Rituo in Daegu: where the evidence actually stands

One trial has examined Rituo in a human face: 20 subjects, 20 weeks, double-blind split-face, with hyaluronic acid as the comparator (Int J Mol Sci. 2026;27(5):2193).

The design is good. Split-face comparison removes between-person variation, and double-blinding limits the assessor’s expectations from leaking into the result. The problem is size. At 20 subjects, only a fairly large difference between arms will reach statistical significance.

One qualification belongs here. The paper does not name the product. We confirmed the identity by cross-checking the trial registration number recorded in it (NCT07155278). We were not able to verify the funding source or the conflict-of-interest statement.

One Korean trial is registered. The design is three intradermal sessions one month apart; it began in November 2024 and completed in May 2025. The results have still not been posted.

This matters more than it looks, because the most widely quoted figure in the market — “three sessions, one month apart” — comes from that protocol. A number taken from a design is not a number validated by a result. As things stand there is no basis for saying three is better than two, or sufficient against four. Calling it convention is the accurate description.

This is the figure most often cited for the category: a multicentre double-blind randomised non-inferiority trial of micronised ADM against a cross-linked collagen filler, 202 randomised and 175 completing, nasolabial folds, six months.

The arms came out close. But a qualification must travel with these numbers: the product in that trial is Chinese and is not distributed in Korea. Falling into the same category name — micronised ADM — does not make the manufacturing process, the particle size or the residual content the same. Reading this result as the performance of the Korean product goes beyond what the study supports.

We spell this out because we have repeatedly seen the figure quoted in Korean material without distinguishing the products.

Collecting only the favourable studies is not a summary. Here is the other side.

• In one rat model, hADM performed worse than its comparator (Front Bioeng Biotechnol. 2026;14:1745558). Animal data, but the direction is opposite and belongs in the record.
• For another paper, an international journal published a formal Comment and Response exchange (ACS Appl Bio Mater. 2025;8(12):10827–10838; Comment and Response, August 2026).
• A large review of the burns and wound literature (170 clinical studies, Scars Burns Heal. 2022) makes no mention of micronised or injectable forms. The long track record of sheet ADM does not underwrite the injectable.

Animal studies are not scarce. One compared injectable and sheet forms histologically in 50 mice at 2, 4, 8, 12 and 24 weeks; another compared four products in nude mice and reported a volume retention of 113.5% at eight weeks.

That 113.5% is a value in mice over eight weeks. It cannot be read across as a duration in a human face. We could not find a study confirming the same finding in human facial skin.

Rituo is neither a drug nor a medical device; it enters through the human tissue route (Act on Safety and Management of Human Tissue — tissue bank licensing art. 13, import art. 17). Consequently the “approved indication” field that other products carry does not exist for this category. That is not a judgement on quality; the verification route is simply different.

An amendment to the associated rules was published for comment on 16 July 2026 (MFDS notice 2026-340, comments closing 25 August 2026) and had not been promulgated as of September 2026. Some press reports stated it would restrict advertising for cosmetic use; that item does not appear in the published summary, and we were not able to verify it against the primary text.

We chose to state the size of the evidence rather than work around it. In consultation we put it like this.

• The human evidence is one 20-subject study. A result at that size is a hint about direction, not a settled fact.
• The 175-subject trial is a different product. We do not present it as our product’s performance.
• Sessions are described as convention. The number comes from a protocol whose results are still unpublished.
• We include the contrary evidence. One animal study went the other way, and a journal exchange is on the record.
• It still becomes a candidate when the dermis is the main concern. A small evidence base is not the same as a reason never to use something.

Which treatment suits you depends on your skin condition, how much change you want, and what you have already had. The size of the evidence is one input to that decision, not the decision itself.

• Rituo in Daegu: five things worth checking · Which skin it suits
• Pain, bruising and anaesthesia
• hADM evidence · hADM versus PN · Rituo and Rejuran
• When the citation outlives the paper · Reading approval numbers
• Re2O product reference · CellreDM

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

• The funding source and conflict-of-interest statement of the 20-subject trial.
• The results of the Korean registered trial — unposted more than a year after completion.
• Any comparison of process or particle size between the Korean product and the one in the 175-subject trial.
• Volume per injection — absent from the paper, the registry and the manufacturer material.
• National adverse-event tallies for hADM in Korea, and the primary documents for tissue bank licensing.
• Whether the July 2026 draft amendment restricts advertising for cosmetic use — not present in the published summary.