Profhilo
Also known as: Profhilo Body, Profhilo Structura
Profhilo is IBSA's family of injectable hyaluronic-acid products used to improve skin appearance. The original product and Profhilo Body are intended for skin quality and laxity, while Profhilo Structura has a different formulation and facial-tissue purpose. Each requires assessment as a specific injectable product.
In plain English — Profhilo is a range of hyaluronic-acid injections used for skin appearance. Studies have reported improvements in some skin measurements and visible features, but results depend on the product and what is being measured. A clinical assessment is needed to choose an appropriate treatment and discuss the injection risks.
Evidence status
Manufacturer-supported
Product-specific clinical evidence; substantial commercial involvement. Studies report benefits in hydration and selected appearance outcomes, with much of the literature uncontrolled or commercially supported. Small controlled trials give different answers for different endpoints, including some positive findings and some null comparisons. Product identity, anatomical site and injection safety remain essential to interpretation.
What Profhilo is, and the types available#
Profhilo is a family of injectable hyaluronic-acid products manufactured by IBSA Farmaceutici Italia. The original formulation is used for skin quality and laxity in the face and neck. Profhilo Body is presented for body skin, while Structura has a distinct facial-tissue purpose.[1, 2]Profhilo is an IBSA injectable HA product family with original, Body and Structura formulations and distinct intended tissue/site uses.Directly tested by the source[1] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo and Profhilo Body. Revision 2, August 2023; publicly hosted January 2025. Pages 1–10 and revision table. Accessed 16 September 2026.Tier 4[2] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo Structura. Revision 2, January 2024; publicly hosted January 2025.Tier 4
| Product | HA in the documented presentation | Intended context in the manufacturer’s summary |
|---|---|---|
| Original Profhilo | 64 mg in 2 mL: 32 mg high- and 32 mg low-molecular-weight HA | Face/neck skin quality and laxity |
| Profhilo Body | 96 mg in 3 mL: 48 mg of each HA component | Body skin laxity and related labelled uses |
| Profhilo Structura | 90 mg in 2 mL: 45 mg of each HA component | Facial tissue restoration, including the adipose-tissue context |
These are manufacturer formulation and purpose descriptions, not interchangeable clinical outcomes. Original and Body have the same 32 mg/mL concentration despite their different total syringe contents. Structura differs in concentration as well as purpose.[1, 2]iManufacturer summaries specify original 64 mg/2 mL, Body 96 mg/3 mL and Structura 90 mg/2 mL, each combining high- and low-molecular-weight HA; original and Body therefore share 32 mg/mL concentration while Structura differs.Inferred from adjacent evidence[1] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo and Profhilo Body. Revision 2, August 2023; publicly hosted January 2025. Pages 1–10 and revision table. Accessed 16 September 2026.Tier 4[2] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo Structura. Revision 2, January 2024; publicly hosted January 2025.Tier 4
For UK supply, IBSA UK&I’s March 2026 release identifies IBSA Pharma Limited, whose registered identity is company 03929804, and describes official supply through IBSA and pharmacy partners. The supply record is separate from evidence of treatment benefit.[3, 4]The March 2026 IBSA UK&I release identifies IBSA Pharma Limited and official supply through IBSA/pharmacy partners; Companies House confirms company 03929804. These records support identity/supply, not efficacy.Directly tested by the source[3] IBSA UK&I. ACE 2026 press release. 26 March 2026.Tier 4[4] Companies House. IBSA Pharma Limited, company 03929804. Company overview accessed 16 September 2026.Tier 1
The focus here extends the general skin-boosters reference with Profhilo-specific formulations, trials and documents, without treating the whole skin-booster category as one formulation.
Use of Profhilo in aesthetic practice#
Consultation starts with the intended change—such as skin feel, visible lines or a facial-volume concern—and the specific product proposed for it. This is an injectable intervention requiring clinical assessment, anatomical competence, sterile traceability, informed consent and a plan for recognising and managing complications. A supplier’s training course does not replace those responsibilities.[1, 2, 3, 23]iSelection requires exact product/site/purpose, clinical assessment, traceable sterile supply, competence, consent, aftercare and access to management of injection complications.Inferred from adjacent evidence[1] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo and Profhilo Body. Revision 2, August 2023; publicly hosted January 2025. Pages 1–10 and revision table. Accessed 16 September 2026.Tier 4[2] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo Structura. Revision 2, January 2024; publicly hosted January 2025.Tier 4[3] IBSA UK&I. ACE 2026 press release. 26 March 2026.Tier 4[23] US Food and Drug Administration. Dermal Fillers (Soft Tissue Fillers). Accessed 16 September 2026.Tier 1
Product-market status
The retrieved manufacturer safety/performance summaries describe EU-MDR class III devices and CE documentation.[1, 2, 15]iRetrieved manufacturer summaries describe EU-MDR class III devices and CE documentation. GB and NI conformity routes require separate checking.Inferred from adjacent evidence[1] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo and Profhilo Body. Revision 2, August 2023; publicly hosted January 2025. Pages 1–10 and revision table. Accessed 16 September 2026.Tier 4[2] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo Structura. Revision 2, January 2024; publicly hosted January 2025.Tier 4[15] MHRA. Regulating medical devices in the UK. Updated 20 February 2026; accessed 16 September 2026.Tier 1 A current UKCA certificate was not retrieved in this review; that does not establish that none exists.[no source found]A current UKCA certificate for these products was not retrieved in this review; this does not establish that none exists.We looked and found no source either wayCheck the actual product’s current conformity documents, intended site and supply route. The original/Body summary is manufacturer-authored and its revision table says revision 2 was not yet notified-body validated; it should not be presented as an independent efficacy assessment.[1]
GB and NI differ:MHRA guidance describes the GB UK-device framework, registration and applicable conformity routes, including transitional CE recognition; NI follows EU device requirements. Market conformity does not determine who is permitted or competent to inject a patient. Nor does a manufacturer’s prescription-sale wording by itself classify the device as a UK prescription-only medicine.[1, 2, 15]iRetrieved manufacturer summaries describe EU-MDR class III devices and CE documentation. GB and NI conformity routes require separate checking.Inferred from adjacent evidence[1] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo and Profhilo Body. Revision 2, August 2023; publicly hosted January 2025. Pages 1–10 and revision table. Accessed 16 September 2026.Tier 4[2] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo Structura. Revision 2, January 2024; publicly hosted January 2025.Tier 4[15] MHRA. Regulating medical devices in the UK. Updated 20 February 2026; accessed 16 September 2026.Tier 1
In the US, IBSA’s 28 July 2026 Evolus agreement describes clinical development and future authorisation aims. It is a development announcement, not an FDA approval.[25]IBSA's July 2026 Evolus announcement describes future US development/authorisation aims; the announcement is not an FDA approval.Directly tested by the source[25] IBSA. IBSA expands its presence in the US aesthetic medicine market with an agreement with Evolus. 28 July 2026.Tier 4
Four-nation practice position
Checked 16 September 2026:
- England: the 2023 consultation proposed an amber category for HA injections; the 2025 response describes further development rather than itself creating an operative licence. The separate 2021 Act prohibits cosmetic filler injections into under-18s, subject to statutory defences. Its definition depends on filling purpose, not whether a service is marketed as a skin booster, so that label is not an exemption.[16, 17, 18]iEngland's 2023 HA-injection amber tier was proposed; the 2025 response did not itself implement licensing. The 2021 Act prohibits cosmetic filler injections into under-18s subject to statutory defences, using a purpose-based filler definition rather than a marketing category.Inferred from adjacent evidence[16] DHSC. The licensing of non-surgical cosmetic procedures in England. Consultation, 2023.Tier 1[17] DHSC. The licensing of non-surgical cosmetic procedures in England: consultation response. 7 August 2025.Tier 1[18] Botulinum Toxin and Cosmetic Fillers (Children) Act 2021, section 1.Tier 1
- Scotland: the 2026 Act includes cosmetic injections into or under skin. Commencement No. 1 brought selected provisions into force on 22 July 2026, not the under-18 or premises offences. Section 3 cannot commence before 6 September 2027; that restriction is not itself a commencement date. Check the latest instruments before practice.[19, 20]Scotland's 2026 Act covers cosmetic injections; Commencement No. 1 began selected provisions on 22 July 2026, not the under-18/premises offences. Section 3 cannot commence before 6 September 2027, which is not itself an appointed commencement date.Directly tested by the source[19] Non-surgical Procedures and Functions of Medical Reviewers (Scotland) Act 2026, asp 13, sections 1–5 and 24, schedule 1.Tier 1[20] Scottish Ministers. Non-surgical Procedures and Functions of Medical Reviewers (Scotland) Act 2026 (Commencement No. 1 and Saving Provision) Regulations 2026. S.S.I. 2026/206.Tier 1
- Wales: the special-procedures scheme covers acupuncture, body piercing, electrolysis and tattooing. That source is not a general permission to provide injectable treatments; the proposed service and premises require their own scope check.[21]iWales's four-procedure special-licensing scheme is not a general injectable authorisation.Inferred from adjacent evidence[21] Welsh Government. Licensing scheme for special procedures. Updated 30 July 2026.Tier 1
- Northern Ireland: the April 2026 ministerial answer reported no current plans for a broad scheme in the remaining mandate. Existing professional and other applicable obligations still need checking.[22]iThe April 2026 NI answer reports no current plans for a broad scheme during the remaining mandate; it is not permission to disregard existing obligations.Inferred from adjacent evidence[22] Northern Ireland Assembly. AQW 41857/22–27. Minister of Health answer, 1 April 2026.Tier 1
Contraindications and cautions#
Pregnancy and breastfeeding, relevant allergy and autoimmune disease are exclusions in the retrieved manufacturer summaries. These are product instructions, not a claim that trials established pregnancy harm or proved safety in excluded populations. The exact current instructions supplied with the product govern.[1, 2]Retrieved manufacturer summaries contraindicate use in pregnancy/breastfeeding, relevant allergy and autoimmune disease; prohibit injection into inflamed skin or blood vessels; and prohibit use in conjunction with laser resurfacing or medium/deep chemical peels. Exact current product instructions govern.Directly tested by the source[1] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo and Profhilo Body. Revision 2, August 2023; publicly hosted January 2025. Pages 1–10 and revision table. Accessed 16 September 2026.Tier 4[2] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo Structura. Revision 2, January 2024; publicly hosted January 2025.Tier 4
Do not inject inflamed skin or use the products in conjunction with laser resurfacing or medium/deep chemical peels: these are explicit manufacturer prohibitions. The summaries also prohibit intravascular administration. Previous injectable reactions, current medical treatment and an uncertain diagnosis need clinical assessment before selection.[1, 2]Retrieved manufacturer summaries contraindicate use in pregnancy/breastfeeding, relevant allergy and autoimmune disease; prohibit injection into inflamed skin or blood vessels; and prohibit use in conjunction with laser resurfacing or medium/deep chemical peels. Exact current product instructions govern.Directly tested by the source[1] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo and Profhilo Body. Revision 2, August 2023; publicly hosted January 2025. Pages 1–10 and revision table. Accessed 16 September 2026.Tier 4[2] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo Structura. Revision 2, January 2024; publicly hosted January 2025.Tier 4
Check the exact formulation, intended anatomical site, sterile package, batch and expiry. A clinical trial’s eligibility criteria do not substitute for the product’s current contraindications.[1, 2]
Clinical uses and the evidence behind them#
Skin quality and hydration
An IBSA-funded systematic review, with three IBSA employee authors, searched to 23 February 2024 and included nine studies with 278 participants. It concluded favourably on outcomes including hydration, laxity, elasticity and wrinkles, mainly from uncontrolled studies across several sites. It does not supply pooled comparative efficacy or include the later 2026 randomised studies described below.[5]An IBSA-funded systematic review searching to February 2024 included nine studies/278 participants and concluded favourably on several skin outcomes, predominantly from uncontrolled studies; this does not include later 2026 RCTs or provide pooled comparative efficacy.Directly tested by the source[5] 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. 2026;46(2):80–92. doi:10.1097/PSN.0000000000000637. PMID:41920062.Tier 1
Cheng and colleagues followed 30 Chinese women aged 38–60 in Singapore after facial treatment, with 26 final clinical assessments at week 12. Hydration testing was added during the study after an early observation: eight participants had earlier measurements and six had final hydration measurements. Hydration improved, but the small selected subset and lack of control limit the conclusion. Neoasia funded the study; IBSA supported medical writing and employed two authors.[8]In Cheng's commercially supported Singapore study of 30 Chinese women aged 38–60, hydration measurements improved in a subset added mid-study, with six assessed at week 12; the uncontrolled cohort did not provide 30 independent hydration observations at final follow-up.Directly tested by the source[8] Cheng SWN, Lim SYD, Cigni C, Grimolizzi F, Goh CL. Efficacy and Tolerability of Stable Hybrid Cooperative Complexes of High- and Low-Molecular Weight Hyaluronic Acid in Asian Patients: An Open-Label Study. Aesthetic Plast Surg. 2026;50(1):27–36. Published online 2025. doi:10.1007/s00266-025-05188-x. PMID:40921777.Tier 3
A separate 24-woman, fixed-side cheek comparison followed Profhilo and Belotero Revive over 14 weeks. Both improved several measurements from baseline, including hydration and elasticity, without significant between-product differences. The authors concluded positively about skin quality. The retrieved original abstract does not establish full funding or conflict details; the study is not a formal demonstration of equivalence.[9]iIn a fixed-side cheek study of 24 healthy women followed 14 weeks, Profhilo and Belotero Revive improved several measures from baseline without significant between-product differences; this is not proof of equivalence or superiority.Inferred from adjacent evidence[9] 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;21(11):5576–5583. doi:10.1111/jocd.15157. PMID:35699361.Tier 3
Perioral lines and upper-face combinations
A 12-woman Brazilian split-face trial, ages 45–65, compared Profhilo with saline around the mouth. Its abstract reports wrinkle and pore improvements at day 60, after two research sessions a month apart, while the dermal-thickness effect did not exceed placebo. That is a positive appearance finding alongside a null result for a different measurement. The authors declared no conflicts; separate funding and full methods were not available in the retrieved record.[6]A 12-woman Brazilian saline-controlled perioral trial reported wrinkle/pore improvements at day 60 after two research sessions, while product-associated thickness did not exceed placebo; original abstract only, separate funding unavailable.Directly tested by the source[6] Zanella G, de Souza Ataíde FT, de Lima Bonato TC, et al. Effects of Profhilo Tissue Bioremodeling on Skin Texture and Perioral Wrinkles: A Randomized Controlled Triple-Blind Clinical Trial. Aesthetic Plast Surg. 2026;50(11):4324–4332. doi:10.1007/s00266-026-05634-4. PMID:41731228.Tier 2
Saffarian and colleagues studied a different question: adding Profhilo to botulinum toxin for the forehead and glabella. Twenty Iranian adults, 15 men and five women aged 18–42, phototypes II–IV, were randomised ten per arm. At three months after the final treatment, adding Profhilo did not produce a significant additional short-term wrinkle or ultrasound benefit. The authors reported no funding to declare and no conflicts. This small combination trial addresses that incremental use, not every purpose of Profhilo.[7]A 20-person Iranian forehead/glabella RCT found no significant added short-term wrinkle or ultrasound benefit from Profhilo added to botulinum toxin at three months after last treatment. This comparison does not establish lack of benefit for every product use.Directly tested by the source[7] Saffarian Z, Rahimnia A, Ehsani A, et al. Combined Use of Botulinum Toxin A and Profhilo for Upper Face Rejuvenation: A Randomized Clinical Trial. Health Sci Rep. 2026;9(5):e71973. doi:10.1002/hsr2.71973. PMID:42063688.Tier 2
Structura and facial tissue
An uncontrolled Structura series enrolled 22 adults, 20 women and two men aged 36–60, with midface volume deficit. Ultrasound tissue thickness changed significantly at three months from the first treatment, but not at six months, although the authors described continuing visible improvement. IBSA funded writing, editing and publication, and two authors were employees. The interpretation of tissue regeneration is addressed in Commonly misstated claims.[10]In 22 adults aged 36–60 with midface volume deficit, an uncontrolled Structura series reported significant ultrasound thickness change at three but not six months from first treatment; authors described favourable clinical change.Directly tested by the source[10] Cassuto D, Cigni C, Bellia G, Schiraldi C. Restoring Adipose Tissue Homeostasis in Response to Aging: Initial Clinical Experience with Profhilo Structura. Gels. 2023;9(8):614. doi:10.3390/gels9080614. PMID:37623069.Tier 3
Use alongside acne-scar treatment
In a 12-adult Iranian split-face trial, ages 18–45, adding Profhilo to subcision improved satisfaction compared with subcision alone at three months after the final session. Between-side differences in scar score, sonographic depth and global assessment were not significant. The abstract’s authors nevertheless concluded favourably about the addition; both findings matter. Tehran University grant support is indexed, but full conflict declarations were unavailable. Broader treatment selection belongs in acne scarring.[11]A 12-adult split-face subcision trial found greater satisfaction with added Profhilo but no significant between-side scar-score/depth/global difference at three months after final treatment; original abstract only.Directly tested by the source[11] Dastgheib M, Heidari S, Azizipour A, et al. Investigating the impact of added Profhilo mesogel to subcision versus subcision monotherapy in treating acne scars; a single-blinded, split-face randomized trial. J Cosmet Dermatol. 2024;23(6):1992–2000. doi:10.1111/jocd.16258. PMID:38429946.Tier 2
The treatment courses above describe research, not a prescribing or injection protocol.
Selecting a Profhilo product#
Match the specific product and its intended site to the client’s assessed concern. Hydration, a wrinkle grade, tissue thickness and satisfaction are different outcomes; agree which change will be reviewed.[1, 2, 6, 7, 8, 9, 10, 11]
Verify current instructions and conformity documentation, traceable authorised supply, sterile integrity and the practitioner’s training and indemnity for the actual intervention. Discuss the expected recovery and ensure the client has a clear route to urgent assessment if something unexpected occurs.[1, 2, 3, 23]iSelection requires exact product/site/purpose, clinical assessment, traceable sterile supply, competence, consent, aftercare and access to management of injection complications.Inferred from adjacent evidence[1] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo and Profhilo Body. Revision 2, August 2023; publicly hosted January 2025. Pages 1–10 and revision table. Accessed 16 September 2026.Tier 4[2] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo Structura. Revision 2, January 2024; publicly hosted January 2025.Tier 4[3] IBSA UK&I. ACE 2026 press release. 26 March 2026.Tier 4[23] US Food and Drug Administration. Dermal Fillers (Soft Tissue Fillers). Accessed 16 September 2026.Tier 1[15]
The manufacturer describes product-specific administration methods. This reference does not prescribe an injection map, plane, dose, interval or combination regimen; those decisions require the current instructions and accountable clinical judgement.
Adverse effects and their management#
Local reactionsinclude swelling, bruising, pain and redness. The systematic review’s six-study pooled estimate for mild adverse events was 46.0% (95% CI 19.6–74.9%). The wide interval and differing studies make this a summary of reported mild events, not a precise prediction for an individual product/site or a serious-complication rate.[1, 5]Local swelling, bruising, pain and erythema are recognised. The review's six-study pooled mild-adverse-event estimate was 46.0% with 95% CI 19.6–74.9%; it is not a serious-event rate or a prediction for every product/site.Directly tested by the source[1] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo and Profhilo Body. Revision 2, August 2023; publicly hosted January 2025. Pages 1–10 and revision table. Accessed 16 September 2026.Tier 4[5] 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. 2026;46(2):80–92. doi:10.1097/PSN.0000000000000637. PMID:41920062.Tier 1
Persistent swelling, nodules or suspected infection need clinical review and an accurate product/batch record.[1, 23]The manufacturer’s spontaneous-report database specifically records swelling and nodules. Its 2025 update reported 371 events for original Profhilo and 11 for Body through October 2023, including an embolism and a vascular-occlusion event for the original product. These are event records, not necessarily separate people.[12]Salti 2025 reports 371 original-product events and 11 Body events from spontaneous manufacturer surveillance through October 2023, including an embolism and a vascular-occlusion event; exposure was estimated from syringes sold, not a prospectively followed patient cohort.Directly tested by the source[12] Salti G, Tateo A, Cassuto D, et al. Hyaluronic Acid Hybrid Cooperative Complexes Nearing 10 Years of Use: Update on Safety Assessment Based on Post-Marketing Surveillance Data. J Cosmet Dermatol. 2025;24(7):e70197. doi:10.1111/jocd.70197. PMID:40654100.Tier 3
The exposure denominator was estimated from syringes sold rather than a prospectively followed patient cohort. Under-reporting therefore prevents reading the paper’s very low reporting ratio as a person’s measured complication risk. The authors concluded favourably about overall safety; the dataset was manufacturer-controlled and five authors were IBSA employees.[12]Salti 2025 reports 371 original-product events and 11 Body events from spontaneous manufacturer surveillance through October 2023, including an embolism and a vascular-occlusion event; exposure was estimated from syringes sold, not a prospectively followed patient cohort.Directly tested by the source[12] Salti G, Tateo A, Cassuto D, et al. Hyaluronic Acid Hybrid Cooperative Complexes Nearing 10 Years of Use: Update on Safety Assessment Based on Post-Marketing Surveillance Data. J Cosmet Dermatol. 2025;24(7):e70197. doi:10.1111/jocd.70197. PMID:40654100.Tier 3
Unexpected severe pain, blanching or other skin-colour change, or any visual or neurological symptom after injection requires immediate medical assessment. Do not wait for a routine review or assume it is an ordinary lump. This escalation advice draws on general injectable-filler safety guidance, not a Profhilo-specific incidence estimate.[23, 24]iUnusual severe pain, blanching/colour change, vision change or stroke symptoms after an HA injection require immediate medical assessment; suspected anaphylaxis is an emergency.Inferred from adjacent evidence[23] US Food and Drug Administration. Dermal Fillers (Soft Tissue Fillers). Accessed 16 September 2026.Tier 1[24] NHS. Anaphylaxis. Accessed 16 September 2026.Tier 4
Referral and scope boundaries#
Injection selection and complication management require an appropriately competent clinician. A practitioner who cannot assess the medical concern or manage the foreseeable complication pathway should refer before treatment. Supplier access and brand training are separate from clinical responsibility.[1, 2, 3, 23]iSelection requires exact product/site/purpose, clinical assessment, traceable sterile supply, competence, consent, aftercare and access to management of injection complications.Inferred from adjacent evidence[1] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo and Profhilo Body. Revision 2, August 2023; publicly hosted January 2025. Pages 1–10 and revision table. Accessed 16 September 2026.Tier 4[2] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo Structura. Revision 2, January 2024; publicly hosted January 2025.Tier 4[3] IBSA UK&I. ACE 2026 press release. 26 March 2026.Tier 4[23] US Food and Drug Administration. Dermal Fillers (Soft Tissue Fillers). Accessed 16 September 2026.Tier 1
Visual change or stroke-like symptoms after injection require emergency care. Suspected anaphylaxis, including rapidly developing airway or breathing symptoms, is an emergency: call 999.[23, 24]iUnusual severe pain, blanching/colour change, vision change or stroke symptoms after an HA injection require immediate medical assessment; suspected anaphylaxis is an emergency.Inferred from adjacent evidence[23] US Food and Drug Administration. Dermal Fillers (Soft Tissue Fillers). Accessed 16 September 2026.Tier 1[24] NHS. Anaphylaxis. Accessed 16 September 2026.Tier 4
For a person primarily concerned about scars, pigment or an active eruption, establish the diagnosis and relevant care pathway before offering an injectable appearance treatment. The small acne-scar combination study does not make routine cosmetic injection a substitute for a scar assessment.[1, 11]
Mechanism of action#
HA binds water. IBSA’s formulation combines high- and low-molecular-weight HA in thermally produced hybrid cooperative complexes, with a physicochemical rationale involving hydration and tissue interaction. These properties explain the product design; visible and patient-important benefits still need clinical measurements.[1, 13]iHA water-binding and the manufacturer's high/low molecular-weight hybrid-complex design provide a physicochemical rationale; cellular mechanism experiments are separate from demonstrated clinical endpoints.Inferred from adjacent evidence[1] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo and Profhilo Body. Revision 2, August 2023; publicly hosted January 2025. Pages 1–10 and revision table. Accessed 16 September 2026.Tier 4[13] Stellavato A, Corsuto L, D'Agostino A, et al. Hyaluronan Hybrid Cooperative Complexes as a Novel Frontier for Cellular Bioprocesses Re-Activation. PLoS One. 2016;11(10):e0163510. doi:10.1371/journal.pone.0163510. PMID:27723763. See attached 2024 Expression of Concern.Tier 3
Stellavato’s 2016 laboratory study used human cell cultures and a reconstructed full-thickness skin model, not biopsies from living patients after injection. It reported matrix-related cellular responses. Public MIUR funding was accompanied by IBSA materials/copyediting support; an IBSA medical-marketing author contributed to initial design and four authors were patent inventors.[13]Stellavato 2016 tested human cell cultures and reconstructed skin, reporting cellular/matrix responses; it is not living-patient injection evidence.Directly tested by the source[13] Stellavato A, Corsuto L, D'Agostino A, et al. Hyaluronan Hybrid Cooperative Complexes as a Novel Frontier for Cellular Bioprocesses Re-Activation. PLoS One. 2016;11(10):e0163510. doi:10.1371/journal.pone.0163510. PMID:27723763. See attached 2024 Expression of Concern.Tier 3
That paper has a 2024 Expression of Concernabout unavailable underlying quantitative data for two figures. A separate image-overlap issue was corrected to the editors’ satisfaction without affecting their assessment of the conclusions on that issue. The notice is not a retraction or a finding that every result is false, but the laboratory paper should not carry a confident clinical collagen-production claim.[14]The 2024 PLOS Expression of Concern concerns missing underlying quantitative data; a separate image-overlap issue was corrected to editors' satisfaction. It is not a retraction or blanket finding of false results.Directly tested by the source[14] PLOS ONE Editors. Expression of Concern: Hyaluronan Hybrid Cooperative Complexes as a Novel Frontier for Cellular Bioprocesses Re-Activation. PLoS One. 2024;19(4):e0302213. doi:10.1371/journal.pone.0302213.Tier 4
Commonly misstated claims#
Total syringe content treated as concentration
Claim heard:“Original Profhilo contains 64 mg of HA per millilitre.”
Literature finding:The manufacturer’s documented presentation contains 64 mg in 2 mL, made from 32 mg of each HA component.[1, 2]iManufacturer summaries specify original 64 mg/2 mL, Body 96 mg/3 mL and Structura 90 mg/2 mL, each combining high- and low-molecular-weight HA; original and Body therefore share 32 mg/mL concentration while Structura differs.Inferred from adjacent evidence[1] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo and Profhilo Body. Revision 2, August 2023; publicly hosted January 2025. Pages 1–10 and revision table. Accessed 16 September 2026.Tier 4[2] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo Structura. Revision 2, January 2024; publicly hosted January 2025.Tier 4
Supported statement: The original concentration is 32 mg/mL; total content and concentration are different quantities.
Tissue thickness treated as new fat-cell production
Claim heard:“The Structura study proves that patients grew new fat cells.”
Literature finding:The clinical series measured ultrasound tissue thickness and appearance. It did not biopsy treated patients to establish newly generated adipocytes. The authors’ regenerative interpretation goes beyond what that clinical measurement alone demonstrates.[10]iThe Structura clinical series measured ultrasound tissue thickness and appearance, not biopsy-confirmed production of new adipocytes in patients.Inferred from adjacent evidence[10] Cassuto D, Cigni C, Bellia G, Schiraldi C. Restoring Adipose Tissue Homeostasis in Response to Aging: Initial Clinical Experience with Profhilo Structura. Gels. 2023;9(8):614. doi:10.3390/gels9080614. PMID:37623069.Tier 3
Supported statement: The series reports a tissue-thickness observation and favourable appearance findings; it does not directly prove new fat-cell production in patients.
Results transferred across the product family
Claim heard:“A positive original-Profhilo trial proves the same result for Body or Structura.”
Literature finding: The manufacturer documents different presentations and intended tissue/site uses, and clinical studies use specific products and outcomes.[1, 2]Profhilo is an IBSA injectable HA product family with original, Body and Structura formulations and distinct intended tissue/site uses.Directly tested by the source[1] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo and Profhilo Body. Revision 2, August 2023; publicly hosted January 2025. Pages 1–10 and revision table. Accessed 16 September 2026.Tier 4[2] IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo Structura. Revision 2, January 2024; publicly hosted January 2025.Tier 4[6, 10]
Supported statement: Identify the formulation, treatment site and measured endpoint before transferring a claim.
Areas of remaining uncertainty#
- Which outcome matters most to this client?Record the agreed concern and a consistent baseline, so a measurement change can be judged alongside the person’s experience.[6, 7, 11]
- How long is a useful benefit maintained for this product and site? Discuss follow-up and cost without turning the differing study schedules into a universal maintenance requirement.[5, 9, 10]
- How should treatment be coordinated with other procedures? Check current product restrictions and the full clinical plan rather than assuming that evidence for one combination covers another.[1, 2, 7]
Frequently asked questions#
Is Profhilo a skin booster?
Original Profhilo is commonly discussed in that context, but the product family includes distinct formulations and purposes. Use the exact product name rather than the category alone when discussing treatment.[1, 2, 5]
What should someone bring to a consultation?
Their treatment goal, medical and allergy history, current medicines and details of previous injectables or planned procedures. These help the clinician assess suitability for the actual product.[1, 2]
Does “bio-remodelling” describe a measured result?
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.
- IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo and Profhilo Body. Revision 2, August 2023; publicly hosted January 2025. Pages 1–10 and revision table. Accessed 16 September 2026.Tier 4Supports: Manufacturer identity, original 64 mg/2 mL and Body 96 mg/3 mL, intended purposes, EU-MDR class III certificate details, precautions and contraindications. Revision table says this revision was not yet notified-body validated; not an independent efficacy review or verified UKCA certificate.Funding / interest: Manufacturer-authored safety/performance summary. Its technical and labelled information is distinguished from independent clinical evidence.
- IBSA Farmaceutici Italia. Summary of Safety and Clinical Performance for users: Profhilo Structura. Revision 2, January 2024; publicly hosted January 2025.Tier 4Supports: Distinct 90 mg/2 mL formulation, intended facial/adipose-tissue use, EU-MDR class III status and product warnings. Labelled regenerative purpose is not histological proof of new fat in treated patients.Funding / interest: Manufacturer-authored summary; revision table reports notified-body validation. Not an independently funded comparative study.
- IBSA UK&I. ACE 2026 press release. 26 March 2026.Tier 4Supports: Current UK commercial identity, IBSA Pharma Limited registration number and official Profhilo supply through IBSA and its pharmacy partners, with UK&I hologram. Promotional efficacy statements are not used as trial evidence.Funding / interest: Commercial corporate press release from IBSA UK&I.
- Companies House. IBSA Pharma Limited, company 03929804. Company overview accessed 16 September 2026.Tier 1Supports: Active registered UK corporate identity matching the IBSA UK&I release; not clinical approval or proof of ultimate beneficial ownership.Funding / interest: Public corporate register; not a clinical study.
- 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. 2026;46(2):80–92. doi:10.1097/PSN.0000000000000637. PMID:41920062.Tier 1Supports: Nine studies/278 participants, search to 23 February 2024; favourable outcomes from predominantly uncontrolled studies, plus six-study mild-adverse-event meta-analysis with CI. Not comparative pooled efficacy or inclusion of later 2026 RCTs.Funding / interest: IBSA funded the review and medical writing; Cigni, Tanzini and Grimolizzi were IBSA employees. Sparavigna and Lualdi were DERMING-affiliated and declared no conflicts.
- Zanella G, de Souza Ataíde FT, de Lima Bonato TC, et al. Effects of Profhilo Tissue Bioremodeling on Skin Texture and Perioral Wrinkles: A Randomized Controlled Triple-Blind Clinical Trial. Aesthetic Plast Surg. 2026;50(11):4324–4332. doi:10.1007/s00266-026-05634-4. PMID:41731228.Tier 2Supports: Original abstract: 12 Brazilian women aged 45–65, perioral split-face saline comparison, two sessions 30 days apart, day-60 assessment. Wrinkle/pore improvement, thickness not beyond placebo. Full methods unavailable; satisfaction denominator not assumed.Funding / interest: Authors declared no conflicts in publisher record. Funding not established from the retrieved abstract/declarations; independence is not inferred.
- Saffarian Z, Rahimnia A, Ehsani A, et al. Combined Use of Botulinum Toxin A and Profhilo for Upper Face Rejuvenation: A Randomized Clinical Trial. Health Sci Rep. 2026;9(5):e71973. doi:10.1002/hsr2.71973. PMID:42063688.Tier 2Supports: Twenty Iranian adults, 15 men/5 women, ages 18–42, phototypes II–IV; forehead/glabella botulinum toxin with/without Profhilo, ten per arm, three months after last treatment. No significant added short-term wrinkle or ultrasound benefit.Funding / interest: Funding statement says authors have nothing to report; no conflicts declared. Academic hospital research centres acknowledged for technical/editorial assistance. No manufacturer sponsorship asserted.
- Cheng SWN, Lim SYD, Cigni C, Grimolizzi F, Goh CL. Efficacy and Tolerability of Stable Hybrid Cooperative Complexes of High- and Low-Molecular Weight Hyaluronic Acid in Asian Patients: An Open-Label Study. Aesthetic Plast Surg. 2026;50(1):27–36. Published online 2025. doi:10.1007/s00266-025-05188-x. PMID:40921777.Tier 3Supports: Thirty Chinese women aged 38–60 in Singapore, facial treatment, week-12 follow-up, 26 final clinical assessments. Hydration testing added mid-study with eight early/six final participants; positive hydration observation, not 30-person controlled hydration evidence.Funding / interest: Neoasia Pte funded the study; IBSA funded medical writing. Cigni and Grimolizzi were IBSA employees.
- 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;21(11):5576–5583. doi:10.1111/jocd.15157. PMID:35699361.Tier 3Supports: Original MEDLINE abstract retrieved through Europe PMC: 24 healthy women, fixed-side Profhilo/Belotero Revive cheek comparison, three research occasions, 14 weeks; both improved from baseline without significant between-product differences.Funding / interest: Full funding/conflict declarations unavailable in the retrieved original abstract. Neither independent funding nor manufacturer sponsorship is assumed.
- Cassuto D, Cigni C, Bellia G, Schiraldi C. Restoring Adipose Tissue Homeostasis in Response to Aging: Initial Clinical Experience with Profhilo Structura. Gels. 2023;9(8):614. doi:10.3390/gels9080614. PMID:37623069.Tier 3Supports: Uncontrolled Structura study in 22 adults, 20 women/two men, ages 36–60, midface volume deficit; ultrasound thickness significant at three but not six months from first treatment. No biopsy proof of new adipocytes.Funding / interest: IBSA funded writing, editing and publication. Cigni and Bellia were IBSA employees.
- Dastgheib M, Heidari S, Azizipour A, et al. Investigating the impact of added Profhilo mesogel to subcision versus subcision monotherapy in treating acne scars; a single-blinded, split-face randomized trial. J Cosmet Dermatol. 2024;23(6):1992–2000. doi:10.1111/jocd.16258. PMID:38429946.Tier 2Supports: Original MEDLINE abstract retrieved through Europe PMC: 12 Iranian adults aged 18–45, facial atrophic acne scars, subcision with/without Profhilo, three months after final session; satisfaction favoured addition while scar-score/depth/global comparisons were not significant.Funding / interest: Indexed Tehran University grant support. Full conflict declarations were not available in the retrieved abstract.
- Salti G, Tateo A, Cassuto D, et al. Hyaluronic Acid Hybrid Cooperative Complexes Nearing 10 Years of Use: Update on Safety Assessment Based on Post-Marketing Surveillance Data. J Cosmet Dermatol. 2025;24(7):e70197. doi:10.1111/jocd.70197. PMID:40654100.Tier 3Supports: Manufacturer spontaneous-report data through October 2023, including original-product embolism/vascular-occlusion events. Events and sales-derived exposure estimates are not prospective patient incidence.Funding / interest: Manufacturer-controlled IBSA safety database; five authors were IBSA employees. Medical writing acknowledged; separate funding not explicitly declared.
- Stellavato A, Corsuto L, D'Agostino A, et al. Hyaluronan Hybrid Cooperative Complexes as a Novel Frontier for Cellular Bioprocesses Re-Activation. PLoS One. 2016;11(10):e0163510. doi:10.1371/journal.pone.0163510. PMID:27723763. See attached 2024 Expression of Concern.In vitroTier 3Supports: Human cell cultures and reconstructed full-thickness skin model; gene/protein responses and mechanistic rationale, not living-patient injection biopsies or quantified clinical collagen production.Funding / interest: MIUR public funding plus IBSA materials and copyediting support; IBSA medical-marketing co-author participated in initial design, and four authors were patent inventors.
- PLOS ONE Editors. Expression of Concern: Hyaluronan Hybrid Cooperative Complexes as a Novel Frontier for Cellular Bioprocesses Re-Activation. PLoS One. 2024;19(4):e0302213. doi:10.1371/journal.pone.0302213.Tier 4Supports: Missing underlying quantitative data for Figures 5/10; Figure 9 overlap corrected with editors satisfied that this issue did not affect conclusions. An expression of concern, not a retraction or proof that all findings are false.Funding / interest: Publisher editorial notice; no product sponsor stated.
- MHRA. Regulating medical devices in the UK. Updated 20 February 2026; accessed 16 September 2026.Tier 1Supports: Distinct GB/NI market routes and conformity/registration requirements; not the rules governing who may inject a patient.Funding / interest: Official UK regulatory guidance.
- DHSC. The licensing of non-surgical cosmetic procedures in England. Consultation, 2023.Tier 1Supports: Proposed amber classification of HA injections; proposal only and England only.Funding / interest: Official government policy consultation.
- DHSC. The licensing of non-surgical cosmetic procedures in England: consultation response. 7 August 2025.Tier 1Supports: Further licensing development rather than a licence created by the response itself.Funding / interest: Official government response.
- Botulinum Toxin and Cosmetic Fillers (Children) Act 2021, section 1.Tier 1Supports: England under-18 cosmetic-filler offence, purpose-based filler definition and statutory defences. Not a four-nation instrument.Funding / interest: Primary legislation.
- Non-surgical Procedures and Functions of Medical Reviewers (Scotland) Act 2026, asp 13, sections 1–5 and 24, schedule 1.Tier 1Supports: Covered cosmetic injections, staged powers/offences and statutory prohibition on commencing section 3 before 6 September 2027. Read alongside commencement.Funding / interest: Primary Scottish legislation.
- Scottish Ministers. Non-surgical Procedures and Functions of Medical Reviewers (Scotland) Act 2026 (Commencement No. 1 and Saving Provision) Regulations 2026. S.S.I. 2026/206.Tier 1Supports: Selected provisions commenced 22 July 2026; not the section 2(1) under-18 offence or section 3 premises offence.Funding / interest: Primary Scottish commencement instrument.
- Welsh Government. Licensing scheme for special procedures. Updated 30 July 2026.Tier 1Supports: Four named special procedures, not blanket injectable permission.Funding / interest: Official Welsh government guidance.
- Northern Ireland Assembly. AQW 41857/22–27. Minister of Health answer, 1 April 2026.Tier 1Supports: No current plans for a broad non-surgical cosmetic licensing scheme during the remaining mandate at that date; no blanket exemption from other obligations.Funding / interest: Official parliamentary answer.
- US Food and Drug Administration. Dermal Fillers (Soft Tissue Fillers). Accessed 16 September 2026.Tier 1Supports: General injectable-filler safety context and immediate assessment for unusual pain, skin colour change, vision change or stroke symptoms. Not Profhilo-specific incidence or UK licensing.Funding / interest: US regulator safety information.
- NHS. Anaphylaxis. Accessed 16 September 2026.Tier 4Supports: Emergency response for suspected anaphylaxis; public patient information, not a formal evidence-graded guideline.Funding / interest: NHS public information; no commercial sponsor stated.
- IBSA. IBSA expands its presence in the US aesthetic medicine market with an agreement with Evolus. 28 July 2026.Tier 4Supports: US development/commercialisation partnership announcement; FDA authorisation described as a future aim, not an approval granted by this announcement.Funding / interest: Manufacturer corporate announcement.