DMFI300 versus Ellansé‑M for nasolabial fold wrinkles
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
Run by Samyang Biopharmaceuticals Corporation · NCT07467239 · Data updated 2026-11-12
This test will try DMFI300 in adults with moderate-to-severe nasolabial folds to see if it smooths wrinkles as well as or better than Ellansé‑M.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Samyang Biopharmaceuticals Corporation Industry-sponsored |
| Locations | 1 site (Marbella) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | March 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | March 12, 2026 |
| Trial ID | NCT07467239 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with moderate-to-severe nasolabial folds (WSRS score 3–4) who are willing to undergo split-face filler treatment and attend follow-up visits are ideal candidates.
✕Probably not a fit
Patients who are pregnant or breastfeeding, have bleeding disorders, are taking contraindicated medications, or whose wrinkle severity falls outside the WSRS 3–4 range are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, controlled split-face investigation enrolling 30 adults with moderate-to-severe nasolabial folds (WSRS 3–4). Each participant will receive DMFI300 on one side of the face and Ellansé‑M on the other, with wrinkle severity measured using validated aesthetic scales at defined follow-up visits. Safety will be monitored throughout for adverse events related to the devices and injection procedures. Participants must meet standard inclusion/exclusion criteria such as age 18–70, not being pregnant or breastfeeding, and avoiding certain medications and other facial procedures during the study.
Why it matters
Potential benefit: If successful, DMFI300 could provide patients an alternative dermal filler option that offers comparable or improved wrinkle correction and safety versus an existing product.
How similar studies have gone: Collagen-stimulating fillers like Ellansé have published evidence of efficacy and durability, while DMFI300 appears to be a newer investigational product with limited prior clinical data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Ocean Clinic
Marbella, Spain Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.