Ingredient Beauty BenefitsRoute · Injection
PLLA: one of the few procedures on this layer where **superiority** was actually shown
In a 2025 multicentre randomised **superiority** trial of 331 people against hyaluronic acid, the midfacial volume response rate was **90.57% versus 51.01%** (difference 39.56%, 95% CI 30.34–48.78). Among the eleven procedures on this site, that is a rare case of a trial not ending in 'no difference'. The 'regeneration' evidence, though, still sits at tissue level.
Last checked Sep 17, 2026
Poly-L-lactic acid (PLLA) is a biodegradable polymer. It belongs to the class described as inducing collagen formation as it degrades rather than filling a space directly — the so-called biostimulators. In Korea the best-known brand is Sculptra.
This site has three others of the same class: CaHA, PCL and hADM. Read the four together and you find they are each other's control groups.
This is not a topical cosmetic. It is an injected procedure performed in a clinic, and this layer is kept separate from the ingredient layer.
We have not opened the Korean device approval record, so the classification here says 'being verified'.
What is established
A 331-person superiority trial — it beat hyaluronic acid
The 2025 trial has the most ambitious design on this layer. Most aesthetic trials are non-inferiority studies built to show a product is no worse than an existing one. This one is a superiority trial: a design that fails if it does not win.
331 subjects with midfacial volume loss or contour defects were randomised to PLLA (experimental) or hyaluronic acid (control). Multicentre, assessor-blinded.
The response rate on the Midfacial Volume Scale was 90.57% for PLLA against 51.01% for hyaluronic acid — a difference of 39.56%, 95% CI 30.34–48.78%. Results held in worst-case and per-protocol analyses.
It continues across time points:
- 6 months: MMVS 93.04% against 69.33%; investigator GAIS 99.37% against 86.67%
- 12 months: MMVS 84.91% against 46.98%; investigator GAIS 94.34% against 74.50% (p < .05)
We record this as it stands. This site has written 'no difference' nine times. Here there was a difference, the sample was large, and the design was built to show it.
The remaining limits: the control is hyaluronic acid — so the question is not 'better than doing nothing' but 'better than hyaluronic acid'. And the two materials work differently, so the durability axis is not the same to begin with. We could not identify the funding source from the abstract.
- Randomised controlled trial in people · 331 participants · 52 weeks · Compared with another active ingredient · Funding not declared · Endpoint scores from blinded assessors PMID 40679154
In nasolabial folds it was 24-month non-inferiority
The 2026 trial is a double-blind, randomised, non-inferiority, split-face study run in France. A new PLLA filler (Gana V) was compared against Sculptra, injected into either side of the same person's nasolabial folds.
The primary outcome was the Wrinkle Severity Rating Scale grade assessed by blinded investigators. Six-month interim results came first; this paper is the 24-month final report.
Twenty-four months of follow-up is rare in aesthetic trials. Most of the device pages on this site stopped at three to six months.
But the structure returns to the familiar one — PLLA against PLLA, and non-inferiority. The question answered is not 'does PLLA work' but 'is this PLLA no worse than that one'.
We could not confirm the participant count from the abstract, so the sample-size field is left empty.
- Randomised controlled trial in people · sample size not reported · 104 weeks · Compared with another active ingredient · Funding not declared · Endpoint scores from blinded assessors PMID 40897963
The 'regeneration' claim rests on tissue-level evidence
The central phrase in PLLA marketing is collagen regeneration. There is real data behind that claim — and it is the same data described on the CaHA page, because these are head-to-head comparisons of the two materials.
2025 gene analysis (13-week randomised, single-centre): PLLA and CaHA were injected into nasolabial folds, with punch biopsies at baseline and day 90 compared for gene expression. PLLA stimulated more extracellular matrix components with less inflammatory response; the authors read this as a regenerative pathway. CaHA fell on the inflammatory side.
2024 RNA sequencing: comparing the same two materials, it proposes an adipocyte-mediated regenerative mechanism unique to PLLA.
A 2024 histology study sits alongside these, looking at how long the biostimulatory activity of injected PLLA lasts.
To be fair, this item has to be read the way the CaHA page was read. There we wrote: this is a head-to-head between two products, we could not identify the funding from the abstract, and a comparative trial favouring one product should be read alongside the question of who ran it.
Those caveats apply just as much when the arrow points the other way. These two papers favour PLLA, and they need the same caution.
And there is a more basic limit. Gene expression and histology are not clinical outcomes. The first two items above are clinical outcomes, and they were established separately from this mechanistic work. It is not that the mechanism is right and therefore it works; it is that it works and the mechanistic account is plausible.
- Randomised controlled trial in people · sample size not reported · 13 weeks · Compared with another active ingredient · Funding not declared · Endpoint biopsy findings PMID 39761144
- Randomised controlled trial in people · sample size not reported · Compared with another active ingredient · Funding not declared · Endpoint biopsy findings PMID 39480040
Two confirmed cases of visual loss
The 2026 systematic review collected reports of visual loss from vascular occlusion with non-hyaluronic-acid injectables.
PLLA: two confirmed reports of visual loss. One followed injection to the periorbital/nasal region, the other injection to the temple.
In the same review, CaHA had at least 11. PLLA's number being smaller is a fact, but usage volumes and reporting practices differ, so it cannot be read straight off as a risk ranking.
And the decisive difference from hyaluronic acid applies here too: PLLA has no antidote comparable to hyaluronidase.
The temple case is worth noting separately. The temple is a common site for PLLA treatment, and this review records a case there.
- Open-label trial in people · 2 participants · Compared with no control group (before-and-after only) · Funding not declared · Endpoint clinical events (cancers, lesion counts) PMID 41263987
Known risks
- Pain, swelling and bruising at the injection site.
- Nodules and granulomas. PLLA has long been associated with this, and it is why post-treatment massage instructions exist.
- Vascular occlusion. As above, visual loss has been reported.
- There is no antidote. This differs from hyaluronic acid fillers.
- The effect appears gradually, so adding more because it looks insufficient early leads to overcorrection later.
- Any adverse reaction needs to be seen immediately by the clinic that performed the procedure. With vascular symptoms, time matters.
What is not established
- How it compares against doing nothing — the control was always another injectable.
- We found no trial directly showing that the mechanistic data (genes, tissue) translates into the clinical outcome.
- We could not identify the funding source of the 2025 superiority trial from the abstract.
- Follow-up beyond 12–24 months.
- We have not verified the Korean device approval class.
Whether to have it done is a decision to make with a doctor.
What this article relies on
- PubMed — 미국 국립의학도서관 문헌 데이터베이스National Library of Medicine · Checked on 2026-09-16