DMFI300 versus Ellansé‑M for nasolabial fold wrinkles
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
NA · Samyang Biopharmaceuticals Corporation · NCT07467239
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Samyang Biopharmaceuticals Corporation (industry) |
| Locations | 1 site (Marbella) |
| Trial ID | NCT07467239 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Marbella
- Ocean Clinic — Marbella, Spain (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nasolabial Folds, Wrinkles