What Is Profhilo? How It Works, What the Studies Show, Cautions and Approval Status

What is Profhilo and what is it made of

Profhilo is an injectable hyaluronic acid (HA) from the company IBSA that mixes large and small HA molecules in equal amounts and binds them with heat, without chemical cross-linking. [1][2] This structure is called hybrid cooperative complexes (HCC), and the maker calls the technology NAHYCO. [2]

The authors of one review explain that the process is heating followed by cooling, which forms hydrogen bonds between the molecules without adding a cross-linker, giving low viscosity, easy spread in the tissue and more resistance to hyaluronidase than large-molecule HA alone. [1]

According to the maker's documents the product is used for skin laxity of the face and neck, and a body version, Profhilo Body, exists. [2] Cross-linked HA fillers differ in that they are designed to last longer and to restore volume. [1]

Compare skin boosters with fillers in [[skin-booster-vs-filler]], read how to decode an HA label in [[hyaluronic-acid-label]], and see the wider trend ingredients such as PN, PDLLA and exosome in [[collagen-stimulator-types-explained]].

What does Profhilo do and what did the studies measure

The studies measured elasticity, hydration, laxity and wrinkles; a maker-funded review reports improvement, but the randomized trial against saline that we could open had 12 participants and the thickness of the dermis did not beat the placebo. [2][4] The table below summarizes the studies we could open, with the limits of each.

A 2026 systematic review of 9 studies with 278 participants reports that elasticity, hydration, density and laxity of the skin changed significantly or trended toward improvement in the areas studied. [2] All were single-centre, six had fewer than 30 participants, only one included men, and the authors say most studied White women. [2] The work was funded by the maker and three authors are its employees. [2]

Another review, which had no external funding, points out that many studies were funded by the maker or had authors with a related interest, followed people for up to about 6 months, lost some participants, and sometimes relied on what participants reported themselves. [1]

A triple-blind randomized split-face trial compared Profhilo with saline around the mouth in 12 women. Wrinkles and pores looked better on 3D photographs, but the thickness of the dermis on ultrasound rose on both the Profhilo side and the saline side, and the authors concluded that the effect on thickness did not exceed the placebo. [4] Some respondents were not satisfied with the result. [4]

Another randomized trial in 20 participants compared Profhilo added to botulinum toxin (Botox) in the upper face with botulinum toxin alone; wrinkles improved in both groups with no difference, and the authors concluded there was no short-term advantage. [5]

The studies reviewed followed people for up to about 6 months, so there is no standard figure for how long an effect lasts. [1] A result measured by an instrument or photograph does not mean everyone sees the same.

What cautions and side effects does Profhilo have

Most reported side effects are mild and settle within days; the rare but serious risk of injectable HA is accidental injection into a blood vessel. [2][3][6] The systematic review reports that effects such as bruising, swelling, a pinching feeling, a small bump and a local haematoma were mild and usually settled within 72 hours. [2]

Worldwide post-marketing data from 2018 to October 2023 estimate that about 1.09 million people received the face version, with 371 adverse events reported, about 0.034% of those treated; the most common were swelling, redness and discomfort at the injection site. [3] Vascular events such as vessel blockage were very rare. [3]

These data have limits: many authors are employees of the maker, the number of people treated is an estimate, and events come from doctors reporting on their own initiative; many patients do not report an effect that settles by itself, so the true figure may be higher. [3]

The authors of the post-marketing data say serious events such as vessel blockage were due to poor injection technique more than the product itself. [3] This is the authors' opinion and does not mean the risk is gone.

The US FDA says the rare but serious risks of dermal fillers include tissue death, visual changes including blindness, and stroke. [6] This is general information on dermal fillers regulated by the FDA, not specific to Profhilo.

If you have severe pain, skin colour change, a change in vision or a hard red lump that does not settle after an injection, contact the doctor who injected you at once.

Is Profhilo approved: the status that can be checked

According to the distributor in Thailand, Profhilo is approved by the Thai FDA for the face and neck, but we have not opened a Thai FDA document ourselves; in the US the maker says clinical development comes before sale. [8][9] This section was checked on 12 October 2026.

Thailand: on 12 December 2024 the company that distributes Profhilo in Thailand announced that it was recently approved by the Thai FDA for the face and neck, with the stated use of treating skin laxity and supporting the repair of skin tissue in acne scars. [8] This is the distributor's statement, not a Thai FDA document, so ask for the product registration number and check it with the Thai FDA yourself.

United States: on 28 July 2026 IBSA announced an agreement with Evolus for the clinical development and later commercialisation of Profhilo in the US. [9] This is not an approval document, and we found no FDA approval document for Profhilo among the sources we could open.

The US FDA says information on approved dermal fillers is in its PMA database, searchable by the product code for facial dermal fillers. [7] That page was last updated in 2020, so search the database yourself for the latest status.

This article did not check Europe or other countries; if you receive treatment abroad, ask for the registration number valid in that country.

What to ask a doctor before choosing Profhilo

Ask about the exact product and its registration number, the doctor's experience, whether it suits your goal, and the plan if something goes wrong; injections must be done by a licensed doctor. [6] The US FDA advises choosing a licensed provider trained to inject dermal fillers and never injecting fillers yourself. [6]

The list below is a starting set of questions; the right answers for you depend on your skin, your health history and the product the clinic really uses.

• Which product is it (face, neck or body version)? Ask to see the box, label and the registration number in Thailand. [2][8]
• Is your goal to add volume or to improve skin quality, and does Profhilo suit that goal compared with a filler or another skin booster? [1]
• How has the doctor managed lumps or vascular problems after HA injections? [3][6]
• How do your allergies, raised scars, skin conditions and current medicines affect the decision?
• If you have severe pain, colour change or a change in vision after the injection, whom do you contact and what do you do? [6]