Ellansé is a dermal filler made of polycaprolactone, a slowly dissolving plastic, and it has been sold in Europe and other markets since 2009 as a "collagen stimulator". About 1,500 Americans a month search for it (clickstream estimate, October 2026), although it is not approved in the United States. This page sets out what is in the syringe, where it is approved, what the trials measured, and what the harm reports describe, as of 17 October 2026. It makes no recommendation; whether any filler suits a face is a question for a licensed clinician.
What is in the syringe
Polycaprolactone (PCL) is a biodegradable polyester used in absorbable sutures and surgical implants. In Ellansé it is made into smooth, round microspheres 25 to 50 micrometres across and suspended in a carboxymethylcellulose (CMC) gel, about 30% microspheres and 70% gel by volume. Those figures come from a 2020 review of the polymer by Christen and Vercesi (PMID 32161484), whose disclosure states that both authors are consultants to Sinclair Pharma, the product's distributor. The review describes a division of labour: the gel provides volume on the day and is absorbed over weeks, while the microspheres stay longer and are surrounded by new collagen.
The versions named in the review — Ellansé-S, -M and -L — differ in how long the polymer chains take to break down. The review gives Ellansé-S a duration of at least 18 months and Ellansé-M at least 24. The microsphere size matters to the design: the review argues that particles under about 20 micrometres are cleared by immune cells quickly and provoke more inflammation, which is why the spheres are kept larger.
The product is made by AQTIS Medical B.V. in the Netherlands, the name on both its registered trials and its US adverse-event report.
Where it is approved
| Market | Status | Source |
|---|---|---|
| European Union | CE marked as a Class III medical device, 2009, for facial wrinkles and age-related volume loss and for the hands | 2020 review |
| United States | No approval or clearance. FDA's premarket approval, 510(k) and device identification databases returned no record for Ellansé or a polycaprolactone filler | openFDA, 17 Oct 2026 |
| United States, in progress | Randomized, double-blind, split-face trial NCT06984835 against a calcium hydroxylapatite filler | ClinicalTrials.gov, 17 Oct 2026 |
The US trial is the most useful single record on the product. Registered by AQTIS Medical, it randomizes 126 people with moderate to severe nasolabial folds to Ellansé-S on one side and a calcium hydroxylapatite filler in a CMC gel — the composition of Radiesse — on the other, with a masked evaluator scoring the folds at six months. It started in March 2025, was listed as active and not recruiting, and gives an estimated primary completion of August 2026 and a study end in December 2027. No results were posted on 17 October 2026. Until it reports, there is no head-to-head evidence against an FDA-approved biostimulator. A second AQTIS trial, in China, randomizes 159 adults with hollow temples to PCL or no treatment (NCT06972940, still listed as recruiting). The only registered study with posted results is a Merz-sponsored one in 20 people in Spain who had six products, Ellansé among them, injected into marked sites on the abdomen months before a planned surgery, with the tissue response measured by ultrasound (NCT06093815); it recorded no serious adverse events in any arm. Where the two FDA-approved products stand is set out in our guide to biostimulators.
What the trials measured
A PubMed search for the name returned 21 records on 17 October 2026: case reports, technique papers, reviews and one trial tagged as randomized. None is retracted. The name search misses the trials that call the product only "PCL", so the table below was assembled from a wider search for polycaprolactone fillers in randomized designs.
| Trial | People | Comparison | What was reported |
|---|---|---|---|
| Moers-Carpi 2013, Germany (PMID 23350617) | 40 | Two PCL formulas, nasolabial folds, 24 months | Sustained improvement at 12 months in 90% and 91.4%; satisfaction at 24 months 72.4% and 81.7%; the longer-lasting formula held through two years |
| Galadari 2015, UAE (PMID 25564797) | 40 | PCL on one fold, a hyaluronic-acid filler on the other | PCL side better on wrinkle severity at 6, 9 and 12 months; safety similar |
| Zhao 2023, China (PMID 36191597) | 160 | PCL vs sodium hyaluronate gel | Responders at 12 months 88.8% vs 23.8%; injection-related adverse events 8.8% vs 11.3%; one author's affiliation is a Hangzhou medical company |
| Park 2022, Korea (PMID 35419911) | not stated in the abstract | A new PCL filler vs Ellansé-M, split fold | New filler non-inferior to Ellansé-M at 12 months |
Three things limit the table. Every trial treated nasolabial folds, while the product is used across the face and on the hands. The comparators are hyaluronic-acid fillers, which break down sooner by design, so a longer-lasting result against them is expected rather than surprising. And the longest follow-up is two years, in 40 people.
A fifth comparison, a 2025 trial of a PCL filler against a polynucleotide filler in 218 people's crow's feet, was retracted in 2026 at the authors' request: the comparator had been misidentified as a pegylated PCL product when it was pure PCL (retraction notice, PMID 41834780). It should not be cited for either product; our page on polynucleotides for skin records the same retraction from the other side.
The harm record
In trials, reported events were swelling, pain, redness and bruising at the injection site, mostly resolving within days. In case reports, the pattern is the one shared by every particle-based biostimulator — late inflammatory lumps:
- a foreign-body granuloma three years after injection (Moon 2017, PMID 29084645);
- an eruptive granuloma treated with methotrexate (2020) and bilateral cheek granulomas from an absorbable filler (2026);
- a case of cutaneous and lymph-node sarcoidosis after a PCL facial filler, discussed as a possible autoimmune reaction (2021);
- Ellansé-M nodules broken down with collagenase in a 2025 case series, which drew a published commentary and reply.
Vessel blockage is the serious risk with any filler. A 2026 systematic review of visual loss after biostimulators found no published case of blindness with PCL but one case of facial-artery embolism (Young 2026, PMID 41263987); by comparison it counted at least 11 cases with calcium hydroxylapatite. A modified Delphi consensus published on 30 September 2026 (seven experts, one of them an author of the 2020 distributor review) concluded that the CMC gel, not the microspheres, is the main cause of blockage, that diluting the product 1:5 cut its viscosity about 80-fold in laboratory tests, and that hyaluronidase added nothing over saline (PMID 42819331). It recommends saline flushing first and says the algorithm still needs clinical testing.
FDA's adverse-event database held one report naming Ellansé on 17 October 2026, received in August 2025: a 32-year-old trial participant with a history of retinal detachment had a burning sensation behind one eye and worsened floaters the morning after injection, which resolved the same day with a normal eye examination. One report from a trial in progress is not a rate.
What is not established
Whether Ellansé performs differently from Sculptra, which has never been compared with it; whether it performs differently from Radiesse, which the US trial will test; how it behaves outside the nasolabial fold in controlled trials; how often granulomas occur; and whether the duration claims hold in studies not written by the maker's consultants. The neighbouring products are covered on our pages for Sculptra, Radiesse's side effects, Juvelook and HArmonyCa. Anyone considering an injectable should take these questions to a licensed clinician.
Sources
Opened 17 October 2026: Christen and Vercesi, Clin Cosmet Investig Dermatol 2020 (PMC7065466, composition, CE date, durations and disclosure); ClinicalTrials.gov records NCT06984835, NCT06972940 and NCT06093815; openFDA device PMA, 510(k), UDI and MAUDE searches for "ellanse" and "polycaprolactone"; PubMed records 23350617, 25564797, 36191597, 35419911, 41834780, 29084645, 41263987 and 42819331 and the searches ellanse[tiab] OR ellansé[tiab] (21; 1 randomized-trial tag; 0 retracted). Corrections go to the contact page.