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A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds
Sponsor: Samyang Biopharmaceuticals Corporation
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. The study will assess wrinkle severity using validated aesthetic evaluation scales, as well as overall safety.
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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-03-02
Completion Date
2027-05-31
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
DMFI300
Injection of DMFI300 for nasolabial folds.
Ellansé-M
Injection of Ellansé-M for nasolabial folds.
Locations (1)
Ocean Clinic
Marbella, Spain