New filler aims to smooth deep wrinkles

NCT ID NCT07467239

Symptom relief Sponsor: Samyang Biopharmaceuticals Corporation Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new injectable called DMFI300 for treating nasolabial folds (the lines from nose to mouth corners). Thirty adults will receive DMFI300 on one side of the face and a comparator filler on the other. Researchers will check wrinkle severity and safety over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: polycaprolactone 300 (DMFI300)
What this could lead to: If it works, this could offer a new option for reducing deep smile lines with effects lasting up to a year.
What could go wrong: This is a small, early-stage trial with only 30 people, so results may not apply to everyone. As with any injectable, risks include swelling, bruising, or uneven results.

Why investors are watching

Samyang Holdings Corporation is watching a small, 30-person trial run by its subsidiary, Samyang Biopharmaceuticals Corporation, that tests a new injectable filler called DMFI300 for nasolabial folds, the smile lines around the mouth. The trial uses a split-face design, meaning each participant gets the test filler on one side of the face and a comparator filler on the other, allowing a direct comparison of wrinkle reduction and safety. For a small-cap company, this readout matters because a positive result could validate a new product in the competitive aesthetic medicine market, while a negative result would set back that product's development.

If it works: If the trial shows DMFI300 reduces wrinkle severity as well as or better than the comparator, with a good safety profile, Samyang Biopharmaceuticals could move the product toward regulatory approval and eventual sale. That would give Samyang Holdings a new revenue source in a growing field, which could be meaningful for a company of its size.

If it fails: The trial is small, with only 30 participants, so even a positive result may not prove the filler works in a larger population. Clinical trials often fail to show a clear benefit or reveal safety problems, and any such outcome here could delay or end the product's development, leaving Samyang Holdings without a new aesthetic product to show for the effort.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men and women aged 18-70 years. * Score of 3 to 4 on the Wrinkle Severity Rating Scale (WSRS) for both nasolabial folds. * Willing and able to provide written informed consent. * Willing to comply with study procedures and follow-up visits. * Willing to refrain from other facial cosmetic procedures affecting the nasolabial folds during the study. Exclusion Criteria: * Use of antiplatelet agents, vitamin E, or NSAIDs within 2 weeks before screening or planned use within 2 weeks after treatment. * History or presence of bleeding disorders. * Participation in another clinical investigation within 1 month prior to screening. * Pregnant or breastfeeding women, or women planning pregnancy during the study. * Women of childbearing potential not using an effective method of contraception.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nasolabial folds, wrinkles

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

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New filler aims to smooth deep wrinkles

What the study statuses mean