Nasolabial Folds, WrinklesNCT07467239
A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds
A study testing DMFI300 and Ellansé-M in people with Nasolabial Folds, Wrinkles, run by Samyang Biopharmaceuticals Corporation at 1 site in Spain.
Trial summary
This is a prospective, randomized, controlled clinical investigation designed to evaluate the performance and safety of DMFI300 for the treatment of nasolabial folds. 30 adult participants will receive treatment with the investigational device and the comparator device using a split-face design. 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?
- DMFI300 and Ellansé-M
- 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
- 2 Mar 2026to 31 May 2027
- 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 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.
Who cannot join
- 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.
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, Participant- and Evaluator-blinded, Randomized, Controlled, Split-face Clinical Investigation to Evaluate the Performance and Safety of Polycaprolactone 300 (DMFI300) for the Treatment of Nasolabial Folds
This is a prospective, randomized, controlled clinical investigation designed to evaluate the performance and safety of DMFI300 for the treatment of nasolabial folds. 30 adult participants will receive treatment with the investigational device and the comparator device using a split-face design. The study will assess wrinkle severity using validated aesthetic evaluation scales, as well as overall safety.
- Conditions
- Nasolabial Folds, Wrinkles
- Being tested
- DMFI300, Ellansé-M
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMFI300Device
Injection of DMFI300 for nasolabial folds.
Ellansé-MDevice
Injection of Ellansé-M for nasolabial folds.
| Study group | Role | What they receive |
|---|---|---|
| DMFI300 | Experimental | Injection of DMFI300 Receives: Device: DMFI300 |
| Ellansé-M | Active comparator | Injection of Ellansé-M Receives: Device: Ellansé-M |
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 Evaluating 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 blinded EI will assess the change from baseline to Month 12 for each nasolabial fold treated with DMFI300 or Ellansé-M.
Measured: Baseline to Month 12
Secondary outcomes (5)
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluating 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).
Changes from baseline will be assessed for each nasolabial fold treated with DMFI300 or Ellansé-M by the EI and TI.
Measured: Baseline to Month 1,3,6,9
Global Aesthetic Improvement Scale (GAIS) Assessed by the Treating Investigator (TI) and the Subject
GAIS is a 5-point global improvement scale (3 = Very Much Improved, 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse).
The TI and subject will independently assess GAIS for each nasolabial fold treated with DMFI300 or Ellansé-M.
Measured: Month 1,3,6,9,12
Subject Satisfaction With Treatment Using a Five-Point Likert Scale
Subject satisfaction with treatment will be evaluated using a five-point Likert scale for each nasolabial fold treated with DMFI300 or Ellansé-M.
Measured: Month 12
Proportion of Subjects Receiving Touch-up Treatment
Proportion of subjects who receive additional touch-up treatment at Month 1 after the initial injection if suboptimal improvement is observed.
Measured: Month 1
Incidence of Treatment-Related Adverse Events (TRAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), and Device Deficiencies (DDs)
All TRAEs, AEs, SAEs, and device deficiencies will be recorded and evaluated throughout the clinical investigation.
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 posted12 Mar 2026
- Study start2 Mar 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- 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
- NCT07467239
- Sponsor's protocol ID
- LF30_NLF_EU
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Participant- and Evaluator-blinded, Randomized, Controlled, Split-face Clinical Investigation to Evaluate the Performance and Safety of Polycaprolactone 300 (DMFI300) for the Treatment of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT07467239
- Acronym / sponsor ID
- LF30_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
- 2 Mar 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 12 Mar 2026 (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, randomized, controlled clinical investigation designed to evaluate the performance and safety of DMFI300 for the treatment of nasolabial folds. 30 adult participants will receive treatment with the investigational device and the comparator device using a split-face design. The study will assess wrinkle severity using validated aesthetic evaluation scales, as well as overall safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMFI300 | Experimental | Device: DMFI300Injection of DMFI300 |
| Ellansé-M | Active comparator | Device: Ellansé-MInjection of Ellansé-M |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| DMFI300Injection of DMFI300 for nasolabial folds. | Device | DMFI300 |
| Ellansé-MInjection of Ellansé-M for nasolabial folds. | Device | Ellansé-M |
Primary outcome
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluating 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 blinded EI will assess the change from baseline to Month 12 for each nasolabial fold treated with DMFI300 or Ellansé-M.
5 secondary outcomes
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluating Investigator (EI) and the Treating Investigator (TI)
Time frame: Baseline to Month 1,3,6,9
Global Aesthetic Improvement Scale (GAIS) Assessed by the Treating Investigator (TI) and the Subject
Time frame: Month 1,3,6,9,12
Subject Satisfaction With Treatment Using a Five-Point Likert Scale
Time frame: Month 12
Proportion of Subjects Receiving Touch-up Treatment
Time frame: Month 1
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 12 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 DMFI300 and Ellansé-M 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 5 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 12 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 Evaluating 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 12 Mar 2026.