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New device aims to smooth away smile lines in quick trial

NCT ID NCT07292779

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device called DMFI150 to see if it can safely reduce the deep wrinkles from nose to mouth (nasolabial folds). 30 adults aged 18-70 with moderate to severe wrinkles will get one treatment. Doctors will check wrinkle improvement and safety for up to 12 months.

Why investors are watching

Samyang Holdings Corporation is watching a small clinical trial run by its subsidiary, Samyang Biopharmaceuticals Corporation, that tests a device called DMFI150 on 30 adults with nasolabial folds, the creases running from the nose to the mouth. The trial measures whether the device reduces wrinkle severity and whether it is safe. For a small-cap company, this readout matters because a positive result could support a new product in the aesthetic market, while a negative result would set back that effort.

If it works: If the trial shows DMFI150 safely reduces wrinkle severity, Samyang Biopharmaceuticals could have evidence to advance the device toward broader testing or a commercial launch. That could give Samyang Holdings a new revenue source in aesthetics.

If it fails: The trial could fail to show meaningful wrinkle improvement or reveal safety problems, which would likely end the device's development. Small trials like this often fail, and a negative result would leave Samyang Holdings without a new product from this program.

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

Nov 2025

Expected to finish

Dec 2026

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 WSRS (1 = absent, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme) for both nasolabial folds. * Able and willing to provide written informed consent. * Willing to refrain from facial cosmetic procedures during the study. Exclusion Criteria: * Use of antiplatelet agents, vitamin E, or NSAIDs within 2 weeks before screening or 2 weeks after treatment. * History or current bleeding disorders. * Participation in another clinical trial within 1 month before screening. * Pregnant or breastfeeding women, or planning pregnancy. * Women of childbearing potential not using effective 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.

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ocean Clinic

    RECRUITING

    Marbella, Spain

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