A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds

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.

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.