Of 9 Profhilo studies, how many had a control group

Profhilo is a procedure that injects hyaluronic acid into the skin, looking for changes in hydration and elasticity. The change observed fairly consistently in studies so far has been on the hydration side; for elasticity and wrinkles, results have not shown it to be better than other products or saline.

Studies that reported favorable results mostly followed only people who received the treatment, with no comparator. There were three studies that included a comparator, and none showed a clear advantage for Profhilo. Adverse-event rates also vary widely across sources, because the way counts are compiled differs when researchers observe events themselves versus when clinicians report them voluntarily.

3-line summary

① Most favorable results came from studies with no comparator.

② In the three comparative studies, better results than other options were not confirmed.

③ Adverse-event figures change substantially depending on what is used as the denominator and how cases were found.

It is a product that heat-stabilizes two different hyaluronic acids

Profhilo contains 32mg each of high-molecular-weight and low-molecular-weight hyaluronic acid, in a total of 2mL. Instead of adding a chemical cross-linker, it is stabilized using heat. Differences in composition and manufacturing continue in comparisons of Profhilo with other product families.

Collagen findings did not start from results on human faces

Early results that activity producing collagen and elastic fibers increased came from cultured-cell and skin-model experiments. They should be distinguished from results confirmed after injection into a human face.

The manufacturer supplied materials for this study, and a patent inventor took part as an author. Later, original data for some figures were no longer available, and the editors officially marked a data-availability issue. The paper’s conclusions were retained and it was not retracted.

A study that examined human skin tissue directly enrolled 9 people. After injecting only one arm of people scheduled for arm surgery and then comparing skin from both sides, the injected side showed denser elastic fibers and fewer fragmented fibers. It was, however, a small study of the arm rather than the face, and two of the authors were manufacturer employees.

Comparative studies did not show a clear advantage

Existing studies that collected favorable results were mostly observations of small numbers of people at a single clinic. They did not require a comparator, the manufacturer funded the research, and employees took part as authors.

Results comparing Profhilo with saline, another hyaluronic acid product, and botulinum toxin alone are as follows.

What it was compared with	Area examined	Reported result
Saline	Left and right of the mouth	Dermal thickness increased on both sides, and 54.5% were not satisfied with the treatment result.
Another hyaluronic acid booster	Both cheeks	There was no difference between products on the skin measures observed.
Botulinum toxin alone	Forehead	There was no difference between the two groups in wrinkles, and even in the group treated together there was no clear change in thickness or elasticity.

All three studies were small and looked only at the mouth area, cheeks, and forehead. What the current data support goes only as far as this: it is hard to regard Profhilo as better than the comparators.

Adverse-event rates differ widely because of how they are counted

In data where researchers directly observed treatment and the period after it, a mean of 46% of participants had injection-site reactions. Most were bruising, swelling, stinging, small bumps, or hematomas, and in the same data they resolved within 72 hours. If swelling remains after that, or pain and redness worsen, it is safer to contact the clinic.

By contrast, in 2025 post-marketing data, 371 cases were reported among an estimated 1,091,956 people exposed, tallied as 0.034%. This figure is not a direct count of people treated; it estimates the number exposed from the number of syringes sold.

Figure	What was counted	How it was found	What was mainly included
46%	Study participants	Direct observation by researchers during and after treatment	Includes temporary local reactions
0.034%	People exposed, estimated from sales volume	Spontaneous reports by clinicians	Includes only reported cases

Rather than simply comparing the two numbers, it is more practical to check how swelling and bruising would affect your schedule. For areas that can be felt after treatment, see distinguishing bumps from nodules; for typical adverse-reaction response, see treatment safety and adverse-effect information.

The period studies confirmed is up to 6 months

The period existing clinical studies followed participants was up to 6 months, and the most distinct change was hydration at the skin surface. This number means the point at which the study ended; it is not a value that guarantees duration as such.

In an animal study, the product was detected in tissue for about 10 weeks. The period a product is detected and the period people feel an effect are different pieces of information. All authors of this study were manufacturer employees.

A record that Profhilo was authorized as a filler in the United States was not confirmed, and whether it is licensed in Korea was also not confirmed in public sources. Before treatment, it is advisable to check that official authorization information matches on the product packaging and in Korea's MFDS medical-device lookup.

Injection volume and intervals can differ by clinic

Several studies treated twice at 4-week intervals, but there is also a comparative study that treated three times. Actual injection volume, sites, and number of sessions differ by clinic, so confirm the following in consultation.

• □ In my case, how many mL and how many sessions, at how many days’ interval, will be injected?
• □ Which sites will be injected, and how does the volume differ by site?
• □ Based on my volume and sites, how many days of swelling and bruising are expected?
• □ Will anticoagulants or immunosuppressants I take, and recent procedures, affect the schedule?
• □ The change confirmed consistently in studies is on the hydration side. For elasticity, which is my concern, how much can be expected?
• □ What are the cost of one session and the total for the full plan, respectively?

Profhilo FAQ

Q1. Is Profhilo non-cross-linked hyaluronic acid?

In the sense that a chemical cross-linker is not added, it is often introduced as non-cross-linked. The actual manufacturing method heat-stabilizes different hyaluronic acids.

Q2. How many times is Profhilo injected?

The schedule used most often in studies was twice at 4-week intervals. There are also studies that treated three times, so the actual number and interval should be confirmed together with injection sites and volume.

Q3. Will I swell or hurt afterward?

Temporary reactions at the injection site, such as bruising, swelling, stinging, and small bumps, have been reported. In study data they mostly resolved within 72 hours. If swelling remains after that, or pain and redness worsen, contact the clinic that treated you.

Q4. Can I have it together with other procedures?

There is one comparative study that used it together with botulinum toxin. When Profhilo was added, no additional benefit was observed within 3 months. Combination timing is better decided after disclosing recent procedures and medicines you take.

Q5. What should I confirm before treatment?

You should tell the clinician about anticoagulants and immunosuppressants you take, and recent procedures. Also cross-check the item name marked on the product packaging against Korea's MFDS medical-device lookup.

Related reading

• Comparisons of Profhilo with other product families — differences in composition and choice
• Skin booster guide — composition, evidence, and points to confirm in consultation
• Differences among skin boosters by ingredient — where HA products sit
• Distinguishing bumps from nodules — what can be felt after treatment
• Profhilo treatment information
• Treatment safety and adverse-effect information

The most important question in consultation is whether the change I want was also confirmed in comparative studies.

Results, duration, and suitability vary with individual skin condition, age, and lifestyle, and the same outcome cannot be guaranteed.

Procedures may cause temporary redness or swelling, and contraindications may apply, so please confirm these during your consultation.

This article is general information and does not replace individual medical care. Please confirm diagnosis and treatment suited to your condition during a consultation.

Sources

• Sparavigna A et al., 2026, Plastic and Aesthetic Nursing, systematic review and meta-analysis (9 papers·278 people). PMID 41920062. Full text confirmed: 0 randomized controlled studies; 8 were single-center studies; 6 had fewer than 30 participants. Inclusion criteria were single-arm·left–right comparison·case reports of 10 or more people, and the adverse-event rate was 46%. IBSA-funded; 3 of 5 authors were IBSA employees; the first author was an author on 7 of the 9 included studies.
• Tintor G et al., 2025, Pharmaceuticals, review. PMID 41599673. Full text confirmed: follow-up upper limit 6 months; superficial hydration findings. No external research funding; 1 author disclosed honoraria for distributor training.
• Zanella G et al., 2026, Aesthetic Plastic Surgery, triple-blind placebo-controlled split-face study (n=12). PMID 41731228. Abstract confirmed: Profhilo p=0.016, placebo p<0.001, Face-Q questionnaire result dissatisfied 54.5%.
• Journal of Cosmetic Dermatology, 2022, single-blind split-face head-to-head comparison (n=24). PMID 35699361. Abstract confirmed: no significant difference between products.
• Health Science Reports, 2026, randomized comparative study (n=20). PMID 42063688. Abstract confirmed: no benefit from combining toxin (p=0.633).
• 2025 post-marketing safety study, Journal of Cosmetic Dermatology. PMID 40654100. Abstract confirmed: estimated exposure 1,091,956 people·371 spontaneous reports.
• Cheng SWN et al., 2026, Aesthetic Plastic Surgery, open-label single-arm study (30 women of Chinese ethnicity). PMID 40921777. Full text confirmed: 12-week superficial hydration·transepidermal water loss (TEWL); the relevant analyses N=8·6. Wrinkle and elasticity measures showed no significant difference between time points. Distributor funding·IBSA employee authors·ghostwriting.
• Margara A et al., 2024, Aesthetic Surgery Journal Open Forum, left–right arm tissue comparison (n=9). PMID 38887212. Full text confirmed: elastic-fiber density·alignment. Evidence level 5; IBSA employee authors.
• Stellavato A et al., 2016, PLoS One, cultured cells·three-dimensional skin model. PMID 27723763. Full text confirmed: expression related to collagen types I·III·IV·VII and elastin; composition of 32mg each of high- and low-molecular-weight hyaluronic acid and a total of 2mL·64mg; heat process. Patent number WO 2012/032151. IBSA involvement·patent interests.
• PLoS One editors, 2024, Expression of Concern. PMID 38598440. Full text confirmed: violation of the data-availability policy due to loss of original data; conclusions unchanged; not a retraction.
• Humzah D et al., 2024, International Journal of Molecular Sciences, technical review. PMID 38542191. Full text confirmed: distinction between chemical cross-linking and heat-based physical cross-linking.
• Sparavigna A·Tenconi B, 2016, Clinical, Cosmetic and Investigational Dermatology. PMID 27713647. Abstract confirmed: first journal use of ‘bio-remodeling’ in an aesthetic context. NCBI MeSH·Europe PMC search also checked (2026-08-27): the term is not indexed in MeSH; uses before 2015 referred to collagen grafts.
• Scrima M et al., 2022, Clinical, Cosmetic and Investigational Dermatology, animal ultrasound study. PMID 36523543. Abstract and conflicts confirmed: detected for about 10 weeks. All 9 authors were IBSA employees.
• Manufacturer treatment materials. Confirmation of BAP, the designated facial injection points, and recommended injection sites.
• U.S. FDA PMA·510(k) databases. Scope confirmed: Class III classification of hyaluronic acid fillers; product-code LMH applicant list; IBSA’s knee intra-articular injection PMA P110005.
• Korea's MFDS “Regulation on Medical Device Items and Item-Specific Grades,” Appendix 1, 2026-03-09. Original text confirmed: Class 4 classification of biomaterials for tissue repair B04230.01·B04230.02.