Miso Clinic Daegu · Clinical column

Rejuran: where the evidence now stands

Stated exactly, as of September 2026: among controlled human trials of Rejuran (PN), we found none that beat its comparator on the main aesthetic scales. Trials of 27, 30 and 15 subjects all reported no difference; the systematic review rated nine studies in 219 patients as low to moderate quality; and the long-cited Korean approval phase 3 was retracted in 2016. We also set out why the product is still used.

Clinical column 11 min September 2026 Miso Clinic Daegu · Dr Lee Chi-Hak

The short answer

Not “there is no evidence”. The accurate sentence is “no trial showed it beating its comparator, and what remains is small with short follow-up”. At the same time it is a fact that reported adverse events are generally mild and that no granuloma or vascular occlusion has been reported in the literature. Both belong in the decision.

What was retracted

Sentences still common in Korean clinic material: “as a medical device it required human trial data for approval, and passed a phase 3 with 72 enrolled and 70 analysed”; “95.7% improvement”; “fewer adverse events than control (31.9% vs 48.6%)”.

The source of those numbers, J Korean Med Sci 2014;29(Suppl 3):S201–S209, was retracted in 2016. The notice is in the same journal, 2016;31(2):330, and PubMed lists the publication type as Retracted Publication.

And before retraction, the original abstract itself stated: “the primary and secondary objective efficacy outcome measure showed no statistical significance between the two groups.” The control was not a placebo but a non-crosslinked hyaluronic acid product.

A 2024 trial of 218 subjects that used the same product as comparator (J Cosmet Dermatol 2024;24(1):e16576) has also been retracted. Both are listed in Five retracted papers in aesthetics.

Every non-retracted human dataset

Rejuran (PN) human data, verified September 2026, excluding retracted work
StudyDesign and sizeMain result
Lee YJ et al., 2022 (PMID 32248707)Randomised, double-blind, split-face, 27, three sessions at two-week intervals. Control: non-crosslinked HANo difference on VAS or GAIS. Higher improvement in roughness, pore volume, elasticity, hydration. Dermal density not different
Jeong GJ et al., 2020 (PMID 31680395)Randomised split-face, 30, 12 weeks. Control: PCL fillerNo significant difference in CFGS, GAIS or R value (improvement 48.28% PCL vs 41.38% PN)
Jeon W et al., 2025 (PMID 41361144)Randomised, patient-blinded split-face, 15. Ionization-adjusted vs conventional formulationPain VAS 3.39 vs 5.04 (p<0.005), embossing 13.3% vs 56.7%. CFGS and GAIS not different
Hong JY et al., 2025 (PMID 39370844)Split-face, 10. Needle vs needle-free jetHigher GAIS and satisfaction, lower pain on the jet side. Pore and wrinkle indices improved
Lampridou S et al., 2025 (PMID 39645667)Systematic review — 9 studies, 219 patientsIncluded work rated low to moderate quality; “limited consensus regarding optimal use”; “rigorous, high-quality studies are essential”
Rho NK et al., 2026 (PMID 41939258)Expert opinion — some authors employed by the manufacturerNo granuloma or vascular occlusion reported in the literature. The text itself states the evidence base remains limited

The column to read is the third. All three controlled trials report no difference on the main aesthetic scales. Given that the comparator was another product rather than a placebo, what these trials demonstrated reaches only “not worse than that product”.

But the improvement rates are not low

To avoid the opposite error: in the 30-subject trial, 12-week improvement was 41.38% for PN and 48.28% for the PCL comparator. Close to half of each side was rated improved. “No difference” does not mean neither worked; it means the two could not be separated.

In the 27-subject trial the instrument-measured axes — roughness, pore volume, elasticity, hydration — improved more on the PN side, while the scores humans assigned by looking did not separate. That gap may be what lies behind reviews saying the machine says it improved but the mirror is not sure.

“FDA approved” is not accurate

The list of dermal fillers approved by the US FDA contains only hyaluronic acid, CaHA, PLLA and PMMA; the PN family is not on it. Rejuran is a product approved and used as a medical device in Korea. Advertising that says “FDA approved” is inaccurate.

What we say now

With the pivotal phase 3 gone, we cannot recommend Rejuran on the grounds that its data is thicker. We used to say that, and we corrected the sentence across this site in September 2026.

What we say instead: whether PN, hADM or liquid PCL, no trial has compared two of these families head to head in the same people under the same conditions. The choice is about conditions — what has been lost, whether reversibility matters, whether a multi-session course is acceptable, how many days of downtime you can take.

There is a clear place where Rejuran is the candidate: thin, reactive skin, and cases where you do not yet want irreversible material. Which states qualify is tabulated in Rejuran in Daegu: which skin suits it.

Frequently asked

So Rejuran does not work?

That is the wrong reading. Improvement on the PN side was in the 40% range, and instrument-measured roughness, pore, elasticity and hydration exceeded control. The accurate sentence is not “it does not work” but “it was not shown to be better than the comparator product”.

The phase 3 was retracted — is the approval still valid?

Rejuran remains an approved medical device in Korea. Retraction is a journal withdrawing a paper from the record and is a different process from withdrawing an approval. But the paper's numbers are no longer appropriate to cite.

Why was the control not a placebo?

Placebo control is often difficult in aesthetic trials. But when the comparator is another product, the trial shows “not worse than that product”, not “effective”. That distinction is the one most often lost in advertising.

What does “low to moderate quality” mean?

That the included studies were often small, uncontrolled or unblinded. It does not mean the results are wrong; it means how far you can trust and generalise them is limited.

How long does the effect last?

Follow-up in the pivotal trials ends 12 weeks after the last session. No trial observed one year, so “lasts a year” is an estimate, not a measurement.

Is it safe?

Reported adverse events are generally mild and transient, and a 2026 expert opinion states no granuloma or vascular occlusion appears in the literature. But “none reported” and “long-term safety established” are different statements.

Why do other clinics quote different numbers?

Most likely because they are the retracted paper's numbers. When a journal retracts a paper, nobody notifies the material that cited it. Search the title on PubMed and look for the banner and publication type — five minutes.

Is it still worth having?

That depends on what you want. If texture and density in thin, reactive skin is the goal and you do not yet want irreversible material, it is a candidate. If volume or descent is the main concern, it is the wrong direction.

Read next

Who wrote this

Lee Chi-Hak, Director, Miso Clinic Daegu

4F Bombom Building, 125 Dongdeok-ro, Jung-gu, Daegu, Korea (Exit 1, Kyungpook National University Hospital Station)

+82-53-428-2700 · www.clinicmiso.co.kr

References

  1. Lampridou S, Bassett S, Cavallini M, Christopoulos G. The Effectiveness of Polynucleotides in Esthetic Medicine: A Systematic Review. J Cosmet Dermatol. 2025;24(2):e16721. PMID 39645667
  2. Lee YJ, et al. J Dermatolog Treat. 2022;33(1):254-260. PMID 32248707
  3. Jeong GJ, et al. J Cosmet Dermatol. 2020;19(7):1593-1599. PMID 31680395
  4. Jeon W, et al. Aesthetic Plast Surg. 2025;50(7):2723-2730. PMID 41361144
  5. Hong JY, et al. J Cosmet Dermatol. 2025;24(1):e16595. PMID 39370844
  6. Rho NK, et al. Clin Cosmet Investig Dermatol. 2026;19:557226. PMID 41939258
  7. Pak CS, et al. J Korean Med Sci. 2014;29(Suppl 3):S201-S209. PMID 25473210 — Retracted Publication / Notice of Retraction: 2016;31(2):330. PMID 26839493
  8. Choi SY, et al. J Cosmet Dermatol. 2024;24(1):e16576. PMID 39313949 — Retracted Publication
  9. U.S. Food and Drug Administration. FDA-Approved Dermal Fillers. fda.gov

What we could not verify

  • The class, intended use and approval date in Rejuran's original Korean approval document.
  • The published molecular weight of Rejuran's PN.
  • The stated reason for retraction of the 2024 trial of 218 subjects.
  • Any trial directly comparing PN with hADM or liquid PCL — none exists.
  • Follow-up beyond 12 weeks, and Korean adverse-event tallies.

This is general medical information and does not replace consultation. It is not intended to disparage any product or clinic; the retraction status of every paper cited is public information anyone can verify on PubMed. Treatment should be decided after an in-person consultation.

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