investig Dermatol. 2019;12:791-798. PMID 31749628.Tier 3Supports: Pivotal study of Juvéderm Volite. Describes the product verbatim as 'an injectable crosslinked hyaluronic acid gel designed to improve skin quality attributes such as surface smoothness and hydration' — i.e. a marketed skin booster that IS cross-linked. Prospective, single-arm, no control. n=131 subjects with moderate/severe cheek roughness; intradermal injection to cheeks and forehead and/or neck; 31 (23.7%) needed a touch-up at day 30. Allergan Skin Roughness Scale responder rate (≥1-point improvement): 96.2% at month 1, 76.3% at month 4, 34.9% at month 6, and 87.1% after repeat treatment. In cheeks with severe baseline roughness: 93.8%, 83.1% and 52.3% at months 1, 4 and 6. Skin hydration improved significantly (p<0.01) from baseline at all timepoints through month 9. All treatment-related AEs mild or moderate. Scope limits: no control arm and no blinding, so regression to the mean and the effect of intradermal needling itself cannot be separated; the headline durability collapses between month 4 and month 6 on the objective scale.Funding / interest: Allergan plc. Six authors are Allergan investigators; A. Marx and S. Abrams are Allergan employees; R. Hopfinger was an Allergan employee at the time; J. Chantrey reports personal fees from Allergan as a teaching consultant.
- Kerscher M, Bayrhammer J, Reuther T. Rejuvenating influence of a stabilized hyaluronic acid-based gel of nonanimal origin on facial skin aging. Dermatol Surg. 2008 May;34(5):720-6. PMID 18384619.Tier 3Supports: The founding clinical evidence for the Restylane Vital / 'skin booster' concept, kept as the definitive older primary source. Described by the authors as a pilot study. n=19 women; three treatment sessions four weeks apart with stabilised non-animal HA (NASHA, Restylane Vital, Q-Med) micropuncture-placed into the mid-dermis of the lower cheeks; elasticity, surface roughness, dermal thickness and density assessed at each session and at 4 and 12 weeks after the last. Skin elasticity and surface roughness improved significantly over the course of the study; patient feedback 'extremely positive'. Scope limits: n=19, uncontrolled, unblinded, single centre, female only, no comparator and no placebo; a 2008 record carrying no conflict-of-interest or funding statement, using a product manufactured by Q-Med. Note the product is a stabilised (cross-linked) HA, not a non-cross-linked one.
- Ghatge AS, Ghatge SB. The Effectiveness of Injectable Hyaluronic Acid in the Improvement of the Facial Skin Quality: A Systematic Review. Clin Cosmet Investig Dermatol. 2023 Apr 4;16:891-899. PMID 37038447.Tier 2Supports: The most independent synthesis located. Searched to 31 December 2022; 2,996 articles screened, 13 studies included — eight of HA formulations alone, five of HA plus other actives ('cocktails'). Verbatim finding: 'All types of HA formulations cause a significant improvement in facial skin quality, in terms of hydration, firmness, skin-tiring effect/fatigue, brightness, texture, radiance, and elasticity', with HA monotherapy more effective than combinations, and high safety. Authors' own verdict verbatim: 'The clinical evidence on the use of injectable HA alone in the improvement of the quality of facial skin... is quite promising. Large randomized controlled trials are required in this regard.' Conflict statement verbatim: 'The authors declare that they have no conflict of interest.' Affiliations confirmed: A.S. Ghatge, Department of Dermatology, Apollo Clinic, Mumbai; S.B. Ghatge, Department of Radiology, Sir JJ Group of Hospitals and Grant Government Medical College, Mumbai. Scope limits: only 13 studies, mostly small and uncontrolled; no meta-analysis and no formal risk-of-bias grading reported; facial skin quality only. TIER CORRECTION at verification: downgraded from tier 1 to tier 2. A systematic review inherits the quality of what it pools, and this one pools 13 mostly uncontrolled before-and-after studies with no bias appraisal — the same reasoning already applied to source 12. Leaving it at tier 1 while tier-3-ing the manufacturer review was internally inconsistent.
- Salti G, Tateo A, Cassuto D, Arrigoni F, Godina C, Mazzola F, Cigni C, Grimolizzi F, Bellia G. Hyaluronic Acid Hybrid Cooperative Complexes Nearing 10 Years of Use: Update on Safety Assessment Based on Post-Marketing Surveillance Data. J Cosmet Dermatol. 2025 Jul;24(7):e70197. PMID 40654100. PMCID PMC12257262.Tier 4Supports: Manufacturer's own passive post-marketing surveillance. Product description verbatim (verified against the PMC full text): 'HCC-HAPROF is a 2 mL prefilled syringe containing 32 mg of high-molecular weight HA and 32 mg of low-molecular weight HA. HCC-HAPROF-B is a 3 mL prefilled syringe containing 48 mg of high-molecular weight HA and 48 mg of low-molecular weight HA.' On manufacture, verbatim: HCC-HAPROF 'received Conformité Européenne (CE) marking in 2015 and is a novel HA preparation based on stable hybrid cooperative complexes (HCC-HA), which is the first product developed by NAHYCO Hybrid Technology, an innovative patent protected thermal production process.' On rheology, verbatim: 'Moreover, HCC-HA shows peculiar characteristics in terms of rheology; their high flowability (tanδ > 1) also allows HCC-HA to optimally integrate once injected into the tissues better than synthetic injectables.' IMPORTANT NEGATIVE finding at verification: this paper nowhere states that the NAHYCO process is free of chemical cross-linking agents or BDDE. That widely repeated claim is not in this source. BAP technique verbatim: 'The BAP technique requires the intradermic injection of the product using a 29G × ½" (0.33 × 12 mm) needle. Five injection points (0.2 mL of the product/each bolus) for each side of the face in the malar and submalar regions have been identified, while 10 injection points (0.2 mL of the product/each bolus) have been identified for the treatment... of the face and neck.' Safety numbers: face product, 1 Jan 2018 – 31 Oct 2023, 1,091,956 estimated exposed patients, 371 AEs, 0.034% complaint rate; body product, 1 Jan 2020 – 31 Oct 2023, 27,692 exposed, 11 AEs, 0.040%. Most common categories: administration-site conditions (n=201: swelling face n=24, swelling n=22, injection site swelling n=21, oedema n=12, injection site pain n=10, face oedema n=8, injection site erythema n=8, pain n=7, nodule n=6, injection site nodule n=5, injection site oedema n=5), skin conditions (n=81, including erythema n=21, pruritus n=8, dry skin n=5), periorbital swelling n=19. Verbatim: 'The incidence of vascular AEs such as embolism and vascular occlusion was low (n = 1 for both events).' Authors' own stated limitations: reports arrive 'through the spontaneous initiative of physicians', 'mild or expected AEs are often underreported', 'an underreporting to the manufacturer might occur', and exposure was estimated 'based on the maximum expected usage of syringes, potentially underestimating the actual exposure'. Scope limit: a manufacturer safety database, not an incidence study; complaint rates are a denominator estimate, not a measured event rate, and cannot be read as a true complication rate.Funding / interest: CORRECTED AT VERIFICATION. No funding statement is published with this paper — the previous record asserted one. Conflict statement verbatim: 'G.S., A.T., D.C., and F.A. declare no conflicts of interest in the writing of this manuscript. C.G., F.M., C.C., F.G., and G.B. are currently employees of IBSA Farmaceutici Italia Srl.' Five of the nine authors are therefore IBSA staff: Chiara Godina and Federica Mazzola (IBSA Institut Biochimique SA, Lugano), Clara Cigni, Franco Grimolizzi and Gilberto Bellia (IBSA Farmaceutici Italia Srl, Lodi). The fourth author declaring no conflict is Francesca ARRIGONI (Agorà Clinical Educational Centre, Milan) — the previous record named a non-existent 'F. Ambrosio'. Giovanni Salti (Medlight Institute, Florence), Antonello Tateo (private practice, Milan/Pavia) and Daniel Cassuto (private practice, Israel/Milan) also declare no conflicts, though all three are clinicians in the field. Data come from IBSA's own global safety database, so the source is manufacturer-controlled whether or not a funding line is printed.
- Sparavigna A, Cigni C, Tanzini L, Lualdi R, Grimolizzi F. A Systematic Review of the Efficacy and Safety of Profhilo® and Profhilo® Body. Plast Aesthet Nurs (Phila). 2026;46(2):80-92. PMID 41920062.Tier 3Supports: The largest synthesis of Profhilo evidence, and manufacturer-authored. Nine studies, 278 participants total across face, neck, inner arms, abdomen, hands and knees. Reports 'a statistically significant change or a trend toward an improvement' in viscoelasticity/elasticity/plastoelasticity, hydration, skin density, laxity, Wrinkle Severity Rating Scale and Facial Volume Loss Scale, with photographic improvement in turgor, tone, texture and nasolabial fold depth. Adverse events described as 'mild, expected, and usually resolved within 72 hours' — bruising, oedema, a light pinching sensation, a small bump, localised haematomas. Scope limits, and they are severe: 278 participants across nine studies is a mean of ~31 per study; the review includes no placebo-controlled trial; 'a trend toward an improvement' is reported alongside statistical significance without separating the two in the abstract; no meta-analysis and no risk-of-bias appraisal is reported; and it evaluates only one manufacturer's products. Downgraded from tier 1 despite the systematic-review label because the underlying studies are uncontrolled and the review is written by the product's own medical affairs team.Funding / interest: Three of five authors (C. Cigni, L. Tanzini, F. Grimolizzi) are employees of IBSA Farmaceutici Italia Srl, which manufactures Profhilo. A. Sparavigna and R. Lualdi declare no conflicts of interest, but both are affiliated with DERMING, the Milan clinical research institute that ran several of the IBSA-sponsored studies included in the review — an asymmetry worth naming.
- Stellavato A, Corsuto L, D'Agostino A, La Gatta A, Diana P, Bernini P, De Rosa M, Schiraldi C. Hyaluronan Hybrid Cooperative Complexes as a Novel Frontier for Cellular Bioprocesses Re-Activation. PLoS One. 2016;11(10):e0163510. PMID 27723763. Expression of Concern: PLoS One. 2024;19(4):e0302213.In vitroTier 3Supports: NOT HUMAN DATA. The foundational mechanistic paper behind the 'bio-remodelling' claim. Laboratory work only: cultured keratinocytes and fibroblasts plus the Phenion Full Thickness Skin Model 3D (a reconstructed skin construct, not living human skin). Rheology confirmed hybrid complex formation via a drop in η0 and showed the complexes resisted bovine testicular hyaluronidase digestion. Versus untreated controls and versus high- or low-molecular-weight HA alone, the hybrid complexes increased transcript and protein expression of type I and III collagen in fibroblasts, type IV and VII collagen in keratinocytes, and elastin in both the cell models and the 3D construct out to 7 days. IMPORTANT: PLOS ONE issued an Expression of Concern in April 2024 — CTR panels in Fig 9 'appear to partially overlap with the L-HA panels despite representing different experimental conditions' (attributed by the corresponding author to a figure-preparation error, with corrected versions supplied), and 'the underlying quantitative data for Figs 5 and 10 were no longer available', breaching the journal's data availability policy. The editors stated the conclusions of the article are not affected but issued the notice over the data non-compliance. Scope limits: in vitro; gene and protein expression in culture is not clinical collagen deposition in a patient; no dose, diffusion or clearance realism.Funding / interest: Authors C. Schiraldi, M. De Rosa, A. D'Agostino and A. La Gatta are inventors on a patent on hybrid cooperative complexes, assigned to a company. P. Bernini was affiliated with IBSA as Medical Marketing and contributed to the initial experimental design; IBSA supplied reagents and materials.
- Polvere I, Scrima M, Vito N, Signorino G, Iorio A, Giori AM, Ferravante A. Remodeling Effect of HA Hybrid Cooperative Complexes on Dermal White Adipose Tissue and Its Structure. Clin Cosmet Investig Dermatol. 2026;19:617588. PMID 42518882.Animal studyTier 3Supports: NOT HUMAN DATA. Mouse study of Profhilo Structura (hybrid cooperative complex HA at 45 mg/mL), the fat-compartment variant, not classic Profhilo. 15 SHK-1 female mice: 6 treated, 9 controls; two subcutaneous injections 15 days apart; sacrifice two months after the first injection, two sites sampled per mouse. Treated animals showed a greater number of 'very large' dermal white adipose tissue adipocytes, larger total dWAT area, higher expression of Collagen VI and PPARγ, and greater tissue compactness than controls. Scope limits: rodent skin differs structurally from human facial skin; tiny group sizes; no clinical endpoint; different product from the one usually sold as a 'skin booster'. Cited here to show that the newest 'remodelling' evidence for this technology remains preclinical and manufacturer-generated.Funding / interest: All seven authors are employees of IBSA Farmaceutici Italia / IBSA Group, the manufacturer, working in its Preclinical & Clinical Research and Safety Department. Verbatim: 'Immacolata Polvere, Mario Scrima, Nicoletta Vito, Giacomo Signorino, Antonio Iorio, Andrea Maria Giori and Angela Ferravante are employees of IBSA Farmaceutici Italia, IBSA Group. The authors report no other conflicts of interest in this work.' No funding statement is published.
- RETRACTION: Skin Boosters: Definitions and Varied Classifications. Skin Research and Technology. 2025 Nov;31(11):e70297. doi:10.1111/srt.70297. PMID 41271445; PMCID PMC12638202. Retracting Yi KH, et al. Skin Research and Technology. 2024;30(3):e13627. doi:10.1111/srt.13627. PMID 38481069; PMCID PMC10938033.Tier 4Supports: Formal retraction notice for the 2024 review 'Skin boosters: Definitions and varied classifications'. PubMed classifies the original article as a retracted publication and links this notice as its retraction. The notice lists no authors and gives no abstract or reason for retraction, so it supports the retracted status only, not an explanation.Funding / interest: Journal editorial action; no authors are listed.