HArmonyCa is searched about 2,300 times a month in the US (clickstream estimate, October 2026), which is notable for a product with no FDA approval on the public record. This page sets out what is in it, what its studies measured and who ran them, and where it stands with regulators, as of 15 October 2026. It is not advice about treatment; that is a decision for a qualified clinician. It contains no peptide; it sits on this site beside Sculptra, Radiesse and the other biostimulators because readers compare them.
What is in the syringe
The maker's own papers describe the product the same way. HArmonyCa is 20 mg/mL crosslinked sodium hyaluronate gel with embedded synthetic calcium hydroxylapatite (CaHA) microspheres of 25–45 µm, at 55.7% by weight; HArmonyCa Lidocaine adds 0.3% lidocaine hydrochloride to reduce injection pain (Braz et al., Plastic and Reconstructive Surgery Global Open 2024; Gritti et al., Journal of Cosmetic Dermatology 2025). The design idea, as Allergan's authors put it, is that the hyaluronic acid gives an immediate filling and lifting effect while the microspheres produce new collagen over time.
Two comparisons help place it. The microspheres are the same size range as those in Radiesse, but Radiesse carries them in a carboxymethylcellulose gel rather than hyaluronic acid. And the 55.7% figure is by weight, while Radiesse's composition is usually given by volume, so the two percentages cannot be compared directly without the densities — which the papers we opened do not give.
Where it stands with regulators
We found no FDA approval. A search of FDA's premarket approval database for the trade name HArmonyCa returned no record on 15 October 2026. Every study registered for the product on ClinicalTrials.gov ran outside the United States:
| Registry entry | Design | Where | Size | Status, 15 Oct 2026 |
|---|---|---|---|---|
| NCT05119777 | open-label post-marketing | France | 140 | completed 2023; published |
| NCT04609020 | single group, combined with Juvéderm and Botox | Brazil | 64 | completed 2024; results posted |
| NCT05452070 | phase 3, randomized, evaluator-blinded, untreated control | Canada, Spain, UK | 171 | completed May 2025; no results posted |
| NCT07032597 | phase 3, randomized, evaluator-blinded, vs Restylane Perlane Lidocaine | China | 252 | completed September 2026; no results posted |
The French study is labelled post-marketing and began in October 2021, which means the product was already on sale there by then. The two phase 3 trials are the first randomized, controlled evidence for HArmonyCa that anyone will be able to read, and neither has reported. The Chinese trial compares HArmonyCa head-to-head with an established hyaluronic-acid filler; the registry does not say whether it supports a regulatory application in China or anywhere else.
What the studies measured
The French post-marketing study is the largest published. It gave 140 adults with moderate-to-severe midface volume loss HArmonyCa (110) or HArmonyCa Lidocaine (30) in the cheeks, with optional jawline treatment and a touch-up at two weeks, and followed them for 12 months. At month 1, 82.8% were rated at least one grade better on the Allergan midface volume scale by the evaluating investigator, and the paper reports the rate remained high through month 12. There was no control group and no blinding.
The first clinical paper, from Spain, followed 15 consecutive patients injected in front of the ear and measured volume by 3D photography: a median gain of about 2.1 cc per side at day 180, with elastography read by the authors as consistent with new collagen fibres (Urdiales-Gálvez et al. 2023). Fifteen patients with no comparison group is a description, not a test.
The Brazilian study treated 64 people with HArmonyCa together with Juvéderm fillers and Botox, and measured satisfaction on the FACE-Q questionnaire. Because three products were given together, it cannot say what HArmonyCa contributed.
Across PubMed there were 19 records for “harmonyca” on 15 October 2026. Only one carries a clinical-trial publication type — the 15-patient Spanish study. The rest are case reports, letters, retrospective reviews, laboratory particle studies and a 2026 set of expert recommendations; no record is retracted.
Who produced the evidence
Most of the literature comes from the maker or people it pays, and the papers say so. All five authors of the French study were Allergan employees or a paid consultant. The 2024 data review was funded by Allergan, which “participated in the design, research, analysis, data collection, interpretation of data” and paid for the medical writing. The 2026 global recommendations were written by eight Allergan key opinion leaders, several described as members of the international HArmonyCa faculty, and an Allergan employee (Cavallini et al. 2026). Industry funding does not make a result wrong, but it means there is, as yet, no independent controlled trial to check these results against.
Side effects recorded
In the French study 52 of 140 participants (37.1%) had a treatment-related adverse event. The most common were injection-site pain (11.4%), injection-site mass (10.7%) and headache (7.1%), with every other event under 5%. There were no treatment-related serious events. Sixteen treatment-related events in 11 participants began 30 days or more after treatment, and eight mild events were still ongoing at the end of the study, seven of them injection-site masses. The Brazilian study's posted table lists 2 of 64 participants with a serious event and one with an injection-site nodule.
Calcium hydroxylapatite and hyaluronic acid each carry the risks FDA lists for dermal fillers — lumps, infection, and rarely tissue death or vision loss after injection into a blood vessel — and how those play out for Radiesse is set out on our Radiesse side effects page. Whether combining the two changes any of those risks has not been studied in a trial that has reported.
Events involving HArmonyCa still reach FDA. On 15 October 2026 its device-report database held 108 reports naming HArmonyCa (data last updated 7 October 2026), filed from 2022, as our biostimulators page counts by year. A manufacturer can report events from other countries, which is the likely route for a product without a US approval, though the database does not say so. The most frequent coded problems were a catch-all “no appropriate code” (19), bacterial infection (11), unspecified infection (9) and abscess (6). A report is an allegation, not a finding, and none of these counts is a rate.
What the record does not show
It does not show how HArmonyCa compares with an untreated control or with another filler, because the only two controlled trials have not posted results. It does not show results beyond 12 months. It does not show independent replication. And it does not establish a US approval — on the evidence we could find, there is none. It does show what the product contains, that its maker's open-label study recorded mostly injection-site events, and that lumps were the event most likely to outlast the study. For the closest approved relative, see how Sculptra compares with Radiesse.
Sources and dates
Opened 15 October 2026: ClinicalTrials.gov records NCT05119777, NCT04609020 (posted results), NCT05452070 and NCT07032597; openFDA PMA search for the trade name (no record) and MAUDE device.brand_name:harmonyca (108 reports, counts by patient problem); PubMed records 40948024 (Gritti 2025, with full text via Europe PMC), 39301305 (Braz 2024, full text), 37073433 (Urdiales-Gálvez 2023), 41566538 (Cavallini 2026), and the search harmonyca with publication-type and retraction filters. Corrections go to the contact page.