Profhilo: What the Brand-Specific Studies Actually Show
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Short answer. Evidence label: Limited. Profhilo is an injectable hyaluronic acid (HA) product made by IBSA that combines high- and low-molecular-weight HA into hybrid complexes. Small studies report changes in hydration and skin quality, but the controlled trials are mixed. A 12-woman trial found no more dermal thickening than saline, and a 20-person trial did not detect a significant added short-term benefit over botulinum toxin alone.[^1][^2] Several supportive studies had manufacturer-employed authors or manufacturer funding.
Profhilo is not a topical HA serum or a polynucleotide injection, and it is not the same product as Skinvive. We found no Profhilo match in the openFDA PMA approval, 510(k) clearance or device registration/listing searches we checked on November 8, 2026. That limited search is not a worldwide status check or a safety verdict. This guide is not a treatment recommendation.
What is Profhilo?
Evidence label: Limited. What the product is made of is well described. Its clinical effects are not.
Profhilo is an injectable HA product from IBSA. HA is a molecule in skin that holds water. Molecular weight roughly reflects chain length.
A paper on safety reports collected after launch says Profhilo has been sold since 2015.[^3] It describes how both chain lengths are combined into "hybrid cooperative complexes" using NAHYCO Hybrid Technology, a heat-based process described as using no chemical reagents. Three authors worked for IBSA Farmaceutici Italia and one for IBSA Institut Biochimique. The full text acknowledges IBSA Farmaceutici Italia support for medical writing; a separate study-funding source was not identified.
Many conventional HA fillers use a chemical crosslinker to bind HA chains together. Having no crosslinker does not make Profhilo risk-free or "nonchemical." "Bioremodelling" is a marketing term for an intended effect, not a measured outcome. The studies below measured hydration, wrinkle-scale scores, ultrasound thickness and satisfaction.
Are Profhilo, Profhilo Body and Profhilo Structura the same?
Evidence label: Limited. These products are related, but results from one do not apply to the others.
- Standard Profhilo has been studied mainly on the face and neck.
- Profhilo Body was studied in a single-arm study with no comparison group, which treated women's inner upper arms repeatedly over 12 months.[^4] Three of its five authors were IBSA employees. We could not check funding because only the abstract was available.
- Profhilo Structura is a different formulation. Its studies describe it as intended for facial fat compartments.
A 50-person Structura pilot reported better scores than at baseline 3 months after treatment ended, on the Facial Volume Loss Scale (FVLS) and the Wrinkle Severity Rating Scale (WSRS).[^5] IBSA supported the study, the writing and the publication, and three authors were IBSA employees. A 22-person Structura case series reported thicker soft tissue and good satisfaction over 6 months.[^6] Two authors were IBSA employees. IBSA Farmaceutici Italia supported the article’s writing, editing and publication; this does not establish who funded the clinical work.
Neither study had a comparison group, so neither shows that new fat grew, and neither tells us whether standard Profhilo changes facial fat. In the same way, repeated arm treatments with Profhilo Body do not show how long one facial course lasts.
What do controlled Profhilo trials show?
Evidence label: Limited. The trials are small, and their results on key comparisons are mixed.
A controlled trial compares a treatment with something else over the same period. That helps separate the product's effect from the effect of the injection itself, from what assessors expect to see and from changes over time.
Perioral saline trial. This randomized, triple-blind, split-face trial enrolled 12 women aged 45–65. One side of the area around the mouth got Profhilo and the other got saline.[^1] At 60 days, 3D imaging showed visible wrinkle and pore improvements on the Profhilo side. Ultrasound showed dermal thickness increased on both sides (Profhilo P=.016; saline P<.001). The authors concluded that Profhilo's effect on thickness was no greater than placebo.
Each P value describes the change within one side only. They are not effect sizes, and they do not show which side improved more. The abstract reports dissatisfaction with the decision to have treatment (36.4%) and with the results (54.5%), but it does not make the denominator clear. The authors declared no conflicts. Funding was not stated, and we reviewed only the abstract.
Upper-face trial. In this trial, 20 participants (10 per group, most of them men) got either botulinum toxin type A (BTX-A, a wrinkle-relaxing injection) alone or BTX-A plus Profhilo.[^2] About 3 months after the final session, wrinkles had improved in both groups, with no significant difference between them (P=.633). Neither group showed significant ultrasound changes. The authors did not detect a significant added short-term benefit from Profhilo and called for longer studies. The full text states the authors had no funding to report and no conflicts of interest.
Neck combination trial. This randomized trial compared botulinum toxin alone with botulinum toxin followed by Profhilo.[^7] At 3 months, the combination group had higher hydration and thickness. It also scored better on the Global Aesthetic Improvement Scale (GAIS). The abstract mentions 19 participants but does not make clear whether that is the total or the size of each group. The trial also tested a combination, not Profhilo alone. Funding and conflicts were not stated, and we read only the abstract.
Acne-scar trial. In 12 patients, adding Profhilo to subcision made no significant difference to scar reduction, scar depth or overall improvement, although satisfaction favored the combination.[^8] The record lists a grant from Tehran University of Medical Sciences but no conflict statement. We read only the abstract.
What do Profhilo hydration and neck studies show?
Evidence label: Limited. Most of these studies compare participants with their own baseline and have no control group.
Open-label facial study. Everyone in this study knew they were getting Profhilo. It enrolled 30 Chinese women.[^9] Data were analyzed for 28 women at the early visits and 26 at week 12, and hydration was measured in only 8 and 6 of them. At week 12, surface hydration and transepidermal water loss (TEWL) had improved compared with baseline. FVLS and WSRS scores changed across the study as a whole, but comparisons between specific visits were not significant, so the study does not show that wrinkles were lifted. Neoasia Pte Ltd funded the study, IBSA funded medical writing support, and two authors were IBSA employees. The acknowledged medical writer was an employee of Papyrus Medical Communications Ltd.
Systematic review. A review of Profhilo and Profhilo Body covered nine studies with 278 participants in total.[^10] Those studies used varied designs and body sites; they were not nine randomized trials. The review reports improvements or trends in elasticity, hydration, density, laxity and wrinkle scores. IBSA funded the review and the first-draft medical writing by an employee of Papyrus Medical Communications Ltd. Three of the five authors were IBSA employees.
Neck studies. A 25-person study with no control group reported improvements rated by clinicians, measured by instruments and reported by participants at 1 and 4 months after the first treatment.[^11] Three authors were IBSA employees. IBSA Farmaceutici Italia sponsored the study and supported medical writing.
A satisfaction survey of 26 patients in Malaysia, Singapore and Indonesia reported that average grades on an IBSA neck-laxity scale fell from 3.08 to 2.12 by day 90.[^12] The survey had no comparison group and used a scale the manufacturer developed. Four authors were IBSA employees. The full text acknowledges IBSA-funded medical writing and an IBSA employee’s contribution to scientific discussion; a separate survey-funding source was not identified. For other options, see our neck lines guide.
How does Profhilo compare with Skinvive, Rejuran and other injectables?
Evidence label: Limited. The abstracts we reviewed include very few direct comparisons.
Only one study in our selection compared Profhilo directly with another product: Belotero Revive, a lightly crosslinked HA with glycerol, tested in 24 women.[^13] The abstract describes the study as single-blind and describes fixed placement, with Profhilo on the right cheek. Randomization cannot be established from the abstract. Both products improved measures such as hydration and elasticity compared with baseline, with no significant differences between them up to week 14. That does not prove the two work equally well. Funding and conflicts were not stated, and we read only the abstract.
| Product or category | What it is | Direct comparison with Profhilo in abstracts reviewed | Evidence |
|---|---|---|---|
| Profhilo | Injectable hybrid complexes of high- and low-molecular-weight HA | Not applicable | Limited |
| Belotero Revive | Lightly crosslinked HA with glycerol | One 24-woman split-face study; no significant differences | Limited |
| Skinvive | A different HA injectable with its own trials and label | None found | Very limited |
| Rejuran | A polynucleotide injection, not HA | None found | Very limited |
| Conventional volumizing HA fillers | HA gels, often crosslinked; products differ | None found | Very limited |
| Sculptra and Radiesse | Biostimulators, a different injectable category | None found | Very limited |
Profhilo is usually marketed for skin quality rather than volume, yet some papers call it a filler.[^3][^8] What a product was studied for matters more than its label.
How long do Profhilo results last in studies?
Evidence label: Limited. We can report only how long each study followed people. That is not how long results last for any one person.
| Study | Product | Design and size | Last observation | Evidence |
|---|---|---|---|---|
| Perioral saline trial[^1] | Standard | Randomized, 12 women | 60 days | Limited |
| Upper-face BTX-A trial[^2] | Standard with BTX-A | Randomized, 20 people | About 3 months after final session | Limited |
| Open-label facial study[^9] | Standard | No control group, 30 enrolled | Week 12 | Very limited |
| Neck study[^11] | Standard | No control group, 25 people | Month 4 after first treatment | Very limited |
| Structura pilot[^5] | Structura | Observational, 50 people | 3 months after treatment ended | Very limited |
| Structura case series[^6] | Structura | Case series, 22 people | 6 months | Very limited |
| Inner-arm study[^4] | Body | Single group, repeated treatments | 12 months, treatments throughout | Very limited |
The Structura and Body rows apply only to those variants. The Body study gave treatments throughout the year, so it does not show that one treatment lasts a year. Its participant numbers also don't reconcile. The abstract says 34 people got the first treatments and 32 got the later ones, yet it reports bruising (ecchymosis) in 36, so we have not calculated a side-effect rate. None of these studies sets a treatment schedule, so ask your clinician about timing.
What side effects of Profhilo are reported?
Evidence label: Limited. There is little evidence on how often complications happen or on long-term safety.
Small trials and surveys mostly describe short-lived reactions at the injection site. The review lists bruising, swelling, a light pinching feeling, a small bump and localized hematomas, described as mild and usually gone within 72 hours.[^10] In the perioral trial, most participants reported mild recovery symptoms, and one reported extreme sensitivity, discomfort and itching.[^1] Patients in the neck survey reported low to moderate pain.[^12] Studies this small cannot rule out rare serious complications.
Two manufacturer papers analyzed spontaneous reports, meaning side effects that clinicians chose to report to the company. The more recent paper covered facial use from 2018 to October 2023 and body use from 2020 to October 2023.[^14] It counted 371 facial and 11 body adverse events against an estimated 1,091,956 and 27,692 treated patients. Edema, erythema and discomfort were the most common. Five authors disclosed IBSA employment; affiliations include both IBSA Institut Biochimique SA and IBSA Farmaceutici Italia. The authors thanked an employee of a scientific communications company for medical writing support, and we could not confirm who paid for that writing. An earlier paper counted 12 reports between February 2015 and February 2018, none rated serious, against an estimate of more than 40,000 patients.[^3]
Voluntary reporting misses many events, and the patient totals are estimates, so these counts do not show your real chance of a complication. By contrast, the review's pooled estimate across six studies found mild side effects in 46% of participants (95% confidence interval 20–75%).[^10] These estimates use different ascertainment methods, populations and study designs, so they are not directly comparable and do not rank products for safety. A qualified clinician should check any new or worsening symptom after an injection.
Is Profhilo FDA-approved or FDA-cleared?
Evidence label: Very limited. This section reports a database search, not clinical evidence.
We found no Profhilo match in the openFDA PMA approval, 510(k) clearance or device registration/listing searches we checked on November 8, 2026. openFDA is the FDA's public data service. PMA (premarket approval) and 510(k) clearance are different routes for medical devices. Registration/listing records companies and their products, and a listing would not by itself prove approval or clearance.
We searched for the product name in specific fields and across all searchable fields of each database. Searches by manufacturer name returned records for unrelated products. We did not search every other name the product might be sold under. The PMA dataset was last updated on October 26, 2026.
Finding no match is not a full legal-status opinion. It says nothing about the product's status outside the US, and it does not mean the product is unsafe. Approval of other HA products does not carry over to Profhilo. Database records change, so recheck the FDA databases before relying on this search.
Where the evidence stops
Evidence label: Limited.
Most supportive studies have manufacturer ties, as noted for each study above. When a record gives no funding or conflict statement, that information is missing; it does not mean there was no funding. The two trials whose authors declared no conflicts both had neutral results on key comparisons,[^1][^2] but two trials are too few to show a pattern.
The samples are also small, and the products, body sites and designs vary. Most facial studies followed participants for only a few months; the Body study repeated treatments over a year. For several studies we could read only the abstract. None of the selected studies measured collagen change directly as a clinical outcome. If you are weighing Profhilo, discuss these limits with your clinician.
FAQ
What is Profhilo and is it hyaluronic acid?
Yes. Profhilo is an injectable product made by IBSA from hybrid complexes of high- and low-molecular-weight hyaluronic acid. Papers with company authors describe a heat-based manufacturing process that uses no chemical crosslinkers. That does not make it risk-free. A clinician injects it, so it is not the same as a topical HA serum. Its 'bioremodelling' label is marketing language, not a measured outcome.
Is Profhilo the same as filler?
The terms vary. Profhilo is usually marketed for skin quality, such as hydration and texture, rather than for adding volume. Still, some published papers call it a filler, including a safety paper with manufacturer authors and an acne-scar trial. The label tells you less than two other things: what each study measured, and which product variant it used.
What did controlled Profhilo trials find?
The two clearest controlled trials were small, and their key comparisons were mostly neutral. In a 12-woman split-face trial against saline, dermal thickness rose on both sides and Profhilo did not beat placebo, although the Profhilo side showed visual wrinkle and pore improvements. In a 20-person trial, the trial did not detect a significant added short-term benefit from adding Profhilo to botulinum toxin for upper-face wrinkles about 3 months after the final session.
How long do Profhilo results last in studies?
Studies can only show what they saw during follow-up. For standard Profhilo, follow-up ended at 60 days in the saline trial, about 3 months after the final session in the botulinum toxin trial, week 12 in an open-label facial study and month 4 in a neck study. A 12-month Profhilo Body arm study gave treatments throughout the year, so it does not show one treatment lasting a year.
Is Profhilo the same as Skinvive or Rejuran?
What is different about Profhilo Structura?
Structura is a separate Profhilo formulation. Its studies describe it as intended for facial fat compartments. A 50-person pilot and a 22-person case series reported improvements compared with baseline, but neither had a comparison group, and both had IBSA employee authors. These results do not show new fat growth, and they should not be applied to standard Profhilo.
What side effects are reported with Profhilo?
Studies mostly report short-lived reactions at the injection site, such as bruising, swelling, redness, discomfort and small bumps. Small trials cannot rule out rare serious complications. The manufacturer's safety counts rely on voluntary reports and estimated patient numbers, so they miss events and do not show your real chance of a complication. A qualified clinician should check any new or worsening symptom after an injection.
Is Profhilo FDA-approved?
We found no Profhilo match in the openFDA PMA approval, 510(k) clearance or device registration/listing searches we checked on November 8, 2026. That limited search is not a full legal-status opinion. It says nothing about other countries, and it is not a safety verdict. Approval, clearance and registration are different things, and database records change. Ask your clinician about the specific product and its labeling.
References
[^1]: Effects of Profhilo® Tissue Bioremodeling on Skin Texture and Perioral Wrinkles: A Randomized Controlled Triple-Blind Clinical Trial. PubMed PMID 41731228. Abstract and record metadata only; full text not accessed. Funding/COI: funding not stated in the PubMed record; authors declare no conflicts of interest.
[^2]: Combined Use of Botulinum Toxin A and Profhilo for Upper Face Rejuvenation: A Randomized Clinical Trial. PubMed PMID 42063688. Abstract and accessible full text reviewed. Funding/COI: full text states the authors have nothing to report for funding; authors declare no conflicts of interest.
[^3]: Safety Assessment of High- and Low-Molecular-Weight Hyaluronans (Profhilo®) as Derived from Worldwide Postmarketing Data. PubMed PMID 32685528. Abstract, PubMed metadata and accessible full text reviewed. Funding/COI: IBSA Farmaceutici Italia supported medical writing; separate study funding was not identified; three authors employed by IBSA Farmaceutici Italia Srl and one by IBSA Institut Biochimique SA; other authors declare no conflicts.
[^4]: Long-Term Safety and Efficacy of Hybrid Cooperative Complexes of High- and Low-Molecular Weight Hyaluronic Acid to Improve Skin Laxity of the Inner Upper Arms: A Single-Arm Study. PubMed PMID 41457907. Abstract only. Funding/COI: funding not stated or verified; three authors are IBSA Farmaceutici employees; two declare no conflict.
[^5]: Efficacy and tolerability of Profhilo® Structura intended to restore lateral cheek fat compartment: An observational pilot study. PubMed PMID 38260185. Abstract and accessible full text reviewed. Funding/COI: IBSA Farmaceutici Italia Srl supported the clinical study, article writing and publication; three authors are IBSA employees; two declare no conflict.
[^6]: Restoring Adipose Tissue Homeostasis in Response to Aging: Initial Clinical Experience with Profhilo Structura®. PubMed PMID 37623069. Abstract, metadata and accessible full text reviewed. Funding/COI: IBSA Farmaceutici Italia supported article writing, editing and publication; two authors were IBSA employees and two declared no conflicts.
[^7]: Botulinum toxin injection as a single or combined treatment with non-cross-linked high molecular weight and low molecular weight hyaluronic acid gel for neck rejuvenation: A randomized clinical trial. PubMed PMID 35775872. Abstract only. Funding/COI: funding and conflict-of-interest statement not stated in the record.
[^8]: Investigating the impact of added Profhilo mesogel to subcision versus subcision monotherapy in treating acne scars; a single-blinded, split-face randomized trial. PubMed PMID 38429946. Abstract only. Funding/COI: grant listed from Tehran University of Medical Sciences and Health Services; conflict-of-interest statement not stated in the record.
[^9]: Efficacy and Tolerability of Stable Hybrid Cooperative Complexes of High- and Low-Molecular Weight Hyaluronic Acid in Asian Patients: An Open-Label Study. PubMed PMID 40921777. Abstract and accessible full text reviewed. Funding/COI: study funded by Neoasia Pte Ltd; medical writing support funded by IBSA Farmaceutici Italia Srl; acknowledged medical writer employed by Papyrus Medical Communications Ltd; two authors are IBSA employees; other authors declare no conflicts.
[^10]: A Systematic Review of the Efficacy and Safety of Profhilo® and Profhilo® Body. PubMed PMID 41920062. Abstract and accessible full text reviewed. Funding/COI: review and first-draft medical writing (Papyrus Medical Communications Ltd) funded by IBSA Farmaceutici Italia Srl; three authors are IBSA employees; two declare no conflicts.
[^11]: Efficacy and Tolerability of Hybrid Complexes of High- and Low-Molecular-Weight Hyaluronan Intradermal Injections for the Treatment of Skin Roughness and Laxity of the Neck. PubMed PMID 36164489. Abstract, metadata and accessible full text reviewed. Funding/COI: IBSA Farmaceutici Italia sponsored the study and supported medical writing; three authors were IBSA employees and one declared no conflicts.
[^12]: Patient Satisfaction Using Hybrid Cooperative Complexes of Hyaluronic Acid for Neck Laxity: A Survey of Asian Populations. PubMed PMID 40627798. Abstract, metadata and accessible full text reviewed. Funding/COI: IBSA funded medical writing and an IBSA employee contributed to scientific discussion; four authors were IBSA employees, and six clinician authors declared no financial conflicts.
[^13]: A split-face comparative performance evaluation of injectable hyaluronic acid-based preparations HCC and CPM-HA20G in healthy females. PubMed PMID 35699361. Abstract only. Funding/COI: funding and conflict-of-interest statement not stated in the record.
[^14]: Hyaluronic Acid Hybrid Cooperative Complexes Nearing 10 Years of Use: Update on Safety Assessment Based on Post-Marketing Surveillance Data. PubMed PMID 40654100. Abstract and accessible full text reviewed. Funding/COI: funding source not stated in the material accessed; medical writing support from an Aran Scientific Communications Ltd employee acknowledged; five authors disclosed IBSA employment; affiliations include both IBSA Institut Biochimique SA and IBSA Farmaceutici Italia; four declare no conflicts.