Nasolabial Folds, WrinklesNCT07292779
A Prospective Clinical Investigation of DMFI150 for Treating Nasolabial Folds
A study testing DMFI150 in people with Nasolabial Folds, Wrinkles, run by Samyang Biopharmaceuticals Corporation at 1 site in Spain.
Trial summary
This is a prospective clinical investigation designed to evaluate the performance and safety of DMFI150 for the treatment of nasolabial folds. 30 adult participants will receive a single treatment with the investigational device. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasolabial Folds, Wrinkles
- What is being tested?
- DMFI150
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 24 Nov 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Ocean Clinic
Marbella
Vanessa, +34 951 775 518, admon@oceanclinic.net
About this study
Official title: A Prospective, Clinical Investigation to Evaluate the Performance and Safety of DMFI150 for the Treatment of Nasolabial Folds
This is a prospective clinical investigation designed to evaluate the performance and safety of DMFI150 for the treatment of nasolabial folds. 30 adult participants will receive a single treatment with the investigational device. The study will assess wrinkle severity using validated aesthetic evaluation scales, as well as overall safety.
- Conditions
- Nasolabial Folds, Wrinkles
- Being tested
- DMFI150
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMFI150Device
Injection of DMFI150 for nasolabial folds.
| Study group | Role | What they receive |
|---|---|---|
| DMFI150 | Experimental | Single injection of DMFI150 Receives: Device: DMFI150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluator Investigator (EI)
WSRS is a validated 5-point ordinal scale used to evaluate wrinkle severity
(1 = Absent, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme). Higher scores indicate more severe wrinkles. The EI will assess the change from baseline to Month 12.
Measured: Baseline to Month 12
Secondary outcomes (3)
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluator Investigator (EI) and the Treating Investigator (TI)
WSRS is a validated 5-point ordinal scale used to evaluate wrinkle severity (1 = Absent, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme). Higher scores indicate more severe wrinkles. Changes from baseline will be assessed by both EI and TI.
Measured: Baseline to Month 1,3,6,9,12
Change from Baseline in Global Aesthetic Improvement Scale (GAIS) Assessed by the Treating Investigator (TI) and by the Subject
GAIS is a 5-point global improvement scale (3 = Very Much Improved, 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse). Higher scores indicate greater improvement. Both the subject and TI will rate GAIS.
Measured: Baseline to Month 1,3,6,9,12
Incidence of Treatment-Related Adverse Events (TRAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), and Device Deficiencies (DDs)
All TRAEs, AEs, SAEs, and DDs will be recorded and assessed according to the clinical investigation plan.
Measured: Baseline through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start24 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial Folds, WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292779
- Sponsor's protocol ID
- LF15_NLF_EU
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Clinical Investigation to Evaluate the Performance and Safety of DMFI150 for the Treatment of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT07292779
- Acronym / sponsor ID
- LF15_NLF_EU
- Conditions
- Nasolabial Folds, Wrinkles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective clinical investigation designed to evaluate the performance and safety of DMFI150 for the treatment of nasolabial folds. 30 adult participants will receive a single treatment with the investigational device. The study will assess wrinkle severity using validated aesthetic evaluation scales, as well as overall safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DMFI150 | Experimental | Device: DMFI150Single injection of DMFI150 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMFI150Injection of DMFI150 for nasolabial folds. | Device | DMFI150 |
Primary outcome
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluator Investigator (EI)
Time frame: Baseline to Month 12
WSRS is a validated 5-point ordinal scale used to evaluate wrinkle severity (1 = Absent, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme). Higher scores indicate more severe wrinkles. The EI will assess the change from baseline to Month 12.
3 secondary outcomes
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluator Investigator (EI) and the Treating Investigator (TI)
Time frame: Baseline to Month 1,3,6,9,12
Change from Baseline in Global Aesthetic Improvement Scale (GAIS) Assessed by the Treating Investigator (TI) and by the Subject
Time frame: Baseline to Month 1,3,6,9,12
Incidence of Treatment-Related Adverse Events (TRAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), and Device Deficiencies (DDs)
Time frame: Baseline through Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DMFI150 in people with Nasolabial Folds, Wrinkles, run by Samyang Biopharmaceuticals Corporation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluator Investigator (EI) (time frame: Baseline to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.